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Introduction

T
he American Diabetes Association position statements is included on p. e3 of represents the panel’s collective analysis,
(ADA) has been actively involved in this supplement. evaluation, and opinion at that point in
the development and dissemination time based in part on the conference
of diabetes care standards, guidelines, and ADA scientific statement. A scholarly proceedings. The need for a consensus
related documents for many years. These synopsis of a topic related to diabetes, report arises when clinicians or scientists
statements are published in one or more which may or may not contain clinical or desire guidance on a subject for which the
of the Association’s professional journals. research recommendations. Any recom- evidence is contradictory or incomplete.
This supplement contains the latest update mendations included represent the official Once written by the panel, a consensus
of the ADA’s major position statement, point of view or belief of the ADA. Work report is not subject to subsequent review
“Standards of Medical Care in Diabetes,” Group Reports fall into this category. Sci- or approval and does not represent official
which contains all of the Association’s key entific statements are published in the ADA Association opinion. A list of recent con-
recommendations. In addition, contained journals and other scientific/medical pub- sensus reports is included on p. e2 of this
herein are selected position statements on lications as appropriate. Scientific state- supplement.
certain topics not adequately covered in ments must be reviewed and approved by
the “Standards.” ADA hopes that this is a the Professional Practice Committee and, Professional Practice Committee. The
convenient and important resource for all subsequently, by the Executive Committee Association’s Professional Practice
health care professionals who care for of the Board of Directors. A list of recent Committee is responsible for reviewing
people with diabetes. scientific statements is included on p. e4 of ADA systematic reviews, scientific state-
ADA Clinical Practice Recommenda- this supplement. ments, and position statements, as well
tions consist of position statements that as for overseeing revisions of the latter as
represent official ADA opinion as denoted Systematic review. A balanced review needed. Appointment to the Profes-
by formal review and approval by the and analysis of the literature on a scien- sional Practice Committee is based on
Professional Practice Committee and the tific or medical topic related to diabetes. excellence in clinical practice and/or
Executive Committee of the Board of Effective January 2010, technical reviews research. The committee comprises
Directors. Consensus reports and system- were replaced by systematic reviews, for physicians, diabetes educators, regis-
atic reviews are not official ADA recom- which a priori search and inclusion/ tered dietitians, and others who have
mendations; however, they are produced exclusion criteria are developed and pub- expertise in a range of areas, including
under the auspices of the Association by lished. The systematic review provides a adult and pediatric endocrinology, epi-
invited experts. These publications may scientific rationale for a position state- demiology, and public health, lipid
be used by the Professional Practice Com- ment and undergoes critical peer review research, hypertension, and preconcep-
mittee as source documents to update the before submission to the Professional tion and pregnancy care. All members of
“Standards.” Practice Committee for approval. A list the Professional Practice Committee are
ADA has adopted the following def- of past systematic reviews is included on required to disclose potential conflicts
initions for its clinically related reports. p. e1 of this supplement. of interest (listed on p. S109).

ADA position statement. An official Consensus report. A comprehensive ex- Grading of scientific evidence. There
point of view or belief of the ADA. amination by a panel of experts (i.e., con- has been considerable evolution in the
Position statements are issued on scien- sensus panel) of a scientific or medical evaluation of scientific evidence and in
tific or medical issues related to diabetes. issue related to diabetes. Effective January the development of evidence-based guide-
They may be authored or unauthored and 2010, consensus statements were re- lines since the ADA first began publishing
are published in ADA journals and other named consensus reports. The category practice guidelines. Accordingly, we de-
scientific/medical publications as appro- may also include task force and expert veloped a classification system to grade the
priate. Position statements must be re- committee reports. Consensus reports do quality of scientific evidence supporting
viewed and approved by the Professional not have the Association’s name included ADA recommendations for all new and
Practice Committee and, subsequently, in the title or subtitle and include a dis- revised ADA position statements.
by the Executive Committee of the Board claimer in the introduction stating that any Recommendations are assigned rat-
of Directors. ADA position statements recommendations are not ADA position. A ings of A, B, or C, depending on the
are typically based on a systematic re- consensus report is typically developed quality of evidence (Table 1). Expert
view or other review of published litera- immediately following a consensus confer- opinion (E) is a separate category for
ture. They are reviewed on an annual basis ence at which presentations are made on recommendations in which there is as
and updated as needed. A list of recent the issue under review. The statement yet no evidence from clinical trials, in
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
which clinical trials may be impractical,
or in which there is conflicting evidence.
DOI: 10.2337/dc13-S001
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly
Recommendations with an “A” rating are
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ based on large well-designed clini-
licenses/by-nc-nd/3.0/ for details. cal trials or well-done meta-analyses.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S1


Introduction

Table 1dADA evidence-grading system for clinical practice recommendations as a heading for a group of recommenda-
tions or in parentheses after a given rec-
Level of ommendation.
evidence Description Of course, evidence is only one compo-
nent of clinical decision making. Clinicians
A Clear evidence from well-conducted, generalizable, randomized controlled trials care for patients, not populations;
Ć that are adequately powered, including: guidelines must always be interpreted
c Evidence from a well-conducted multicenter trial with the needs of the individual patient
c Evidence from a meta-analysis that incorporated quality ratings in the in mind. Individual circumstances,
Ć analysis such as comorbid and coexisting dis-
Compelling nonexperimental evidence, i.e., the “all or none” rule developed by eases, age, education, disability, and,
Ć the Centre for Evidence-Based Medicine at Oxford above all, patients’ values and prefer-
Supportive evidence from well-conducted randomized controlled trials that are ences, must also be considered and may
Ć adequately powered, including: lead to different treatment targets and
c Evidence from a well-conducted trial at one or more institutions strategies. Also, conventional evidence
c Evidence from a meta-analysis that incorporated quality ratings in the hierarchies, such as the one adapted by
Ć analysis the ADA, may miss some nuances that
B Supportive evidence from well-conducted cohort studies, including: are important in diabetes care. For
c Evidence from a well-conducted prospective cohort study or registry example, while there is excellent evi-
c Evidence from a well-conducted meta-analysis of cohort studies dence from clinical trials supporting
Supportive evidence from a well-conducted case-control study the importance of achieving multiple
C Supportive evidence from poorly controlled or uncontrolled studies, including: risk factor control, the optimal way to
c Evidence from randomized clinical trials with one or more major or Ćthree or more achieve this result is less clear. It is
Ć minor methodological flaws that could invalidate the results difficult to assess each component of
c Evidence from observational studies with high potential for bias (such as case such a complex intervention.
Ć series with comparison to historical controls) ADA will continue to improve and
c Evidence from case series or case reports update the Clinical Practice Recommen-
Conflicting evidence with the weight of evidence supporting the recommendation dations to ensure that clinicians, health
E Expert consensus or clinical experience plans, and policymakers can continue
to rely on them as the most authorita-
tive and current guidelines for diabetes
Generally, these recommendations have with lower levels of evidence may be care. Our Clinical Practice Recom-
the best chance of improving outcomes equally important but are not as well sup- mendations are also available on the
when applied to the population to which ported. The level of evidence supporting Association’s website at www.diabetes.
they are appropriate. Recommendations a given recommendation is noted either org/diabetescare.

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S U M M A R Y O F R E V I S I O N S

Summary of Revisions for the 2013


Clinical Practice Recommendations

Revisions to the Standards National Standards for Diabetes Self- micro- and macroalbuminuria, other than
of Medical Care in Management Education and Support. when discussion of past studies requires
Diabetesd2013 c Section V.K. Hypoglycemia has been the distinction.
In addition to many small changes related revised to emphasize the need to assess c Section VI.C. Retinopathy Screening and
to new evidence since the prior year, and hypoglycemia and cognitive function Treatment has been revised to include
to clarify recommendations, the follow- when indicated. anti–vascular endothelial growth factor
ing sections have undergone more sub- c Section V.M. Immunization has been therapy for diabetic macular edema.
stantive changes: updated to include the new Centers for c Section IX.A. Diabetes Care in the
Disease Control and Prevention (CDC) Hospital has been revised to include a
c Section II.C. Screening for Type 1 recommendations for hepatitis B vac- recommendation to consider obtaining
Diabetes has been revised to include cination for people with diabetes. an A1C in patients with risk factors for
more specific recommendations. c Section VI.A.1. Hypertension/Blood undiagnosed diabetes who exhibit hy-
c Section IV. Prevention/Delay of Type 2 Pressure Control has been revised to perglycemia in the hospital.
Diabetes has been revised to reflect suggest that the systolic blood pressure
the importance of screening for and goal for many people with diabetes and Revised Position Statement
treating other cardiovascular risk fac- hypertension should be ,140 mmHg,
c The position statement “Diagnosis and
tors. but that lower systolic targets (such as
Classification of Diabetes Mellitus” has
c Section V.C.a. Glucose Monitoring has ,130 mmHg) may be appropriate for
been revised slightly to add newer in-
been revised to highlight the need for certain individuals, such as younger
formation about monogenic forms of
patients on intensive insulin regimens patients, if it can be achieved without
diabetes.
to do frequent self-monitoring of blood undue treatment burden.
glucose. c Section VI.A.2. Dyslipidemia/Lipid
c Section V.D. Pharmacological and Management and Table 10 have been Revisions to the National
Overall Approaches to Treatment has revised to emphasize the importance of Standards for Diabetes
been revised to add a section with more statin therapy over particular LDL Self-Management Education
specific recommendations for insulin cholesterol goals in high-risk patients. and Support
therapy in type 1 diabetes. c Section VI.B. Nephropathy Screening c The task force report “National Standards
c Section V.F. Diabetes Self-Management and Treatment and Table 11 have been for Diabetes Self-Management Education
Education and Support has been revised revised to highlight increased urinary and Support” represents a major revision
to be consistent with the newly revised albumin excretion over the terms completed in 2012.

c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
DOI: 10.2337/dc13-S003
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/
licenses/by-nc-nd/3.0/ for details.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S3


E X E C U T I V E S U M M A R Y

Executive Summary: Standards of


Medical Care in Diabetesd2013

Current criteria for the Screening for type 2 (IFG) (E), or an A1C 5.7–6.4% (E)
diagnosis of diabetes diabetes in children should be referred to an effective on-
c A1C $6.5%. The test should be per- c Testing to detect type 2 diabetes and going support program targeting weight
formed in a laboratory using a method prediabetes should be considered in loss of 7% of body weight and in-
that is NGSP certified and standardized children and adolescents who are over- creasing physical activity to at least 150
to the Diabetes Control and Compli- weight and who have two or more ad- min/week of moderate activity such
cations Trial (DCCT) assay; or ditional risk factors for diabetes (see as walking.
c fasting plasma glucose (FPG) $126 Table 5 of the “Standards of Medical c Follow-up counseling appears to be
mg/dL (7.0 mmol/L). Fasting is de- Care in Diabetesd2013”). (E) important for success. (B)
fined as no caloric intake for at least c Based on the cost-effectiveness of diabetes
8 h; or Screening for type 1 prevention, such programs should be
c 2-h plasma glucose $200 mg/dL (11.1 diabetes covered by third-party payers. (B)
mmol/L) during an oral glucose toler- c Consider referring relatives of those c Metformin therapy for prevention of
ance test (OGTT). The test should be with type 1 diabetes for antibody test- type 2 diabetes may be considered in
performed as described by the World ing for risk assessment in the setting those with IGT (A), IFG (E), or an A1C
Health Organization, using a glucose of a clinical research study. (E) 5.7–6.4% (E), especially for those with
load containing the equivalent of 75 g BMI .35 kg/m2, aged ,60 years, and
anhydrous glucose dissolved in water; or Detection and diagnosis women with prior GDM. (A)
c in a patient with classic symptoms of of gestational diabetes c At least annual monitoring for the de-
hyperglycemia or hyperglycemic crisis, mellitus velopment of diabetes in those with
a random plasma glucose $200 mg/dL c Screen for undiagnosed type 2 diabetes
prediabetes is suggested. (E)
(11.1 mmol/L); at the first prenatal visit in those with c Screening for and treatment of modifi-
c in the absence of unequivocal hyper- risk factors, using standard diagnostic able risk factors for CVD is suggested. (B)
glycemia, result should be confirmed criteria. (B)
by repeat testing. c In pregnant women not previously
Glucose monitoring
known to have diabetes, screen for c Patients on multiple-dose insulin
Testing for diabetes in gestational diabetes mellitus (GDM) (MDI) or insulin pump therapy should
asymptomatic patients at 24–28 weeks of gestation, using a do self-monitoring of blood glucose
c Testing to detect type 2 diabetes and 75-g 2-h OGTT and the diagnostic cut (SMBG) at least prior to meals and
prediabetes in asymptomatic people points in Table 6 of the “Standards of snacks, occasionally postprandially, at
should be considered in adults of Medical Care in Diabetesd2013.” (B) bedtime, prior to exercise, when they
any age who are overweight or obese c Screen women with GDM for persistent suspect low blood glucose, after treat-
(BMI $25 kg/m2 ) and who have diabetes at 6–12 weeks postpartum, ing low blood glucose until they are
one or more additional risk fac- using the OGTT and nonpregnancy normoglycemic, and prior to critical
tors for diabetes (see Table 4 of diagnostic criteria. (E) tasks such as driving. (B)
the “Standards of Medical Care in c Women with a history of GDM should c When prescribed as part of a broader
Diabetesd2013”). In those without have lifelong screening for the de- educational context, SMBG results may
these risk factors, testing should be- velopment of diabetes or prediabetes at be helpful to guide treatment decisions
gin at age 45 years. (B) least every 3 years. (B) and/or patient self-management for
c If tests are normal, repeat testing at least c Women with a history of GDM found patients using less frequent insulin in-
at 3-year intervals is reasonable. (E) to have prediabetes should receive jections or noninsulin therapies. (E)
c To test for diabetes or prediabetes, the lifestyle interventions or metformin to c When prescribing SMBG, ensure that
A1C, FPG, or 75-g 2-h OGTT are ap- prevent diabetes. (A) patients receive ongoing instruction
propriate. (B) and regular evaluation of SMBG tech-
c In those identified with prediabetes, Prevention/delay of type 2 nique and SMBG results, as well as
identify and, if appropriate, treat other diabetes their ability to use SMBG data to adjust
cardiovascular disease (CVD) risk fac- c Patients with impaired glucose toler- therapy. (E)
tors. (B) ance (IGT) (A), impaired fasting glucose c Continuous glucose monitoring (CGM)
in conjunction with intensive insulin
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
regimens can be a useful tool to lower
A1C in selected adults (aged $25 years)
DOI: 10.2337/dc13-S004
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly with type 1 diabetes. (A)
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ c Although the evidence for A1C lowering
licenses/by-nc-nd/3.0/ for details. is less strong in children, teens, and

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Executive Summary

younger adults, CGM may be helpful in c Most people with type 1 diabetes c For weight loss, either low-carbohydrate,
these groups. Success correlates with ad- should be educated in how to match low-fat calorie-restricted, or Mediterra-
herence to ongoing use of the device. (C) prandial insulin dose to carbohydrate nean diets may be effective in the short
c CGM may be a supplemental tool to intake, premeal blood glucose, and term (up to 2 years). (A)
SMBG in those with hypoglycemia un- anticipated activity. (E) c For patients on low-carbohydrate di-
awareness and/or frequent hypoglyce- c Most people with type 1 diabetes ets, monitor lipid profiles, renal func-
mic episodes. (E) should use insulin analogs to reduce tion, and protein intake (in those with
hypoglycemia risk. (A) nephropathy) and adjust hypoglyce-
A1C c Consider screening those with type 1 mic therapy as needed. (E)
diabetes for other autoimmune dis- c Physical activity and behavior modifi-
c Perform the A1C test at least two
eases (thyroid, vitamin B12 deficiency, cation are important components of
times a year in patients who are meet-
celiac) as appropriate. (B) weight loss programs and are most
ing treatment goals (and who have helpful in maintenance of weight loss. (B)
stable glycemic control). (E)
Pharmacological therapy for
c Perform the A1C test quarterly in pa-
hyperglycemia in type 2 diabetes Recommendations for primary
tients whose therapy has changed or
who are not meeting glycemic goals. (E)
c Metformin, if not contraindicated and prevention of type 2 diabetes
if tolerated, is the preferred initial c Among individuals at high risk for
c Use of point-of-care testing for A1C
pharmacological agent for type 2 di- developing type 2 diabetes, structured
provides the opportunity for more
abetes. (A) programs that emphasize lifestyle changes
timely treatment changes. (E)
c In newly diagnosed type 2 diabetic that include moderate weight loss (7%
patients with markedly symptomatic body weight) and regular physical activity
Glycemic goals in adults
and/or elevated blood glucose levels or (150 min/week), with dietary strategies
c Lowering A1C to below or around 7% A1C, consider insulin therapy, with or including reduced calories and reduced
has been shown to reduce microvas- without additional agents, from the intake of dietary fat, can reduce the risk
cular complications of diabetes, and outset. (E) for developing diabetes and are therefore
if implemented soon after the di- c If noninsulin monotherapy at maximal recommended. (A)
agnosis of diabetes is associated with tolerated dose does not achieve or main- c Individuals at risk for type 2 diabetes
long-term reduction in macrovascular tain the A1C target over 3–6 months, should be encouraged to achieve the
disease. Therefore, a reasonable A1C add a second oral agent, a glucagon-like U.S. Department of Agriculture (USDA)
goal for many nonpregnant adults is peptide-1 (GLP-1) receptor agonist, or recommendation for dietary fiber (14 g
,7%. (B) insulin. (A) fiber/1,000 kcal) and foods contain-
c Providers might reasonably suggest c A patient-centered approach should be ing whole grains (one-half of grain
more stringent A1C goals (such as used to guide choice of pharmacologi- intake). (B)
,6.5%) for selected individual pa- cal agents. Considerations include c Individuals at risk for type 2 diabetes
tients, if this can be achieved without efficacy, cost, potential side effects, should be encouraged to limit their
significant hypoglycemia or other ad- effects on weight, comorbidities, hy- intake of sugar-sweetened beverages
verse effects of treatment. Appropriate poglycemia risk, and patient prefer- (SSBs). (B)
patients might include those with short ences. (E)
duration of diabetes, long life expec- c Due to the progressive nature of type 2 Recommendations for management
tancy, and no significant CVD. (C) diabetes, insulin therapy is eventually of diabetes
c Less stringent A1C goals (such as indicated for many patients with type 2 Macronutrients in diabetes management
,8%) may be appropriate for patients diabetes. (B) c The mix of carbohydrate, protein, and
with a history of severe hypoglycemia,
fat may be adjusted to meet the meta-
limited life expectancy, advanced mi-
Medical nutrition therapy bolic goals and individual preferences
crovascular or macrovascular compli-
General recommendations of the person with diabetes. (C)
cations, extensive comorbid conditions,
c Individuals who have prediabetes or c Monitoring carbohydrate, whether by
and those with long-standing diabetes
diabetes should receive individualized carbohydrate counting, choices, or
in whom the general goal is difficult to
medical nutrition therapy (MNT) as experience-based estimation, remains
attain despite diabetes self-management
needed to achieve treatment goals, a key strategy in achieving glycemic
education (DSME), appropriate glucose
preferably provided by a registered di- control. (B)
monitoring, and effective doses of
etitian familiar with the components of c Saturated fat intake should be ,7% of
multiple glucose-lowering agents in-
diabetes MNT. (A) total calories. (B)
cluding insulin. (B)
c Because MNT can result in cost-savings c Reducing intake of trans fat lowers LDL
and improved outcomes (B), MNT cholesterol and increases HDL choles-
Pharmacological and overall terol (A); therefore, intake of trans fat
approaches to treatment should be adequately covered by in-
surance and other payers. (E) should be minimized. (E)
Insulin therapy for type 1 diabetes Other nutrition recommendations
c Most people with type 1 diabetes should Energy balance, overweight, and c If adults with diabetes choose to use
be treated with MDI injections (three to obesity alcohol, they should limit intake to a
four injections per day of basal and c Weight loss is recommended for all moderate amount (one drink per day
prandial insulin) or continuous sub- overweight or obese individuals who or less for adult women and two drinks
cutaneous insulin infusion (CSII). (A) have or are at risk for diabetes. (A) per day or less for adult men) and

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S5


Executive Summary

should take extra precautions to pre- c Psychosocial screening and follow-up c Patients with type 2 diabetes who have
vent hypoglycemia. (E) may include, but are not limited to, undergone bariatric surgery need lifelong
c Routine supplementation with anti- attitudes about the illness, expectations lifestyle support and medical monitor-
oxidants, such as vitamins E and C and for medical management and out- ing. (B)
carotene, is not advised because of lack comes, affect/mood, general and di- c Although small trials have shown gly-
of evidence of efficacy and concern re- abetes-related quality of life, resources cemic benefit of bariatric surgery in
lated to long-term safety. (A) (financial, social, and emotional), and patients with type 2 diabetes and BMI
c It is recommended that individualized psychiatric history. (E) 30–35 kg/m2, there is currently in-
meal planning include optimization of c Screen for psychosocial problems such sufficient evidence to generally recom-
food choices to meet recommended di- as depression and diabetes-related mend surgery in patients with BMI ,35
etary allowance (RDA)/dietary reference distress, anxiety, eating disorders, kg/m2 outside of a research protocol. (E)
intake (DRI) for all micronutrients. (E) and cognitive impairment when self- c The long-term benefits, cost-effectiveness,
management is poor. (B) and risks of bariatric surgery in in-
Diabetes self-management dividuals with type 2 diabetes should be
education and support Hypoglycemia studied in well-designed controlled
c Individuals at risk for hypoglycemia trials with optimal medical and lifestyle
c People with diabetes should receive
should be asked about symptomatic therapy as the comparator. (E)
DSME and diabetes self-management
support (DSMS) according to National and asymptomatic hypoglycemia at
each encounter. (C) Immunization
Standards for Diabetes Self-Manage-
c Glucose (15–20 g) is the preferred c Annually provide an influenza vaccine
ment Education and Support when
their diabetes is diagnosed and as treatment for the conscious individual to all diabetic patients $6 months of
needed thereafter. (B) with hypoglycemia, although any form age. (C)
c Effective self-management and quality
of carbohydrate that contains glucose c Administer pneumococcal polysaccha-

of life are the key outcomes of DSME may be used. If SMBG 15 min after ride vaccine to all diabetic patients $2
and DSMS and should be measured treatment shows continued hypogly- years of age. A one-time revaccination
and monitored as part of care. (C) cemia, the treatment should be re- is recommended for individuals .64
c DSME and DSMS should address
peated. Once SMBG glucose returns to years of age previously immunized
psychosocial issues, since emotional normal, the individual should con- when they were ,65 years of age if the
well-being is associated with positive sume a meal or snack to prevent re- vaccine was administered .5 years
diabetes outcomes. (C) currence of hypoglycemia. (E) ago. Other indications for repeat vac-
c Glucagon should be prescribed for all cination include nephrotic syndrome,
c DSME and DSMS programs are ap-
propriate venues for people with pre- individuals at significant risk of severe chronic renal disease, and other im-
diabetes to receive education and hypoglycemia, and caregivers or family munocompromised states, such as af-
support to develop and maintain be- members of these individuals should ter transplantation. (C)
haviors that can prevent or delay the be instructed on its administration. c Administer hepatitis B vaccination to

onset of diabetes. (C) Glucagon administration is not limited unvaccinated adults with diabetes who
c Because DSME and DSMS can result
to health care professionals. (E) are aged 19 through 59 years. (C)
c Hypoglycemia unawareness or one or c Consider administering hepatitis B vac-
in cost-savings and improved out-
comes (B), DSME and DSMS should be more episodes of severe hypoglycemia cination to unvaccinated adults with
adequately reimbursed by third-party should trigger re-evaluation of the diabetes who are aged $60 years. (C)
payers. (E) treatment regimen. (E)
c Insulin-treated patients with hypogly- Hypertension/blood
cemia unawareness or an episode of pressure control
Physical activity severe hypoglycemia should be advised
c Adults with diabetes should be advised
Screening and diagnosis
to raise their glycemic targets to strictly c Blood pressure should be measured at
to perform at least 150 min/week of avoid further hypoglycemia for at least
moderate-intensity aerobic physical every routine visit. Patients found to
several weeks, to partially reverse hy- have elevated blood pressure should
activity (50–70% of maximum heart poglycemia unawareness, and to re-
rate), spread over at least 3 days/week have blood pressure confirmed on a
duce risk of future episodes. (A) separate day. (B)
with no more than 2 consecutive days c Ongoing assessment of cognitive func-
without exercise. (A) tion is suggested with increased vigilance Goals
c In the absence of contraindications, for hypoglycemia by the clinician, c People with diabetes and hypertension
adults with type 2 diabetes should be patient, and caregivers if low cognition should be treated to a systolic blood
encouraged to perform resistance and/or declining cognition is found. (B) pressure goal of ,140 mmHg. (B)
training at least twice per week. (A) c Lower systolic targets, such as ,130
Bariatric surgery mmHg, may be appropriate for certain
Psychosocial assessment c Bariatric surgery may be considered for individuals, such as younger patients, if
and care adults with BMI $35 kg/m2 and type 2 it can be achieved without undue
c It is reasonable to include assessment of diabetes, especially if the diabetes or treatment burden. (C)
the patient’s psychological and social associated comorbidities are difficult to c Patients with diabetes should be trea-
situation as an ongoing part of the control with lifestyle and pharmaco- ted to a diastolic blood pressure ,80
medical management of diabetes. (E) logical therapy. (B) mmHg. (B)

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Executive Summary

Treatment acids, viscous fiber and plant stanols/ diabetes at low CVD risk (10-year CVD
c Patients with a blood pressure .120/80 sterols; weight loss (if indicated); and risk ,5%, such as in men aged ,50 years
mmHg should be advised on lifestyle increased physical activity should be and women aged ,60 years with no
changes to reduce blood pressure. (B) recommended to improve the lipid major additional CVD risk factors), since
c Patients with confirmed blood pressure profile in patients with diabetes. (A) the potential adverse effects from bleed-
$140/80 mmHg should, in addition to c Statin therapy should be added to life- ing likely offset the potential benefits. (C)
lifestyle therapy, have prompt initia- style therapy, regardless of baseline c In patients in these age-groups with
tion and timely subsequent titration of lipid levels, for diabetic patients: multiple other risk factors (e.g., 10-
pharmacological therapy to achieve year risk 5–10%), clinical judgment is
c with overt CVD (A)
blood pressure goals. (B) required. (E)
c without CVD who are over the age of
c Lifestyle therapy for elevated blood pres- c Use aspirin therapy (75–162 mg/day) as a
40 years and have one or more other
sure consists of weight loss, if overweight; secondary prevention strategy in those
CVD risk factors (family history of
Dietary Approaches to Stop Hyperten- with diabetes with a history of CVD. (A)
CVD, hypertension, smoking, dysli-
sion (DASH)-style dietary pattern in- c For patients with CVD and docu-
cluding reducing sodium and increasing pidemia, or albuminuria). (A) mented aspirin allergy, clopidogrel (75
potassium intake; moderation of alcohol c For lower-risk patients than the above mg/day) should be used. (B)
intake; and increased physical activity. (B) (e.g., without overt CVD and under the c Combination therapy with aspirin
c Pharmacological therapy for patients age of 40 years), statin therapy should (75–162 mg/day) and clopidogrel (75
with diabetes and hypertension should be considered in addition to lifestyle mg/day) is reasonable for up to a year
be with a regimen that includes either therapy if LDL cholesterol remains after an acute coronary syndrome. (B)
an ACE inhibitor or an angiotensin above 100 mg/dL or in those with
receptor blocker (ARB). If one class is multiple CVD risk factors. (C)
not tolerated, the other should be c In individuals without overt CVD, the Smoking cessation
substituted. (C) goal is LDL cholesterol ,100 mg/dL c Advise all patients not to smoke or use
c Multiple-drug therapy (two or more (2.6 mmol/L). (B) tobacco products. (A)
agents at maximal doses) is generally c In individuals with overt CVD, a lower c Include smoking cessation counseling
required to achieve blood pressure LDL cholesterol goal of ,70 mg/dL and other forms of treatment as a routine
targets. (B) (1.8 mmol/L), using a high dose of a component of diabetes care. (B)
c Administer one or more antihyperten- statin, is an option. (B)
sive medications at bedtime. (A) c If drug-treated patients do not reach Coronary heart disease
c If ACE inhibitors, ARBs, or diuretics the above targets on maximal tolerated screening and treatment
are used, serum creatinine/estimated statin therapy, a reduction in LDL Screening
glomerular filtration rate (eGFR) and cholesterol of ;30–40% from baseline c In asymptomatic patients, routine
serum potassium levels should be is an alternative therapeutic goal. (B) screening for coronary artery disease
monitored. (E) c Triglyceride levels ,150 mg/dL (1.7 (CAD) is not recommended, as it does
c In pregnant patients with diabetes and mmol/L) and HDL cholesterol .40 not improve outcomes as long as CVD
chronic hypertension, blood pressure mg/dL (1.0 mmol/L) in men and .50 risk factors are treated. (A)
target goals of 110–129/65–79 mmHg mg/dL (1.3 mmol/L) in women are
are suggested in the interest of long- desirable (C). However, LDL choles- Treatment
term maternal health and minimizing terol–targeted statin therapy remains c In patients with known CVD, consider
impaired fetal growth. ACE inhibitors the preferred strategy. (A) ACE inhibitor therapy (C) and use as-
and ARBs are contraindicated during c Combination therapy has been shown pirin and statin therapy (A) (if not
pregnancy. (E) not to provide additional cardiovascu- contraindicated) to reduce the risk of
lar benefit above statin therapy alone cardiovascular events. In patients with a
Dyslipidemia/lipid and is not generally recommended. (A) prior myocardial infarction, b-blockers
management c Statin therapy is contraindicated in should be continued for at least 2 years
Screening pregnancy. (B) after the event. (B)
c In most adult patients with diabetes, c Avoid thiazolidinedione treatment in pa-

measure fasting lipid profile at least tients with symptomatic heart failure. (C)
Antiplatelet agents c Metformin may be used in patients with
annually. (B)
c Consider aspirin therapy (75–162 mg/ stable congestive heart failure (CHF) if
c In adults with low-risk lipid values
day) as a primary prevention strategy in renal function is normal. It should be
(LDL cholesterol ,100 mg/dL, HDL
those with type 1 or type 2 diabetes at avoided in unstable or hospitalized
cholesterol .50 mg/dL, and trigly-
increased cardiovascular risk (10-year patients with CHF. (C)
cerides ,150 mg/dL), lipid assessments
risk .10%). This includes most men
may be repeated every 2 years. (E)
aged .50 years or women aged .60
years who have at least one additional Nephropathy screening and
Treatment recommendations and major risk factor (family history of treatment
goals CVD, hypertension, smoking, dyslipi- General recommendations
c Lifestyle modification focusing on the demia, or albuminuria). (C) c To reduce the risk or slow the pro-
reduction of saturated fat, trans fat, and c Aspirin should not be recommended gression of nephropathy, optimize glu-
cholesterol intake; increase of n-3 fatty for CVD prevention for adults with cose control. (A)

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S7


Executive Summary

c To reduce the risk or slow the pro- Screening c The presence of retinopathy is not a
gression of nephropathy, optimize blood c Adults and children aged $10 years contraindication to aspirin therapy for
pressure control. (A) with type 1 diabetes should have an cardioprotection, as this therapy does
initial dilated and comprehensive eye not increase the risk of retinal hemor-
Screening rhage. (A)
examination by an ophthalmologist or
c Perform an annual test to assess urine
optometrist within 5 years after the
albumin excretion in type 1 diabetic Neuropathy screening and
onset of diabetes. (B)
patients with diabetes duration of $5 treatment
c Patients with type 2 diabetes should
years and in all type 2 diabetic patients c All patients should be screened for
have an initial dilated and compre-
starting at diagnosis. (B) distal symmetric polyneuropathy (DPN)
hensive eye examination by an oph-
c Measure serum creatinine at least an-
thalmologist or optometrist shortly starting at diagnosis of type 2 diabetes
nually in all adults with diabetes re- and 5 years after the diagnosis of type 1
after the diagnosis of diabetes. (B)
gardless of the degree of urine albumin diabetes and at least annually thereafter,
c Subsequent examinations for type 1
excretion. The serum creatinine should using simple clinical tests. (B)
and type 2 diabetic patients should be
be used to estimate glomerular filtra- c Electrophysiological testing is rarely
repeated annually by an ophthalmolo-
tion rate (GFR) and stage the level needed, except in situations where the
gist or optometrist. Less frequent exams
of chronic kidney disease (CKD), if clinical features are atypical. (E)
(every 2–3 years) may be considered
present. (E) c Screening for signs and symptoms of
following one or more normal eye ex-
Treatment ams. Examinations will be required cardiovascular autonomic neuropathy
c In the treatment of the nonpregnant more frequently if retinopathy is pro- (CAN) should be instituted at diagnosis
patient with modestly elevated (30– gressing. (B) of type 2 diabetes and 5 years after the
299 mg/day) (C) or higher levels c High-quality fundus photographs can diagnosis of type 1 diabetes. Special
($300 mg/day) of urinary albumin detect most clinically significant di- testing is rarely needed and may not
excretion (A), either ACE inhibitors or abetic retinopathy. Interpretation of affect management or outcomes. (E)
the images should be performed by a c Medications for the relief of specific
ARBs are recommended.
c Reduction of protein intake to 0.8–1.0 trained eye care provider. While retinal symptoms related to painful DPN and
g/kg body wt per day in individuals photography may serve as a screening autonomic neuropathy are recom-
with diabetes and the earlier stages of tool for retinopathy, it is not a sub- mended, as they improve the quality of
CKD and to 0.8 g/kg body wt per day stitute for a comprehensive eye exam, life of the patient. (E)
in the later stages of CKD may improve which should be performed at least
initially and at intervals thereafter as Foot care
measures of renal function (urine al-
bumin excretion rate, GFR) and is recommended by an eye care pro- c For all patients with diabetes, perform

recommended. (C) fessional. (E) an annual comprehensive foot exami-


c When ACE inhibitors, ARBs, or diu- c Women with pre-existing diabetes who nation to identify risk factors predic-
retics are used, monitor serum creati- are planning pregnancy or who have tive of ulcers and amputations. The
nine and potassium levels for the become pregnant should have a com- foot examination should include in-
development of increased creatinine or prehensive eye examination and be spection, assessment of foot pulses,
changes in potassium. (E) counseled on the risk of development and testing for loss of protective sen-
c Continued monitoring of urine albu- and/or progression of diabetic reti- sation (LOPS) (10-g monofilament
min excretion to assess both response nopathy. Eye examination should oc- plus testing any one of the following:
to therapy and progression of disease is cur in the first trimester with close vibration using 128-Hz tuning fork,
reasonable. (E) follow-up throughout pregnancy and pinprick sensation, ankle reflexes, or
c When eGFR is ,60 mL/min/1.73 m ,
2 for 1 year postpartum. (B) vibration perception threshold). (B)
evaluate and manage potential com- c Provide general foot self-care education
plications of CKD. (E) to all patients with diabetes. (B)
c Consider referral to a physician Treatment c A multidisciplinary approach is rec-
experienced in the care of kidney c Promptly refer patients with any level ommended for individuals with foot
disease for uncertainty about the eti- of macular edema, severe nonproliferative ulcers and high-risk feet, especially
ology of kidney disease, difficult diabetic retinopathy (NPDR), or any those with a history of prior ulcer or
management issues, or advanced proliferative diabetic retinopathy (PDR) amputation. (B)
kidney disease. (B) to an ophthalmologist who is knowl- c Refer patients who smoke, have LOPS
edgeable and experienced in the man- and structural abnormalities, or have a
Retinopathy screening and agement and treatment of diabetic history of prior lower-extremity com-
treatment retinopathy. (A) plications to foot care specialists for
c Laser photocoagulation therapy is in- ongoing preventive care and lifelong
General recommendations dicated to reduce the risk of vision loss surveillance. (C)
c To reduce the risk or slow the pro- in patients with high-risk PDR, clini- c Initial screening for peripheral arterial
gression of retinopathy, optimize gly- cally significant macular edema, and in disease (PAD) should include a history
cemic control. (A) some cases of severe NPDR. (A) for claudication and an assessment of
c To reduce the risk or slow the pro- c Anti–vascular endothelial growth fac- the pedal pulses. Consider obtaining
gression of retinopathy, optimize blood tor (VEGF) therapy is indicated for di- an ankle-brachial index (ABI), as many
pressure control. (A) abetic macular edema. (A) patients with PAD are asymptomatic. (C)

S8 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Executive Summary

c Refer patients with significant claudica- c Pharmacological treatment of hyperten- Less frequent examinations may be ac-
tion or a positive ABI for further vascular sion (systolic or diastolic blood pressure ceptable on the advice of an eye care
assessment and consider exercise, med- consistently above the 95th percentile professional. (E)
ications, and surgical options. (C) for age, sex, and height or consistently
.130/80 mmHg, if 95% exceeds that Celiac disease
Assessment of common value) should be considered as soon as c Consider screening children with type 1
comorbid conditions the diagnosis is confirmed. (E) diabetes for celiac disease by measuring
c ACE inhibitors should be considered tissue transglutaminase or antiendo-
c For patients with risk factors, signs,
for the initial treatment of hypertension, mysial antibodies, with documentation
or symptoms, consider assessment following appropriate reproductive
and treatment for common diabetes- of normal total serum IgA levels, soon
counseling due to its potential tera- after the diagnosis of diabetes. (E)
associated conditions (see Table 14 of togenic effects. (E) c Testing should be considered in chil-
the “Standards of Medical Care in c The goal of treatment is a blood pres-
Diabetesd2013”). (B) dren with growth failure, failure to gain
sure consistently ,130/80 or below weight, weight loss, diarrhea, flatu-
the 90th percentile for age, sex, and lence, abdominal pain, or signs of
Children and adolescents height, whichever is lower. (E) malabsorption or in children with fre-
c As is the case for all children, children quent unexplained hypoglycemia or
with diabetes or prediabetes should be Dyslipidemia deterioration in glycemic control. (E)
encouraged to engage in at least 60 min Screening c Consider referral to a gastroenterolo-
of physical activity each day. (B) c If there is a family history of hyper- gist for evaluation with possible en-
cholesterolemia or a cardiovascular doscopy and biopsy for confirmation of
Type 1 diabetes event before age 55 years, or if family celiac disease in asymptomatic children
Glycemic control history is unknown, then consider with positive antibodies. (E)
c Consider age when setting glycemic obtaining a fasting lipid profile on c Children with biopsy-confirmed celiac
goals in children and adolescents with children .2 years of age soon after disease should be placed on a gluten-free
type 1 diabetes. (E) diagnosis (after glucose control has diet and have consultation with a dietitian
been established). If family history is experienced in managing both diabetes
Screening and management not of concern, then consider the first and celiac disease. (B)
of chronic complications in lipid screening at puberty ($10 years
children and adolescents of age). For children diagnosed with Hypothyroidism
with type 1 diabetes diabetes at or after puberty, consider c Consider screening children with type

Nephropathy obtaining a fasting lipid profile soon 1 diabetes for thyroid peroxidase and
c Annual screening for microalbuminuria,
after the diagnosis (after glucose con- thyroglobulin antibodies soon after
with a random spot urine sample for trol has been established). (E) diagnosis. (E)
c For both age-groups, if lipids are ab- c Measuring thyroid-stimulating hormone
albumin-to-creatinine ratio (ACR), should
be considered once the child is 10 normal, annual monitoring is reason- (TSH) concentrations soon after diagnosis
years of age and has had diabetes for able. If LDL cholesterol values are within of type 1 diabetes, after metabolic control
5 years. (B) the accepted risk levels (,100 mg/dL has been established, is reasonable. If
c Treatment with an ACE inhibitor, ti-
[2.6 mmol/L]), a lipid profile repeated normal, consider rechecking every 1–2
trated to normalization of albumin ex- every 5 years is reasonable. (E) years, especially if the patient develops
cretion, should be considered when Treatment symptoms of thyroid dysfunction, thyro-
elevated ACR is subsequently con- c Initial therapy may consist of optimiza- megaly, or an abnormal growth rate. (E)
firmed on two additional specimens tion of glucose control and MNT using a
from different days. (E) Step 2 American Heart Association Transition from pediatric to
(AHA) diet aimed at a decrease in the adult care
Hypertension amount of saturated fat in the diet. (E)
c As teens transition into emerging
c Blood pressure should be measured at c After the age of 10 years, the addition
of a statin in patients who, after MNT adulthood, health care providers and
each routine visit. Children found to families must recognize their many
have high-normal blood pressure or and lifestyle changes, have LDL cho-
lesterol .160 mg/dL (4.1 mmol/L) or vulnerabilities (B) and prepare the de-
hypertension should have blood pres- veloping teen, beginning in early to
sure confirmed on a separate day. (B) LDL cholesterol .130 mg/dL (3.4
mmol/L) and one or more CVD risk mid adolescence and at least 1 year
c Initial treatment of high-normal blood
factors is reasonable. (E) prior to the transition. (E)
pressure (systolic or diastolic blood c Both pediatricians and adult health
pressure consistently above the 90th c The goal of therapy is an LDL cholesterol
value ,100 mg/dL (2.6 mmol/L). (E) care providers should assist in pro-
percentile for age, sex, and height) in- viding support and links to resources
cludes dietary intervention and exer- Retinopathy for the teen and emerging adult. (B)
cise, aimed at weight control and c The first ophthalmologic examination
increased physical activity, if appro- should be obtained once the child is
priate. If target blood pressure is not $10 years of age and has had diabetes Preconception care
reached with 3–6 months of lifestyle for 3–5 years. (B) c A1C levels should be as close to normal as
intervention, pharmacological treat- c After the initial examination, annual rou- possible (,7%) in an individual patient
ment should be considered. (E) tine follow-up is generally recommended. before conception is attempted. (B)

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S9


Executive Summary

c Starting at puberty, preconception screening test for CFRD is not recom- c Scheduled subcutaneous insulin with
counseling should be incorporated in mended. (B) basal, nutritional, and correction com-
the routine diabetes clinic visit for all c During a period of stable health, the ponents is the preferred method for
women of childbearing potential. (C) diagnosis of CFRD can be made in achieving and maintaining glucose con-
c Women with diabetes who are con- cystic fibrosis patients according to trol in non–critically ill patients. (C)
templating pregnancy should be eval- usual glucose criteria. (E) c Glucose monitoring should be initiated
uated and, if indicated, treated for c Patients with CFRD should be treated in any patient not known to be diabetic
diabetic retinopathy, nephropathy, with insulin to attain individualized who receives therapy associated with
neuropathy, and CVD. (B) glycemic goals. (A) high risk for hyperglycemia, including
c Medications used by such women should c Annual monitoring for complications high-dose glucocorticoid therapy, ini-
be evaluated prior to conception, since of diabetes is recommended, beginning tiation of enteral or parenteral nutri-
drugs commonly used to treat diabet- 5 years after the diagnosis of CFRD. (E) tion, or other medications such as
es and its complications may be con- octreotide or immunosuppressive med-
traindicated or not recommended in ications (B). If hyperglycemia is docu-
pregnancy, including statins, ACE in- Diabetes care in the hospital mented and persistent, consider treating
hibitors, ARBs, and most noninsulin c All patients with diabetes admitted to
such patients to the same glycemic goals
therapies. (E) the hospital should have their diabetes as patients with known diabetes. (E)
c Since many pregnancies are un- clearly identified in the medical record. c A hypoglycemia management protocol
planned, consider the potential risks (E) should be adopted and implemented
and benefits of medications that are c All patients with diabetes should have
by each hospital or hospital system. A
contraindicated in pregnancy in all an order for blood glucose monitoring, plan for preventing and treating hy-
women of childbearing potential and with results available to all members of poglycemia should be established for
counsel women using such medi- the health care team. (E) each patient. Episodes of hypoglycemia
cations accordingly. (E) c Goals for blood glucose levels:
in the hospital should be documented
c Critically ill patients: Insulin
in the medical record and tracked. (E)
therapy should be initiated for c Consider obtaining an A1C on patients
Older adults
treatment of persistent hyperglyce- with diabetes admitted to the hospital if
c Older adults who are functional, cog- the result of testing in the previous 2–3
nitively intact, and have significant life mia starting at a threshold of no
greater than 180 mg/dL (10 mmol/L). months is not available. (E)
expectancy should receive diabetes c Consider obtaining an A1C in patients
care with goals similar to those de- Once insulin therapy is started, a
glucose range of 140–180 mg/dL with risk factors for undiagnosed di-
veloped for younger adults. (E) abetes who exhibit hyperglycemia in
c Glycemic goals for some older adults
(7.8–10 mmol/L) is recommended
for the majority of critically ill the hospital. (E)
might reasonably be relaxed, using in- c Patients with hyperglycemia in the
dividual criteria, but hyperglycemia patients. (A)
c More stringent goals, such as 110–
hospital who do not have a prior di-
leading to symptoms or risk of acute agnosis of diabetes should have ap-
hyperglycemic complications should 140 mg/dL (6.1–7.8 mmol/L)
may be appropriate for selected propriate plans for follow-up testing
be avoided in all patients. (E) and care documented at discharge. (E)
c Other cardiovascular risk factors patients, as long as this can be ach-
should be treated in older adults with ieved without significant hypoglyce-
mia. (C) Strategies for improving
consideration of the time frame of
c Critically ill patients require an in- diabetes care
benefit and the individual patient.
travenous insulin protocol that has c Care should be aligned with components
Treatment of hypertension is indicated
in virtually all older adults, and lipid demonstrated efficacy and safety in of the Chronic Care Model (CCM) to
and aspirin therapy may benefit those achieving the desired glucose range ensure productive interactions between
with life expectancy at least equal to the without increasing risk for severe a prepared proactive practice team and
time frame of primary or secondary hypoglycemia. (E) an informed activated patient. (A)
c Non–critically ill patients: There c When feasible, care systems should
prevention trials. (E)
c Screening for diabetes complications
is no clear evidence for specific support team-based care, community
should be individualized in older blood glucose goals. If treated with involvement, patient registries, and
adults, but particular attention should insulin, the premeal blood glucose embedded decision support tools to
be paid to complications that would targets generally ,140 mg/dL (7.8 meet patient needs. (B)
mmol/L) with random blood glu- c Treatment decisions should be timely
lead to functional impairment. (E)
cose ,180 mg/dL (10.0 mmol/L) and based on evidence-based guide-
are reasonable, provided these tar- lines that are tailored to individual
Cystic fibrosis–related gets can be safely achieved. More patient preferences, prognoses, and
diabetes stringent targets may be appropri- comorbidities. (B)
c Annual screening for cystic fibrosis– ate in stable patients with previous c A patient-centered communication
related diabetes (CFRD) with OGTT tight glycemic control. Less strin- style should be employed that in-
should begin by age 10 years in all gent targets may be appropriate corporates patient preferences, assesses
patients with cystic fibrosis who do not in those with severe comorbidi- literacy and numeracy, and addresses
have CFRD (B). Use of A1C as a ties. (E) cultural barriers to care. (B)

S10 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


P O S I T I O N S T A T E M E N T

Standards of Medical Care in


Diabetesd2013
AMERICAN DIABETES ASSOCIATION

D
iabetes mellitus is a chronic illness These standards of care are revised does not use industry support for these
that requires continuing medical care annually by the ADA’s multidisciplinary purposes.
and ongoing patient self-management Professional Practice Committee, incor-
education and support to prevent acute porating new evidence. For the current I. CLASSIFICATION AND
complications and to reduce the risk of revision, committee members systemati- DIAGNOSIS
long-term complications. Diabetes care is cally searched Medline for human stud-
complex and requires multifactorial risk ies related to each subsection and A. Classification
reduction strategies beyond glycemic con- published since 1 January 2011. Recom- The classification of diabetes includes
trol. A large body of evidence exists that mendations (bulleted at the beginning four clinical classes:
supports a range of interventions to improve of each subsection and also listed in
diabetes outcomes. the “Executive Summary: Standards of c Type 1 diabetes (results from b-cell
These standards of care are intended Medical Care in Diabetesd2013”) were destruction, usually leading to absolute
to provide clinicians, patients, researchers, revised based on new evidence or, in insulin deficiency)
payers, and other interested individuals some cases, to clarify the prior recom- c Type 2 diabetes (results from a pro-
with the components of diabetes care, mendation or match the strength of the gressive insulin secretory defect on the
general treatment goals, and tools to eval- wording to the strength of the evidence. background of insulin resistance)
uate the quality of care. Although individ- A table linking the changes in recom- c Other specific types of diabetes due to
ual preferences, comorbidities, and other mendations to new evidence can be re- other causes, e.g., genetic defects in
patient factors may require modification of viewed at http://professional.diabetes. b-cell function, genetic defects in in-
goals, targets that are desirable for most org/CPR. As is the case for all position sulin action, diseases of the exocrine
patients with diabetes are provided. Spe- statements, these standards of care were pancreas (such as cystic fibrosis), and
cifically titled sections of the standards reviewed and approved by the Executive drug- or chemical-induced (such as in
address children with diabetes, pregnant Committee of ADA’s Board of Directors, the treatment of HIV/AIDS or after or-
women, and people with prediabetes. which includes health care professionals, gan transplantation)
These standards are not intended to pre- scientists, and lay people. c Gestational diabetes mellitus (GDM)
clude clinical judgment or more extensive Feedback from the larger clinical (diabetes diagnosed during pregnancy
evaluation and management of the patient community was valuable for the 2013 that is not clearly overt diabetes)
by other specialists as needed. For more revision of the standards. Readers who
detailed information about management of wish to comment on the “Standards of Some patients cannot be clearly clas-
diabetes, refer to references (1–3). Medical Care in Diabetesd2013” are sified as type 1 or type 2 diabetic. Clinical
The recommendations included are invited to do so at http://professional. presentation and disease progression vary
screening, diagnostic, and therapeutic diabetes.org/CPR. considerably in both types of diabetes.
actions that are known or believed to Members of the Professional Practice Occasionally, patients who otherwise
favorably affect health outcomes of patients Committee disclose all potential finan- have type 2 diabetes may present with
with diabetes. A large number of these cial conflicts of interest with industry. ketoacidosis. Similarly, patients with type
interventions have been shown to be cost- These disclosures were discussed at the 1 diabetes may have a late onset and slow
effective (4). A grading system (Table 1), onset of the standards revision meeting. (but relentless) progression of disease
developed by the American Diabetes Asso- Members of the committee, their em- despite having features of autoimmune
ciation (ADA) and modeled after existing ployer, and their disclosed conflicts of disease. Such difficulties in diagnosis may
methods, was utilized to clarify and codify interest are listed in the “Professional occur in children, adolescents, and
the evidence that forms the basis for the Practice Committee for the 2013 Clinical adults. The true diagnosis may become
recommendations. The level of evidence Practice Recommendations” table (see more obvious over time.
that supports each recommendation is p. S109). The ADA funds development
B. Diagnosis of diabetes
listed after each recommendation using of the standards and all its position state-
the letters A, B, C, or E. ments out of its general revenues and For decades, the diagnosis of diabetes was
based on plasma glucose criteria, either
the fasting plasma glucose (FPG) or the
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
2-h value in the 75-g oral glucose toler-
Originally approved 1988. Most recent review/revision October 2012. ance test (OGTT) (5).
DOI: 10.2337/dc13-S011
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly In 2009, an International Expert
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ Committee that included representatives
licenses/by-nc-nd/3.0/ for details. of the ADA, the International Diabetes

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S11


Position Statement

Table 1dADA evidence grading system for clinical practice recommendations PG) remain valid as well (Table 2). Just as
there is less than 100% concordance be-
Level of tween the FPG and 2-h PG tests, there is
evidence Description no perfect concordance between A1C and
either glucose-based test. Analyses of the
A Clear evidence from well-conducted, generalizable RCTs that are adequately National Health and Nutrition Examina-
powered, including: tion Survey (NHANES) data indicate that,
c Evidence from a well-conducted multicenter trial assuming universal screening of the un-
c Evidence from a meta-analysis that incorporated quality ratings in the diagnosed, the A1C cut point of $6.5%
analysis identifies one-third fewer cases of undiag-
Compelling nonexperimental evidence, i.e., “all or none” rule developed by the nosed diabetes than a fasting glucose cut
Centre for Evidence-Based Medicine at the University of Oxford point of $126 mg/dL (7.0 mmol/L) (11),
Supportive evidence from well-conducted RCTs that are adequately powered, and numerous studies have confirmed
including: that at these cut points the 2-h OGTT
c Evidence from a well-conducted trial at one or more institutions value diagnoses more screened people
c Evidence from a meta-analysis that incorporated quality ratings in the analysis with diabetes (12). However, in practice, a
B Supportive evidence from well-conducted cohort studies large portion of the diabetic population re-
c Evidence from a well-conducted prospective cohort study or registry mains unaware of its condition. Thus, the
c Evidence from a well-conducted meta-analysis of cohort studies lower sensitivity of A1C at the designated
Supportive evidence from a well-conducted case-control study cut point may well be offset by the test’s
C Supportive evidence from poorly controlled or uncontrolled studies greater practicality, and wider application
c Evidence from randomized clinical trials with one or more major or three or of a more convenient test (A1C) may actu-
more minor methodological flaws that could invalidate the results ally increase the number of diagnoses made.
c Evidence from observational studies with high potential for bias (such as case As with most diagnostic tests, a test
series with comparison with historical controls) result diagnostic of diabetes should be
c Evidence from case series or case reports repeated to rule out laboratory error,
Conflicting evidence with the weight of evidence supporting the recommendation unless the diagnosis is clear on clinical
E Expert consensus or clinical experience grounds, such as a patient with a hyper-
glycemic crisis or classic symptoms of
hyperglycemia and a random plasma
Federation (IDF), and the European have posited that glycation rates differ by glucose $200 mg/dL. It is preferable
Association for the Study of Diabetes race (with, for example, African Americans that the same test be repeated for confir-
(EASD) recommended the use of the A1C having higher rates of glycation), but this is mation, since there will be a greater likeli-
test to diagnose diabetes, with a threshold controversial. A recent epidemiological hood of concurrence in this case. For
of $6.5% (6), and the ADA adopted this study found that, when matched for FPG, example, if the A1C is 7.0% and a repeat
criterion in 2010 (5). The diagnostic test African Americans (with and without dia- result is 6.8%, the diagnosis of diabetes is
should be performed using a method that betes) indeed had higher A1C than whites, confirmed. However, if two different tests
is certified by the NGSP and standardized but also had higher levels of fructosamine (such as A1C and FPG) are both above the
or traceable to the Diabetes Control and and glycated albumin and lower levels of diagnostic thresholds, the diagnosis of di-
Complications Trial (DCCT) reference as- 1,5 anhydroglucitol, suggesting that their abetes is also confirmed.
say. Although point-of-care (POC) A1C as- glycemic burden (particularly postpran- On the other hand, if two different
says may be NGSP certified, proficiency dially) may be higher (9). Epidemiological tests are available in an individual and the
testing is not mandated for performing studies forming the framework for recom- results are discordant, the test whose result
the test, so use of these assays for diagnostic mending use of the A1C to diagnose diabe- is above the diagnostic cut point should be
purposes could be problematic. tes have all been in adult populations. repeated, and the diagnosis is made based
Epidemiological datasets show a sim- Whether the cut point would be the same on the confirmed test. That is, if a patient
ilar relationship for A1C to the risk of to diagnose children or adolescents with meets the diabetes criterion of the A1C (two
retinopathy as has been shown for the type 2 diabetes is an area of uncertainty results $6.5%) but not the FPG (,126 mg/
corresponding FPG and 2-h PG thresh- (3,10). A1C inaccurately reflects glycemia dL or 7.0 mmol/L), or vice versa, that per-
olds. The A1C has several advantages to with certain anemias and hemoglobinopa- son should be considered to have diabetes.
the FPG and OGTT, including greater thies. For patients with an abnormal hemo- Since there is preanalytical and ana-
convenience (since fasting is not required), globin but normal red cell turnover, such as lytical variability of all the tests, it is also
evidence to suggest greater preanalytical sickle cell trait, an A1C assay without inter- possible that when a test whose result was
stability, and less day-to-day perturbations ference from abnormal hemoglobins should above the diagnostic threshold is re-
during periods of stress and illness. These be used (an updated list is available at www. peated, the second value will be below
advantages must be balanced by greater ngsp.org/interf.asp). For conditions with the diagnostic cut point. This is least
cost, the limited availability of A1C testing abnormal red cell turnover, such as preg- likely for A1C, somewhat more likely for
in certain regions of the developing world, nancy, recent blood loss or transfusion, or FPG, and most likely for the 2-h PG.
and the incomplete correlation between some anemias, the diagnosis of diabetes Barring a laboratory error, such patients
A1C and average glucose in certain indi- must employ glucose criteria exclusively. are likely to have test results near the
viduals. In addition, HbA1c levels may vary The established glucose criteria for margins of the threshold for a diagnosis.
with patients’ race/ethnicity (7,8). Some the diagnosis of diabetes (FPG and 2-h The health care professional might opt to

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Position Statement

follow the patient closely and repeat the used A1C to predict the progression to Table 3dCategories of increased risk for
testing in 3–6 months. diabetes demonstrated a strong, continu- diabetes (prediabetes)*
The current diagnostic criteria for ous association between A1C and sub- FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL
diabetes are summarized in Table 2. sequent diabetes. In a systematic review of (6.9 mmol/L) (IFG)
44,203 individuals from 16 cohort stud- OR
C. Categories of increased risk ies with a follow-up interval averaging 5.6 2-h plasma glucose in the 75-g OGTT 140 mg/dL
for diabetes (prediabetes) years (range 2.8–12 years), those with an (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L)
In 1997 and 2003, the Expert Committee A1C between 5.5 and 6.0% had a substan- (IGT)
on Diagnosis and Classification of Diabe- tially increased risk of diabetes with 5-year OR
tes Mellitus (13,14) recognized an inter- incidences ranging from 9 to 25%. An A1C A1C 5.7–6.4%
mediate group of individuals whose range of 6.0–6.5% had a 5-year risk of de-
glucose levels, although not meeting cri- veloping diabetes between 25 to 50% and *For all three tests, risk is continuous, extending be-
low the lower limit of the range and becoming dis-
teria for diabetes, are nevertheless too relative risk (RR) 20 times higher compared proportionately greater at higher ends of the range.
high to be considered normal. These per- with an A1C of 5.0% (15). In a community-
sons were defined as having impaired fast- based study of black and white adults
ing glucose (IFG) (FPG levels 100 mg/dL without diabetes, baseline A1C was a For many illnesses, there is a major dis-
[5.6 mmol/L] to 125 mg/dL [6.9 mmol/L]) stronger predictor of subsequent diabetes tinction between screening and diagnostic
or impaired glucose tolerance (IGT) (2-h and cardiovascular events than was fast- testing. However, for diabetes, the same
values in the OGTT of 140 mg/dL [7.8 ing glucose (16). Other analyses suggest tests would be used for “screening” as for
mmol/L] to 199 mg/dL [11.0 mmol/L]). It that an A1C of 5.7% is associated with diagnosis. Diabetes may be identified any-
should be noted that the World Health diabetes risk similar to that in the high- where along a spectrum of clinical scenar-
Organization (WHO) and a number of risk participants in the Diabetes Prevention ios ranging from a seemingly low-risk
other diabetes organizations define the cut- Program (DPP) (17). individual who happens to have glucose
off for IFG at 110 mg/dL (6.1 mmol/L). Hence, it is reasonable to consider an testing, to a higher-risk individual whom
Individuals with IFG and/or IGT have A1C range of 5.7–6.4% as identifying in- the provider tests because of high suspicion
been referred to as having prediabetes, dividuals with prediabetes. As is the case of diabetes, to the symptomatic patient.
indicating the relatively high risk for the for individuals found to have IFG and The discussion herein is primarily framed
future development of diabetes. IFG and IGT, individuals with an A1C of 5.7–6.4% as testing for diabetes in those without
IGT should not be viewed as clinical should be informed of their increased risk symptoms. The same assays used for test-
entities in their own right but rather risk for diabetes as well as CVD and counseled ing for diabetes will also detect individuals
factors for diabetes as well as cardiovascular about effective strategies to lower their risks with prediabetes.
disease (CVD). IFG and IGT are associated (see Section IV). As with glucose measure-
with obesity (especially abdominal or vis- ments, the continuum of risk is curvilinear, A. Testing for type 2 diabetes and
ceral obesity), dyslipidemia with high tri- so that as A1C rises, the risk of diabetes rises risk of future diabetes in adults
glycerides and/or low HDL cholesterol, and disproportionately (15). Accordingly, inter- Prediabetes and diabetes meet established
hypertension. ventions should be most intensive and criteria for conditions in which early de-
As is the case with the glucose mea- follow-up particularly vigilant for those tection is appropriate. Both conditions are
sures, several prospective studies that with A1Cs above 6.0%, who should be con- common, increasing in prevalence, and
sidered to be at very high risk. impose significant public health burdens.
Table 2dCriteria for the diagnosis of Table 3 summarizes the categories of There is a long presymptomatic phase
diabetes prediabetes. before the diagnosis of type 2 diabetes is
usually made. Relatively simple tests are
A1C $6.5%. The test should be performed in II. TESTING FOR DIABETES IN available to detect preclinical disease. Ad-
a laboratory using a method that is NGSP ASYMPTOMATIC PATIENTS ditionally, the duration of glycemic burden
certified and standardized to the DCCT is a strong predictor of adverse outcomes,
assay.* Recommendations and effective interventions exist to prevent
OR c Testing to detect type 2 diabetes and progression of prediabetes to diabetes (see
FPG $126 mg/dL (7.0 mmol/L). Fasting is prediabetes in asymptomatic people Section IV) and to reduce risk of compli-
defined as no caloric intake for at least 8 h.* should be considered in adults of any cations of diabetes (see Section VI).
OR age who are overweight or obese (BMI Type 2 diabetes is frequently not di-
2-h plasma glucose $200 mg/dL (11.1 mmol/L) $25 kg/m2) and who have one or more agnosed until complications appear, and
during an OGTT. The test should be additional risk factors for diabetes (Table approximately one-fourth of all people
performed as described by the WHO, using 4). In those without these risk factors, with diabetes in the U.S. may be undiag-
a glucose load containing the equivalent of testing should begin at age 45. (B) nosed. The effectiveness of early identifica-
75 g anhydrous glucose dissolved in water.* c If tests are normal, repeat testing at least tion of prediabetes and diabetes through
OR at 3-year intervals is reasonable. (E) mass testing of asymptomatic individuals
In a patient with classic symptoms of c To test for diabetes or prediabetes, the has not been proven definitively, and
hyperglycemia or hyperglycemic crisis, A1C, FPG, or 75-g 2-h OGTT are appro- rigorous trials to provide such proof are
a random plasma glucose $200 mg/dL priate. (B) unlikely to occur. In a large randomized
(11.1 mmol/L). c In those identified with prediabetes, controlled trial (RCT) in Europe, general
*In the absence of unequivocal hyperglycemia, re- identify and, if appropriate, treat other practice patients between the ages of 40–
sult should be confirmed by repeat testing. CVD risk factors. (B) 69 years were screened for diabetes and

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S13


Position Statement

then randomly assigned by practice to 24 kg/m2 in South Asians, 25 kg/m2 in seek, or have access to, appropriate follow-up
routine care of diabetes or intensive treat- Chinese, and 26 kg/m2 in African Ameri- testing and care. Conversely, there may be
ment of multiple risk factors. After 5.3 cans (21). Disparities in screening rates, failure to ensure appropriate repeat testing
years of follow-up, CVD risk factors were not explainable by insurance status, are for individuals who test negative. Commu-
modestly but significantly more improved highlighted by evidence that despite nity screening may also be poorly targeted; i.
with intensive treatment. Incidence of first much higher prevalence of type 2 diabe- e., it may fail to reach the groups most at risk
CVD event and mortality rates were not tes, non-Caucasians in an insured popu- and inappropriately test those at low risk (the
significantly different between groups lation are no more likely than Caucasians worried well) or even those already diag-
(18). This study would seem to add sup- to be screened for diabetes (22). Because nosed.
port for early treatment of screen-detected age is a major risk factor for diabetes, test-
diabetes, as risk factor control was excel- ing of those without other risk factors
lent even in the routine treatment arm should begin no later than age 45 years. B. Screening for type 2 diabetes
and both groups had lower event rates The A1C, FPG, or the 2-h OGTT are in children
than predicted. The absence of a control appropriate for testing. It should be noted Recommendations
unscreened arm limits the ability to defi- that the tests do not necessarily detect c Testing to detect type 2 diabetes and
nitely prove that screening impacts out- diabetes in the same individuals. The prediabetes should be considered in chil-
comes. Mathematical modeling studies efficacy of interventions for primary pre- dren and adolescents who are overweight
suggest that screening independent of vention of type 2 diabetes (23–29) has and who have two or more additional
risk factors beginning at age 30 years primarily been demonstrated among in- risk factors for diabetes (Table 5). (E)
or age 45 years is highly cost-effective dividuals with IGT, not for individuals
(,$11,000 per quality-adjusted life- with isolated IFG or for individuals with The incidence of type 2 diabetes in
year gained) (19). specific A1C levels. adolescents has increased dramatically in
Recommendations for testing for di- The appropriate interval between the last decade, especially in minority
abetes in asymptomatic, undiagnosed tests is not known (30). The rationale populations (31), although the disease
adults are listed in Table 4. Testing should for the 3-year interval is that false nega- remains rare in the general pediatric pop-
be considered in adults of any age with tives will be repeated before substantial ulation (32). Consistent with recom-
BMI $25 kg/m2 and one or more of the time elapses, and there is little likelihood mendations for adults, children and
known risk factors for diabetes. In addi- that an individual will develop significant youth at increased risk for the presence
tion to the listed risk factors, certain med- complications of diabetes within 3 years or the development of type 2 diabetes
ications, such as glucocorticoids and of a negative test result. In the modeling should be tested within the health care
antipsychotics (20), are known to in- study, repeat screening every 3 or 5 years setting (33). The recommendations of
crease the risk of type 2 diabetes. There was cost-effective (19). the ADA consensus statement “Type 2
is compelling evidence that lower BMI cut Because of the need for follow-up and Diabetes in Children and Adolescents,”
points suggest diabetes risk in some racial discussion of abnormal results, testing with some modifications, are summa-
and ethnic groups. In a large multiethnic should be carried out within the health rized in Table 5.
cohort study, for an equivalent incidence care setting. Community screening outside
rate of diabetes conferred by a BMI of 30 a health care setting is not recommended
kg/m2 in whites, the BMI cutoff value was because people with positive tests may not C. Screening for type 1 diabetes
Recommendations
c Consider referring relatives of those
Table 4dCriteria for testing for diabetes in asymptomatic adult individuals with type 1 diabetes for antibody test-
ing for risk assessment in the setting
1. Testing should be considered in all adults who are overweight (BMI $25 kg/m2*)
of a clinical research study. (E)
and have additional risk factors:
c physical inactivity
Generally, people with type 1 diabetes
c first-degree relative with diabetes
present with acute symptoms of diabetes
c high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian
and markedly elevated blood glucose
American, Pacific Islander)
levels, and some cases are diagnosed with
c women who delivered a baby weighing .9 lb or were diagnosed with GDM
life-threatening ketoacidosis. Evidence
c hypertension ($140/90 mmHg or on therapy for hypertension)
from several studies suggests that mea-
c HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride
surement of islet autoantibodies in rela-
level .250 mg/dL (2.82 mmol/L)
tives of those with type 1 diabetes
c women with polycystic ovary syndrome
identifies individuals who are at risk for
c A1C $5.7%, IGT, or IFG on previous testing
developing type 1 diabetes. Such testing,
c other clinical conditions associated with insulin resistance (e.g., severe obesity,
coupled with education about symptoms
acanthosis nigricans)
of diabetes and follow-up in an observa-
c history of CVD
tional clinical study, may allow earlier
2. In the absence of the above criteria, testing for diabetes should begin at age 45 years.
identification of onset of type 1 diabetes
3. If results are normal, testing should be repeated at least at 3-year intervals, with
and lessen presentation with ketoacidosis
consideration of more frequent testing depending on initial results (e.g., those with
at time of diagnosis. This testing may be
prediabetes should be tested yearly) and risk status.
appropriate in those who have relatives
*At-risk BMI may be lower in some ethnic groups. with type 1 diabetes, in the context of

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Position Statement

Table 5dTesting for type 2 diabetes in asymptomatic children* screen women with risk factors for type
Criteria 2 diabetes (Table 4) for diabetes at their
c Overweight (BMI .85th percentile for age and sex, weight for height .85th percentile, or initial prenatal visit, using standard diag-
weight .120% of ideal for height) nostic criteria (Table 2). Women with di-
Plus any two of the following risk factors: abetes found at this visit should receive
c Family history of type 2 diabetes in first- or second-degree relative a diagnosis of overt, not gestational,
c Race/ethnicity (Native American, African American, Latino, Asian American, Pacific diabetes.
Islander) GDM carries risks for the mother and
c Signs of insulin resistance or conditions associated with insulin resistance (acanthosis neonate. The Hyperglycemia and Ad-
nigricans, hypertension, dyslipidemia, polycystic ovary syndrome, or small-for-gestational- verse Pregnancy Outcome (HAPO) study
age birth weight) (37), a large-scale (;25,000 pregnant
c Maternal history of diabetes or GDM during the child’s gestation women) multinational epidemiological
Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a younger age study, demonstrated that risk of adverse
Frequency: every 3 years maternal, fetal, and neonatal outcomes
continuously increased as a function of
*Persons aged 18 years and younger. maternal glycemia at 24–28 weeks, even
within ranges previously considered nor-
mal for pregnancy. For most complica-
clinical research studies (see, for example, GDM at 24–28 weeks of gestation, tions, there was no threshold for risk.
http://www.diabetestrialnet.org). However, using a 75-g 2-h OGTT and the di- These results have led to careful recon-
widespread clinical testing of asymptomatic agnostic cut points in Table 6. (B) sideration of the diagnostic criteria for
low-risk individuals cannot currently be c Screen women with GDM for persistent GDM. After deliberations in 2008–
recommended, as it would identify very diabetes at 6–12 weeks postpartum, 2009, the International Association of
few individuals in the general population using the OGTT and nonpregnancy Diabetes and Pregnancy Study Groups
who are at risk. Individuals who screen diagnostic criteria. (E) (IADPSG), an international consensus
positive should be counseled about their c Women with a history of GDM should group with representatives from multiple
risk of developing diabetes and symptoms have lifelong screening for the de- obstetrical and diabetes organizations,
of diabetes, followed closely to prevent de- velopment of diabetes or prediabetes at including ADA, developed revised rec-
velopment of diabetic ketoacidosis, and least every 3 years. (B) ommendations for diagnosing GDM.
informed about clinical trials. Clinical c Women with a history of GDM found The group recommended that all women
studies are being conducted to test various to have prediabetes should receive not known to have prior diabetes
methods of preventing type 1 diabetes in lifestyle interventions or metformin to undergo a 75-g OGTT at 24–28 weeks
those with evidence of autoimmunity. prevent diabetes. (A) of gestation. Additionally, the group de-
Some interventions have demonstrated veloped diagnostic cut points for the fast-
modest efficacy in slowing b-cell loss early For many years, GDM was defined as ing, 1-h, and 2-h plasma glucose
in type 1 diabetes (34,35), and further re- any degree of glucose intolerance with measurements that conveyed an odds
search is needed to determine whether onset or first recognition during preg- ratio for adverse outcomes of at least
they may be effective in preventing type nancy (13), whether or not the condition 1.75 compared with women with the
1 diabetes. persisted after pregnancy, and not ex- mean glucose levels in the HAPO study.
cluding the possibility that unrecognized Current screening and diagnostic strate-
glucose intolerance may have antedated gies, based on the IADPSG statement
III. DETECTION AND or begun concomitantly with the preg- (38), are outlined in Table 6.
DIAGNOSIS OF GDM nancy. This definition facilitated a uniform These new criteria will significantly
strategy for detection and classification of increase the prevalence of GDM, primar-
Recommendations GDM, but its limitations were recognized ily because only one abnormal value, not
c Screen for undiagnosed type 2 diabetes for many years. As the ongoing epidemic two, is sufficient to make the diagnosis.
at the first prenatal visit in those with of obesity and diabetes has led to more The ADA recognizes the anticipated sig-
risk factors, using standard diagnostic type 2 diabetes in women of childbearing nificant increase in the incidence of GDM
criteria. (B) age, the number of pregnant women with diagnosed by these criteria and is sensitive
c In pregnant women not previously undiagnosed type 2 diabetes has increased to concerns about the “medicalization” of
known to have diabetes, screen for (36). Because of this, it is reasonable to pregnancies previously categorized as nor-
mal. These diagnostic criteria changes are
being made in the context of worrisome
Table 6dScreening for and diagnosis of GDM worldwide increases in obesity and diabe-
tes rates, with the intent of optimizing ges-
Perform a 75-g OGTT, with plasma glucose measurement fasting and at 1 and 2 h, at 24–28
tational outcomes for women and their
weeks of gestation in women not previously diagnosed with overt diabetes.
babies.
The OGTT should be performed in the morning after an overnight fast of at least 8 h.
Admittedly, there are few data from
The diagnosis of GDM is made when any of the following plasma glucose values are exceeded:
randomized clinical trials regarding ther-
c Fasting: $92 mg/dL (5.1 mmol/L)
apeutic interventions in women who will
c 1 h: $180 mg/dL (10.0 mmol/L)
now be diagnosed with GDM based on
c 2 h: $153 mg/dL (8.5 mmol/L)
only one blood glucose value above the

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Position Statement

specified cut points (in contrast to the older IV. PREVENTION/DELAY A1C of 5.7–6.4%, IGT, or IFG should be
criteria that stipulated at least two abnor- OF TYPE 2 DIABETES counseled on lifestyle changes with goals
mal values). However, there is emerging similar to those of the DPP (7% weight
observational and retrospective evidence Recommendations loss and moderate physical activity of at
that women diagnosed with the new c Patients with IGT (A), IFG (E), or an A1C least 150 min/week). Regarding drug
criteria (even if they would not have of 5.7–6.4% (E) should be referred to an therapy for diabetes prevention, metfor-
been diagnosed with older criteria) have effective ongoing support program tar- min has a strong evidence base and dem-
increased rates of poor pregnancy out- geting weight loss of 7% of body weight onstrated long-term safety (53). For other
comes similar to those of women with and increasing physical activity to at least drugs, issues of cost, side effects, and lack
GDM by prior criteria (39,40). Expected 150 min/week of moderate activity such of persistence of effect in some studies
benefits to these pregnancies and offspring as walking. (54) require consideration. Metformin
are inferred from intervention trials that c Follow-up counseling appears to be was less effective than lifestyle modifica-
focused on women with more mild hyper- important for success. (B) tion in the DPP and DPPOS, but may be
glycemia than identified using older GDM c Based on the cost-effectiveness of diabetes cost-saving over a 10-year period (51). It
diagnostic criteria and that found modest prevention, such programs should be was as effective as lifestyle modification
benefits (41,42). The frequency of follow- covered by third-party payers. (B) in participants with a BMI of at least 35
up and blood glucose monitoring for these c Metformin therapy for prevention of kg/m2, but not significantly better than
women is not yet clear, but likely to be less type 2 diabetes may be considered in placebo than those over age 60 years
intensive than for women diagnosed by the those with IGT (A), IFG (E), or an A1C of (23). In women in the DPP with a history
older criteria. It is important to note that 5.7–6.4% (E), especially for those with of GDM, metformin and intensive lifestyle
80–90% of women in both of the mild BMI .35 kg/m2, aged ,60 years, and modification led to an equivalent 50% re-
GDM studies (whose glucose values over- women with prior GDM. (A) duction in the risk of diabetes (55). Met-
lapped with the thresholds recommended c At least annual monitoring for the de- formin therefore might reasonably be
herein) could be managed with lifestyle velopment of diabetes in those with recommended for very high-risk individ-
therapy alone. prediabetes is suggested. (E) uals (those with a history of GDM, the
The American College of Obstetri- c Screening for and treatment of modifi- very obese, and/or those with more severe
cians and Gynecologists announced in able risk factors for CVD is suggested. (B) or progressive hyperglycemia).
2011 that they continue to recommend People with prediabetes often have
use of prior diagnostic criteria for GDM RCTs have shown that individuals at other cardiovascular risk factors, such as
(43). Several other countries have high risk for developing type 2 diabetes obesity, hypertension, and dyslipidemia.
adopted the new criteria, and a report (those with IFG, IGT, or both) can signif- Assessing and treating these risk factors is
from the WHO on this topic is pending icantly decrease the rate of onset of diabetes an important aspect of reducing cardio-
at the time of publication of these stand- with particular interventions (23–29). metabolic risk. In the DPP and DPPOS,
ards. The National Institutes of Health is These include intensive lifestyle modifica- cardiovascular event rates have been very
planning to hold a consensus develop- tion programs that have been shown to be low, perhaps due to appropriate manage-
ment conference on this topic in 2013. very effective (;58% reduction after 3 ment of cardiovascular risk factors in all
Because some cases of GDM may years) and use of the pharmacological arms of the study (56).
represent pre-existing undiagnosed type agents metformin, a-glucosidase inhibi-
2 diabetes, women with a history of tors, orlistat, and thiazolidinediones, each V. DIABETES CARE
GDM should be screened for diabetes of which has been shown to decrease inci-
6–12 weeks postpartum, using nonpreg- dent diabetes to various degrees. Follow-up A. Initial evaluation
nant OGTT criteria. Because of their pre- of all three large studies of lifestyle interven- A complete medical evaluation should be
partum treatment for hyperglycemia, use tion has shown sustained reduction in the performed to classify the diabetes, detect
of the A1C for diagnosis of persistent di- rate of conversion to type 2 diabetes, with the presence of diabetes complications,
abetes at the postpartum visit is not rec- 43% reduction at 20 years in the Da Qing review previous treatment and risk factor
ommended (44). Women with a history study (47), 43% reduction at 7 years in the control in patients with established diabe-
of GDM have a greatly increased subse- Finnish Diabetes Prevention Study (DPS) tes, assist in formulating a management
quent risk for diabetes (45) and should (48), and 34% reduction at 10 years in plan, and provide a basis for continuing
be followed up with subsequent screen- the U.S. Diabetes Prevention Program care. Laboratory tests appropriate to the
ing for the development of diabetes or Outcomes Study (DPPOS) (49). A cost- evaluation of each patient’s medical condi-
prediabetes, as outlined in Section II. effectiveness model suggested that lifestyle tion should be performed. A focus on the
Lifestyle interventions or metformin interventions as delivered in the DPP are components of comprehensive care (Table
should be offered to women with a his- cost-effective (50), and actual cost data 7) will assist the health care team to ensure
tory of GDM who develop prediabetes, from the DPP and DPPOS confirm that life- optimal management of the patient with
as discussed in Section IV. In the pro- style interventions are highly cost-effective diabetes.
spective Nurses’ Health Study II, risk of (51). Group delivery of the DPP interven-
subsequent diabetes after a history of tion in community settings has the poten- B. Management
GDM was significantly lower in women tial to be significantly less expensive while People with diabetes should receive med-
who followed healthy eating patterns. still achieving similar weight loss (52). ical care from a team that may include
Adjusting for BMI moderately, but not Based on the results of clinical trials physicians, nurse practitioners, physician’s
completely, attenuated this association and the known risks of progression of assistants, nurses, dietitians, pharmacists,
(46). prediabetes to diabetes, persons with an and mental health professionals with

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Position Statement

Table 7dComponents of the comprehensive diabetes evaluation and conditions, physical activity, eating
Medical history patterns, social situation and cultural fac-
c Age and characteristics of onset of diabetes (e.g., DKA, asymptomatic laboratory finding) tors, and presence of complications of di-
c Eating patterns, physical activity habits, nutritional status, and weight history; growth and abetes or other medical conditions.
development in children and adolescents
c Diabetes education history C. Glycemic control
c Review of previous treatment regimens and response to therapy (A1C records)
c Current treatment of diabetes, including medications, medication adherence and barriers
1. Assessment of glycemic control
Two primary techniques are available for
thereto, meal plan, physical activity patterns, and readiness for behavior change
c Results of glucose monitoring and patient’s use of data
health providers and patients to assess the
c DKA frequency, severity, and cause
effectiveness of the management plan on
c Hypoglycemic episodes
glycemic control: patient self-monitoring
c Hypoglycemia awareness
of blood glucose (SMBG) or interstitial
c Any severe hypoglycemia: frequency and cause
glucose, and A1C.
c History of diabetes-related complications
c Microvascular: retinopathy, nephropathy, neuropathy (sensory, including history of foot a. Glucose monitoring
lesions; autonomic, including sexual dysfunction and gastroparesis) Recommendations
c Macrovascular: CHD, cerebrovascular disease, and PAD c Patients on multiple-dose insulin (MDI)
c Other: psychosocial problems*, dental disease* or insulin pump therapy should do
Physical examination SMBG at least prior to meals and snacks,
c Height, weight, BMI occasionally postprandially, at bedtime,
c Blood pressure determination, including orthostatic measurements when indicated prior to exercise, when they suspect low
c Fundoscopic examination* blood glucose, after treating low blood
c Thyroid palpation glucose until they are normoglycemic,
c Skin examination (for acanthosis nigricans and insulin injection sites) and prior to critical tasks such as driv-
c Comprehensive foot examination ing. (B)
c Inspection c When prescribed as part of a broader
c Palpation of dorsalis pedis and posterior tibial pulses educational context, SMBG results may
c Presence/absence of patellar and Achilles reflexes be helpful to guide treatment decisions
c Determination of proprioception, vibration, and monofilament sensation and/or patient self-management for
Laboratory evaluation patients using less frequent insulin in-
c A1C, if results not available within past 2–3 months jections or noninsulin therapies. (E)
If not performed/available within past year c When prescribing SMBG, ensure that
c Fasting lipid profile, including total, LDL and HDL cholesterol and triglycerides patients receive ongoing instruction
c Liver function tests and regular evaluation of SMBG tech-
c Test for urine albumin excretion with spot urine albumin-to-creatinine ratio nique and SMBG results, as well as their
c Serum creatinine and calculated GFR ability to use SMBG data to adjust ther-
c TSH in type 1 diabetes, dyslipidemia or women over age 50 years apy. (E)
Referrals c Continuous glucose monitoring (CGM)
c Eye care professional for annual dilated eye exam in conjunction with intensive insulin
c Family planning for women of reproductive age regimens can be a useful tool to lower
c Registered dietitian for MNT A1C in selected adults (aged $25 years)
c DSME with type 1 diabetes. (A)
c Dentist for comprehensive periodontal examination c Although the evidence for A1C lower-
c Mental health professional, if needed ing is less strong in children, teens, and
younger adults, CGM may be helpful
*See appropriate referrals for these categories. in these groups. Success correlates with
adherence to ongoing use of the device.
(C)
c CGM may be a supplemental tool to
expertise and a special interest in diabetes. of problem-solving skills in the various SMBG in those with hypoglycemia
It is essential in this collaborative and in- aspects of diabetes management. Imple- unawareness and/or frequent hypogly-
tegrated team approach that individuals mentation of the management plan re- cemic episodes. (E)
with diabetes assume an active role in their quires that the goals and treatment plan
care. are individualized and take patient pref- Major clinical trials of insulin-treated
The management plan should be erences into account. The management patients that demonstrated the benefits of
formulated as a collaborative therapeutic plan should recognize diabetes self- intensive glycemic control on diabetes
alliance among the patient and family, management education (DSME) and on- complications have included SMBG as
the physician, and other members of the going diabetes support as an integral part of multifactorial interventions, sug-
health care team. A variety of strategies component of care. In developing the gesting that SMBG is a component of
and techniques should be used to provide plan, consideration should be given to effective therapy. SMBG allows patients
adequate education and development the patient’s age, school or work schedule to evaluate their individual response to

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S17


Position Statement

therapy and assess whether glycemic tar- one study of insulin-naïve patients with and for the burgeoning work on “artificial
gets are being achieved. Results of SMBG suboptimal initial glycemic control, use pancreas” systems.
can be useful in preventing hypoglycemia of structured SMBG (a paper tool to col-
and adjusting medications (particularly lect and interpret 7-point SMBG profiles b. A1C
prandial insulin doses), medical nutrition over 3 days at least quarterly) reduced Recommendations
therapy (MNT), and physical activity. A1C by 0.3% more than in an active con- c Perform the A1C test at least two
The frequency and timing of SMBG trol group (65). Patients should be taught times a year in patients who are meet-
should be dictated by the particular needs how to use SMBG data to adjust food in- ing treatment goals (and who have
and goals of the patient. SMBG is espe- take, exercise, or pharmacological therapy stable glycemic control). (E)
cially important for patients treated with to achieve specific goals, and the ongoing c Perform the A1C test quarterly in pa-
insulin to monitor for and prevent asymp- need for and frequency of SMBG should be tients whose therapy has changed or
tomatic hypoglycemia and hyperglyce- re-evaluated at each routine visit. who are not meeting glycemic goals. (E)
mia. Most patients with type 1 diabetes Real-time CGM through the measure- c Use of POC testing for A1C provides
and others on intensive insulin regimens ment of interstitial glucose (which corre- the opportunity for more timely treat-
(MDI or insulin pump therapy) should do lates well with plasma glucose) is available. ment changes. (E)
SMBG at least prior to meals and snacks, These sensors require calibration with
occasionally postprandially, at bedtime, SMBG, and the latter are still recommended Because A1C is thought to reflect aver-
prior to exercise, when they suspect low for making acute treatment decisions. age glycemia over several months (63) and
blood glucose, after treating low blood CGM devices have alarms for hypo- and has strong predictive value for diabetes
glucose until they are normoglycemic, hyperglycemic excursions. A 26-week ran- complications (71,72), A1C testing
and prior to critical tasks such as driving. domized trial of 322 type 1 diabetic pa- should be performed routinely in all pa-
For many patients, this will require test- tients showed that adults aged $25 years tients with diabetes, at initial assessment
ing 6–8 times daily, although individual using intensive insulin therapy and CGM and then as part of continuing care. Mea-
needs may be greater. Although there are experienced a 0.5% reduction in A1C surement approximately every 3 months
few rigorous studies, a database study of (from ;7.6 to 7.1%) compared with usual determines whether patient’s glycemic tar-
almost 27,000 children and adolescents intensive insulin therapy with SMBG (66). gets have been reached and maintained.
with type 1 diabetes showed that, after Sensor use in children, teens, and adults to For any individual patient, the frequency
adjustment for multiple confounders, in- age 24 years did not result in significant of A1C testing should be dependent on
creased daily frequency of SMBG was sig- A1C lowering, and there was no significant the clinical situation, the treatment regimen
nificantly associated with lower A1C difference in hypoglycemia in any group. used, and the judgment of the clinician.
(20.2% per additional test per day, level- Importantly, the greatest predictor of A1C Some patients with stable glycemia well
ing off at five tests per day) and with fewer lowering in this study for all age-groups within target may do well with testing
acute complications (57). The optimal was frequency of sensor use, which was only twice per year, while unstable or
frequency of SMBG for patients on non- lower in younger age-groups. In a smaller highly intensively managed patients (e.g.,
intensive regimens, such as those with RCT of 129 adults and children with base- pregnant type 1 diabetic women) may be
type 2 diabetes on basal insulin, is not line A1C ,7.0%, outcomes combining tested more frequently than every 3
known, although a number of studies A1C and hypoglycemia favored the group months. The availability of the A1C result
have used fasting SMBG for patient or pro- utilizing CGM, suggesting that CGM is also at the time that the patient is seen (POC
vider titration of the basal insulin dose. beneficial for individuals with type 1 dia- testing) has been reported in small studies
The evidence base for SMBG for patients betes who have already achieved excellent to result in increased intensification of ther-
with type 2 diabetes on noninsulin therapy control (67). apy and improvement in glycemic control
is somewhat mixed. Several randomized A trial comparing CGM plus insulin (73,74). However, two recent systematic
trials have called into question the clinical pump to SMBG plus multiple injections reviews and meta-analyses found no signif-
utility and cost-effectiveness of routine of insulin in adults and children with type icant difference in A1C between POC and
SMBG in non–insulin-treated patients 1 diabetes showed significantly greater laboratory A1C usage (75,76).
(58–60). A recent meta-analysis suggested improvements in A1C with “sensor- The A1C test is subject to certain
that SMBG reduced A1C by 0.25% at 6 augmented pump” therapy (68,69), but limitations. Conditions that affect eryth-
months (61), while a Cochrane review con- this trial did not isolate the effect of CGM rocyte turnover (hemolysis, blood loss)
cluded that the overall effect of SMBG in itself. Overall, meta-analyses suggest that and hemoglobin variants must be consid-
such patients is small up to 6 months after compared with SMBG, CGM lowers A1C ered, particularly when the A1C result
initiation and subsides after 12 months (62). by ;0.26% (70). Altogether, these data does not correlate with the patient’s clin-
Because the accuracy of SMBG is suggest that, in appropriately selected pa- ical situation (63). In addition, A1C does
instrument and user dependent (63), it tients who are motivated to wear it most of not provide a measure of glycemic vari-
is important to evaluate each patient’s the time, CGM reduces A1C. The technol- ability or hypoglycemia. For patients
monitoring technique, both initially and ogy may be particularly useful in those with prone to glycemic variability (especially
at regular intervals thereafter. Optimal hypoglycemia unawareness and/or fre- type 1 diabetic patients or type 2 diabetic
use of SMBG requires proper review and quent episodes of hypoglycemia, although patients with severe insulin deficiency),
interpretation of the data, both by the pa- studies as yet have not shown significant glycemic control is best judged by the
tient and provider. Among patients who reductions in severe hypoglycemia (70). combination of results of self-monitoring
checked their blood glucose at least once CGM forms the underpinning for the de- and the A1C. The A1C may also serve as a
daily, many reported taking no action velopment of pumps that suspend insulin check on the accuracy of the patient’s me-
when results were high or low (64). In delivery when hypoglycemia is developing ter (or the patient’s reported SMBG

S18 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

results) and the adequacy of the SMBG there are significant differences in how microvascular (retinopathy and nephro-
testing schedule. A1C relates to average glucose in children pathy) and neuropathic complications.
Table 8 contains the correlation be- or in African American patients is an area Follow-up of the DCCT cohorts in the Ep-
tween A1C levels and mean plasma glu- for further study. For the time being, the idemiology of Diabetes Interventions and
cose levels based on data from the question has not led to different recom- Complications (EDIC) study (80,81) dem-
international A1C-Derived Average Glu- mendations about testing A1C or to dif- onstrated persistence of these microvascu-
cose (ADAG) trial utilizing frequent ferent interpretations of the clinical lar benefits in previously intensively treated
SMBG and CGM in 507 adults (83% Cau- meaning of given levels of A1C in those subjects, even though their glycemic con-
casian) with type 1, type 2, and no diabe- populations. trol approximated that of previous stan-
tes (77). The ADA and the American For patients in whom A1C/eAG and dard arm subjects during follow-up.
Association for Clinical Chemistry have measured blood glucose appear discrep- The Kumamoto Study (82) and UK
determined that the correlation (r 5 ant, clinicians should consider the possi- Prospective Diabetes Study (UKPDS)
0.92) is strong enough to justify reporting bilities of hemoglobinopathy or altered (83,84) confirmed that intensive glycemic
both an A1C result and an estimated av- red cell turnover, and the options of more control was associated with significantly
erage glucose (eAG) result when a clini- frequent and/or different timing of SMBG decreased rates of microvascular and neu-
cian orders the A1C test. The table in pre- or use of CGM. Other measures of chronic ropathic complications in patients with
2009 versions of the “Standards of Medi- glycemia such as fructosamine are avail- type 2 diabetes. Long-term follow-up of
cal Care in Diabetes” describing the cor- able, but their linkage to average glucose the UKPDS cohorts showed persistence of
relation between A1C and mean glucose and their prognostic significance are not the effect of early glycemic control on
was derived from relatively sparse data as clear as is the case for A1C. most microvascular complications (85).
(one 7-point profile over 1 day per A1C Subsequent trials in patients with
reading) in the primarily Caucasian type 1 2. Glycemic goals in adults more long-standing type 2 diabetes, de-
diabetic participants in the DCCT (78). Recommendations signed primarily to look at the role of
Clinicians should note that the numbers c Lowering A1C to below or around 7% intensive glycemic control on cardiovas-
in the table are now different, as they are has been shown to reduce microvas- cular outcomes, also confirmed a benefit,
based on ;2,800 readings per A1C in the cular complications of diabetes and if although more modest, on onset or pro-
ADAG trial. implemented soon after the diagnosis gression of microvascular complications.
In the ADAG trial, there were no sig- of diabetes is associated with long-term The Veterans Affairs Diabetes Trial
nificant differences among racial and eth- reduction in macrovascular disease. (VADT) showed significant reductions
nic groups in the regression lines between Therefore, a reasonable A1C goal for in albuminuria with intensive (achieved
A1C and mean glucose, although there many nonpregnant adults is ,7%. (B) median A1C 6.9%) compared with stan-
was a trend toward a difference between c Providers might reasonably suggest dard glycemic control, but no difference
African/African American participants more stringent A1C goals (such as in retinopathy and neuropathy (86,87).
and Caucasian ones. A small study com- ,6.5%) for selected individual pa- The Action in Diabetes and Vascular Dis-
paring A1C to CGM data in type 1 di- tients, if this can be achieved without ease: Preterax and Diamicron MR Con-
abetic children found a highly statistically significant hypoglycemia or other ad- trolled Evaluation (ADVANCE) study of
significant correlation between A1C and verse effects of treatment. Appropriate intensive versus standard glycemic con-
mean blood glucose, although the corre- patients might include those with short trol in type 2 diabetes found a statistically
lation (r 5 0.7) was significantly lower duration of diabetes, long life expec- significant reduction in albuminuria, but
than in the ADAG trial (79). Whether tancy, and no significant CVD. (C) not in neuropathy or retinopathy, with an
c Less stringent A1C goals (such as A1C target of ,6.5% (achieved median
Table 8dCorrelation of A1C with average
,8%) may be appropriate for patients A1C 6.3%) compared with standard ther-
glucose
with a history of severe hypoglycemia, apy achieving a median A1C of 7.0% (88).
limited life expectancy, advanced mi- Analyses from the Action to Control Car-
crovascular or macrovascular complica- diovascular Risk in Diabetes (ACCORD)
Mean plasma glucose tions, extensive comorbid conditions, trial have shown lower rates of onset or
A1C (%) mg/dL mmol/L and those with long-standing diabetes in progression of early-stage microvascular
whom the general goal is difficult to at- complications in the intensive glycemic
6 126 7.0 tain despite DSME, appropriate glucose control arm compared with the standard
7 154 8.6 monitoring, and effective doses of mul- arm (89,90).
8 183 10.2 tiple glucose-lowering agents including Epidemiological analyses of the DCCT
9 212 11.8 insulin. (B) and UKPDS (71,72) demonstrate a curvi-
10 240 13.4 linear relationship between A1C and mi-
11 269 14.9 Hyperglycemia defines diabetes, and crovascular complications. Such analyses
12 298 16.5 glycemic control is fundamental to the suggest that, on a population level, the
These estimates are based on ADAG data of ;2,700 management of diabetes. The DCCT greatest number of complications will be
glucose measurements over 3 months per A1C (71), a prospective RCT of intensive ver- averted by taking patients from very poor
measurement in 507 adults with type 1, type 2, and sus standard glycemic control in patients control to fair or good control. These anal-
no diabetes. The correlation between A1C and av- with relatively recently diagnosed type 1 yses also suggest that further lowering of
erage glucose was 0.92 (ref. 77). A calculator for
converting A1C results into eAG, in either mg/dL or
diabetes, showed definitively that A1C from 7 to 6% is associated with further
mmol/L, is available at http://professional.diabetes improved glycemic control is associ- reduction in the risk of microvascular
.org/eAG. ated with significantly decreased rates of complications, albeit the absolute risk

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S19


Position Statement

reductions become much smaller. Given All three of these trials were conducted in was associated with excess mortality in
the substantially increased risk of hypogly- participants with more long-standing di- either arm, but the association was stron-
cemia (particularly in those with type 1 di- abetes (mean duration 8–11 years) and ger in those randomized to the standard
abetes, but also in the recent type 2 diabetes either known CVD or multiple cardiovas- glycemic control arm (97). Unlike the
trials), the concerning mortality findings in cular risk factors. Details of these three case with the DCCT trial, where lower
the ACCORD trial (91), and the relatively studies are reviewed extensively in an achieved A1C levels were related to sig-
much greater effort required to achieve ADA position statement (94). nificantly increased rates of severe hypo-
near-normoglycemia, the risks of lower gly- The ACCORD study enrolled partici- glycemia, in ACCORD every 1% decline
cemic targets may outweigh the potential pants with either known CVD or two or in A1C from baseline to 4 months into the
benefits on microvascular complications more major cardiovascular risk factors trial was associated with a significant de-
on a population level. However, selected and randomized them to intensive glyce- crease in the rate of severe hypoglycemia
individual patients, especially those with mic control (goal A1C ,6%) or standard in both arms (96).
little comorbidity and long life expectancy glycemic control (goal A1C 7–8%). The The primary outcome of ADVANCE
(who may reap the benefits of further low- glycemic control comparison was halted was a combination of microvascular
ering of glycemia below 7%), may, based early due to the finding of an increased events (nephropathy and retinopathy)
on provider judgment and patient prefer- rate of mortality in the intensive arm com- and major adverse cardiovascular events
ences, adopt more intensive glycemic tar- pared with the standard arm (1.41% vs. (MI, stroke, and cardiovascular death).
gets (e.g., an A1C target ,6.5%) as long as 1.14% per year; HR 1.22; 95% CI 1.01– Intensive glycemic control (to a goal A1C
significant hypoglycemia does not become 1.46), with a similar increase in cardiovas- ,6.5% vs. treatment to local standards)
a barrier. cular deaths. This increase in mortality in significantly reduced the primary end
CVD, a more common cause of death the intensive glycemic control arm was point. However, this was due to a significant
in populations with diabetes than micro- seen in all prespecified patient subgroups. reduction in the microvascular outcome, pri-
vascular complications, is less clearly The primary outcome of ACCORD (non- marily development of macroalbuminuria,
impacted by levels of hyperglycemia or fatal MI, nonfatal stroke, or cardiovascu- with no significant reduction in the macro-
the intensity of glycemic control. In the lar death) was nonsignificantly lower in vascular outcome. There was no difference
DCCT, there was a trend toward lower the intensive glycemic control group in overall or cardiovascular mortality be-
risk of CVD events with intensive control, due to a reduction in nonfatal MI, both tween the intensive compared with the
and in 9-year post-DCCT follow-up of the when the glycemic control comparison standard glycemic control arms (88).
EDIC cohort participants previously ran- was halted and all participants transi- The VADT randomized participants
domized to the intensive arm had a sig- tioned to the standard glycemic control with type 2 diabetes uncontrolled on
nificant 57% reduction in the risk of intervention (91), and at completion of insulin or maximal-dose oral agents (me-
nonfatal myocardial infarction (MI), stroke, the planned follow-up (95). dian entry A1C 9.4%) to a strategy of
or CVD death compared with those pre- Exploratory analyses of the mortality intensive glycemic control (goal A1C
viously in the standard arm (92). The ben- findings of ACCORD (evaluating vari- ,6.0%) or standard glycemic control,
efit of intensive glycemic control in this ables including weight gain, use of any with a planned A1C separation of at least
type 1 diabetic cohort has recently been specific drug or drug combination, and 1.5%. The primary outcome of the VADT
shown to persist for several decades (93). hypoglycemia) were reportedly unable to was a composite of CVD events. The cu-
In type 2 diabetes, there is evidence identify a clear explanation for the excess mulative primary outcome was nonsig-
that more intensive treatment of glycemia mortality in the intensive arm (91). The nificantly lower in the intensive arm
in newly diagnosed patients may reduce ACCORD investigators subsequently (86). An ancillary study of the VADT
long-term CVD rates. During the UKPDS published additional epidemiological demonstrated that intensive glycemic
trial, there was a 16% reduction in car- analyses showing no increase in mortality control significantly reduced the primary
diovascular events (combined fatal or in the intensive arm participants who CVD outcome in individuals with less
nonfatal MI and sudden death) in the achieved A1C levels below 7% nor in atherosclerosis at baseline (assessed by
intensive glycemic control arm that did those who lowered their A1C quickly af- coronary calcium) but not in persons
not reach statistical significance (P 5 ter trial enrollment. In fact, although there with more extensive baseline atheroscle-
0.052), and there was no suggestion of was no A1C level at which intensive arm rosis (98). A post hoc analysis showed a
benefit on other CVD outcomes such as participants had significantly lower mor- complex relationship between duration
stroke. However, after 10 years of follow- tality than standard arm participants, the of diabetes before glycemic intensifica-
up, those originally randomized to inten- highest risk for mortality was observed in tion and mortality: mortality in the inten-
sive glycemic control had significant intensive arm participants with the high- sive vs. standard glycemic control arm
long-term reductions in MI (15% with est A1C levels (96). was inversely related to duration of dia-
sulfonylurea or insulin as initial pharma- The role of hypoglycemia in the ex- betes at the time of study enrollment.
cotherapy, 33% with metformin as initial cess mortality findings was also complex. Those with diabetes duration less than
pharmacotherapy) and in all-cause mor- Severe hypoglycemia was significantly 15 years had a mortality benefit in the in-
tality (13% and 27%, respectively) (85). more likely in participants randomized tensive arm, while those with duration of
Three more recent large trials to the intensive glycemic control arm. 20 years or more had higher mortality in
(ACCORD, ADVANCE, and VADT) sug- However, excess mortality in the inten- the intensive arm (99).
gested no significant reduction in CVD sive versus standard arms was only sig- The evidence for a cardiovascular ben-
outcomes with intensive glycemic control nificant for participants with no severe efit of intensive glycemic control primarily
in participants who had more advanced hypoglycemia, and not for those with one rests on long-term follow-up of study
type 2 diabetes than UKPDS participants. or more episodes. Severe hypoglycemia cohorts treated early in the course of type

S20 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

1 and type 2 diabetes and subset analyses of The issue of pre- versus postprandial c preprandial: #95 mg/dL (5.3 mmol/L),
ACCORD, ADVANCE, and VADT. A SMBG targets is complex (102). Elevated and either:
group-level meta-analysis of the latter three postchallenge (2-h OGTT) glucose values c 1-h postmeal: #140 mg/dL (7.8 mmol/L)
trials suggests that glucose lowering has a have been associated with increased car- or
modest (9%) but statistically significant diovascular risk independent of FPG in c 2-h postmeal: #120 mg/dL (6.7 mmol/L)
reduction in major CVD outcomes, pri- some epidemiological studies. In diabetic
marily nonfatal MI, with no significant subjects, some surrogate measures of For women with pre-existing type 1
effect on mortality. However, heterogeneity vascular pathology, such as endothelial or type 2 diabetes who become pregnant, a
of the mortality effects across studies was dysfunction, are negatively affected by recent consensus statement (106) recom-
noted, precluding firm summary measures postprandial hyperglycemia (103). It is mended the following as optimal glycemic
of the mortality effects. A prespecified sub- clear that postprandial hyperglycemia, goals, if they can be achieved without ex-
group analysis suggested that major CVD like preprandial hyperglycemia, contrib- cessive hypoglycemia:
outcome reduction occurred in patients utes to elevated A1C levels, with its rela-
without known CVD at baseline (HR 0.84, tive contribution being higher at A1C c premeal, bedtime, and overnight glu-
95% CI 0.74–0.94) (100). Conversely, the levels that are closer to 7%. However, cose 60–99 mg/dL (3.3–5.4 mmol/L)
mortality findings in ACCORD and sub- outcome studies have clearly shown c peak postprandial glucose 100–129
group analyses of the VADT suggest that A1C to be the primary predictor of com- mg/dL (5.4–7.1 mmol/L)
the potential risks of intensive glycemic plications, and landmark glycemic con- c A1C ,6.0%
control may outweigh its benefits in some trol trials such as the DCCT and UKPDS
patients, such as those with very long du- relied overwhelmingly on preprandial
ration of diabetes, known history of severe SMBG. Additionally, an RCT in patients D. Pharmacological and overall
hypoglycemia, advanced atherosclerosis, with known CVD found no CVD benefit approaches to treatment
and advanced age/frailty. Certainly, provid- of insulin regimens targeting postpran-
ers should be vigilant in preventing severe dial glucose compared with those 1. Insulin therapy for type 1 diabetes
hypoglycemia in patients with advanced targeting preprandial glucose (104). A Recommendations
disease and should not aggressively at- reasonable recommendation for post- c Most people with type 1 diabetes should
tempt to achieve near-normal A1C levels prandial testing and targets is that for in- be treated with MDI injections (three
in patients in whom such a target cannot dividuals who have premeal glucose to four injections per day of basal and
be safely and reasonably easily achieved. values within target but have A1C values prandial insulin) or continuous sub-
Severe or frequent hypoglycemia is an ab- above target, monitoring postprandial cutaneous insulin infusion (CSII). (A)
solute indication for the modification of plasma glucose (PPG) 1–2 h after the start c Most people with type 1 diabetes
treatment regimens, including setting of the meal and treatment aimed at reduc- should be educated in how to match
higher glycemic goals. Many factors, in- ing PPG values to ,180 mg/dL may help prandial insulin dose to carbohydrate
cluding patient preferences, should be lower A1C. intake, premeal blood glucose, and
taken into account when developing a pa- Glycemic goals for children are pro- anticipated activity. (E)
tient’s individualized goals (101). vided in Section VIII.A.1.a. As regards goals c Most people with type 1 diabetes
Recommended glycemic goals for for glycemic control for women with should use insulin analogs to reduce
many nonpregnant adults are shown in GDM, recommendations from the Fifth hypoglycemia risk. (A)
Table 9. The recommendations are based International Workshop-Conference on c Consider screening those with type 1
on those for A1C values, with listed blood Gestational Diabetes Mellitus (105) were diabetes for other autoimmune dis-
glucose levels that appear to correlate to target maternal capillary glucose con- eases (thyroid, vitamin B12 deficiency,
with achievement of an A1C of ,7%. centrations of: celiac) as appropriate. (B)

The DCCT clearly showed that inten-


Table 9dSummary of glycemic recommendations for many nonpregnant adults with diabetes sive insulin therapy (three or more in-
jections per day of insulin, CSII, or insulin
A1C ,7.0%* pump therapy) was a key part of im-
Preprandial capillary plasma glucose 70–130 mg/dL* (3.9–7.2 mmol/L) proved glycemia and better outcomes
Peak postprandial capillary plasma glucose† ,180 mg/dL* (,10.0 mmol/L) (71,92). At the time of the study, therapy
c *Goals should be individualized based on:
was carried out with short- and intermedi-
c duration of diabetes
ate-acting human insulins. Despite better
c age/life expectancy
microvascular outcomes, intensive insulin
c comorbid conditions
therapy was associated with a high rate in
c known CVD or advanced microvascular complications
severe hypoglycemia (62 episodes per 100
c hypoglycemia unawareness
patient-years of therapy). Since the time of
c individual patient considerations
the DCCT, a number of rapid-acting and
c More or less stringent glycemic goals may be appropriate
long-acting insulin analogs have been de-
for individual patients veloped. These analogs are associated with
c Postprandial glucose may be targeted if A1C goals are
less hypoglycemia with equal A1C lower-
not met despite reaching preprandial glucose goals ing in type 1 diabetes (107,108).
†Postprandial glucose measurements should be made 1–2 h after the beginning of the meal, generally peak Recommended therapy for type 1 di-
levels in patients with diabetes. abetes consists of the following components:

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S21


Position Statement

1) use of MDI injections (three to four in- diabetes (111). This 2012 position state- Energy balance, overweight, and obesity
jections per day of basal and prandial in- ment is less prescriptive than prior algo- c Weight loss is recommended for all
sulin) or CSII therapy; 2) matching of rithms and discusses advantages and overweight or obese individuals who
prandial insulin to carbohydrate intake, disadvantages of the available medication have or are at risk for diabetes. (A)
premeal blood glucose, and anticipated classes and considerations for their use. A c For weight loss, either low-carbohydrate,
activity; and 3) for most patients (espe- patient-centered approach is stressed, low-fat calorie-restricted, or Mediterra-
cially if hypoglycemia is a problem), use taking into account patient preferences, nean diets may be effective in the short-
of insulin analogs. There are excellent re- cost and potential side effects of each term (up to 2 years). (A)
views available that guide the initiation class, effects on body weight, and hypo- c For patients on low-carbohydrate diets,
and management of insulin therapy glycemia risk. The position statement re- monitor lipid profiles, renal function,
to achieve desired glycemic goals affirms metformin as the preferred initial and protein intake (in those with ne-
(107,109,110). Although most studies of agent, barring contraindication or intoler- phropathy) and adjust hypoglycemic
MDI versus pump therapy have been small ance, either in addition to lifestyle coun- therapy as needed. (E)
and of short duration, a systematic review seling and support for weight loss and c Physical activity and behavior modifi-
and meta-analysis concluded that there exercise, or when lifestyle efforts alone cation are important components of
were no systematic differences in A1C or have not achieved or maintained glycemic weight loss programs and are most
rates of severe hypoglycemia in children goals. Metformin has a long-standing helpful in maintenance of weight
and adults between the two forms of inten- evidence base for efficacy and safety, is loss. (B)
sive insulin therapy (70). inexpensive, and may reduce risk of car-
Because of the increased frequency diovascular events (85). When metformin
Recommendations for primary
of other autoimmune diseases in type 1 fails to achieve or maintain glycemic goals,
prevention of type 2 diabetes
diabetes, screening for thyroid dysfunc- another agent should be added. Although c Among individuals at high risk for de-
tion, vitamin B12 deficiency, or celiac there are a number of trials comparing veloping type 2 diabetes, structured
disease should be considered based on dual therapy to metformin alone, few di- programs that emphasize lifestyle
signs and symptoms. Periodic screening rectly compare drugs as add-on therapy. changes that include moderate weight
in absence of symptoms has been recom- Comparative effectiveness meta-analyses loss (7% body weight) and regular
mended, but the effectiveness and opti- (112) suggest that overall each new class physical activity (150 min/week), with
mal frequency are unclear. of noninsulin agents added to initial ther- dietary strategies including reduced
apy lowers A1C around 0.9–1.1%. calories and reduced intake of dietary
2. Pharmacological therapy for hyper- Many patients with type 2 diabetes fat, can reduce the risk for developing
glycemia in type 2 diabetes eventually benefit from insulin therapy. diabetes and are therefore recom-
Recommendations The progressive nature of type 2 diabetes mended. (A)
c Metformin, if not contraindicated and if and its therapies should regularly be c Individuals at risk for type 2 diabetes
tolerated, is the preferred initial pharma- explained in a matter-of-fact manner to should be encouraged to achieve the
cological agent for type 2 diabetes. (A) patients, avoiding using insulin as a threat U.S. Department of Agriculture (USDA)
c In newly diagnosed type 2 diabetic or describing it as a failure or punishment. recommendation for dietary fiber (14 g
patients with markedly symptomatic Providing patients with an algorithm for fiber/1,000 kcal) and foods containing
and/or elevated blood glucose levels or self-titration of insulin doses based on whole grains (one-half of grain intake).
A1C, consider insulin therapy, with or SMBG results improves glycemic control (B)
without additional agents, from the in type 2 diabetic patients initiating c Individuals at risk for type 2 diabetes
outset. (E) insulin (113). For more details on phar- should be encouraged to limit their
c If noninsulin monotherapy at maximal macotherapy for hyperglycemia in type intake of sugar-sweetened beverages
tolerated dose does not achieve or main- 2 diabetes, including a table of informa- (SSBs). (B)
tain the A1C target over 3–6 months, tion about currently approved classes
add a second oral agent, a glucagon-like of medications for treating hyperglyce-
peptide-1 (GLP-1) receptor agonist, or mia in type 2 diabetes, readers are referred Recommendations for management
insulin. (A) to the ADA-EASD position statement of diabetes
c A patient-centered approach should be (111). Macronutrients in diabetes management
used to guide choice of pharmacological c The mix of carbohydrate, protein, and
agents. Considerations include efficacy, fat may be adjusted to meet the meta-
cost, potential side effects, effects on E. MNT bolic goals and individual preferences
weight, comorbidities, hypoglycemia General recommendations of the person with diabetes. (C)
risk, and patient preferences. (E) c Individuals who have prediabetes or c Monitoring carbohydrate, whether by
c Due to the progressive nature of type 2 diabetes should receive individualized carbohydrate counting, choices, or ex-
diabetes, insulin therapy is eventually MNT as needed to achieve treatment perience-based estimation, remains a key
indicated for many patients with type 2 goals, preferably provided by a regis- strategy in achieving glycemic control. (B)
diabetes. (B) tered dietitian familiar with the com- c Saturated fat intake should be ,7% of
ponents of diabetes MNT. (A) total calories. (B)
The ADA and EASD have recently c Because MNT can result in cost-savings c Reducing intake of trans fat lowers LDL
partnered on guidance for individualiza- and improved outcomes (B), MNT cholesterol and increases HDL choles-
tion of use of medication classes and should be adequately covered by in- terol (A); therefore, intake of trans fat
combinations in patients with type 2 surance and other payers. (E) should be minimized. (E)

S22 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

Other nutrition recommendations loss diets has not been established. A type 2 diabetes. One-year results of the in-
c If adults with diabetes choose to use systematic review of 80 weight loss studies tensive lifestyle intervention in this trial
alcohol, they should limit intake to a of $1-year duration demonstrated that show an average 8.6% weight loss, signifi-
moderate amount (one drink per day or moderate weight loss achieved through cant reduction of A1C, and reduction in
less for adult women and two drinks diet alone, diet and exercise, and meal re- several CVD risk factors (138), with benefits
per day or less for adult men) and should placements can be achieved and main- sustained at 4 years (139). At the time this
take extra precautions to prevent hypo- tained (4.8–8% weight loss at 12 months) article was going to press, the Look AHEAD
glycemia. (E) (125). Both low-fat low-carbohydrate and trial was halted early, after 11 years of fol-
c Routine supplementation with anti- Mediterranean style eating patterns have low-up, because there was no significant
oxidants, such as vitamins E and C and been shown to promote weight loss with difference in the primary cardiovascular
carotene, is not advised because of lack similar results after 1 to 2 years of follow- outcome between the weight loss and stan-
of evidence of efficacy and concern re- up (126–129). A meta-analysis showed dard care group (http://www.nih.gov/news/
lated to long-term safety. (A) that at 6 months, low-carbohydrate diets health/oct2012/niddk-19.htm). Multiple
c It is recommended that individualized were associated with greater improvements cardiovascular risk factors were improved
meal planning include optimization of in triglyceride and HDL cholesterol concen- with weight loss, and those participants
food choices to meet recommended di- trations than low-fat diets; however, LDL on average were on fewer medications to
etary allowance (RDA)/dietary reference cholesterol was significantly higher on the achieve these improvements.
intake (DRI) for all micronutrients. (E) low-carbohydrate diets (130). Although numerous studies have at-
Because of the effects of obesity on tempted to identify the optimal mix of
MNT is an integral component of di- insulin resistance, weight loss is an im- macronutrients for meal plans of people
abetes prevention, management, and self- portant therapeutic objective for over- with diabetes, a recent systematic review
management education. In addition to its weight or obese individuals who are at (140) confirms that there is no most effec-
role in preventing and controlling diabetes, risk for diabetes (131). The multifactorial tive mix that applies broadly, and that
the ADA recognizes the importance of intensive lifestyle intervention used in the macronutrient proportions should be indi-
nutrition as an essential component of an DPP, which included reduced intake of fat vidualized. It must be clearly recognized
overall healthy lifestyle. A full review of the and calories, led to weight loss averaging that regardless of the macronutrient mix,
evidence regarding nutrition in preventing 7% at 6 months and maintenance of 5% total caloric intake must be appropriate to
and controlling diabetes and its complica- weight loss at 3 years, associated with a weight management goal. Further, individ-
tions and additional nutrition-related rec- 58% reduction in incidence of type 2 di- ualization of the macronutrient composi-
ommendations can be found in the ADA abetes (23). An RCT looking at high-risk tion will depend on the metabolic status
position statement “Nutrition Recommen- individuals in Spain showed that the of the patient (e.g., lipid profile, renal func-
dations and Interventions for Diabetes” Mediterranean dietary pattern reduced tion) and/or food preferences. A variety of
(114), which is being updated as of 2013. the incidence of diabetes in the absence dietary meal patterns are likely effective in
Achieving nutrition-related goals requires a of weight loss by 52% compared with the managing diabetes including Mediterra-
coordinated team effort that includes the ac- low-fat control group (132). nean-style, plant-based (vegan or vegetar-
tive involvement of the person with predia- Although our society abounds with ian), low-fat and lower-carbohydrate eating
betes or diabetes. Because of the complexity examples of high-calorie nutrient-poor patterns (127,141–143).
of nutrition issues, it is recommended that a foods, large increases in the consumption It should be noted that the RDA for
registered dietitian who is knowledgeable of SSBs have coincided with the epidemics digestible carbohydrate is 130 g/day and is
and skilled in implementing nutrition of obesity and type 2 diabetes. In a meta- based on providing adequate glucose as the
therapy into diabetes management and analysis of eight prospective cohort stud- required fuel for the central nervous system
education be the team member who pro- ies (n 5 310,819), a diet high in consump- without reliance on glucose production
vides MNT. tion of SSBs was associated with the from ingested protein or fat. Although
Clinical trials/outcome studies of development of type 2 diabetes (n 5 brain fuel needs can be met on lower
MNT have reported decreases in A1C at 15,043). Individuals in the highest versus carbohydrate diets, long-term metabolic
3–6 months ranging from 0.25 to 2.9% lowest quantile of SSB intake had a 26% effects of very low-carbohydrate diets are
with higher reductions seen in type 2 greater risk of developing diabetes (133). unclear and such diets eliminate many
diabetes of shorter duration. Multiple For individuals with type 2 diabetes, foods that are important sources of energy,
studies have demonstrated sustained im- studies have demonstrated that moderate fiber, vitamins, and minerals and are im-
provements in A1C at 12 months and lon- weight loss (5% of body weight) is associ- portant in dietary palatability (144).
ger when a registered dietitian provided ated with decreased insulin resistance, im- Saturated and trans fatty acids are the
follow-up visits ranging from monthly to proved measures of glycemia and lipemia, principal dietary determinants of plasma
3 sessions per year (115–122). Studies in and reduced blood pressure (134); longer- LDL cholesterol. There is a lack of evi-
nondiabetic individuals suggest that term studies ($52 weeks) showed mixed dence on the effects of specific fatty acids
MNT reduces LDL cholesterol by 15–25 effects on A1C in adults with type 2 diabetes on people with diabetes, so the recom-
mg/dL up to 16% (123) and support a (135–137), and in some studies results mended goals are consistent with those
role for lifestyle modification in treating were confounded by pharmacological for individuals with CVD (123,145).
hypertension (123,124). weight loss therapy. Look AHEAD (Action
Although the importance of weight loss for Health in Diabetes) is a large clinical trial Reimbursement for MNT
for overweight and obese individuals is well designed to determine whether long-term MNT, when delivered by a registered
documented, an optimal macronutrient weight loss will improve glycemia and pre- dietitian according to nutrition practice
distribution and dietary pattern of weight vent cardiovascular events in subjects with guidelines, is reimbursed as part of the

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S23


Position Statement

Medicare program as overseen by the Current best practice of DSME is a DSMS and to assist diabetes educators
Centers for Medicare and Medicaid Serv- skill-based approach that focuses on in a variety of settings to provide evidence-
ices (CMS), as well as many health in- helping those with diabetes make in- based education and self-management
surance plans. formed self-management choices. DSME support (152). The standards, recently up-
has changed from a didactic approach dated, are reviewed and updated every 5
F. Diabetes self-management focusing on providing information to years by a task force representing key or-
education and support more theoretically based empowerment ganizations involved in the field of diabetes
Recommendations models that focus on helping those with education and care.
c People with diabetes should receive diabetes make informed self-management
DSME and diabetes self-management decisions. Care of diabetes has shifted to DSME and DSMS providers and peo-
support (DSMS) according to National an approach that is more patient centered ple with prediabetes
Standards for Diabetes Self-Manage- and places the person with diabetes The new standards for DSME and DSMS
ment Education and Support when and his or her family at the center of the also apply to the education and support of
their diabetes is diagnosed and as care model working in collaboration people with prediabetes. Currently, there
needed thereafter. (B) with health care professionals. Patient- are significant barriers to the provision of
c Effective self-management and quality centered care is respectful of and respon- education and support to those with pre-
of life are the key outcomes of DSME sive to individual patient preferences, diabetes. However, the strategies for sup-
and DSMS and should be measured needs, and values and ensures that patient porting successful behavior change and
and monitored as part of care. (C) values guide all decision making (154). the healthy behaviors recommended for
c DSME and DSMS should address people with prediabetes are largely iden-
psychosocial issues, since emotional Evidence for the benefits of DSME and tical to those for people with diabetes. As
well-being is associated with positive DSMS barriers to care are overcome, providers of
diabetes outcomes. (C) Multiple studies have found that DSME is DSME and DSMS, given their training and
c DSME and DSMS programs are appro- associated with improved diabetes knowl- experience, are particularly well equipped
priate venues for people with prediabetes edge and improved self-care behavior to assist people with prediabetes in de-
to receive education and support to de- (146), improved clinical outcomes such veloping and maintaining behaviors that
velop and maintain behaviors that can as lower A1C (147,148,150,151,155– can prevent or delay the onset of diabetes
prevent or delay the onset of diabetes. (C) 158), lower self-reported weight (146), im- (152,186).
c Because DSME and DSMS can result in proved quality of life (149,156,159),
cost-savings and improved outcomes (B), healthy coping (160), and lower costs Reimbursement for DSME and DSMS
DSME and DSMS should be adequately (161). Better outcomes were reported for DSME, when provided by a program that
reimbursed by third-party payers. (E) DSME interventions that were longer and meets national standards for DSME and is
included follow-up support (DSMS) recognized by the ADA or other approval
DSME and DSMS are essential ele- (146,162–165), that were culturally bodies, is reimbursed as part of the Medicare
ments of diabetes care (146–151), and re- (166,167) and age appropriate (168,169) program as overseen by the CMS. DSME
cently updated National Standards for and were tailored to individual needs and is also covered by most health insurance
Diabetes Self-Management Education and preferences, and that addressed psychoso- plans. Although DSMS has been shown to
Support (152) are based on evidence for its cial issues and incorporated behavioral be instrumental for improving outcomes, as
benefits. Education helps people with dia- strategies (146,150,170,171). Both indi- described in the “Evidence for the benefits of
betes initiate effective self-management and vidual and group approaches have been DSME and DSMS,” and can be provided in
cope with diabetes when they are first di- found effective (172,173). There is growing formats such as phone calls and via tele-
agnosed. Ongoing DSME and DSMS also evidence for the role of community health health, it currently has limited reimburse-
help people with diabetes maintain effec- workers and peer (174–180) and lay lead- ment as face-to-face visits included as
tive self-management throughout a lifetime ers (181) in delivering DSME and DSMS in follow-up to DSME.
of diabetes as they face new challenges and conjunction with the core team (182).
treatment advances become available. Diabetes education is associated with G. Physical activity
DSME helps patients optimize metabolic increased use of primary and preventive Recommendations
control, prevent and manage complica- services (161,183) and lower use of acute, c Adults with diabetes should be advised
tions, and maximize quality of life in a inpatient hospital services (161). Patients to perform at least 150 min/week of
cost-effective manner (153). who participate in diabetes education are moderate-intensity aerobic physical
DSME and DSMS are the ongoing more likely to follow best practice treat- activity (50–70% of maximum heart
processes of facilitating the knowledge, ment recommendations, particularly rate), spread over at least 3 days/week
skill, and ability necessary for diabetes among the Medicare population, and with no more than two consecutive
self-care. This process incorporates the have lower Medicare and commercial days without exercise. (A)
needs, goals, and life experiences of the claim costs (184,185). c In the absence of contraindications,
person with diabetes. The overall objec- adults with type 2 diabetes should be
tives of DSME and DSMS are to support The National Standards for Diabetes encouraged to perform resistance train-
informed decision making, self-care behav- Self-Management Education and ing at least twice per week. (A)
iors, problem-solving, and active collabo- Support
ration with the health care team to improve The National Standards for Diabetes Self- Exercise is an important part of the
clinical outcomes, health status, and qual- Management Education and Support are diabetes management plan. Regular exer-
ity of life in a cost-effective manner (152). designed to define quality DSME and cise has been shown to improve blood

S24 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

glucose control, reduce cardiovascular risk at least one set of five or more different non-PDR (NPDR), vigorous aerobic or
factors, contribute to weight loss, and resistance exercises involving the large resistance exercise may be contraindi-
improve well-being. Furthermore, regular muscle groups (189). cated because of the risk of triggering
exercise may prevent type 2 diabetes in vitreous hemorrhage or retinal detach-
high-risk individuals (23–25). Structured Evaluation of the diabetic patient before ment (198).
exercise interventions of at least 8 weeks’ recommending an exercise program Peripheral neuropathy. Decreased pain
duration have been shown to lower A1C by Prior guidelines suggested that before sensation in the extremities results in
an average of 0.66% in people with type recommending a program of physical activ- increased risk of skin breakdown and
2 diabetes, even with no significant change ity, the provider should assess patients with infection and of Charcot joint destruc-
in BMI (187). Higher levels of exercise in- multiple cardiovascular risk factors for cor- tion. Prior recommendations have ad-
tensity are associated with greater improve- onary artery disease (CAD). As discussed vised non–weight-bearing exercise for
ments in A1C and in fitness (188). A joint more fully in Section VI.A.5, the area of patients with severe peripheral neuropa-
position statement of the ADA and the screening asymptomatic diabetic patients thy. However, studies have shown that
American College of Sports Medicine for CAD remains unclear, and a recent ADA moderate-intensity walking may not
(ACSM) summarizes the evidence for the consensus statement on this issue con- lead to increased risk of foot ulcers or
benefits of exercise in people with type 2 cluded that routine screening is not recom- reulceration in those with peripheral
diabetes (189). mended (196). Providers should use clinical neuropathy (199). All individuals with
judgment in this area. Certainly, high-risk peripheral neuropathy should wear
Frequency and type of exercise patients should be encouraged to start with proper footwear and examine their feet
The U.S. Department of Health and Human short periods of low-intensity exercise and daily to detect lesions early. Anyone
Services’ Physical Activity Guidelines for increase the intensity and duration slowly. with a foot injury or open sore should
Americans (190) suggest that adults over Providers should assess patients for be restricted to non–weight-bearing ac-
age 18 years do 150 min/week of moder- conditions that might contraindicate cer- tivities.
ate-intensity, or 75 min/week of vigorous tain types of exercise or predispose to Autonomic neuropathy. Autonomic neu-
aerobic physical activity, or an equivalent injury, such as uncontrolled hyperten- ropathy can increase the risk of exercise-
combination of the two. In addition, the sion, severe autonomic neuropathy, se- induced injury or adverse event through
guidelines suggest that adults also do vere peripheral neuropathy or history of decreased cardiac responsiveness to exer-
muscle-strengthening activities that in- foot lesions, and unstable proliferative cise, postural hypotension, impaired ther-
volve all major muscle groups $2 days/ retinopathy. The patient’s age and pre- moregulation, impaired night vision due to
week. The guidelines suggest that adults vious physical activity level should be impaired papillary reaction, and unpredict-
over age 65 years, or those with disabili- considered. able carbohydrate delivery from gastropa-
ties, follow the adult guidelines if possible resis predisposing to hypoglycemia (200).
or (if this is not possible) be as physically Exercise in the presence of nonoptimal Autonomic neuropathy is also strongly as-
active as they are able. Studies included in glycemic control sociated with CVD in people with diabetes
the meta-analysis of effects of exercise in- Hyperglycemia. When people with type (201,202). People with diabetic autonomic
terventions on glycemic control (187) 1 diabetes are deprived of insulin for 12– neuropathy should undergo cardiac inves-
had a mean number of sessions per 48 h and are ketotic, exercise can worsen tigation before beginning physical activity
week of 3.4, with a mean of 49 min per hyperglycemia and ketosis (197); there- more intense than that to which they are
session. The DPP lifestyle intervention, fore, vigorous activity should be avoided accustomed.
which included 150 min/week of moder- in the presence of ketosis. However, it is Albuminuria and nephropathy. Physical
ate-intensity exercise, had a beneficial not necessary to postpone exercise based activity can acutely increase urinary pro-
effect on glycemia in those with predia- simply on hyperglycemia, provided the tein excretion. However, there is no evi-
betes. Therefore, it seems reasonable to patient feels well and urine and/or blood dence that vigorous exercise increases the
recommend that people with diabetes ketones are negative. rate of progression of diabetic kidney
try to follow the physical activity guide- Hypoglycemia. In individuals taking in- disease, and there is likely no need for
lines for the general population. sulin and/or insulin secretagogues, phys- any specific exercise restrictions for peo-
Progressive resistance exercise im- ical activity can cause hypoglycemia if ple with diabetic kidney disease (203).
proves insulin sensitivity in older men medication dose or carbohydrate con-
with type 2 diabetes to the same or even a sumption is not altered. For individuals H. Psychosocial assessment and care
greater extent as aerobic exercise (191). on these therapies, added carbohydrate Recommendations
Clinical trials have provided strong evidence should be ingested if pre-exercise glucose c It is reasonable to include assessment of
for the A1C lowering value of resistance levels are ,100 mg/dL (5.6 mmol/L). Hy- the patient’s psychological and social
training in older adults with type 2 dia- poglycemia is rare in diabetic individuals situation as an ongoing part of the
betes (192,193) and for an additive ben- who are not treated with insulin or insulin medical management of diabetes. (E)
efit of combined aerobic and resistance secretagogues, and no preventive mea- c Psychosocial screening and follow-up
exercise in adults with type 2 diabetes sures for hypoglycemia are usually ad- may include, but is not limited to, at-
(194,195). In the absence of contraindi- vised in these cases. titudes about the illness, expectations
cations, patients with type 2 diabetes for medical management and out-
should be encouraged to do at least two Exercise in the presence of specific comes, affect/mood, general and di-
weekly sessions of resistance exercise (ex- long-term complications of diabetes abetes-related quality of life, resources
ercise with free weights or weight ma- Retinopathy. In the presence of prolifer- (financial, social, and emotional), and
chines), with each session consisting of ative diabetic retinopathy (PDR) or severe psychiatric history. (E)

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S25


Position Statement

c Screen for psychosocial problems such incorporate psychological assessment The hospitalized patient should be
as depression and diabetes-related and treatment into routine care rather treated by a physician with expertise in
distress, anxiety, eating disorders, than waiting for identification of a specific the management of diabetes. For further
and cognitive impairment when self- problem or deterioration in psychological information on management of patients
management is poor. (B) status (170). Although the clinician may with hyperglycemia in the hospital, see
not feel qualified to treat psychological Section IX.A. For further information
It is important to establish that emotional problems (219), utilizing the patient- on management of DKA or hyperglycemic
well-being is part of diabetes care and self- provider relationship as a foundation nonketotic hyperosmolar state, refer to the
management. Psychological and social can increase the likelihood that the pa- ADA statement on hyperglycemic crises
problems can impair the individual’s tient will accept referral for other services. (222).
(204–207) or family’s ability to carry out Collaborative care interventions and
diabetes care tasks and therefore compro- using a team approach have demon-
mise health status. There are opportuni- strated efficacy in diabetes and depres- K. Hypoglycemia
ties for the clinician to assess psychosocial sion (220,221). Recommendations
status in a timely and efficient manner so c Individuals at risk for hypoglycemia
that referral for appropriate services can should be asked about symptomatic
be accomplished. A systematic review and I. When treatment goals are not met and asymptomatic hypoglycemia at
meta-analysis showed that psychosocial For a variety of reasons, some people with each encounter. (C)
interventions modestly but significantly diabetes and their health care providers c Glucose (15–20 g) is the preferred
improved A1C (standardized mean differ- do not achieve the desired goals of treat- treatment for the conscious individual
ence 20.29%) and mental health out- ment (Table 9). Rethinking the treatment with hypoglycemia, although any form
comes. However, there was a limited regimen may require assessment of barri- of carbohydrate that contains glucose
association between the effects on A1C ers including income, health literacy, may be used. If SMBG 15 min after
and mental health, and no intervention diabetes distress, depression, and com- treatment shows continued hypogly-
characteristics predicted benefit on both peting demands, including those related cemia, the treatment should be re-
outcomes (208). to family responsibilities and dynamics. peated. Once SMBG glucose returns to
Other strategies may include culturally normal, the individual should consume a
Key opportunities for screening of
appropriate and enhanced DSME and meal or snack to prevent recurrence of
psychosocial status occur at diagnosis,
DSMS, co-management with a diabetes
during regularly scheduled management hypoglycemia. (E)
team, referral to a medical social worker
visits, during hospitalizations, at discov- c Glucagon should be prescribed for all
for assistance with insurance coverage, or
ery of complications, or when problems individuals at significant risk of severe
change in pharmacological therapy. Initi-
with glucose control, quality of life, or hypoglycemia, and caregivers or family
ation of or increase in SMBG, utilization
adherence are identified. Patients are members of these individuals should
of CGM, frequent contact with the pa-
likely to exhibit psychological vulnerabil- be instructed on its administration.
tient, or referral to a mental health pro-
ity at diagnosis and when their medical Glucagon administration is not limited
fessional or physician with special
status changes (e.g., the end of the hon- to health care professionals. (E)
expertise in diabetes may be useful.
eymoon period), when the need for in- c Hypoglycemia unawareness or one or
tensified treatment is evident, and when more episodes of severe hypoglycemia
complications are discovered (206). J. Intercurrent illness should trigger re-evaluation of the
Depression affects about 20–25% of The stress of illness, trauma, and/or sur- treatment regimen. (E)
people with diabetes (207) and increases gery frequently aggravates glycemic con- c Insulin-treated patients with hypogly-
the risk for MI and post-MI (209,210) and trol and may precipitate diabetic cemia unawareness or an episode of
all-cause (211) mortality. Other issues ketoacidosis (DKA) or nonketotic hyper- severe hypoglycemia should be advised
known to impact self-management and osmolar statedlife-threatening conditions to raise their glycemic targets to strictly
health outcomes include but are not limited that require immediate medical care to pre- avoid further hypoglycemia for at least
to attitudes about the illness, expectations vent complications and death. Any condi- several weeks, to partially reverse hy-
for medical management and outcomes, tion leading to deterioration in glycemic poglycemia unawareness, and to re-
affect/mood, general and diabetes-related control necessitates more frequent monitor- duce risk of future episodes. (A)
quality of life, diabetes-related distress ing of blood glucose and (in ketosis-prone c Ongoing assessment of cognitive func-
(212,213), resources (financial, social, patients) urine or blood ketones. Marked tion is suggested with increased vigilance
and emotional) (214), and psychiatric his- hyperglycemia requires temporary adjust- for hypoglycemia by the clinician, pa-
tory (215–217). Screening tools are avail- ment of the treatment program and, if ac- tient, and caregivers if low cognition
able for a number of these areas (170). companied by ketosis, vomiting, or and/or declining cognition is found. (B)
Indications for referral to a mental health alteration in level of consciousness, imme-
specialist familiar with diabetes manage- diate interaction with the diabetes care Hypoglycemia is the leading limiting
ment may include gross disregard for the team. The patient treated with noninsulin factor in the glycemic management of type
medical regimen (by self or others) (217), therapies or MNT alone may temporarily 1 and insulin-treated type 2 diabetes (223).
depression, possibility of self-harm, debil- require insulin. Adequate fluid and caloric Mild hypoglycemia may be inconvenient
itating anxiety (alone or with depression), intake must be assured. Infection or dehy- or frightening to patients with diabetes,
indications of an eating disorder (218), or dration is more likely to necessitate hospi- and more severe hypoglycemia can cause
cognitive functioning that significantly talization of the person with diabetes than acute harm to the person with diabetes or
impairs judgment. It is preferable to the person without diabetes. others, if it causes falls, motor vehicle

S26 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

accidents, or other injury. A large cohort unconsciousness) should be treated using c Although small trials have shown gly-
study suggested that among older adults emergency glucagon kits, which require a cemic benefit of bariatric surgery in
with type 2 diabetes, a history of severe prescription. Those in close contact with, patients with type 2 diabetes and BMI
hypoglycemia was associated with greater or having custodial care of, people with 30–35 kg/m2, there is currently in-
risk of dementia (224). Conversely, in a hypoglycemia-prone diabetes (family sufficient evidence to generally rec-
substudy of the ACCORD trial, cognitive members, roommates, school personnel, ommend surgery in patients with BMI
impairment at baseline or decline in cog- child care providers, correctional institu- ,35 kg/m2 outside of a research pro-
nitive function during the trial was signif- tion staff, or coworkers) should be in- tocol. (E)
icantly associated with subsequent structed in use of such kits. An individual c The long-term benefits, cost-effectiveness,
episodes of severe hypoglycemia (225). does not need to be a health care pro- and risks of bariatric surgery in indivi-
Evidence from the DCCT/EDIC trial, fessional to safely administer glucagon. duals with type 2 diabetes should be
which involved younger adults and ado- Care should be taken to ensure that un- studied in well-designed controlled trials
lescents with type 1 diabetes, suggested no expired glucagon kits are available. with optimal medical and lifestyle therapy
association of frequency of severe hypo- Prevention of hypoglycemia is a crit- as the comparator. (E)
glycemia with cognitive decline (226). As ical component of diabetes management.
discussed in the Section VIII.A.1.a, a few Particularly for insulin-treated patients, Gastric reduction surgery, either gas-
studies have suggested that severe hypo- SMBG and, for some patients, CGM to tric banding or procedures that involve
glycemia in very young children is associ- detect incipient hypoglycemia and assess bypassing, transposing, or resecting sec-
ated with mild impairments in cognitive adequacy of treatment are a key compo- tions of the small intestine, when part of a
function. nent of safe therapy. Patients should un- comprehensive team approach, can be an
As described in the Section V.b.2, derstand situations that increase their risk effective weight loss treatment for severe
severe hypoglycemia was associated with of hypoglycemia, such as when fasting for obesity, and national guidelines support
mortality in participants in both the stan- tests or procedures, during or after in- its consideration for people with type
dard and intensive glycemia arms of the tense exercise, and during sleep and that 2 diabetes who have BMI of 35 kg/m2
ACCORD trial, but the relationships with increase the risk of harm to self or others or greater. Bariatric surgery has been
achieved A1C and treatment intensity from hypoglycemia, such as with driving. shown to lead to near- or complete nor-
were not straightforward. An association Teaching people with diabetes to balance malization of glycemia in ;40–95% of
of severe hypoglycemia with mortality insulin use, carbohydrate intake, and patients with type 2 diabetes, depending
was also found in the ADVANCE trial exercise is a necessary but not always on the study and the surgical procedure
(227), but its association with other out- sufficient strategy for prevention. In type (230–232). A meta-analysis of studies of
comes such as pulmonary and skin disor- 1 diabetes and severely insulin-deficient bariatric surgery involving 3,188 patients
ders raises the question of whether severe type 2 diabetes, the syndrome of hypo- with diabetes reported that 78% had re-
hypoglycemia is a marker for a sicker pa- glycemia unawareness, or hypoglycemia- mission of diabetes (normalization of
tient, rather than a cause of mortality. An associated autonomic failure, can severely blood glucose levels in the absence of
association of self-reported severe hypo- compromise stringent diabetes control medications) and that the remission rates
glycemia with 5-year mortality has also and quality of life. The deficient counter- were sustained in studies that had follow-
been reported in clinical practice (228). regulatory hormone release and autonomic up exceeding 2 years (233). Remission
At the time this statement went to press, responses in this syndrome are both risk rates tend to be lower with procedures
the ADA and The Endocrine Society were factors for, and caused by, hypoglycemia. A that only constrict the stomach and
finalizing a Hypoglycemia Work Group corollary to this “vicious cycle” is that sev- higher with those that bypass portions
report, where the causes of and associa- eral weeks of avoidance of hypoglycemia of the small intestine. Additionally, there
tions with hypoglycemia are discussed in has been demonstrated to improve is a suggestion that intestinal bypass pro-
depth. counter-regulation and awareness to some cedures may have glycemic effects that are
Treatment of hypoglycemia (plasma extent in many patients (229). Hence, independent of their effects on weight,
glucose ,70 mg/dL) requires ingestion of patients with one or more episodes of perhaps involving the incretin axis.
glucose- or carbohydrate-containing severe hypoglycemia may benefit from There is also evidence for diabetes
foods. The acute glycemic response cor- at least short-term relaxation of glycemic remission in subjects who are less obese.
relates better with the glucose content targets. One randomized trial compared adjust-
than with the carbohydrate content of able gastric banding to “best available”
the food. Although pure glucose is the medical and lifestyle therapy in subjects
preferred treatment, any form of carbohy- L. Bariatric surgery with type 2 diabetes and BMI 30–40 kg/m2
drate that contains glucose will raise Recommendations (234). Overall, 73% of surgically treated
blood glucose. Added fat may retard and c Bariatric surgery may be considered for patients achieved “remission” of their di-
then prolong the acute glycemic response. adults with BMI $35 kg/m2 and type 2 abetes compared with 13% of those trea-
Ongoing activity of insulin or insulin sec- diabetes, especially if the diabetes or ted medically. The latter group lost only
retagogues may lead to recurrence of hypo- associated comorbidities are difficult to 1.7% of body weight, suggesting that
glycemia unless further food is ingested control with lifestyle and pharmaco- their therapy was not optimal. Overall
after recovery. logical therapy. (B) the trial had 60 subjects, and only 13
Severe hypoglycemia (where the in- c Patients with type 2 diabetes who have had a BMI under 35 kg/m2, making it dif-
dividual requires the assistance of an- undergone bariatric surgery need life- ficult to generalize these results widely to
other person and cannot be treated with long lifestyle support and medical diabetic patients who are less severely
oral carbohydrate due to confusion or monitoring. (B) obese or with longer duration of diabetes.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S27


Position Statement

In a recent nonrandomized study of 66 age previously immunized when they HBV in long-term care facilities and hos-
people with BMI of 30–35 kg/m2, 88% were ,65 years of age if the vaccine pitals have been reported to the CDC,
of participants had remission of their was administered .5 years ago. Other with the majority involving adults with
type 2 diabetes up to 6 years after surgery indications for repeat vaccination in- diabetes receiving “assisted blood glucose
(235). clude nephrotic syndrome, chronic monitoring,” in which such monitoring is
Bariatric surgery is costly in the short- renal disease, and other immunocom- done by a health care professional with
term and has some risks. Rates of mor- promised states, such as after trans- responsibility for more than one patient.
bidity and mortality directly related to the plantation. (C) HBV is highly transmissible and stable for
surgery have been reduced considerably c Administer hepatitis B vaccination to long periods of time on surfaces such as
in recent years, with 30-day mortality unvaccinated adults with diabetes who lancing devices and blood glucose meters,
rates now 0.28%, similar to those of are aged 19 through 59 years. (C) even when no blood is visible. Blood suf-
laparoscopic cholecystectomy (236). c Consider administering hepatitis B vac- ficient to transmit the virus has also been
Longer-term concerns include vitamin cination to unvaccinated adults with found in the reservoirs of insulin pens,
and mineral deficiencies, osteoporosis, diabetes who are aged $60 years. (C) resulting in warnings against sharing
and rare but often severe hypoglycemia such devices between patients.
from insulin hypersecretion. Cohort Influenza and pneumonia are common, The CDC analyses suggest that, ex-
studies attempting to match subjects preventable infectious diseases associated cluding persons with HBV-related risk
suggest that the procedure may reduce with high mortality and morbidity in the behaviors, acute HBV infection is about
longer-term mortality rates (237). Recent elderly and in people with chronic dis- twice as high among adults with diabetes
retrospective analyses and modeling eases. Though there are limited studies aged $23 years compared with adults
studies suggest that these procedures reporting the morbidity and mortality of without diabetes. Seroprevalence of anti-
may be cost-effective, when one considers influenza and pneumococcal pneumonia body to HBV core antigen, suggesting past
reduction in subsequent health care costs specifically in people with diabetes, ob- or current infection, is 60% higher among
(238–240). servational studies of patients with a va- adults with diabetes than those without,
Some caution about the benefits of riety of chronic illnesses, including and there is some evidence that diabetes
bariatric surgery might come from recent diabetes, show that these conditions are imparts a higher HBV case fatality rate.
studies. Propensity score–adjusted anal- associated with an increase in hospital- The age differentiation in the recommen-
yses of older severely obese patients with izations for influenza and its complica- dations stems from CDC economic mod-
high baseline mortality in Veterans Af- tions. People with diabetes may be at els suggesting that vaccination of adults
fairs Medical Centers found that the use increased risk of the bacteremic form of with diabetes who were aged 20–59 years
of bariatric surgery was not associated pneumococcal infection and have been would cost an estimated $75,000 per
with decreased mortality compared with reported to have a high risk of nosocomial quality-adjusted life-year saved, while
usual care during a mean 6.7 years of bacteremia, which has a mortality rate as cost per quality-adjusted life-year saved
follow-up (241). A study that followed high as 50% (243). increased significantly at higher ages. In
patients who had undergone laparo- Safe and effective vaccines are avail- addition to competing causes of mortality
scopic adjustable gastric banding able that can greatly reduce the risk of in older adults, the immune response to
(LAGB) for 12 years found that 60% serious complications from these diseases the vaccine declines with age (246).
were satisfied with the procedure. Nearly (244,245). In a case-control series, influ- These new recommendations regard-
one out of three patients experienced enza vaccine was shown to reduce dia- ing HBV vaccinations serve as a reminder
band erosion, and almost half required betes-related hospital admission by as to clinicians that children and adults with
removal of their bands. The authors’ con- much as 79% during flu epidemics diabetes need a number of vaccinations,
clusion was that “LAGB appears to result (244). There is sufficient evidence to sup- both those specifically indicated because
in relatively poor long-term outcomes” port that people with diabetes have of diabetes as well as those recommended
(242). Studies of the mechanisms of gly- appropriate serological and clinical re- for the general population (http://www.
cemic improvement and long-term bene- sponses to these vaccinations. The Cen- cdc.gov/vaccines/recs/).
fits and risks of bariatric surgery in ters for Disease Control and Prevention
individuals with type 2 diabetes, espe- (CDC) Advisory Committee on Immuni- VI. PREVENTION AND
cially those who are not severely obese, zation Practices recommends influenza MANAGEMENT OF DIABETES
will require well-designed clinical trials, and pneumococcal vaccines for all indi- COMPLICATIONS
with optimal medical and lifestyle ther- viduals with diabetes (http://www.cdc.
apy of diabetes and cardiovascular risk gov/vaccines/recs/). A. CVD
factors as the comparator. Late in 2012, the Advisory Commit- CVD is the major cause of morbidity and
tee on Immunization Practices of the CDC mortality for individuals with diabetes
M. Immunization recommended that all previously unvac- and the largest contributor to the direct
Recommendations cinated adults with diabetes aged 19 and indirect costs of diabetes. The common
c Annually provide an influenza vaccine through 59 years be vaccinated against conditions coexisting with type 2 diabetes
to all diabetic patients $6 months of hepatitis B virus (HBV) as soon as possible (e.g., hypertension and dyslipidemia) are
age. (C) after a diagnosis of diabetes is made and clear risk factors for CVD, and diabetes
c Administer pneumococcal polysaccharide that vaccination be considered for those itself confers independent risk. Numerous
vaccine to all diabetic patients $2 years aged $60 years, after assessing risk and studies have shown the efficacy of con-
of age. A one-time revaccination is rec- likelihood of an adequate immune re- trolling individual cardiovascular risk
ommended for individuals .64 years of sponse (246). At least 29 outbreaks of factors in preventing or slowing CVD in

S28 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

people with diabetes. Large benefits are c If ACE inhibitors, ARBs, or diuretics are pressure to ,140 mmHg systolic and
seen when multiple risk factors are ad- used, serum creatinine/estimated glo- ,80 mmHg diastolic in individuals with
dressed globally (247,248). There is evi- merular filtration rate (eGFR) and serum diabetes (252,255–257). The evidence for
dence that measures of 10-year coronary potassium levels should be monitored. benefits from lower systolic blood pres-
heart disease (CHD) risk among U.S. (E) sure targets is, however, limited.
adults with diabetes have improved signif- c In pregnant patients with diabetes and The ACCORD trial examined
icantly over the past decade (249). chronic hypertension, blood pressure whether blood pressure lowering to sys-
target goals of 110–129/65–79 mmHg tolic blood pressure ,120 mmHg pro-
are suggested in the interest of long- vides greater cardiovascular protection
1. Hypertension/blood pressure term maternal health and minimizing than a systolic blood pressure level of
control impaired fetal growth. ACE inhibitors 130–140 mmHg in patients with type 2
Recommendations and ARBs are contraindicated during diabetes at high risk for CVD (258). The
Screening and diagnosis pregnancy. (E) blood pressure achieved in the intensive
c Blood pressure should be measured at group was 119/64 mmHg and in the stan-
every routine visit. Patients found to Hypertension is a common comor- dard group 133/70 mmHg; the goals were
have elevated blood pressure should bidity of diabetes, affecting the majority of attained with an average of 3.4 medica-
have blood pressure confirmed on a patients, with prevalence depending on tions per participant in the intensive
separate day. (B) type of diabetes, age, obesity, and ethnic- group and 2.1 in the standard therapy
Goals ity. Hypertension is a major risk factor for group. The hazard ratio for the primary
c People with diabetes and hypertension both CVD and microvascular complica- end point (nonfatal MI, nonfatal stroke,
should be treated to a systolic blood tions. In type 1 diabetes, hypertension is and CVD death) in the intensive group
pressure goal of ,140 mmHg. (B) often the result of underlying nephropa- was 0.88 (95% CI 0.73–1.06, P 5 0.20).
c Lower systolic targets, such as ,130 thy, while in type 2 diabetes it usually Of the prespecified secondary end points,
mmHg, may be appropriate for certain coexists with other cardiometabolic risk only stroke and nonfatal stroke were sta-
individuals, such as younger patients, factors. tistically significantly reduced by inten-
if it can be achieved without undue sive blood pressure treatment, with a
treatment burden. (C) Screening and diagnosis hazard ratio of 0.59 (95% CI 0.39–0.89,
c Patients with diabetes should be treated Measurement of blood pressure in the P 5 0.01) and 0.63 (95% CI 0.41–0.96,
to a diastolic blood pressure ,80 mmHg. office should be done by a trained in- P 5 0.03), respectively. Absolute stroke
(B) dividual and follow the guidelines es- event rates were low; the number needed
Treatment tablished for nondiabetic individuals: to treat to prevent one stroke over the
c Patients with a blood pressure .120/ measurement in the seated position, course of 5 years with intensive blood
80 mmHg should be advised on life- with feet on the floor and arm supported pressure management is 89. Serious ad-
style changes to reduce blood pressure. at heart level, after 5 min of rest. Cuff size verse event rates (including syncope and
(B) should be appropriate for the upper arm hyperkalemia) were higher with intensive
c Patients with confirmed blood pressure circumference. Elevated values should be targets (3.3% vs. 1.3%, P 5 0.001). Rates
$140/80 mmHg should, in addition to confirmed on a separate day. of albuminuria were reduced with more
lifestyle therapy, have prompt initia- Home blood pressure self-monitoring intensive blood pressure goals, but there
tion and timely subsequent titration of and 24-h ambulatory blood pressure were no differences in renal function in
pharmacological therapy to achieve monitoring may provide additional evi- this 5-year trial (and in fact more adverse
blood pressure goals. (B) dence of “white coat” and masked hyper- events related to reduced eGFR with more
c Lifestyle therapy for elevated blood tension and other discrepancies between intensive goals) nor in other microvascu-
pressure consists of weight loss, if office and “true” blood pressure. Studies lar complications.
overweight; Dietary Approaches to in nondiabetic populations found that Other recent randomized trial data
Stop Hypertension (DASH)-style di- home measurements may better correlate include those of the ADVANCE trial in
etary pattern including reducing so- with CVD risk than office measurements which treatment with an ACE inhibitor
dium and increasing potassium intake; (250,251). However, the preponderance and a thiazide-type diuretic reduced the
moderation of alcohol intake; and in- of the evidence of benefits of treatment of rate of death but not the composite
creased physical activity. (B) hypertension in people with diabetes is macrovascular outcome. However, the
c Pharmacological therapy for patients based on office measurements. ADVANCE trial had no specified targets
with diabetes and hypertension should for the randomized comparison, and the
be with a regimen that includes either Treatment goals mean systolic blood pressure in the in-
an ACE inhibitor or an angiotensin Epidemiological analyses show that blood tensive group (135 mmHg) was not as low
receptor blocker (ARB). If one class is pressure .115/75 mmHg is associated as the mean systolic blood pressure even
not tolerated, the other should be sub- with increased cardiovascular event rates in the ACCORD standard-therapy group
stituted. (C) and mortality in individuals with diabetes (259). Post hoc analysis of achieved blood
c Multiple-drug therapy (two or more (252–254) and that systolic blood pres- pressure in several hypertension treat-
agents at maximal doses) is generally sure above 120 mmHg predicts long-term ment trials has suggested no benefit of
required to achieve blood pressure end-stage renal disease (ESRD). Random- lower achieved systolic blood pressure.
targets. (B) ized clinical trials have demonstrated the As an example, among 6,400 patients
c Administer one or more antihyperten- benefit (reduction of CHD events, stroke, with diabetes and CAD enrolled in one
sive medications at bedtime. (A) and nephropathy) of lowering blood trial, “tight control” (achieved systolic

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S29


Position Statement

blood pressure ,130 mmHg) was not as- appropriately have lower systolic targets including a large subset with diabetes,
sociated with improved cardiovascular such as ,130 mmHg. This would espe- an ACE inhibitor reduced CVD outcomes
outcomes compared with “usual care” cially be the case if this can be achieved (270). In patients with congestive heart
(achieved systolic blood pressure 130– with few drugs and without side effects of failure (CHF), including diabetic sub-
140 mmHg) (260). Similar finding therapy. groups, ARBs have been shown to reduce
emerged from an analysis of another trial, major CVD outcomes (271–274), and in
but additionally those with achieved sys- Treatment strategies type 2 diabetic patients with significant
tolic blood pressure (,115 mmHg) had Although there are no well-controlled nephropathy, ARBs were superior to cal-
increased rates of CVD events (though studies of diet and exercise in the treat- cium channel blockers for reducing heart
lower rates of stroke) (261). ment of elevated blood pressure or hy- failure (275). Though evidence for dis-
Observational data, including those pertension in individuals with diabetes, tinct advantages of RAS inhibitors on
derived from clinical trials, may be in- the DASH study in nondiabetic individu- CVD outcomes in diabetes remains con-
appropriate to use for defining blood als has shown antihypertensive effects flicting (255,269), the high CVD risks as-
pressure targets since sicker patients similar to pharmacological monotherapy. sociated with diabetes, and the high
may have low blood pressure or, con- Lifestyle therapy consists of reducing prevalence of undiagnosed CVD, may still
versely, healthier or more adherent pa- sodium intake (to below 1,500 mg/day) favor recommendations for their use as
tients may achieve goals more readily. A and excess body weight; increasing con- first-line hypertension therapy in people
recent meta-analysis of randomized trials sumption of fruits, vegetables (8–10 serv- with diabetes (252).
of adults with type 2 diabetes comparing ings per day), and low-fat dairy products Recently, the blood pressure arm of
prespecified blood pressure targets found (2–3 servings per day); avoiding excessive the ADVANCE trial demonstrated that
no significant reduction in mortality or alcohol consumption (no more than two routine administration of a fixed combi-
nonfatal MI. There was a statistically servings per day for men and no more nation of the ACE inhibitor perindopril
significant 35% relative reduction in than one serving per day for women) and the diuretic indapamide significantly
stroke, but the absolute risk reduction (264); and increasing activity levels reduced combined microvascular and
was only 1% (262). Other outcomes, such (252). These nonpharmacological strate- macrovascular outcomes, as well as CVD
as indicators of microvascular complica- gies may also positively affect glycemia and total mortality. The improved out-
tions, were not examined. Another and lipid control and as a result should comes could also have been due to
meta-analysis that included both trials be encouraged in those with even mildly lower achieved blood pressure in the
comparing blood pressure goals and trials elevated blood pressure. Their effects on perindopril-indapamide arm (259). An-
comparing treatment strategies con- cardiovascular events have not been es- other trial showed a decrease in morbidity
cluded that a systolic treatment goal of tablished. Nonpharmacological therapy and mortality in those receiving benaze-
130–135 mmHg was acceptable. With is reasonable in diabetic individuals with pril and amlodipine compared with bena-
goals ,130 mmHg, there were greater re- mildly elevated blood pressure (systolic zepril and hydrochlorothiazide (HCTZ).
ductions in stroke, a 10% reduction in blood pressure .120 mmHg or diastolic The compelling benefits of RAS inhibitors
mortality, but no reduction of other blood pressure .80 mmHg). If the blood in diabetic patients with albuminuria or
CVD events and increased rates of serious pressure is confirmed to be $140 mmHg renal insufficiency provide additional ra-
adverse events. Systolic blood pressure systolic and/or $80 mmHg diastolic, tionale for use of these agents (see Section
,130 mmHg was associated with re- pharmacological therapy should be initi- VI.B). If needed to achieve blood pressure
duced onset and progression of albumin- ated along with nonpharmacological targets, amlodipine, HCTZ, or chlorthali-
uria. However, there was heterogeneity in therapy (252). done can be added. If eGFR is ,30 mL/
the measure, rates of more advanced renal Lowering of blood pressure with regi- min/m2, a loop diuretic rather than HCTZ
disease outcomes were not affected, and mens based on a variety of antihypertensive or chlorthalidone should be prescribed.
there were no significant changes in reti- drugs, including ACE inhibitors, ARBs, Titration of and/or addition of further
nopathy or neuropathy (263). b-blockers, diuretics, and calcium channel blood pressure medications should be
This change in the “default” systolic blockers, has been shown to be effective in made in timely fashion to overcome clin-
blood pressure target is not meant to reducing cardiovascular events. Several ical inertia in achieving blood pressure
downplay the importance of treating hy- studies suggested that ACE inhibitors may targets.
pertension in patients with diabetes or to be superior to dihydropyridine calcium Evidence is emerging that health in-
imply that lower targets than ,140 channel blockers in reducing cardiovascu- formation technology can be used safely
mmHg are generally inappropriate. The lar events (265–267). However, a variety of and effectively as a tool to enable attain-
clear body of evidence that systolic blood other studies have shown no specific ad- ment of blood pressure goals. Using
pressure over 140 mmHg is harmful sug- vantage to ACE inhibitors as initial treat- a telemonitoring intervention to direct
gests that clinicians should promptly ini- ment of hypertension in the general titrations of antihypertensive medications
tiate and titrate therapy in an ongoing hypertensive population, but rather an ad- between medical office visits has been
fashion to achieve and maintain systolic vantage on cardiovascular outcomes of ini- demonstrated to have a profound impact
blood pressure below 140 mmHg in vir- tial therapy with low-dose thiazide diuretics on systolic blood pressure control (276).
tually all patients. Additionally, patients (252,268,269). An important caveat is that most
with long life expectancy (in whom there In people with diabetes, inhibitors of patients with hypertension require
may be renal benefits from long-term the renin-angiotensin system (RAS) may multiple-drug therapy to reach treatment
stricter blood pressure control) or those have unique advantages for initial or early goals (252). Identifying and addressing
in whom stroke risk is a concern might, therapy of hypertension. In a nonhyper- barriers to medication adherence (such
as part of shared decision making, tension trial of high-risk individuals, as cost and side effects) should routinely

S30 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

be done. If blood pressure is refractory CVD risk factors (family history of MI) are greatest in people with high base-
despite confirmed adherence to optimal CVD, hypertension, smoking, dysli- line CVD risk (known CVD and/or very
doses of at least three antihypertensive pidemia, or albuminuria) (A) high LDL cholesterol levels), but overall
agents of different classifications, one of c For lower-risk patients than the above the benefits of statin therapy in people
which should be a diuretic, clinicians (e.g., without overt CVD and under the with diabetes at moderate or high risk
should consider an evaluation for sec- age of 40 years), statin therapy should for CVD are convincing.
ondary forms of hypertension. Growing be considered in addition to lifestyle There is an increased risk of incident
evidence suggests that there is an associ- therapy if LDL cholesterol remains diabetes with statin use (289,290), which
ation between increase in sleep-time above 100 mg/dL or in those with may be limited to those with risk factors
blood pressure and incidence of CVD multiple CVD risk factors. (C) for diabetes. These patients may benefit
events. A recent RCT of 448 participants c In individuals without overt CVD, the additionally from diabetes screening
with type 2 diabetes and hypertension goal is LDL cholesterol ,100 mg/dL when on statin therapy. In an analysis of
demonstrated reduced cardiovascular (2.6 mmol/L). (B) one of the initial studies suggesting that
events and mortality with median c In individuals with overt CVD, a lower statins are linked to risk of diabetes, the
follow-up of 5.4 years if at least one an- LDL cholesterol goal of ,70 mg/dL cardiovascular event rate reduction with
tihypertensive medication was given at (1.8 mmol/L), using a high dose of a statins outweighed the risk of incident di-
bedtime (277). statin, is an option. (B) abetes even for patients at highest risk for
During pregnancy in diabetic women c If drug-treated patients do not reach diabetes. The absolute risk increase was
with chronic hypertension, target blood the above targets on maximal tolerated small (over 5 years of follow-up, 1.2% of
pressure goals of systolic blood pressure statin therapy, a reduction in LDL participants on placebo developed diabe-
110–129 mmHg and diastolic blood pres- cholesterol of ;30–40% from baseline tes and 1.5% on rosuvastatin) (291). The
sure 65–79 mmHg are reasonable, as they is an alternative therapeutic goal. (B) relative risk-benefit ratio favoring statins
contribute to long-term maternal health. c Triglycerides levels ,150 mg/dL (1.7 is further supported by meta-analysis of
Lower blood pressure levels may be asso- mmol/L) and HDL cholesterol .40 individual data of over 170,000 persons
ciated with impaired fetal growth. During mg/dL (1.0 mmol/L) in men and .50 from 27 randomized trials. This demon-
pregnancy, treatment with ACE inhibi- mg/dL (1.3 mmol/L) in women are strated that individuals at low risk of vas-
tors and ARBs is contraindicated because desirable (C). However, LDL cholesterol– cular disease, including those undergoing
they can cause fetal damage. Antihyper- targeted statin therapy remains the primary prevention, received benefits
tensive drugs known to be effective and preferred strategy. (A) from statins that included reductions in
safe in pregnancy include methyldopa, c Combination therapy has been shown major vascular events and vascular death
labetalol, diltiazem, clonidine, and pra- not to provide additional cardiovascu- without increase in incidence of cancer or
zosin. Chronic diuretic use during preg- lar benefit above statin therapy alone deaths from other causes (280).
nancy has been associated with restricted and is not generally recommended. (A) Low levels of HDL cholesterol, often
maternal plasma volume, which might c Statin therapy is contraindicated in associated with elevated triglyceride lev-
reduce uteroplacental perfusion (278). pregnancy. (B) els, are the most prevalent pattern of
dyslipidemia in persons with type 2 di-
2. Dyslipidemia/lipid management Evidence for benefits of lipid-lowering abetes. However, the evidence base for
Recommendations therapy drugs that target these lipid fractions is
Screening Patients with type 2 diabetes have an significantly less robust than that for
c In most adult patients with diabetes, increased prevalence of lipid abnormali- statin therapy (292). Nicotinic acid has
measure fasting lipid profile at least ties, contributing to their high risk of been shown to reduce CVD outcomes
annually. (B) CVD. Multiple clinical trials demon- (293), although the study was done in a
c In adults with low-risk lipid values strated significant effects of pharmacolog- nondiabetic cohort. Gemfibrozil has been
(LDL cholesterol ,100 mg/dL, HDL ical (primarily statin) therapy on CVD shown to decrease rates of CVD events in
cholesterol .50 mg/dL, and trigly- outcomes in subjects with CHD and for subjects without diabetes (294,295) and
cerides ,150 mg/dL), lipid assessments primary CVD prevention (279,280). Sub- in the diabetic subgroup of one of the
may be repeated every 2 years. (E) analyses of diabetic subgroups of larger larger trials (294). However, in a large trial
Treatment recommendations and goals trials (281–285) and trials specifically in specific to diabetic patients, fenofibrate
c Lifestyle modification focusing on the subjects with diabetes (286,287) showed failed to reduce overall cardiovascular
reduction of saturated fat, trans fat, and significant primary and secondary pre- outcomes (296).
cholesterol intake; increase of n-3 fatty vention of CVD events 1/2 CHD deaths Combination therapy, with a statin
acids, viscous fiber, and plant stanols/ in diabetic populations. Meta-analyses in- and a fibrate or statin and niacin, may be
sterols; weight loss (if indicated); and cluding data from over 18,000 patients efficacious for treatment for all three lipid
increased physical activity should be with diabetes from 14 randomized trials fractions, but this combination is associ-
recommended to improve the lipid of statin therapy, followed for a mean of ated with an increased risk for abnormal
profile in patients with diabetes. (A) 4.3 years, demonstrate a 9% proportional transaminase levels, myositis, or rhabdo-
c Statin therapy should be added to life- reduction in all-cause mortality and 13% myolysis. The risk of rhabdomyolysis is
style therapy, regardless of baseline reduction in vascular mortality, for each higher with higher doses of statins and
lipid levels, for diabetic patients: mmol/L reduction in LDL cholesterol with renal insufficiency and seems to be
c with overt CVD (A) (288). As is the case in nondiabetic indi- lower when statins are combined with
c without CVD who are over the age of viduals, absolute reductions in “hard” fenofibrate than gemfibrozil (297). In the
40 years and have one or more other CVD outcomes (CHD death and nonfatal ACCORD study, the combination of

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S31


Position Statement

fenofibrate and simvastatin did not re- glucose control, or if the patient has variable, and this variable response is
duce the rate of fatal cardiovascular increased cardiovascular risk (e.g., multi- poorly understood (307). Reduction of
events, nonfatal MI, or nonfatal stroke, ple cardiovascular risk factors or long CVD events with statins correlates very
as compared with simvastatin alone, in duration of diabetes). Very little clinical closely with LDL cholesterol lowering
patients with type 2 diabetes who were trial evidence exists for type 2 diabetic (279). If initial attempts to prescribe a
at high risk for CVD. Prespecified sub- patients under the age 40 years, or for statin leads to side effects, clinicians
group analyses suggested heterogeneity type 1 diabetic patients of any age. In the should attempt to find a dose or alterna-
in treatment effects according to sex, Heart Protection Study (lower age limit tive statin that the patient can tolerate.
with a benefit of combination therapy 40 years), the subgroup of ;600 patients There is evidence for significant LDL
for men and possible harm for women, with type 1 diabetes had a reduction in cholesterol lowering from even ex-
and a possible benefit for patients with risk proportionately similar to that of pa- tremely low, less than daily, statin doses
both triglyceride level $204 mg/dL and tients with type 2 diabetes, although not (308). When maximally tolerated doses
HDL cholesterol level #34 mg/dL (298). statistically significant (282). Although of statins fail to significantly lower LDL
The AIM-HIGH trial randomized over the data are not definitive, consideration cholesterol (,30% reduction from the
3,000 patients (about one-third with di- should be given to similar lipid-lowering patient’s baseline), there is no strong ev-
abetes) with established CVD, low levels goals in type 1 diabetic patients as in type idence that combination therapy should
of HDL cholesterol, and triglyceride levels 2 diabetic patients, particularly if they be used to achieve additional LDL cho-
of 150–400 mg/dL to statin therapy plus have other cardiovascular risk factors. lesterol lowering. Niacin, fenofibrate,
extended release niacin or matching pla- ezetimibe, and bile acid sequestrants all
cebo. The trial was halted early due to lack Alternative lipoprotein goals offer additional LDL cholesterol lowering
of efficacy on the primary CVD outcome Virtually all trials of statins and CVD to statins alone, but without evidence
and a possible increase in ischemic stroke outcome tested specific doses of statins that such combination therapy for LDL
in those on combination therapy (299). against placebo, other doses of statin, or cholesterol lowering provides a signifi-
Hence, combination lipid-lowering ther- other statins, rather than aiming for spe- cant increment in CVD risk reduction
apy cannot be broadly recommended. cific LDL cholesterol goals (301). Placebo- over statin therapy alone.
controlled trials generally achieved LDL
Dyslipidemia treatment and target cholesterol reductions of 30–40% from Treatment of other lipoprotein frac-
lipid levels baseline. Hence, LDL cholesterol lower- tions or targets
For most patients with diabetes, the first ing of this magnitude is an acceptable out- Hypertriglyceridemia should be ad-
priority of dyslipidemia therapy (unless come for patients who cannot reach LDL dressed with dietary and lifestyle changes.
severe hypertriglyceridemia with risk of cholesterol goals due to severe baseline Severe hypertriglyceridemia (.1,000
pancreatitis is the immediate issue) is to elevations in LDL cholesterol and/or in- mg/dL) may warrant immediate pharma-
lower LDL cholesterol to a target goal of tolerance of maximal, or any, statin doses. cological therapy (fibric acid derivative,
,100 mg/dL (2.60 mmol/L) (300). Life- Additionally for those with baseline LDL niacin, or fish oil) to reduce the risk of
style intervention, including MNT, in- cholesterol minimally above 100 mg/dL, acute pancreatitis. In the absence of se-
creased physical activity, weight loss, prescribing statin therapy to lower LDL vere hypertriglyceridemia, therapy target-
and smoking cessation, may allow some cholesterol about 30–40% from baseline ing HDL cholesterol or triglycerides lacks
patients to reach lipid goals. Nutrition in- is probably more effective than prescrib- the strong evidence base of statin therapy.
tervention should be tailored according to ing just enough to get LDL cholesterol If the HDL cholesterol is ,40 mg/dL and
each patient’s age, type of diabetes, phar- slightly below 100 mg/dL. the LDL cholesterol is between 100 and
macological treatment, lipid levels, and Clinical trials in high-risk patients, 129 mg/dL, a fibrate or niacin might be
other medical conditions and should fo- such as those with acute coronary syn- used, especially if a patient is intolerant to
cus on the reduction of saturated fat, cho- dromes or previous cardiovascular events statins. Niacin is the most effective drug
lesterol, and trans unsaturated fat intake (302–304), have demonstrated that more for raising HDL cholesterol. It can signif-
and increases in n-3 fatty acids, viscous aggressive therapy with high doses of sta- icantly increase blood glucose at high doses,
fiber (such as in oats, legumes, citrus), tins to achieve an LDL cholesterol of ,70 but at modest doses (750–2,000 mg/day)
and plant stanols/sterols. Glycemic con- mg/dL led to a significant reduction in significant improvements in LDL choles-
trol can also beneficially modify plasma further events. Therefore, a reduction in terol, HDL cholesterol, and triglyceride
lipid levels, particularly in patients with LDL cholesterol to a goal of ,70 mg/dL is levels are accompanied by only modest
very high triglycerides and poor glycemic an option in very high-risk diabetic pa- changes in glucose that are generally ame-
control. tients with overt CVD (305). Some ex- nable to adjustment of diabetes therapy
In those with clinical CVD or over age perts recommend a greater focus on (299,309,310).
40 years with other CVD risk factors, non–HDL cholesterol, apolipoprotein B Table 10 summarizes common treat-
pharmacological treatment should be (apoB), or lipoprotein particle measure- ment goals for A1C, blood pressure, and
added to lifestyle therapy regardless of ments to assess residual CVD risk in LDL cholesterol.
baseline lipid levels. Statins are the drugs statin-treated patients who are likely to
of choice for LDL cholesterol lowering have small LDL particles, such as people
and cardioprotection. In patients other with diabetes (306), but it is unclear 3. Antiplatelet agents
than those described above, statin treat- whether clinical management would Recommendations
ment should be considered if there is an change with these measurements. c Consider aspirin therapy (75–162
inadequate LDL cholesterol response to In individual patients, LDL choles- mg/day) as a primary prevention strategy
lifestyle modifications and improved terol lowering with statins is highly in those with type 1 or type 2 diabetes

S32 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

at increased cardiovascular risk (10-year The Antithrombotic Trialists’ (ATT) In 2010, a position statement of the
risk .10%). This includes most men collaborators recently published an indi- ADA, the American Heart Association
aged .50 years or women aged .60 vidual patient-level meta-analysis of the (AHA), and the American College of
years who have at least one additional six large trials of aspirin for primary pre- Cardiology Foundation (ACCF) updated
major risk factor (family history of CVD, vention in the general population. These prior joint recommendations for primary
hypertension, smoking, dyslipidemia, or trials collectively enrolled over 95,000 prevention (315). Low-dose (75–162
albuminuria). (C) participants, including almost 4,000 mg/day) aspirin use for primary preven-
c Aspirin should not be recommended with diabetes. Overall, they found that as- tion is reasonable for adults with diabetes
for CVD prevention for adults with pirin reduced the risk of vascular events and no previous history of vascular dis-
diabetes at low CVD risk (10-year CVD by 12% (RR 0.88, 95% CI 0.82–0.94). ease who are at increased CVD risk (10-
risk ,5%, such as in men aged ,50 The largest reduction was for nonfatal year risk of CVD events over 10%) and
years and women aged ,60 years with MI with little effect on CHD death (RR who are not at increased risk for bleeding.
no major additional CVD risk factors), 0.95, 95% CI 0.78–1.15) or total stroke. This generally includes most men over
since the potential adverse effects from There was some evidence of a difference age 50 years and women over age 60 years
bleeding likely offset the potential in aspirin effect by sex. Aspirin signifi- who also have one or more of the follow-
benefits. (C) cantly reduced CHD events in men but ing major risk factors: 1) smoking, 2) hy-
c In patients in these age-groups with not in women. Conversely, aspirin had pertension, 3) dyslipidemia, 4) family
multiple other risk factors (e.g., 10- no effect on stroke in men but signifi- history of premature CVD, and 5) albu-
year risk 5–10%), clinical judgment is cantly reduced stroke in women. Notably, minuria.
required. (E) sex differences in aspirin’s effects have not However, aspirin is no longer recom-
c Use aspirin therapy (75–162 mg/day) been observed in studies of secondary mended for those at low CVD risk
as a secondary prevention strategy in prevention (311). In the six trials exam- (women under age 60 years and men
those with diabetes with a history of ined by the ATT collaborators, the effects under age 50 years with no major CVD
CVD. (A) of aspirin on major vascular events were risk factors; 10-year CVD risk under 5%)
c For patients with CVD and docu- similar for patients with or without diabe- as the low benefit is likely to be out-
mented aspirin allergy, clopidogrel (75 tes: RR 0.88 (95% CI 0.67–1.15) and 0.87 weighed by the risks of significant bleed-
mg/day) should be used. (B) (95% CI 0.79–0.96), respectively. The ing. Clinical judgment should be used for
c Combination therapy with aspirin (75– confidence interval was wider for those those at intermediate risk (younger pa-
162 mg/day) and clopidogrel (75 mg/day) with diabetes because of their smaller tients with one or more risk factors, or
is reasonable for up to a year after an number. older patients with no risk factors; those
acute coronary syndrome. (B) Based on the currently available evi- with 10-year CVD risk of 5–10%) until
dence, aspirin appears to have a modest further research is available. Use of aspirin
Aspirin has been shown to be effective effect on ischemic vascular events with in patients under the age of 21 years is
in reducing cardiovascular morbidity and the absolute decrease in events depend- contraindicated due to the associated
mortality in high-risk patients with pre- ing on the underlying CVD risk. The risk of Reye syndrome.
vious MI or stroke (secondary prevention). main adverse effects appear to be an Average daily dosages used in most
Its net benefit in primary prevention increased risk of gastrointestinal bleed- clinical trials involving patients with di-
among patients with no previous cardio- ing. The excess risk may be as high as 1–5 abetes ranged from 50 to 650 mg but
vascular events is more controversial, both per 1,000 per year in real-world settings. were mostly in the range of 100 to 325
for patients with and without a history of In adults with CVD risk greater than 1% mg/day. There is little evidence to sup-
diabetes (311). Two recent RCTs of aspirin per year, the number of CVD events pre- port any specific dose, but using the
specifically in patients with diabetes failed vented will be similar to or greater than lowest possible dosage may help reduce
to show a significant reduction in CVD end the number of episodes of bleeding in- side effects (316). In the U.S., the most
points, raising further questions about the duced, although these complications do common low dose tablet is 81 mg. Al-
efficacy of aspirin for primary prevention in not have equal effects on long-term though platelets from patients with dia-
people with diabetes (312,313). health (314). betes have altered function, it is unclear
what, if any, impact that finding has on
the required dose of aspirin for cardio-
Table 10dSummary of recommendations for glycemic, blood pressure, and lipid control for protective effects in the patient with di-
most adults with diabetes abetes. Many alternate pathways for
A1C ,7.0%*
platelet activation exist that are indepen-
Blood pressure ,140/80 mmHg**
dent of thromboxane A2 and thus not
Lipids
sensitive to the effects of aspirin (317).
LDL cholesterol ,100 mg/dL (,2.6 mmol/L)†
Therefore, while “aspirin resistance” ap-
Statin therapy for those with history of MI or age over 401
pears higher in the diabetic patients when
other risk factors
measured by a variety of ex vivo and in
vitro methods (platelet aggregometry,
*More or less stringent glycemic goals may be appropriate for individual patients. Goals should be in- measurement of thromboxane B2), these
dividualized based on duration of diabetes, age/life expectancy, comorbid conditions, known CVD or ad- observations alone are insufficient to em-
vanced microvascular complications, hypoglycemia unawareness, and individual patient considerations.
**Based on patient characteristics and response to therapy, lower systolic blood pressure targets may be
pirically recommend higher doses of as-
appropriate. †In individuals with overt CVD, a lower LDL cholesterol goal of ,70 mg/dL (1.8 mmol/L), using pirin be used in the diabetic patient at this
a high dose of a statin, is an option. time.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S33


Position Statement

Clopidogrel has been demonstrated Treatment Although asymptomatic diabetic patients


to reduce CVD events in diabetic individ- c In patients with known CVD, consider found to have a higher coronary disease
uals (318). It is recommended as adjunc- ACE inhibitor therapy (C) and use as- burden have more future cardiac events
tive therapy in the first year after an acute pirin and statin therapy (A) (if not (326–328), the role of these tests beyond
coronary syndrome or as alternative ther- contraindicated) to reduce the risk of risk stratification is not clear. Their rou-
apy in aspirin-intolerant patients. cardiovascular events. In patients with a tine use leads to radiation exposure and
prior MI, b-blockers should be contin- may result in unnecessary invasive testing
ued for at least 2 years after the event. (B) such as coronary angiography and revas-
4. Smoking cessation
c Avoid thiazolidinedione treatment in cularization procedures. The ultimate
Recommendations
patients with symptomatic heart fail- balance of benefit, cost, and risks of
c Advise all patients not to smoke or use
ure. (C) such an approach in asymptomatic pa-
tobacco products. (A)
c Metformin may be used in patients tients remains controversial, particularly
c Include smoking cessation counseling
with stable CHF if renal function is in the modern setting of aggressive CVD
and other forms of treatment as a rou-
normal. It should be avoided in unstable risk factor control.
tine component of diabetes care. (B)
or hospitalized patients with CHF. (C) In all patients with diabetes, cardio-
A large body of evidence from epide- vascular risk factors should be assessed
Screening for CAD is reviewed in a at least annually. These risk factors
miological, case-control, and cohort stud-
recently updated consensus statement include dyslipidemia, hypertension,
ies provides convincing documentation
(196). To identify the presence of CAD smoking, a positive family history of
of the causal link between cigarette smok-
in diabetic patients without clear or sug- premature coronary disease, and the
ing and health risks. Much of the work
gestive symptoms, a risk factor–based ap- presence of micro- or macroalbu-
documenting the impact of smoking on
health did not separately discuss results proach to the initial diagnostic evaluation minuria. Abnormal risk factors should
and subsequent follow-up has intuitive be treated as described elsewhere in
on subsets of individuals with diabetes,
appeal. However, recent studies con- these guidelines. Patients at increased
but suggests that the identified risks are at
cluded that using this approach fails to CHD risk should receive aspirin and a
least equivalent to those found in the
identify which patients with type 2 diabe- statin, and ACE inhibitor or ARB therapy
general population. Other studies of in-
tes will have silent ischemia on screening if hypertensive, unless there are contra-
dividuals with diabetes consistently dem-
tests (201,321). indications to a particular drug class.
onstrate that smokers have a heightened
Candidates for cardiac testing include Although clear benefit exists for ACE
risk of CVD, premature death, and in-
those with 1) typical or atypical cardiac inhibitor and ARB therapy in patients
creased rate of microvascular complica-
symptoms and 2) an abnormal resting with nephropathy or hypertension, the
tions of diabetes. Smoking may have a
role in the development of type 2 diabetes. ECG. The screening of asymptomatic pa- benefits in patients with CVD in the
tients remains controversial. Intensive absence of these conditions are less clear,
One study in smokers with newly diag-
medical therapy that would be indicated especially when LDL cholesterol is con-
nosed type 2 diabetes found that smoking
cessation was associated with amelioration anyway for diabetic patients at high risk comitantly controlled (329,330).
for CVD seems to provide equal outcomes
of metabolic parameters and reduced blood
to invasive revascularization (322,323).
pressure and albuminuria at 1 year (319).
There is also some evidence that silent B. Nephropathy screening and
The routine and thorough assessment
myocardial ischemia may reverse over treatment
of tobacco use is important as a means of
time, adding to the controversy concern- Recommendations
preventing smoking or encouraging ces-
ing aggressive screening strategies (324). General recommendations
sation. A number of large randomized
Finally, a recent randomized observa- c To reduce the risk or slow the progres-
clinical trials have demonstrated the effi-
tional trial demonstrated no clinical ben- sion of nephropathy, optimize glucose
cacy and cost-effectiveness of brief coun-
efit to routine screening of asymptomatic control. (A)
seling in smoking cessation, including the
use of quitlines, in the reduction of patients with type 2 diabetes and normal c To reduce the risk or slow the pro-
ECGs (325). Despite abnormal myocar- gression of nephropathy, optimize
tobacco use. For the patient motivated
dial perfusion imaging in more than one blood pressure control. (A)
to quit, the addition of pharmacological
in five patients, cardiac outcomes were Screening
therapy to counseling is more effective
essentially equal (and very low) in c Perform an annual test to assess urine
than either treatment alone. Special con-
screened compared with unscreened pa- albumin excretion in type 1 diabetic
siderations should include assessment of
tients. Accordingly, the overall effective- patients with diabetes duration of $5
level of nicotine dependence, which is
ness, especially the cost-effectiveness, of years and in all type 2 diabetic patients
associated with difficulty in quitting and
such an indiscriminate screening strategy starting at diagnosis. (B)
relapse (320).
is now questioned. c Measure serum creatinine at least annually
Newer noninvasive CAD screening in all adults with diabetes regardless of the
5. CHD screening and treatment methods, such as computed tomography degree of urine albumin excretion. The
Recommendations (CT) and CT angiography have gained in serum creatinine should be used to esti-
Screening popularity. These tests infer the presence mate GFR and stage the level of chronic
c In asymptomatic patients, routine of coronary atherosclerosis by measuring kidney disease (CKD), if present. (E)
screening for CAD is not recommended, the amount of calcium in coronary arter- Treatment
as it does not improve outcomes as long ies and, in some circumstances, by c In the treatment of the nonpregnant
as CVD risk factors are treated. (A) direct visualization of luminal stenoses. patient with modestly elevated (30–299

S34 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

mg/day) (C) or higher levels ($300 pressure (,140 mmHg) resulting from Assessment of albuminuria status and
mg/day) of urinary albumin excretion treatment using ACE inhibitors provides a renal function
(A), either ACE inhibitors or ARBs are selective benefit over other antihyperten- Screening for increased urinary albumin
recommended. sive drug classes in delaying the progres- excretion can be performed by measure-
c Reduction of protein intake to 0.8–1.0 sion of increased urinary albumin excretion ment of the albumin-to-creatinine ratio
g/kg body wt per day in individuals and can slow the decline in GFR in patients in a random spot collection; 24-h or
with diabetes and the earlier stages of with higher levels of albuminuria (337– timed collections are more burdensome
CKD and to 0.8 g/kg body wt per day in 339). In type 2 diabetes with hypertension and add little to prediction or accuracy
the later stages of CKD may improve and normoalbuminuria, RAS inhibition (358,359). Measurement of a spot urine
measures of renal function (urine al- has been demonstrated to delay onset of for albumin only, whether by immunoas-
bumin excretion rate, GFR) and is microalbuminuria (340,341). In the latter say or by using a dipstick test specific for
recommended. (C) study, there was an unexpected higher rate microalbumin, without simultaneously
c When ACE inhibitors, ARBs, or diu- of fatal cardiovascular events with olmesar- measuring urine creatinine, is somewhat
retics are used, monitor serum creati- tan among patients with preexisting CHD. less expensive but susceptible to false-
nine and potassium levels for the ACE inhibitors have been shown to negative and false-positive determina-
development of increased creatinine or reduce major CVD outcomes (i.e., MI, tions as a result of variation in urine
changes in potassium. (E) stroke, death) in patients with diabetes concentration due to hydration and other
c Continued monitoring of urine albu- (270), thus further supporting the use of factors.
min excretion to assess both response these agents in patients with albuminuria, a Abnormalities of albumin excretion
to therapy and progression of disease is CVD risk factor. ARBs do not prevent onset and the linkage between albumin-to-
reasonable. (E) of albuminuria in normotensive patients creatinine ratio and 24-h albumin excre-
c When eGFR ,60 mL/min/1.73 m2, with type 1 or type 2 diabetes (342,343); tion are defined in Table 11. Because of
evaluate and manage potential com- however, ARBs have been shown to reduce variability in urinary albumin excretion,
plications of CKD. (E) the rate of progression from micro- to mac- two of three specimens collected within a
c Consider referral to a physician expe- roalbuminuria as well as ESRD in patients 3- to 6-month period should be abnormal
rienced in the care of kidney disease for with type 2 diabetes (344–346). Some ev- before considering a patient to have de-
uncertainty about the etiology of kid- idence suggests that ARBs have a smaller veloped increased urinary albumin excre-
ney disease, difficult management is- magnitude of rise in potassium compared tion or had a progression in albuminuria.
sues, or advanced kidney disease. (B) with ACE inhibitors in people with ne- Exercise within 24 h, infection, fever,
phropathy (347,348). Combinations of CHF, marked hyperglycemia, and
Diabetic nephropathy occurs in 20–40% drugs that block the renin-angiotensin- marked hypertension may elevate urinary
of patients with diabetes and is the single aldosterone system (e.g., an ACE inhibitor albumin excretion over baseline values.
leading cause of ESRD. Persistent albu- plus an ARB, a mineralocorticoid antago- Information on presence of abnormal
minuria in the range of 30–299 mg/24 h nist, or a direct renin inhibitor) provide urine albumin excretion in addition to
(historically called microalbuminuria) additional lowering of albuminuria (349– level of GFR may be used to stage CKD.
has been shown to be the earliest stage 352). However, such combinations have The National Kidney Foundation classifi-
of diabetic nephropathy in type 1 diabetes been found to provide no additional car- cation (Table 12) is primarily based on
and a marker for development of nephrop- diovascular benefit and have higher ad- GFR levels and therefore differs from
athy in type 2 diabetes. It is also a well- verse event rates (353), and their effects other systems, in which staging is based
established marker of increased CVD risk on major renal outcomes have not yet primarily on urinary albumin excretion
(331,332). Patients with microalbuminuria been proven. (360). Studies have found decreased
who progress to more significant levels Other drugs, such as diuretics, cal- GFR in the absence of increased urine al-
($300 mg/24 h, historically called mac- cium channel blockers, and b-blockers, bumin excretion in a substantial percent-
roalbuminuria) are likely to progress to should be used as additional therapy to age of adults with diabetes (361). Serum
ESRD (333,334). However, a number of further lower blood pressure in patients creatinine should therefore be measured
interventions have been demonstrated to already treated with ACE inhibitors or at least annually in all adults with
reduce the risk and slow the progression ARBs (275), or as alternate therapy in
of renal disease. the rare individual unable to tolerate
Intensive diabetes management with ACE inhibitors or ARBs.
the goal of achieving near-normoglycemia Studies in patients with varying stages Table 11dDefinitions of abnormalities in
has been shown in large prospective ran- of nephropathy have shown that protein albumin excretion
domized studies to delay the onset and restriction of dietary protein helps slow
progression of increased urinary albumin the progression of albuminuria, GFR de-
Spot collection
excretion in patients with type 1 cline, and occurrence of ESRD (354–
Category (mg/mg creatinine)
(335,336) and type 2 (83,84,88,89) dia- 357), although more recent studies have
betes. The UKPDS provided strong evi- provided conflicting results (140). Die- Normal ,30
dence that control of blood pressure can tary protein restriction might be consid- Increased urinary
reduce the development of nephropathy ered particularly in patients whose albumin excretion* $30
(255). In addition, large prospective ran- nephropathy seems to be progressing de-
*Historically, ratios between 30 and 299 have been
domized studies in patients with type 1 spite optimal glucose and blood pressure called microalbuminuria and those 300 or greater
diabetes have demonstrated that achieve- control and use of ACE inhibitor and/or have been called macroalbuminuria (or clinical al-
ment of lower levels of systolic blood ARBs (357). buminuria).

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S35


Position Statement

diabetes, regardless of the degree of urine disease. Consultation with a nephrologist for a comprehensive eye exam, which
albumin excretion. when stage 4 CKD develops has been found should be performed at least initially
Serum creatinine should be used to to reduce cost, improve quality of care, and and at intervals thereafter as recom-
estimate GFR and to stage the level of keep people off dialysis longer (364). How- mended by an eye care professional. (E)
CKD, if present. eGFR is commonly ever, nonrenal specialists should not delay c Women with pre-existing diabetes who
coreported by laboratories or can be educating their patients about the progres- are planning pregnancy or who have
estimated using formulae such as the sive nature of diabetic kidney disease; the become pregnant should have a com-
Modification of Diet in Renal Disease renal preservation benefits of aggressive prehensive eye examination and be
(MDRD) study equation (362). Recent re- treatment of blood pressure, blood glucose, counseled on the risk of development
ports have indicated that the MDRD is and hyperlipidemia; and the potential need and/or progression of diabetic reti-
more accurate for the diagnosis and strat- for renal replacement therapy. nopathy. Eye examination should oc-
ification of CKD in patients with diabetes cur in the first trimester with close
than the Cockcroft-Gault formula (363). C. Retinopathy screening and follow-up throughout pregnancy and
GFR calculators are available at http:// treatment for 1 year postpartum. (B)
www.nkdep.nih.gov. Recommendations Treatment
The role of continued annual quanti- General recommendations c Promptly refer patients with any level
tative assessment of albumin excretion c To reduce the risk or slow the pro- of macular edema, severe NPDR, or any
after diagnosis of albuminuria and insti- gression of retinopathy, optimize gly- PDR to an ophthalmologist who is
tution of ACE inhibitor or ARB therapy cemic control. (A) knowledgeable and experienced in the
and blood pressure control is unclear. c To reduce the risk or slow the pro- management and treatment of diabetic
Continued surveillance can assess both gression of retinopathy, optimize blood retinopathy. (A)
response to therapy and progression of pressure control. (A) c Laser photocoagulation therapy is in-
disease. Some suggest that reducing al- Screening dicated to reduce the risk of vision loss
buminuria to the normal (,30 mg/g) or c Adults and children aged $10 years in patients with high-risk PDR, clini-
near-normal range may improve renal with type 1 diabetes should have an cally significant macular edema, and in
and cardiovascular prognosis, but this ap- initial dilated and comprehensive eye some cases of severe NPDR. (A)
proach has not been formally evaluated in examination by an ophthalmologist or c Anti–vascular endothelial growth fac-
prospective trials. optometrist within 5 years after the tor (VEGF) therapy is indicated for di-
Complications of kidney disease cor- onset of diabetes. (B) abetic macular edema. (A)
relate with level of kidney function. When c Patients with type 2 diabetes should c The presence of retinopathy is not a
the eGFR is ,60 mL/min/1.73 m2, screen- have an initial dilated and compre- contraindication to aspirin therapy for
ing for complications of CKD is indicated hensive eye examination by an oph- cardioprotection, as this therapy does
(Table 13). Early vaccination against hepa- thalmologist or optometrist shortly not increase the risk of retinal hemor-
titis B is indicated in patients likely to prog- after the diagnosis of diabetes. (B) rhage. (A)
ress to end-stage kidney disease. c Subsequent examinations for type 1
Consider referral to a physician expe- and type 2 diabetic patients should be Diabetic retinopathy is a highly specific
rienced in the care of kidney disease when repeated annually by an ophthalmologist vascular complication of both type 1 and
there is uncertainty about the etiology of or optometrist. Less frequent exams type 2 diabetes, with prevalence strongly
kidney disease (heavy proteinuria, active (every 2–3 years) may be considered related to the duration of diabetes. Di-
urine sediment, absence of retinopathy, following one or more normal eye exams. abetic retinopathy is the most frequent
rapid decline in GFR, resistant hyperten- Examinations will be required more fre- cause of new cases of blindness among
sion). Other triggers for referral may in- quently if retinopathy is progressing. (B) adults aged 20–74 years. Glaucoma, cata-
clude difficult management issues (anemia, c High-quality fundus photographs can racts, and other disorders of the eye occur
secondary hyperparathyroidism, metabolic detect most clinically significant di- earlier and more frequently in people with
bone disease, or electrolyte disturbance) or abetic retinopathy. Interpretation of diabetes.
advanced kidney disease. The threshold for the images should be performed by a In addition to duration of diabetes,
referral may vary depending on the fre- trained eye care provider. While retinal other factors that increase the risk of, or
quency with which a provider encounters photography may serve as a screening are associated with, retinopathy include
diabetic patients with significant kidney tool for retinopathy, it is not a substitute chronic hyperglycemia (365), nephrop-
athy (366), and hypertension (367). In-
Table 12dStages of CKD tensive diabetes management with the
goal of achieving near-normoglycemia
GFR (mL/min/1.73 m2 has been shown in large prospective ran-
Stage Description body surface area) domized studies to prevent and/or delay
the onset and progression of diabetic ret-
1 Kidney damage* with normal or increased GFR $90 inopathy (71,83,84,90). Lowering blood
2 Kidney damage* with mildly decreased GFR 60–89 pressure has been shown to decrease the
3 Moderately decreased GFR 30–59 progression of retinopathy (255), al-
4 Severely decreased GFR 15–29 though tight targets (systolic ,120
5 Kidney failure ,15 or dialysis mmHg) do not impart additional benefit
*Kidney damage defined as abnormalities on pathological, urine, blood, or imaging tests. Adapted from ref. (90). Several case series and a controlled
359. prospective study suggest that pregnancy

S36 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

Table 13dManagement of CKD in diabetes risk of development of significant retinop-


athy with a 3-year interval after a normal
GFR Recommended examination (376). Examinations will be
required more frequently if retinopathy is
All patients Yearly measurement of creatinine, urinary albumin excretion, potassium progressing (377).
45–60 Referral to nephrology if possibility for nondiabetic kidney disease exists The use of retinal photography with
(duration of type 1 diabetes ,10 years, heavy proteinuria, abnormal remote reading by experts has great po-
findings on renal ultrasound, resistant hypertension, rapid fall in GFR, tential in areas where qualified eye care
or active urinary sediment on ultrasound) professionals are not available and may
Consider need for dose adjustment of medications also enhance efficiency and reduce costs
Monitor eGFR every 6 months when the expertise of ophthalmologists
Monitor electrolytes, bicarbonate, hemoglobin, calcium, phosphorus, can be utilized for more complex exami-
parathyroid hormone at least yearly nations and for therapy (378). In-person
Assure vitamin D sufficiency exams are still necessary when the photos
Consider bone density testing are unacceptable and for follow-up of ab-
Referral for dietary counseling normalities detected. Photos are not a
30–44 Monitor eGFR every 3 months substitute for a comprehensive eye
Monitor electrolytes, bicarbonate, calcium, phosphorus, parathyroid exam, which should be performed at least
hormone, hemoglobin, albumin, weight every 3–6 months initially and at intervals thereafter as rec-
Consider need for dose adjustment of medications ommended by an eye care professional.
,30 Referral to nephrologist Results of eye examinations should be
Adapted from http://www.kidney.org/professionals/KDOQI/guideline_diabetes/.
documented and transmitted to the refer-
ring health care professional.

in type 1 diabetic patients may aggravate acuity. Recombinant monoclonal neutral-


retinopathy (368,369); laser photocoa- izing antibody to VEGF is a newly ap- D. Neuropathy screening and
gulation surgery can minimize this risk proved therapy that improves vision and treatment
(369). reduces the need for laser photocoa- Recommendations
One of the main motivations for gulation in patients with macular edema c All patients should be screened for distal
screening for diabetic retinopathy is the (372). Other emerging therapies for reti- symmetric polyneuropathy (DPN) start-
long-established efficacy of laser photo- nopathy include sustained intravitreal de- ing at diagnosis of type 2 diabetes and 5
coagulation surgery in preventing visual livery of fluocinolone (373) and the years after the diagnosis of type 1 diabetes
loss. Two large trials, the Diabetic Reti- possibility of prevention with fenofibrate and at least annually thereafter, using
nopathy Study (DRS) in patients with (374,375). simple clinical tests. (B)
PDR and the Early Treatment Diabetic The preventive effects of therapy and c Electrophysiological testing is rarely
Retinopathy Study (ETDRS) in patients the fact that patients with PDR or macular needed, except in situations where the
with macular edema, provide the stron- edema may be asymptomatic provide clinical features are atypical. (E)
gest support for the therapeutic benefits strong support for a screening program c Screening for signs and symptoms of
of photocoagulation surgery. The DRS to detect diabetic retinopathy. As retinop- cardiovascular autonomic neuropathy
(370) showed that panretinal photocoag- athy is estimated to take at least 5 years to (CAN) should be instituted at diagnosis
ulation surgery reduced the risk of severe develop after the onset of hyperglycemia, of type 2 diabetes and 5 years after the
vision loss from PDR from 15.9% in un- patients with type 1 diabetes should have diagnosis of type 1 diabetes. Special
treated eyes to 6.4% in treated eyes, with an initial dilated and comprehensive eye testing is rarely needed and may not
greatest risk-benefit ratio in those with examination within 5 years after the onset affect management or outcomes. (E)
baseline disease (disc neovascularization of diabetes. Patients with type 2 diabetes, c Medications for the relief of specific
or vitreous hemorrhage). who generally have had years of undiag- symptoms related to painful DPN and
The ETDRS (371) established the nosed diabetes and who have a significant autonomic neuropathy are recom-
benefit of focal laser photocoagulation risk of prevalent diabetic retinopathy at mended, as they improve the quality of
surgery in eyes with macular edema, par- time of diabetes diagnosis, should have an life of the patient. (E)
ticularly those with clinically significant initial dilated and comprehensive eye exam-
macular edema, with reduction of dou- ination soon after diagnosis. Examinations The diabetic neuropathies are hetero-
bling of the visual angle (e.g., 20/50 to should be performed by an ophthalmologist geneous with diverse clinical manifesta-
20/100) from 20% in untreated eyes to or optometrist who is knowledgeable and tions. They may be focal or diffuse. Most
8% in treated eyes. The ETDRS also veri- experienced in diagnosing the presence of common among the neuropathies are
fied the benefits of panretinal photocoag- diabetic retinopathy and is aware of its chronic sensorimotor DPN and autonomic
ulation for high-risk PDR and in older- management. Subsequent examinations neuropathy. Although DPN is a diagnosis
onset patients with severe NPDR or less- for type 1 and type 2 diabetic patients are of exclusion, complex investigations to
than-high-risk PDR. generally repeated annually. Less frequent exclude other conditions are rarely needed.
Laser photocoagulation surgery in exams (every 2–3 years) may be cost effec- The early recognition and appropri-
both trials was beneficial in reducing the tive after one or more normal eye exams, ate management of neuropathy in the
risk of further visual loss, but generally not and in a population with well-controlled patient with diabetes is important for a
beneficial in reversing already diminished type 2 diabetes there was essentially no number of reasons: 1) nondiabetic

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S37


Position Statement

neuropathies may be present in patients some societies have developed guidelines history of the disease process, but may
with diabetes and may be treatable; 2) a for screening for CAN, the benefits of so- have a positive impact on the quality of
number of treatment options exist for phisticated testing beyond risk stratifica- life of the patient.
symptomatic diabetic neuropathy; 3) up tion are not clear (384).
to 50% of DPN may be asymptomatic and Gastrointestinal neuropathies (e.g.,
patients are at risk for insensate injury to esophageal enteropathy, gastroparesis, E. Foot care
their feet; and 4) autonomic neuropathy, constipation, diarrhea, fecal inconti- Recommendations
and particularly CAN, is associated with nence) are common, and any section of c For all patients with diabetes, perform
substantial morbidity and even mortality. the gastrointestinal tract may be affected. an annual comprehensive foot exami-
Specific treatment for the underlying Gastroparesis should be suspected in in- nation to identify risk factors predictive
nerve damage is currently not available, dividuals with erratic glucose control or of ulcers and amputations. The foot
other than improved glycemic control, with upper gastrointestinal symptoms examination should include inspection,
which may modestly slow progression without other identified cause. Evalua- assessment of foot pulses, and testing for
(89) but not reverse neuronal loss. Effec- tion of solid-phase gastric emptying using loss of protective sensation (LOPS) (10-g
tive symptomatic treatments are available double-isotope scintigraphy may be done monofilament plus testing any one of
for some manifestations of DPN (379) and if symptoms are suggestive, but test re- the following: vibration using 128-Hz
autonomic neuropathy. sults often correlate poorly with symp- tuning fork, pinprick sensation, ankle
toms. Constipation is the most common reflexes, or vibration perception thresh-
Diagnosis of neuropathy lower-gastrointestinal symptom but can old). (B)
DPN. Patients with diabetes should be alternate with episodes of diarrhea. c Provide general foot self-care education
screened annually for DPN using tests Diabetic autonomic neuropathy is to all patients with diabetes. (B)
such as pinprick sensation, vibration per- also associated with genitourinary tract c A multidisciplinary approach is rec-
ception (using a 128-Hz tuning fork), 10-g disturbances. In men, diabetic autonomic ommended for individuals with foot
monofilament pressure sensation at the neuropathy may cause erectile dysfunc- ulcers and high-risk feet, especially
distal plantar aspect of both great toes and tion and/or retrograde ejaculation. Eval- those with a history of prior ulcer or
metatarsal joints, and assessment of ankle uation of bladder dysfunction should be amputation. (B)
reflexes. Combinations of more than one performed for individuals with diabetes c Refer patients who smoke, have LOPS
test have .87% sensitivity in detecting who have recurrent urinary tract infec- and structural abnormalities, or have
DPN. Loss of 10-g monofilament percep- tions, pyelonephritis, incontinence, or a history of prior lower-extremity com-
tion and reduced vibration perception palpable bladder. plications to foot care specialists for
predict foot ulcers (380). Importantly, in ongoing preventive care and lifelong
patients with neuropathy, particularly Symptomatic treatments surveillance. (C)
when severe, causes other than diabetes DPN. The first step in management of c Initial screening for peripheral arterial
should always be considered, such as neu- patients with DPN should be to aim for disease (PAD) should include a history
rotoxic medications, heavy metal poison- stable and optimal glycemic control. Al- for claudication and an assessment of
ing, alcohol abuse, vitamin B12 deficiency though controlled trial evidence is lack- the pedal pulses. Consider obtaining
(especially in those taking metformin for ing, several observational studies suggest an ankle-brachial index (ABI), as many
prolonged periods (381), renal disease, that neuropathic symptoms improve not patients with PAD are asymptom-
chronic inflammatory demyelinating neu- only with optimization of control, but atic. (C)
ropathy, inherited neuropathies, and vas- also with the avoidance of extreme blood c Refer patients with significant claudi-
culitis (382). glucose fluctuations. Patients with painful cation or a positive ABI for further
Diabetic autonomic neuropathy. The DPN may benefit from pharmacological vascular assessment and consider ex-
symptoms and signs of autonomic dys- treatment of their symptoms: many ercise, medications, and surgical op-
function should be elicited carefully dur- agents have confirmed or probable effi- tions. (C)
ing the history and physical examination. cacy confirmed in systematic reviews of
Major clinical manifestations of diabetic RCTs (379), with several U.S. Food and Amputation and foot ulceration, con-
autonomic neuropathy include resting Drug Administration (FDA)-approved for sequences of diabetic neuropathy and/or
tachycardia, exercise intolerance, ortho- the management of painful DPN. PAD, are common and major causes of
static hypotension, constipation, gastro- Treatment of autonomic neuropathy. morbidity and disability in people with
paresis, erectile dysfunction, sudomotor Gastroparesis symptoms may improve diabetes. Early recognition and manage-
dysfunction, impaired neurovascular func- with dietary changes and prokinetic ment of risk factors can prevent or delay
tion, and, potentially, autonomic failure in agents such as metoclopramide or eryth- adverse outcomes.
response to hypoglycemia (383). romycin. Treatments for erectile dysfunc- The risk of ulcers or amputations is
CAN, a CVD risk factor (93), is the tion may include phosphodiesterase type increased in people who have the follow-
most studied and clinically important 5 inhibitors, intracorporeal or intraure- ing risk factors:
form of diabetic autonomic neuropathy. thral prostaglandins, vacuum devices, or
CAN may be indicated by resting tachy- penile prostheses. Interventions for other c Previous amputation
cardia (.100 bpm), orthostasis (a fall in manifestations of autonomic neuropathy c Past foot ulcer history
systolic blood pressure .20 mmHg upon are described in the ADA statement on c Peripheral neuropathy
standing without an appropriate heart neuropathy (380). As with DPN treat- c Foot deformity
rate response); it is also associated with ments, these interventions do not change c Peripheral vascular disease
increased cardiac event rates. Although the underlying pathology and natural c Visual impairment

S38 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

c Diabetic nephropathy (especially pa- however, identification of the patient with cannot be accommodated with commercial
tients on dialysis) LOPS can easily be carried out without therapeutic footwear may need custom-
c Poor glycemic control this or other expensive equipment. molded shoes.
c Cigarette smoking Initial screening for PAD should Foot ulcers and wound care may
include a history for claudication and an require care by a podiatrist, orthopedic
assessment of the pedal pulses. A diag- or vascular surgeon, or rehabilitation
Many studies have been published nostic ABI should be performed in any specialist experienced in the management
proposing a range of tests that might patient with symptoms of PAD. Due to of individuals with diabetes. Guidelines
usefully identify patients at risk for foot the high estimated prevalence of PAD in for treatment of diabetic foot ulcers have
ulceration, creating confusion among patients with diabetes and the fact that recently been updated (387).
practitioners as to which screening tests many patients with PAD are asymptom-
should be adopted in clinical practice. An atic, an ADA consensus statement on PAD VII. ASSESSMENT OF
ADA task force was therefore assembled (386) suggested that a screening ABI be COMMON COMORBID
in 2008 to concisely summarize recent performed in patients over 50 years of age CONDITIONS
literature in this area and then recommend and be considered in patients under 50
what should be included in the compre- years of age who have other PAD risk fac- Recommendations
hensive foot exam for adult patients with tors (e.g., smoking, hypertension, hyper- c For patients with risk factors, signs or
diabetes. Their recommendations are sum- lipidemia, or duration of diabetes .10 symptoms, consider assessment and
marized below, but clinicians should refer years). Refer patients with significant treatment for common diabetes-asso-
to the task force report (385) for further symptoms or a positive ABI for further ciated conditions (see Table 14). (B)
details and practical descriptions of how vascular assessment and consider exer-
to perform components of the comprehen- cise, medications, and surgical options In addition to the commonly appre-
sive foot examination. (386). ciated comorbidities of obesity, hyperten-
At least annually, all adults with di- Patients with diabetes and high-risk sion, and dyslipidemia, diabetes is also
abetes should undergo a comprehensive foot conditions should be educated re- associated with other diseases or condi-
foot examination to identify high-risk garding their risk factors and appropriate tions at rates higher than those of age-
conditions. Clinicians should ask about management. Patients at risk should un- matched people without diabetes. A few
history of previous foot ulceration or derstand the implications of the loss of of the more common comorbidities are
amputation, neuropathic or peripheral protective sensation, the importance of described herein and listed in Table 14.
vascular symptoms, impaired vision, to- foot monitoring on a daily basis, the
bacco use, and foot care practices. A proper care of the foot, including nail Hearing impairment
general inspection of skin integrity and and skin care, and the selection of appro- Hearing impairment, both high frequency
musculoskeletal deformities should be priate footwear. Patients with LOPS and low/mid frequency, is more common
done in a well-lit room. Vascular assess- should be educated on ways to substitute in people with diabetes, perhaps due to
ment would include inspection and as- other sensory modalities (hand palpation, neuropathy and/or vascular disease. In an
sessment of pedal pulses. visual inspection) for surveillance of early NHANES analysis, hearing impairment
The neurologic exam recommended foot problems. The patients’ understand- was about twice as great in people with
is designed to identify LOPS rather than ing of these issues and their physical abil- diabetes compared with those without,
early neuropathy. The clinical examina- ity to conduct proper foot surveillance after adjusting for age and other risk
tion to identify LOPS is simple and and care should be assessed. Patients factors for hearing impairment (388).
requires no expensive equipment. Five with visual difficulties, physical con- Controlling for age, race, and other demo-
simple clinical tests (use of a 10-g mono- straints preventing movement, or cogni- graphic factors, high frequency loss in
filament, vibration testing using a 128-Hz tive problems that impair their ability to those with diabetes was significantly asso-
tuning fork, tests of pinprick sensation, assess the condition of the foot and to in- ciated with history of CHD and with pe-
ankle reflex assessment, and testing vi- stitute appropriate responses will need ripheral neuropathy, while low/mid
bration perception threshold with a bio- other people, such as family members, frequency loss was associated with low
thesiometer), each with evidence from to assist in their care. HDL cholesterol and with poor reported
well-conducted prospective clinical co- People with neuropathy or evidence health status (389).
hort studies, are considered useful in the of increased plantar pressure (e.g., ery-
diagnosis of LOPS in the diabetic foot. thema, warmth, callus, or measured
The task force agrees that any of the five pressure) may be adequately managed Table 14dCommon comorbidities for which
tests listed could be used by clinicians to with well-fitted walking shoes or athletic increased risk is associated with diabetes
identify LOPS, although ideally two of shoes that cushion the feet and redistrib-
Hearing impairment
these should be regularly performed dur- ute pressure. Callus can be debrided
Obstructive sleep apnea
ing the screening examdnormally the with a scalpel by a foot care specialist
Fatty liver disease
10-g monofilament and one other test. or other health professional with experi-
Low testosterone in men
One or more abnormal tests would sug- ence and training in foot care. People
Periodontal disease
gest LOPS, while at least two normal tests with bony deformities (e.g., hammer-
Certain cancers
(and no abnormal test) would rule out toes, prominent metatarsal heads, bun-
Fractures
LOPS. The last test listed, vibration as- ions) may need extra-wide or -depth
Cognitive impairment
sessment using a biothesiometer or simi- shoes. People with extreme bony
Depression
lar instrument, is widely used in the U.S.; deformities (e.g., Charcot foot) who

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S39


Position Statement

Obstructive sleep apnea analysis (400). Several high-quality RCTs community-dwelling people over the
Age-adjusted rates of obstructive sleep have not shown a significant effect (401). age of 60 years, the presence of diabetes
apnea, a risk factor for CVD, are signifi- at baseline significantly increased the age-
cantly higher (4- to 10-fold) with obesity, Cancer and sex-adjusted incidence of all-cause
especially with central obesity, in men Diabetes (possibly only type 2 diabetes) is dementia, Alzheimer disease, and vascu-
and women (390). The prevalence in gen- associated with increased risk of cancers lar dementia compared with rates in those
eral populations with type 2 diabetes may of the liver, pancreas, endometrium, co- with normal glucose tolerance (410). In a
be up to 23% (391), and in obese partic- lon/rectum, breast, and bladder (402). substudy of the ACCORD study, there
ipants enrolled in the Look AHEAD trial The association may result from shared were no differences in cognitive outcomes
exceeded 80% (392). Treatment of sleep risk factors between type 2 diabetes and between intensive and standard glycemic
apnea significantly improves quality of cancer (obesity, age, and physical inactiv- control, although there was significantly
life and blood pressure control. The evi- ity) but may also be due to hyperinsuline- less of a decrement in total brain volume
dence for a treatment effect on glycemic mia or hyperglycemia (401,403). Patients by magnetic resonance imaging in partic-
control is mixed (393). with diabetes should be encouraged ipants in the intensive arm (411). The ef-
to undergo recommended age- and sex- fects of hyperglycemia and insulin on the
Fatty liver disease appropriate cancer screenings and to re- brain are areas of intense research interest.
Unexplained elevation of hepatic trans- duce their modifiable cancer risk factors
aminase concentrations is significantly (obesity, smoking, and physical inactivity). Depression
associated with higher BMI, waist circum- As discussed in Section V.H, depression is
ference, triglycerides, and fasting insulin, Fractures highly prevalent in people with diabetes
and with lower HDL cholesterol. Type 2 Age-matched hip fracture risk is signifi- and is associated with worse outcomes.
diabetes and hypertension are indepen- cantly increased in both type 1 (summary
dently associated with transaminase ele- RR 6.3) and type 2 diabetes (summary RR VIII. DIABETES CARE IN
vations in women (394). In a prospective 1.7) in both sexes (404). Type 1 diabetes SPECIFIC POPULATIONS
analysis, diabetes was significantly associ- is associated with osteoporosis, but in
ated with incident nonalcoholic chronic type 2 diabetes an increased risk of hip A. Children and adolescents
liver disease and with hepatocellular car- fracture is seen despite higher bone min- Recommendations
cinoma (395). Interventions that improve eral density (BMD) (405). One study c As is the case for all children, children
metabolic abnormalities in patients with showed that prevalent vertebral fractures with diabetes or prediabetes should be
diabetes (weight loss, glycemic control, were significantly more common in men encouraged to engage in at least 60 min
treatment with specific drugs for hyper- and women with type 2 diabetes, but of physical activity each day. (B)
glycemia or dyslipidemia) are also benefi- were not associated with BMD (406). In
cial for fatty liver disease (396). three large observational studies of older 1. Type 1 diabetes
adults, femoral neck BMD T-score and Three-quarters of all cases of type 1 di-
Low testosterone in men the WHO fracture risk algorithm abetes are diagnosed in individuals ,18
Mean levels of testosterone are lower in (FRAX) score were associated with hip years of age. It is appropriate to consider
men with diabetes compared with age- and nonspine fracture, although fracture the unique aspects of care and manage-
matched men without diabetes, but risk was higher in diabetic participants ment of children and adolescents with
obesity is a major confounder (397). The compared with participants without dia- type 1 diabetes. Children with diabetes
issue of treatment in asymptomatic men is betes for a given T-score and age or for a differ from adults in many respects, in-
controversial. The evidence for effects of tes- given FRAX score risk (407). It is appro- cluding changes in insulin sensitivity re-
tosterone replacement on outcomes is priate to assess fracture history and risk lated to sexual maturity and physical
mixed, and recent guidelines suggest that factors in older patients with diabetes and growth, ability to provide self-care, super-
screening and treatment of men without recommend BMD testing if appropriate vision in child care and school, and
symptoms are not recommended (398). for the patient’s age and sex. For at-risk unique neurologic vulnerability to hypo-
patients, it is reasonable to consider stan- glycemia and DKA. Attention to such is-
Periodontal disease dard primary or secondary prevention sues as family dynamics, developmental
Periodontal disease is more severe, but strategies (reduce risk factors for falls, en- stages, and physiological differences re-
not necessarily more prevalent, in pa- sure adequate calcium and vitamin D in- lated to sexual maturity are all essential
tients with diabetes than those without take, avoid use of medications that lower in developing and implementing an opti-
(399). Numerous studies have suggested BMD, such as glucocorticoids), and to con- mal diabetes regimen. Although recom-
associations with poor glycemic control, sider pharmacotherapy for high-risk pa- mendations for children and adolescents
nephropathy, and CVD, but most studies tients. For patients with type 2 diabetes are less likely to be based on clinical trial
are highly confounded. A comprehensive with fracture risk factors, avoiding use of evidence, expert opinion and a review of
assessment, and treatment of identified thiazolidinediones is warranted. available and relevant experimental data
disease, is indicated in patients with dia- are summarized in the ADA statement on
betes, but the evidence that periodontal Cognitive impairment care of children and adolescents with type
disease treatment improves glycemic con- Diabetes is associated with significantly 1 diabetes (412).
trol is mixed. A meta-analysis reported a increased risk of cognitive decline, a Ideally, the care of a child or adoles-
significant 0.47% improvement in A1C, greater rate of cognitive decline, and cent with type 1 diabetes should be pro-
but noted multiple problems with the qual- increased risk of dementia (408,409). vided by a multidisciplinary team of
ity of the published studies included in the In a 15-year prospective study of a specialists trained in the care of children

S40 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

with pediatric diabetes. At the very least, against the risks of hypoglycemia and the should be confirmed on at least three
education of the child and family should developmental burdens of intensive regi- separate days. Normal blood pressure
be provided by health care providers mens in children and youth. Age-specific levels for age, sex, and height and appro-
trained and experienced in childhood glycemic and A1C goals are presented in priate methods for determinations are
diabetes and sensitive to the challenges Table 15. available online at www.nhlbi.nih.gov/
posed by diabetes in this age-group. It is health/prof/heart/hbp/hbp_ped.pdf.
essential that DSME, MNT, and psycho- b. Screening and management
social support be provided at the time of of chronic complications in iii. Dyslipidemia
diagnosis and regularly thereafter by in- children and adolescents Recommendations
dividuals experienced with the educational, with type 1 diabetes Screening
nutritional, behavioral, and emotional needs i. Nephropathy c If there is a family history of hypercho-
of the growing child and family. It is Recommendations lesterolemia or a cardiovascular event
expected that the balance between adult c Annual screening for microalbuminuria,
before age 55 years, or if family history is
supervision and self-care should be defined with a random spot urine sample for unknown, then consider obtaining a
and that it will evolve with physical, psy- albumin-to-creatinine ratio, should be fasting lipid profile on children .2 years
chological, and emotional maturity. considered once the child is 10 years of of age soon after diagnosis (after glucose
age and has had diabetes for 5 years. (B) control has been established). If family
a. Glycemic control c Treatment with an ACE inhibitor, ti-
history is not of concern, then consider
Recommendations trated to normalization of albumin ex- the first lipid screening at puberty ($10
c Consider age when setting glycemic years of age). For children diagnosed
cretion, should be considered when
goals in children and adolescents with elevated albumin-to-creatinine ratio is with diabetes at or after puberty, con-
type 1 diabetes. (E) subsequently confirmed on two addi- sider obtaining a fasting lipid profile
tional specimens from different days. (E) soon after the diagnosis (after glucose
While current standards for diabetes control has been established). (E)
management reflect the need to lower ii. Hypertension c For both age-groups, if lipids are ab-
glucose as safely possible, special consid- Recommendations normal, annual monitoring is reason-
eration should be given to the unique c Blood pressure should be measured at able. If LDL cholesterol values are within
risks of hypoglycemia in young children. each routine visit. Children found to the accepted risk levels (,100 mg/dL
Glycemic goals may need to be modified have high-normal blood pressure or [2.6 mmol/L]), a lipid profile repeated
to take into account the fact that most hypertension should have blood pres- every 5 years is reasonable. (E)
children ,6 or 7 years of age have a form sure confirmed on a separate day. (B) Treatment
of “hypoglycemic unawareness,” includ- c Initial treatment of high-normal blood c Initial therapy may consist of optimi-
ing immaturity and a relative inability to pressure (systolic or diastolic blood pres- zation of glucose control and MNT
recognize and respond to hypoglycemic sure consistently above the 90th percen- using a Step 2 AHA diet aimed at a
symptoms, placing them at greater risk tile for age, sex, and height) includes decrease in the amount of saturated fat
for severe hypoglycemia and its sequelae. dietary intervention and exercise, aimed in the diet. (E)
In addition, and unlike the case in type 1 at weight control and increased physical c After the age of 10 years, the addition
diabetic adults, young children below the activity, if appropriate. If target blood of a statin in patients who, after MNT
age of 5 years may be at risk for perma- pressure is not reached with 3–6 months and lifestyle changes, have LDL choles-
nent cognitive impairment after episodes of lifestyle intervention, pharmacological terol .160 mg/dL (4.1 mmol/L), or LDL
of severe hypoglycemia (413–415). Fur- treatment should be considered. (E) cholesterol .130 mg/dL (3.4 mmol/L)
thermore, the DCCT demonstrated that c Pharmacological treatment of hyperten- and one or more CVD risk factors, is
near-normalization of blood glucose lev- sion (systolic or diastolic blood pressure reasonable. (E)
els was more difficult to achieve in ado- consistently above the 95th percentile for c The goal of therapy is an LDL choles-
lescents than adults. Nevertheless, the age, sex, and height or consistently terol value ,100 mg/dL (2.6 mmol/L). (E)
increased frequency of use of basal-bolus .130/80 mmHg, if 95% exceeds that
regimens and insulin pumps in youth value) should be considered as soon as People diagnosed with type 1 diabetes
from infancy through adolescence has the diagnosis is confirmed. (E) in childhood have a high risk of early
been associated with more children c ACE inhibitors should be considered subclinical (420–422) and clinical (423)
reaching ADA blood glucose targets for the initial treatment of hypertension, CVD. Although intervention data are
(416,417) in those families in which following appropriate reproductive lacking, the AHA categorizes children
both parents and the child with diabetes counseling due to its potential terato- with type 1 diabetes in the highest tier
participate jointly to perform the re- genic effects. (E) for cardiovascular risk and recommends
quired diabetes-related tasks. Further- c The goal of treatment is a blood pres- both lifestyle and pharmacological treat-
more, recent studies documenting sure consistently ,130/80 or below ment for those with elevated LDL choles-
neurocognitive sequelae of hyperglyce- the 90th percentile for age, sex, and terol levels (424,425). Initial therapy
mia in children provide another compel- height, whichever is lower. (E) should be with a Step 2 AHA diet, which
ling motivation for achieving glycemic restricts saturated fat to 7% of total calo-
targets (418,419). It is important that blood pressure ries and restricts dietary cholesterol to
In selecting glycemic goals, the bene- measurements are determined correctly, 200 mg/day. Data from randomized clin-
fits on long-term health outcomes of using the appropriate size cuff, and with ical trials in children as young as 7 months
achieving a lower A1C should be balanced the child seated and relaxed. Hypertension of age indicate that this diet is safe and

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S41


Position Statement

Table 15dPlasma blood glucose and A1C goals for type 1 diabetes by age-group

Plasma blood glucose goal


range (mg/dL)
Before Bedtime/
Values by age (years) meals overnight A1C Rationale
Toddlers and preschoolers (0–6) 100–180 110–200 ,8.5% c Vulnerability to hypoglycemia
c Insulin sensitivity
c Unpredictability in dietary intake and physical activity
c A lower goal (,8.0%) is reasonable if it can be
achieved without excessive hypoglycemia
School age (6–12) 90–180 100–180 ,8% c Vulnerability of hypoglycemia
c A lower goal (,7.5%) is reasonable if it can be
achieved without excessive hypoglycemia
Adolescents and young adults (13–19) 90–130 90–150 ,7.5% c A lower goal (,7.0%) is reasonable if it can be
achieved without excessive hypoglycemia

Key concepts in setting glycemic goals:


c Goals should be individualized and lower goals may be reasonable based on benefit-risk assessment.
c Blood glucose goals should be modified in children with frequent hypoglycemia or hypoglycemia unawareness.
c Postprandial blood glucose values should be measured when there is a discrepancy between preprandial blood glucose values and A1C
levels and to help assess glycemia in those on basal/bolus regimens.

does not interfere with normal growth should be made to eye care professionals individuals compared with 0.3–1% in the
and development (426,427). with expertise in diabetic retinopathy, an general population) (432,433). Symptoms
Neither long-term safety nor cardio- understanding of the risk for retinopathy of celiac disease include diarrhea, weight
vascular outcome efficacy of statin therapy in the pediatric population, and experi- loss or poor weight gain, growth failure,
has been established for children. How- ence in counseling the pediatric patient abdominal pain, chronic fatigue, malnutri-
ever, recent studies have shown short-term and family on the importance of early pre- tion due to malabsorption, and other
safety equivalent to that seen in adults and vention/intervention. gastrointestinal problems, and unexplained
efficacy in lowering LDL cholesterol levels, hypoglycemia or erratic blood glucose con-
improving endothelial function and caus- v. Celiac disease centrations.
ing regression of carotid intimal thickening Recommendations Screening for celiac disease includes
(428–430). No statin is approved for use c Consider screening children with type measuring serum levels of tissue trans-
under the age of 10 years, and statin treat- 1 diabetes for celiac disease by measuring glutaminase or antiendomysial antibodies,
ment should generally not be used in chil- tissue transglutaminase or antiendomysial then small bowel biopsy in antibody-
dren with type 1 diabetes prior to this age. antibodies, with documentation of nor- positive children. Recent European guide-
For postpubertal girls, issues of pregnancy mal total serum IgA levels, soon after the lines on screening for celiac disease in
prevention are paramount, since statins are diagnosis of diabetes. (E) children (not specific to children with type
category X in pregnancy. See Section VIII.B c Testing should be considered in chil- 1 diabetes) suggested that biopsy might
for more information. dren with growth failure, failure to gain not be necessary in symptomatic children
weight, weight loss, diarrhea, flatulence, with positive antibodies, as long as further
iv. Retinopathy abdominal pain, or signs of malabsorp- testing such as genetic or HLA testing was
Recommendations tion or in children with frequent un- supportive, but that asymptomatic but at-
c The first ophthalmologic examination explained hypoglycemia or deterioration risk children should have biopsies (434).
should be obtained once the child is in glycemic control. (E) One small study that included children
$10 years of age and has had diabetes c Consider referral to a gastroenterolo- with and without type 1 diabetes sugges-
for 3–5 years. (B) gist for evaluation with possible en- ted that antibody-positive but biopsy-neg-
c After the initial examination, annual doscopy and biopsy for confirmation of ative children were similar clinically to
routine follow-up is generally recom- celiac disease in asymptomatic children those who were biopsy positive and that
mended. Less frequent examinations with positive antibodies. (E) biopsy-negative children had benefits
may be acceptable on the advice of an c Children with biopsy-confirmed celiac from a gluten-free diet but worsening on a
eye care professional. (E) disease should be placed on a gluten- usual diet (435). Because this study was
free diet and have consultation with a small and because children with type 1 di-
Although retinopathy (like albuminuria) dietitian experienced in managing both abetes already need to follow a careful diet,
most commonly occurs after the onset of diabetes and celiac disease. (B) it is difficult to advocate for not confirming
puberty and after 5–10 years of diabetes the diagnosis by biopsy before recommend-
duration (431), it has been reported in Celiac disease is an immune-mediated dis- ing a lifelong gluten-free diet, especially in
prepubertal children and with diabetes order that occurs with increased frequency asymptomatic children. In symptomatic
duration of only 1–2 years. Referrals in patients with type 1 diabetes (1–16% of children with type 1 diabetes and celiac

S42 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

disease, gluten-free diets reduce symptoms school and day care setting (442) for fur- families (http://www.endo-society.org/
and rates of hypoglycemia (436). ther discussion. clinicalpractice/transition_of_care.cfm).

vi. Hypothyroidism e. Transition from pediatric to adult 2. Type 2 diabetes


Recommendations care The incidence of type 2 diabetes in ado-
c Consider screening children with type Recommendations lescents is increasing, especially in ethnic
1 diabetes for thyroid peroxidase and c As teens transition into emerging minority populations (31). Distinction
thyroglobulin antibodies soon after adulthood, health care providers and between type 1 and type 2 diabetes in
diagnosis. (E) families must recognize their many children can be difficult, since the preva-
c Measuring thyroid-stimulating hor- vulnerabilities (B) and prepare the de- lence of overweight in children continues
mone (TSH) concentrations soon after veloping teen, beginning in early to to rise and since autoantigens and ketosis
diagnosis of type 1 diabetes, after me- mid adolescence and at least 1 year may be present in a substantial number of
tabolic control has been established, prior to the transition. (E) patients with features of type 2 diabetes
is reasonable. If normal, consider re- c Both pediatricians and adult health (including obesity and acanthosis nigri-
checking every 1–2 years, especially if care providers should assist in pro- cans). Such a distinction at the time of
the patient develops symptoms of thy- viding support and links to resources diagnosis is critical because treatment reg-
roid dysfunction, thyromegaly, or an for the teen and emerging adult. (B) imens, educational approaches, and die-
abnormal growth rate. (E) tary counsel will differ markedly between
Care and close supervision of diabetes the two diagnoses.
Autoimmune thyroid disease is the most management is increasingly shifted from Type 2 diabetes has a significant in-
common autoimmune disorder associ- parents and other older adults through- cidence of comorbidities already present
ated with diabetes, occurring in 17–30% out childhood and adolescence. How- at the time of diagnosis (448). It is recom-
of patients with type 1 diabetes (437). ever, the shift from pediatrics to adult mended that blood pressure measurement,
About one-quarter of type 1 diabetic chil- health care providers often occurs very a fasting lipid profile, microalbuminuria as-
dren have thyroid autoantibodies at the abruptly as the older teen enters the next sessment, and dilated eye examination be
time of diagnosis of their diabetes (438), developmental stage referred to as emerg- performed at the time of diagnosis. There-
and the presence of thyroid autoantibod- ing adulthood (443), a critical period for after, screening guidelines and treatment
ies is predictive of thyroid dysfunction, young people who have diabetes; during recommendations for hypertension, dysli-
generally hypothyroidism but less com- this period of major life transitions, youth pidemia, microalbuminuria, and retinopa-
monly hyperthyroidism (439). Subclini- begin to move out of their parents’ home thy in youth with type 2 diabetes are similar
cal hypothyroidism may be associated and must become more fully responsible to those for youth with type 1 diabetes. Ad-
with increased risk of symptomatic hypo- for their diabetes care including the many ditional problems that may need to be ad-
glycemia (440) and with reduced linear aspects of self management, making med- dressed include polycystic ovarian disease
growth (441). Hyperthyroidism alters ical appointments, and financing health and the various comorbidities associated
glucose metabolism, potentially resulting care once they are no longer covered un- with pediatric obesity such as sleep apnea,
in deterioration of metabolic control. der their parents’ health insurance hepatic steatosis, orthopedic complica-
(444,445). In addition to lapses in health tions, and psychosocial concerns. The
c. Self-management care, this is also a period of deterioration ADA consensus statement on this subject
No matter how sound the medical regi- in glycemic control, increased occurrence (33) provides guidance on the prevention,
men, it can only be as good as the ability of acute complications, psycho-social- screening, and treatment of type 2 diabetes
of the family and/or individual to imple- emotional-behavioral issues, and emergence and its comorbidities in young people.
ment it. Family involvement in diabetes of chronic complications (444–447).
remains an important component of opti- Though scientific evidence continues 3. Monogenic diabetes syndromes
mal diabetes management throughout to be limited, it is clear that early and Monogenic forms of diabetes (neonatal
childhood and adolescence. Health care ongoing attention be given to compre- diabetes or maturity-onset diabetes of the
providers who care for children and adoles- hensive and coordinated planning for young) represent a small fraction of chil-
cents, therefore, must be capable of seamless transition of all youth from dren with diabetes (,5%), but the ready
evaluating the educational, behavioral, emo- pediatric to adult health care (444,445). availability of commercial genetic testing
tional, and psychosocial factors that impact A comprehensive discussion regarding is now enabling a true genetic diagnosis
implementation of a treatment plan and the challenges faced during this period, with increasing frequency. It is important
must work with the individual and family to including specific recommendations, is to correctly diagnose one of the mono-
overcome barriers or redefine goals as ap- found in the ADA position statement “Di- genic forms of diabetes, as these children
propriate. abetes Care for Emerging Adults: Recom- may be incorrectly diagnosed with type 1
mendations for Transition From Pediatric or type 2 diabetes, leading to nonoptimal
d. School and day care to Adult Diabetes Care Systems” (445). treatment regimens and delays in diag-
Since a sizable portion of a child’s day is The National Diabetes Education Pro- nosing other family members.
spent in school, close communication gram (NDEP) has materials available to The diagnosis of monogenic diabetes
with and cooperation of school or day facilitate the transition process (http://ndep should be considered in the following
care personnel is essential for optimal di- .nih.gov/transitions/), and The Endocrine settings: diabetes diagnosed within the
abetes management, safety, and maximal Society (in collaboration with the ADA first 6 months of life; in children with
academic opportunities. See the ADA po- and other organizations has developed strong family history of diabetes but with-
sition statement on diabetes care in the transition tools for clinicians and youth/ out typical features of type 2 diabetes

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S43


Position Statement

(nonobese, low-risk ethnic group); in chil- participated in preconception diabetes number may be relatively or absolutely
dren with mild fasting hyperglycemia (100– care programs and women who initiated contraindicated during pregnancy. Sta-
150 mg/dL [5.5–8.5 mmol]), especially if intensive diabetes management after they tins are category X (contraindicated for
young and nonobese; and in children with were already pregnant. The preconcep- use in pregnancy) and should be discon-
diabetes but with negative autoantibodies tion care programs were multidisciplinary tinued before conception, as should ACE
without signs of obesity or insulin resis- and designed to train patients in diabetes inhibitors (450). ARBs are category C
tance. A recent international consensus self-management with diet, intensified (risk cannot be ruled out) in the first tri-
document discusses in further detail the di- insulin therapy, and SMBG. Goals were mester but category D (positive evidence
agnosis and management of children with set to achieve normal blood glucose con- of risk) in later pregnancy and should
monogenic forms of diabetes (449). centrations, and .80% of subjects ach- generally be discontinued before preg-
ieved normal A1C concentrations before nancy. Since many pregnancies are un-
B. Preconception care they became pregnant. In all five studies, planned, health care professionals caring
Recommendations the incidence of major congenital malfor- for any woman of childbearing potential
c A1C levels should be as close to normal mations in women who participated in should consider the potential risks and
as possible (,7%) in an individual pa- preconception care (range 1.0–1.7% of benefits of medications that are contrain-
tient before conception is attempted. (B) infants) was much lower than the inci- dicated in pregnancy. Women using med-
c Starting at puberty, preconception dence in women who did not participate ications such as statins or ACE inhibitors
counseling should be incorporated in (range 1.4–10.9% of infants) (106). One need ongoing family planning counsel-
the routine diabetes clinic visit for all limitation of these studies is that partici- ing. Among the oral antidiabetic agents,
women of childbearing potential. (C) pation in preconception care was self- metformin and acarbose are classified as
c Women with diabetes who are con- selected rather than randomized. Thus, category B (no evidence of risk in hu-
templating pregnancy should be eval- it is impossible to be certain that the lower mans) and all others as category C. Poten-
uated and, if indicated, treated for malformation rates resulted fully from tial risks and benefits of oral antidiabetic
diabetic retinopathy, nephropathy, improved diabetes care. Nonetheless, agents in the preconception period must
neuropathy, and CVD. (B) the evidence supports the concept that be carefully weighed, recognizing that
c Medications used by such women malformations can be reduced or preven- data are insufficient to establish the safety
should be evaluated prior to conception, ted by careful management of diabetes be- of these agents in pregnancy.
since drugs commonly used to treat di- fore pregnancy. For further discussion of preconcep-
abetes and its complications may be Planned pregnancies greatly facilitate tion care, see the ADA’s consensus state-
contraindicated or not recommended in preconception diabetes care. Unfortu- ment on pre-existing diabetes and
pregnancy, including statins, ACE in- nately, nearly two-thirds of pregnancies pregnancy (106) and the position state-
hibitors, ARBs, and most noninsulin in women with diabetes are unplanned, ment (451) on this subject.
therapies. (E) leading to a persistent excess of malfor-
c Since many pregnancies are unplanned, mations in infants of diabetic mothers. To
consider the potential risks and benefits minimize the occurrence of these devas- C. Older adults
of medications that are contraindicated tating malformations, standard care for all Recommendations
in pregnancy in all women of child- women with diabetes who have child- c Older adults who are functional, cog-
bearing potential and counsel women bearing potential, beginning at the onset nitively intact, and have significant life
using such medications accordingly. (E) of puberty or at diagnosis, should include expectancy should receive diabetes
1) education about the risk of malforma- care with goals similar to those de-
Major congenital malformations re- tions associated with unplanned pregnan- veloped for younger adults. (E)
main the leading cause of mortality and cies and poor metabolic control and 2) c Glycemic goals for some older adults
serious morbidity in infants of mothers use of effective contraception at all times, might reasonably be relaxed, using in-
with type 1 and type 2 diabetes. Obser- unless the patient has good metabolic dividual criteria, but hyperglycemia
vational studies indicate that the risk of control and is actively trying to conceive. leading to symptoms or risk of acute
malformations increases continuously Women contemplating pregnancy hyperglycemic complications should
with increasing maternal glycemia during need to be seen frequently by a multidis- be avoided in all patients. (E)
the first 6–8 weeks of gestation, as defined ciplinary team experienced in the man- c Other cardiovascular risk factors
by first-trimester A1C concentrations. agement of diabetes before and during should be treated in older adults with
There is no threshold for A1C values be- pregnancy. The goals of preconception consideration of the time frame of
low which risk disappears entirely. How- care are to 1) involve and empower the benefit and the individual patient.
ever, malformation rates above the 1–2% patient in the management of her diabe- Treatment of hypertension is indicated
background rate of nondiabetic pregnan- tes, 2) achieve the lowest A1C test results in virtually all older adults, and lipid
cies appear to be limited to pregnancies in possible without excessive hypoglycemia, and aspirin therapy may benefit those
which first-trimester A1C concentrations 3) assure effective contraception until sta- with life expectancy at least equal to the
are .1% above the normal range for a ble and acceptable glycemia is achieved, time frame of primary or secondary
nondiabetic pregnant woman. and 4) identify, evaluate, and treat long- prevention trials. (E)
Preconception care of diabetes ap- term diabetes complications such as c Screening for diabetes complications
pears to reduce the risk of congenital retinopathy, nephropathy, neuropathy, should be individualized in older
malformations. Five nonrandomized hypertension, and CHD (106). adults, but particular attention should
studies compared rates of major malfor- Among the drugs commonly used in be paid to complications that would
mations in infants between women who the treatment of patients with diabetes, a lead to functional impairment. (E)

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Position Statement

Diabetes is an important health condi- reducing the risk of microvascular com- screening test for CFRD is not recom-
tion for the aging population; at least 20% plications and more likely to suffer seri- mended. (B)
of patients over the age of 65 years have ous adverse effects from hypoglycemia. c During a period of stable health, the
diabetes, and this number can be expected However, patients with poorly controlled diagnosis of CFRD can be made in
to grow rapidly in the coming decades. diabetes may be subject to acute compli- cystic fibrosis patients according to
Older individuals with diabetes have cations of diabetes, including dehydration, usual glucose criteria. (E)
higher rates of premature death, functional poor wound healing, and hyperglycemic c Patients with CFRD should be treated
disability, and coexisting illnesses such as hyperosmolar coma. Glycemic goals with insulin to attain individualized
hypertension, CHD, and stroke than those at a minimum should avoid these conse- glycemic goals. (A)
without diabetes. Older adults with diabe- quences. c Annual monitoring for complications
tes are also at greater risk than other older Although control of hyperglycemia of diabetes is recommended, beginning
adults for several common geriatric syn- may be important in older individuals 5 years after the diagnosis of CFRD. (E)
dromes, such as polypharmacy, depres- with diabetes, greater reductions in mor-
sion, cognitive impairment, urinary bidity and mortality may result from CFRD is the most common comorbidity
incontinence, injurious falls, and persistent control of other cardiovascular risk fac- in persons with cystic fibrosis, occurring
pain. tors rather than from tight glycemic con- in about 20% of adolescents and 40–50%
A consensus report on diabetes and trol alone. There is strong evidence from of adults. The additional diagnosis of di-
older adults (452) influenced the follow- clinical trials of the value of treating abetes in this population is associated
ing discussion and recommendations. hypertension in the elderly (453,454). with worse nutritional status, more severe
The care of older adults with diabetes is There is less evidence for lipid-lowering inflammatory lung disease, and greater
complicated by their clinical and func- and aspirin therapy, although the benefits mortality from respiratory failure. Insulin
tional heterogeneity. Some older individ- of these interventions for primary and insufficiency related to partial fibrotic de-
uals developed diabetes years earlier and secondary prevention are likely to apply struction of the islet mass is the primary
may have significant complications; oth- to older adults whose life expectancies defect in CFRD. Genetically determined
ers who are newly diagnosed may have equal or exceed the time frames seen in function of the remaining b-cells and in-
had years of undiagnosed diabetes with clinical trials. sulin resistance associated with infection
resultant complications or may have truly Special care is required in prescribing and inflammation may also play a role.
recent-onset disease and few or no com- and monitoring pharmacological therapy Encouraging new data suggest that early
plications. Some older adults with diabe- in older adults. Costs may be a significant detection and aggressive insulin therapy
tes are frail and have other underlying factor, especially since older adults tend have narrowed the gap in mortality be-
chronic conditions, substantial diabetes- to be on many medications. Metformin tween cystic fibrosis patients with and
related comorbidity, or limited physical may be contraindicated because of renal without diabetes and have eliminated
or cognitive functioning. Other older in- insufficiency or significant heart failure. the sex difference in mortality (455).
dividuals with diabetes have little comor- Thiazolidinediones, if used at all, should Recommendations for the clinical
bidity and are active. Life expectancies are be used very cautiously in those with, or management of CFRD can be found in
highly variable for this population, but at risk for, CHF and have also been the recent ADA position statement on this
often longer than clinicians realize. Pro- associated with fractures. Sulfonylureas, topic (456).
viders caring for older adults with diabe- other insulin secretagogues, and insulin
tes must take this heterogeneity into can cause hypoglycemia. Insulin use re- IX. DIABETES CARE IN
consideration when setting and prioritiz- quires that patients or caregivers have good SPECIFIC SETTINGS
ing treatment goals. visual and motor skills and cognitive abil-
There are few long-term studies in ity. Dipeptidyl peptidase 4 (DPP-4) inhib- A. Diabetes care in the hospital
older adults demonstrating the benefits of itors have few side effects, but their costs Recommendations
intensive glycemic, blood pressure, and may be a barrier to some older patients; the c All patients with diabetes admitted to the
lipid control. Patients who can be latter is also the case for GLP-1 agonists. hospital should have their diabetes clearly
expected to live long enough to reap the Screening for diabetes complications identified in the medical record. (E)
benefits of long-term intensive diabetes in older adults also should be individual- c All patients with diabetes should have
management, who have good cognitive ized. Particular attention should be paid an order for blood glucose monitoring,
and functional function, and who choose to complications that can develop over with results available to all members of
to do so via shared decision making may short periods of time and/or that would the health care team. (E)
be treated using therapeutic interventions significantly impair functional status, c Goals for blood glucose levels:
and goals similar to those for younger such as visual and lower-extremity com- c Critically ill patients: Insulin ther-
adults with diabetes. As with all patients, plications. apy should be initiated for treatment
DSME and ongoing DSMS are vital com- of persistent hyperglycemia starting
ponents of diabetes care for older adults at a threshold of no greater than 180
and their caregivers. D. Cystic fibrosis–related diabetes mg/dL (10 mmol/L). Once insulin
For patients with advanced diabetes Recommendations therapy is started, a glucose range of
complications, life-limiting comorbid ill- c Annual screening for cystic fibrosis– 140–180 mg/dL (7.8–10 mmol/L) is
ness, or substantial cognitive or func- related diabetes (CFRD) with OGTT recommended for the majority of
tional impairment, it is reasonable to set should begin by age 10 years in all pa- critically ill patients. (A)
less intensive glycemic target goals. These tients with cystic fibrosis who do not c More stringent goals, such as 110–
patients are less likely to benefit from have CFRD (B). Use of A1C as a 140 mg/dL (6.1–7.8 mmol/L) may be

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S45


Position Statement

appropriate for selected patients, as previously undiagnosed diabetes, or hos- mortality was significantly higher in
long as this can be achieved without pital-related hyperglycemia (fasting the intensive versus the conventional
significant hypoglycemia. (C) blood glucose $126 mg/dL or random group in both surgical and medical pa-
c Critically ill patients require an intrave- blood glucose $200 mg/dL occurring tients, as was mortality from cardiovascu-
nous insulin protocol that has demon- during the hospitalization that reverts to lar causes. Severe hypoglycemia was also
strated efficacy and safety in achieving normal after hospital discharge). The dif- more common in the intensively treated
the desired glucose range without in- ficulty distinguishing between the second group (6.8% vs. 0.5%, P , 0.001). The
creasing risk for severe hypoglycemia. (E) and third categories during the hospitali- precise reason for the increased mortality
c Non–critically ill patients: There is no zation may be overcome by measuring an in the tightly controlled group is un-
clear evidence for specific blood glucose A1C in undiagnosed patients with hyper- known. The results of this study lie in
goals. If treated with insulin, the pre- glycemia, as long as conditions interfering stark contrast to a famous 2001 single-
meal blood glucose targets generally with A1C utility (hemolysis, blood trans- center study that reported a 42% relative
,140 mg/dL (7.8 mmol/L) with ran- fusion) have not occurred. The manage- reduction in intensive care unit (ICU)
dom blood glucose ,180 mg/dL (10.0 ment of hyperglycemia in the hospital has mortality in critically ill surgical patients
mmol/L) are reasonable, provided often been considered secondary in im- treated to a target blood glucose of 80–110
these targets can be safely achieved. portance to the condition that prompted mg/dL (458). Importantly, the control
More stringent targets may be appro- admission (457). However, a body of lit- group in NICE-SUGAR had reasonably
priate in stable patients with previous erature now supports targeted glucose good blood glucose management, main-
tight glycemic control. Less stringent control in the hospital setting for poten- tained at a mean glucose of 144 mg/dL,
targets may be appropriate in those tial improved clinical outcomes. Hyper- only 29 mg/dL above the intensively man-
with severe comorbidities. (E) glycemia in the hospital may result from aged patients. Accordingly, this study’s
c Scheduled subcutaneous insulin with stress, decompensation of type 1 or type 2 findings do not disprove the notion that
basal, nutritional, and correction com- or other forms of diabetes, and/or may be glycemic control in the ICU is important.
ponents is the preferred method for iatrogenic due to withholding of antihy- However, they do strongly suggest that it
achieving and maintaining glucose con- perglycemic medications or administra- may not be necessary to target blood glu-
trol in non–critically ill patients. (C) tion of hyperglycemia-provoking agents cose values ,140 mg/dL and that a highly
c Glucose monitoring should be initiated such as glucocorticoids or vasopressors. stringent target of ,110 mg/dL may actu-
in any patient not known to be diabetic There is substantial observational ev- ally be dangerous.
who receives therapy associated with idence linking hyperglycemia in hospital- In a recent meta-analysis of 26 trials
high risk for hyperglycemia, including ized patients (with or without diabetes) to (N 5 13,567), which included the NICE-
high-dose glucocorticoid therapy, initi- poor outcomes. Cohort studies as well SUGAR data, the pooled RR of death with
ation of enteral or parenteral nutrition, as a few early RCTs suggested that in- intensive insulin therapy was 0.93 as
or other medications such as octreotide tensive treatment of hyperglycemia im- compared with conventional therapy
or immunosuppressive medications. (B) proved hospital outcomes (457–459). In (95% CI 0.83–1.04) (465). Approxi-
If hyperglycemia is documented and general, these studies were heterogeneous mately half of these trials reported hypo-
persistent, consider treating such pa- in terms of patient population, blood glu- glycemia, with a pooled RR of intensive
tients to the same glycemic goals as pa- cose targets and insulin protocols used, therapy of 6.0 (95% CI 4.5–8.0). The
tients with known diabetes. (E) provision of nutritional support, and the specific ICU setting influenced the find-
c A hypoglycemia management protocol proportion of patients receiving insulin, ings, with patients in surgical ICUs ap-
should be adopted and implemented which limits the ability to make meaning- pearing to benefit from intensive insulin
by each hospital or hospital system. A ful comparisons among them. Recent tri- therapy (RR 0.63, 95% CI 0.44–0.91),
plan for preventing and treating hypo- als in critically ill patients have failed to whereas those in other medical and
glycemia should be established for each show a significant improvement in mor- mixed critical care settings did not. It
patient. Episodes of hypoglycemia in tality with intensive glycemic control was concluded that, overall, intensive in-
the hospital should be documented in (460,461) or have even shown increased sulin therapy increased the risk of hypo-
the medial record and tracked. (E) mortality risk (462). Moreover, these re- glycemia but provided no overall benefit
c Consider obtaining an A1C on patients cent RCTs have highlighted the risk of on mortality in the critically ill,
with diabetes admitted to the hospital if severe hypoglycemia resulting from such although a possible mortality benefit to
the result of testing in the previous 2–3 efforts (460–465). patients admitted to the surgical ICU was
months is not available. (E) The largest study to date, NICE- suggested.
c Consider obtaining an A1C in patients SUGAR (Normoglycaemia in Intensive
with risk factors for undiagnosed di- Care Evaluation and Survival Using Glu- 1. Glycemic targets in hospitalized
abetes who exhibit hyperglycemia in cose Algorithm Regulation), a multicen- patients
the hospital. (E) ter, multinational RCT, compared the
c Patients with hyperglycemia in the effect of intensive glycemic control (target Definition of glucose abnormalities in
hospital who do not have a prior di- 81–108 mg/dL, mean blood glucose at- the hospital setting
agnosis of diabetes should have ap- tained 115 mg/dL) to standard glycemic Hyperglycemia in the hospital has been
propriate plans for follow-up testing control (target 144–180 mg/dL, mean defined as any blood glucose .140 mg/dL
and care documented at discharge. (E) blood glucose attained 144 mg/dL) on (7.8 mmol/L). Levels that are significantly
outcomes among 6,104 critically ill par- and persistently above this may require
Hyperglycemia in the hospital can re- ticipants, almost all of whom required me- treatment in hospitalized patients. A1C
present previously known diabetes, chanical ventilation (462). Ninety-day values .6.5% suggest, in undiagnosed

S46 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

patients, that diabetes preceded hospitali- glucose values are ,70 mg/dL (3.9 specific clinical settings including paren-
zation (466). Hypoglycemia has been de- mmol/L), unless the event is easily ex- teral nutrition (476), enteral tube feedings
fined as any blood glucose ,70 mg/dL plained by other factors (such as a missed and with high dose glucocorticoid therapy
(3.9 mmol/L). This is the standard defini- meal). There is some evidence that system- (468).
tion in outpatients and correlates with the atic attention to hyperglycemia in the There are no data on the safety and
initial threshold for the release of counter- emergency room leads to better glycemic efficacy of oral agents and injectable non-
regulatory hormones. Severe hypoglyce- control in the hospital for those subse- insulin therapies such as GLP-1 analogs
mia in hospitalized patients has been de- quently admitted (471). and pramlintide in the hospital. They are
fined by many as ,40 mg/dL (2.2 mmol/L), Occasional patients with a prior his- generally considered to have a limited role
although this is lower than the ;50 mg/dL tory of successful tight glycemic control in in the management of hyperglycemia in
(2.8 mmol/L) level at which cognitive im- the outpatient setting who are clinically conjunction with acute illness. Continu-
pairment begins in normal individuals stable may be maintained with a glucose ation of these agents may be appropriate
(467). As with hyperglycemia, hypoglyce- range below the above cut points. Con- in selected stable patients who are
mia among inpatients is also associated versely, higher glucose ranges may be expected to consume meals at regular
with adverse short- and long-term out- acceptable in terminally ill patients or in intervals, and they may be initiated or
comes. Early recognition and treatment patients with severe comorbidities, as well resumed in anticipation of discharge once
of mild to moderate hypoglycemia (40– as in those in patient care settings where the patient is clinically stable. Specific
69 mg/dL [2.2–3.8 mmol/L]) can prevent frequent glucose monitoring or close caution is required with metformin, due
deterioration to a more severe episode nursing supervision is not feasible. to the possibility that a contraindication
with potential adverse sequelae (468). Clinical judgment, combined with may develop during the hospitalization,
ongoing assessment of the patient’s clini- such as renal insufficiency, unstable he-
Critically ill patients cal status, including changes in the trajec- modynamic status, or need for an imaging
Based on the weight of the available tory of glucose measures, the severity of study that requires a radio-contrast dye.
evidence, for the majority of critically ill illness, nutritional status, or concurrent
patients in the ICU setting, insulin infusion use of medications that might affect glu- 3. Preventing hypoglycemia
should be used to control hyperglycemia, cose levels (e.g., steroids, octreotide), In the hospital, multiple risk factors for
with a starting threshold of no higher than must be incorporated into the day-to- hypoglycemia are present. Patients with
180 mg/dL (10.0 mmol/L). Once intrave- day decisions regarding insulin dosing or without diabetes may experience hy-
nous insulin is started, the glucose level (468). poglycemia in the hospital in association
should be maintained between 140 and with altered nutritional state, heart fail-
180 mg/dL (7.8 and 10.0 mmol/L). Greater 2. Antihyperglycemic agents in ure, renal or liver disease, malignancy,
benefit maybe realized at the lower end of hospitalized patients infection, or sepsis. Additional triggering
this range. Although strong evidence is In the hospital setting, insulin therapy is events leading to iatrogenic hypoglycemia
lacking, somewhat lower glucose targets the preferred method of glycemic control include sudden reduction of corticoste-
may be appropriate in selected patients. in majority of clinical situations (468). In roid dose, altered ability of the patient to
One small study suggested that medical the ICU, intravenous infusion is the pre- report symptoms, reduction of oral in-
intensive care unit (MICU) patients treated ferred route of insulin administration. take, emesis, new NPO status, inappro-
to targets of 120–140 mg/dL had less neg- When the patient is transitioned off intra- priate timing of short- or rapid-acting
ative nitrogen balance than those treated to venous insulin to subcutaneous therapy, insulin in relation to meals, reduction of
higher targets (469). However, targets precautions should be taken to prevent rate of administration of intravenous dex-
,110 mg/dL (6.1 mmol/L) are not recom- hyperglycemia escape (472,473). Outside trose, and unexpected interruption of
mended. Use of insulin infusion protocols of critical care units, scheduled subcuta- enteral feedings or parenteral nutrition.
with demonstrated safety and efficacy, re- neous insulin that delivers basal, nutri- Despite the preventable nature of many
sulting in low rates of hypoglycemia, are tional, and correction (supplemental) inpatient episodes of hypoglycemia, insti-
highly recommended (468). components is preferred. Typical dosing tutions are more likely to have nursing
schemes are based on body weight, with protocols for the treatment of hypoglyce-
Non–critically ill patients some evidence that patients with renal in- mia than for its prevention. Tracking such
With no prospective RCT data to inform sufficiency should be treated with lower episodes and analyzing their causes are
specific glycemic targets in non–critically doses (474). Prolonged therapy with important quality-improvement activities
ill patients, recommendations are based sliding-scale insulin (SSI) as the sole (468).
on clinical experience and judgment regimen is ineffective in the majority of
(470). For the majority of non–critically patients, increases risk of both hypogly- 4. Diabetes care providers in the
ill patients treated with insulin, premeal cemia and hyperglycemia, and has re- hospital
glucose targets should generally be ,140 cently been shown in a randomized trial Inpatient diabetes management may be
mg/dL (7.8 mmol/L) with random blood to be associated with adverse outcomes in effectively championed and/or provided
glucose ,180 mg/dL (10.0 mmol/L), as general surgery patients with type 2 diabe- by primary care physicians, endocrinolo-
long as these targets can be safely achieved. tes (475). SSI is potentially dangerous in gists, intensivists, or hospitalists. Involve-
To avoid hypoglycemia, consideration type 1 diabetes (468). The reader is referred ment of appropriately trained specialists
should be given to reassessing the insulin to several recent publications and reviews or specialty teams may reduce length of
regimen if blood glucose levels fall below that describe currently available insulin stay, improve glycemic control, and im-
100 mg/dL (5.6 mmol/L). Modification of preparations and protocols and provide prove outcomes (468). In the care of di-
the regimen is required when blood guidance in use of insulin therapy in abetes, implementation of standardized

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S47


Position Statement

order sets for scheduled and correction- treatment goals, physiological parame- hematocrit and for interfering substances.
dose insulin may reduce reliance on ters, and medication usage. Consistent Any glucose result that does not correlate
sliding-scale management. As hospitals carbohydrate meal plans are preferred with the patient’s status should be con-
move to comply with “meaningful use” by many hospitals because they facilitate firmed through conventional laboratory
regulations for electronic health records, matching the prandial insulin dose to the sampling of plasma glucose. The FDA
as mandated by the Health Information amount of carbohydrate consumed (481). has become increasingly concerned about
Technology Act, efforts should be made Because of the complexity of nutrition is- the use of POC blood glucose meters in
to assure that all components of struc- sues in the hospital, a registered dietitian, the hospital and is presently reviewing
tured insulin order sets are incorporated knowledgeable and skilled in MNT, matters related to their use.
into electronic insulin order sets (477,478). should serve as an inpatient team mem-
A team approach is needed to estab- ber. The dietitian is responsible for inte- 8. Discharge planning and DSME
lish hospital pathways. To achieve glyce- grating information about the patient’s Transition from the acute care setting is a
mic targets associated with improved clinical condition, eating, and lifestyle high-risk time for all patients, not just those
hospital outcomes, hospitals will need habits and for establishing treatment with diabetes or new hyperglycemia. Al-
multidisciplinary support to develop in- goals in order to determine a realistic though there is an extensive literature
sulin management protocols that effec- plan for nutrition therapy (482,483). concerning safe transition within and
tively and safely enable achievement of from the hospital, little of it is specific to
glycemic targets (479). 7. Bedside blood glucose monitoring diabetes (490). It is important to remember
POC blood glucose monitoring per- that diabetes discharge planning is not a
5. Self-management in the hospital formed at the bedside is used to guide separate entity, but is part of an overall dis-
Self-management of diabetes in the hos- insulin dosing. In the patient who is charge plan. As such, discharge planning
pital may be appropriate for competent receiving nutrition, the timing of glucose begins at admission to the hospital and is
adult patients who have a stable level of monitoring should match carbohydrate updated as projected patient needs change.
consciousness, have reasonably stable exposure. In the patient who is not re- Inpatients may be discharged to var-
daily insulin requirements, successfully ceiving nutrition, glucose monitoring is ied settings, including home (with or
conduct self-management of diabetes at performed every 4 to 6 h (484,485). More without visiting nurse services), assisted
home, have physical skills needed to frequent blood glucose testing ranging living, rehabilitation, or skilled nursing
successfully self-administer insulin and from every 30 min to every 2 h is required facilities. The latter two sites are generally
perform SMBG, have adequate oral in- for patients on intravenous insulin infusions. staffed by health professionals, so diabe-
take, and are proficient in carbohydrate Safety standards should be estab- tes discharge planning will be limited to
counting, use of multiple daily insulin lished for blood glucose monitoring pro- communication of medication and diet
injections or insulin pump therapy, and hibiting sharing of finger-stick lancing orders. For the patient who is discharged
sick-day management. The patient and devices, lancets, needles, and meters to to assisted living or to home, the optimal
physician, in consultation with nursing reduce the risk of transmission of blood program will need to consider the type
staff, must agree that patient self- borne diseases. Shared lancing devices carry and severity of diabetes, the effects of the
management is appropriate under the essentially the same risk as is conferred from patient’s illness on blood glucose levels,
conditions of hospitalization. sharing of syringes and needles (486). and the capacities and desires of the pa-
Patients who use CSII pump therapy Accuracy of blood glucose measure- tient. Smooth transition to outpatient care
in the outpatient setting can be candidates ments using POC meters has limitations should be ensured. The Agency for Health-
for diabetes self-management in the hos- that must be considered. Although the care Research and Quality (AHRQ) recom-
pital, provided that they have the mental FDA allows a 1/2 20% error for blood mends that at a minimum, discharge plans
and physical capacity to do so (468). A glucose meters, questions about the ap- include the following:
hospital policy and procedures delineat- propriateness of these criteria have been
ing inpatient guidelines for CSII therapy raised (388). Glucose measures differ sig- c Medication reconciliation: The pa-
are advisable, and availability of hospital nificantly between plasma and whole tient’s medications must be cross-
personnel with expertise in CSII therapy blood, terms that are often used inter- checked to ensure that no chronic
is essential. It is important that nursing changeably and can lead to misinterpre- medications were stopped and to en-
personnel document basal rates and bolus tation. Most commercially available sure the safety of new prescriptions.
doses taken on a regular basis (at least capillary blood glucose meters introduce a c Whenever possible, prescriptions for
daily). correction factor of ;1.12 to report a new or changed medication should be
“plasma-adjusted” value (487). filled and reviewed with the patient and
6. MNT in the hospital Significant discrepancies between family at or before discharge.
The goals of MNT are to optimize glyce- capillary, venous, and arterial plasma c Structured discharge communication:
mic control, to provide adequate calories samples have been observed in patients Information on medication changes,
to meet metabolic demands, and to with low or high hemoglobin concentra- pending tests and studies, and follow-up
create a discharge plan for follow-up tions, hypoperfusion, and the presence of needs must be accurately and promptly
care (457,480). The ADA does not en- interfering substances particularly communicated to outpatient physicians.
dorse any single meal plan or specified maltose, as contained in immunoglobu- c Discharge summaries should be trans-
percentages of macronutrients, and the lins (488). Analytical variability has been mitted to the primary physician as soon
term “ADA diet” should no longer be described with several POC meters (489). as possible after discharge.
used. Current nutrition recommenda- Increasingly newer generation POC blood c Appointment keeping behavior is
tions advise individualization based on glucose meters correct for variation in enhanced when the inpatient team

S48 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

schedules outpatient medical follow- order to avoid a potentially dangerous impaired consciousness or cognition may
up prior to discharge. Ideally the in- hiatus in care. These supplies/prescrip- lead to drivers being evaluated for fitness to
patient care providers or case managers/ tions should include the following: drive. For diabetes, this typically arises
discharge planners will schedule fol- when the person has had a hypoglycemic
low-up visit(s) with the appropriate c Insulin (vials or pens) if needed episode behind the wheel, even if this did
professionals, including the primary c Syringes or pen needles (if needed) not lead to a motor vehicle accident.
care provider, endocrinologist, and di- c Oral medications (if needed) Epidemiological and simulator data
abetes educator (491). c Blood glucose meter and strips suggest that people with insulin-treated
c Lancets and lancing device diabetes have a small increase in risk of
Teaching diabetes self-management to c Urine ketone strips (type 1) motor vehicle accidents, primarily due to
patients in hospitals is a challenging task. c Glucagon emergency kit (insulin-treated) hypoglycemia and decreased awareness
Patients are ill, under increased stress related c Medical alert application/charm of hypoglycemia. This increase (RR 1.12–
to their hospitalization and diagnosis, and 1.19) is much smaller than the risks asso-
in an environment not conducive to learn- More expanded diabetes education can ciated with teenage male drivers (RR 42),
ing. Ideally, people with diabetes should be be arranged in the community. An out- driving at night (RR 142), driving on rural
taught at a time and place conducive to patient follow-up visit with the primary roads compared with urban roads (RR
learning: as an outpatient in a recognized care provider, endocrinologist, or diabetes 9.2), and obstructive sleep apnea (RR
program of diabetes education. For the educator within 1 month of discharge is 2.4), all of which are accepted for unre-
hospitalized patient, diabetes “survival advised for all patients having hyperglyce- stricted licensure.
skills” education is generally a feasible ap- mia in the hospital. Clear communication The ADA position statement on di-
proach to provide sufficient information with outpatient providers either directly or abetes and driving (493) recommends
and training to enable safe care at home. via hospital discharge summaries facilitates against blanket restrictions based on the
Patients hospitalized because of a crisis re- safe transitions to outpatient care. Provid- diagnosis of diabetes and urges individual
lated to diabetes management or poor care ing information regarding the cause or the assessment by a health care professional
at home need education to prevent subse- plan for determining the cause of hyper- knowledgeable in diabetes if restrictions
quent episodes of hospitalization. An as- glycemia, related complications and co- on licensure are being considered. Pa-
sessment of the need for a home health morbidities, and recommended treatments tients should be evaluated for decreased
referral or referral to an outpatient diabetes can assist outpatient providers as they awareness of hypoglycemia, hypoglyce-
education program should be part of dis- assume ongoing care. mia episodes while driving, or severe hy-
charge planning for all patients. poglycemia. Patients with retinopathy or
DSME cannot wait until discharge, B. Diabetes and employment peripheral neuropathy require assess-
especially in those new to insulin ther- Any person with diabetes, whether in- ment to determine if those complications
apy or in whom the diabetes regimen has sulin treated or noninsulin treated, interfere with operation of a motor vehi-
been substantially altered during the should be eligible for any employment cle. Health care professionals should be
hospitalization. for which he/she is otherwise qualified. cognizant of the potential risk of driving
It is recommended that the following Employment decisions should never be with diabetes and counsel their patients
areas of knowledge be reviewed and based on generalizations or stereotypes about detecting and avoiding hypoglyce-
addressed prior to hospital discharge: regarding the effects of diabetes. When mia while driving.
questions arise about the medical fitness
c Identification of health care provider of a person with diabetes for a particular D. Diabetes management in
who will provide diabetes care after job, a health care professional with ex- correctional institutions
discharge pertise in treating diabetes should per- People with diabetes in correctional facil-
c Level of understanding related to the form an individualized assessment. See ities should receive care that meets na-
diagnosis of diabetes, SMBG, and ex- the ADA position statement on diabetes tional standards. Because it is estimated
planation of home blood glucose goals and employment (492). that nearly 80,000 inmates have diabetes,
c Definition, recognition, treatment, and correctional institutions should have
prevention of hyperglycemia and hy- C. Diabetes and driving written policies and procedures for the
poglycemia A large percentage of people with diabetes management of diabetes and for training
c Information on consistent eating in the U.S. and elsewhere seek a license to of medical and correctional staff in di-
patterns drive, either for personal or employment abetes care practices. See the ADA posi-
c When and how to take blood glucose– purposes. There has been considerable de- tion statement on diabetes management
lowering medications including insulin bate whether, and the extent to which, in correctional institutions (494) for fur-
administration (if going home on in- diabetes may be a relevant factor in de- ther discussion.
sulin) termining the driver ability and eligibility
c Sick-day management for a license. X. STRATEGIES FOR
c Proper use and disposal of needles and People with diabetes are subject to a IMPROVING DIABETES CARE
syringes great variety of licensing requirements ap-
plied by both state and federal jurisdic- Recommendations
It is important that patients be pro- tions, which may lead to loss of c Care should be aligned with compo-
vided with appropriate durable medical employment or significant restrictions nents of the Chronic Care Model
equipment, medication, supplies, and on a person’s license. Presence of a medical (CCM) to ensure productive inter-
prescriptions at the time of discharge in condition that can lead to significantly actions between a prepared proactive

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S49


Position Statement

practice team and an informed acti- six core elements for the provision of op- weight management, effective coping),
vated patient. (A) timal care of patients with chronic dis- b) disease self-management (medication
c When feasible, care systems should ease: 1) delivery system design (moving taking and management; self-monitoring
support team-based care, community from a reactive to a proactive care delivery of glucose and blood pressure when clin-
involvement, patient registries, and system where planned visits are coordi- ically appropriate), and c) prevention of
embedded decision support tools to nated through a team based approach), diabetes complications (self-monitoring
meet patient needs. (B) 2) self-management support, 3) decision of foot health; active participation in
c Treatment decisions should be timely support (basing care on evidence-based, screening for eye, foot, and renal compli-
and based on evidence-based guide- effective care guidelines), 4) clinical infor- cations; immunizations). High-quality
lines that are tailored to individual mation systems (using registries that can DSME has been shown to improve patient
patient preferences, prognoses, and provide patient-specific and population- self-management, satisfaction, and glu-
comorbidities. (B) based support to the care team), 5) cose control (184,516), as has delivery
c A patient-centered communication community resources and policies (iden- of ongoing DSMS so that gains achieved
style should be employed that in- tifying or developing resources to support during DSME are sustained (134,135,152).
corporates patient preferences, assesses healthy lifestyles), and 6) health systems National DSME standards call for an
literacy and numeracy, and addresses (to create a quality-oriented culture). Re- integrated approach that includes clinical
cultural barriers to care. (B) definition of the roles of the clinic staff content and skills, behavioral strategies
and promoting self-management on the (goal-setting, problem solving), and ad-
There has been steady improvement in the part of the patient are fundamental to dressing emotional concerns in each
proportion of diabetic patients achieving the successful implementation of the needed curriculum content area.
recommended levels of A1C, blood pres- CCM (501). Collaborative, multidisci-
sure, and LDL cholesterol in the last 10 plinary teams are best suited to provide Objective 3: Change the system
years, both in primary care settings and in such care for people with chronic of care
endocrinology practices. Mean A1C na- conditions such as diabetes and to facili- The most successful practices have an in-
tionally has declined from 7.82% in 1999– tate patients’ performance of appropriate stitutional priority for providing high qual-
2000 to 7.18% in 2004 based on NHANES self-management (163,165,220,502). ity of care (517). Changes that have been
data (495). This has been accompanied by NDEP maintains an online resource shown to increase quality of diabetes care
improvements in lipids and blood pressure (www.betterdiabetescare.nih.gov) to help include basing care on evidence-based
control and led to substantial reductions in health care professionals design and im- guidelines (518), expanding the role of
end-stage microvascular complications in plement more effective health care deliv- teams and staff (501,519), redesigning the
those with diabetes. Nevertheless in some ery systems for those with diabetes. Three processes of care (520), implementing elec-
studies only 57.1% of adults with diag- specific objectives, with references to lit- tronic health record tools (521,522), acti-
nosed diabetes achieved an A1C of ,7%, erature that outlines practical strategies to vating and educating patients (523,524),
only 45.5% had a blood pressure ,130/80 achieve each, are outlined below. and identifying and/or developing and en-
mmHg, and just 46.5% had a total choles- gaging community resources and public
terol ,200 mg/dL, with only 12.2% of Objective 1: Optimize provider and policy that support healthy lifestyles
people with diabetes achieving all three team behavior (525). Recent initiatives such as the
treatment goals (496). Evidence also sug- The care team should prioritize timely and Patient-Centered Medical Home show
gests that progress in risk factor control appropriate intensification of lifestyle and/ promise to improve outcomes through co-
may be slowing (497). Certain patient or pharmaceutical therapy of patients who ordinated primary care and offer new op-
groups, such as patients with complex co- have not achieved beneficial levels of blood portunities for team-based chronic disease
morbidities, financial or other social hard- pressure, lipid, or glucose control (503). care (526). Alterations in reimbursement
ships, and/or limited English proficiency, Strategies such as explicit goal setting that reward the provision of appropriate
may present particular challenges to goal- with patients (504); identifying and ad- and high-quality care rather than visit-
based care (498,499). Persistent variation dressing language, numeracy, or cultural based billing (527) and that can accommo-
in quality of diabetes care across providers barriers to care (505–508); integrating evi- date the need to personalize care goals may
and across practice settings even after ad- dence-based guidelines and clinical infor- provide additional incentives to improve
justing for patient factors indicates that mation tools into the process of care diabetes care (528).
there remains potential for substantial fur- (509–511); and incorporating care manage- It is clear that optimal diabetes man-
ther improvements in diabetes care. ment teams including nurses, pharmacists, agement requires an organized, system-
Although numerous interventions to and other providers (512–515) have each atic approach and involvement of a
improve adherence to the recommended been shown to optimize provider and team coordinated team of dedicated health
standards have been implemented, a ma- behavior and thereby catalyze reduction in care professionals working in an environ-
jor barrier to optimal care is a delivery A1C, blood pressure, and LDL cholesterol. ment where patient-centered high-quality
system that too often is fragmented, lacks care is a priority.
clinical information capabilities, often Objective 2: Support patient behavior
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S50 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

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Endocrine Society, the International Pediatric Endocrine Society. Diabetes medical intensive care unit patients:
Society for Pediatric and Adolescent Care 2010;33:2697–2708 a randomized, controlled study. Crit
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beneficiaries: 15 randomized trials. 523. Battersby M, Von Korff M, Schaefer J, in North Carolina. J Public Health
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2009;32:234–239 munity leaders to promote better health 2011;365:e31

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P O S I T I O N S T A T E M E N T

Diagnosis and Classification of Diabetes


Mellitus
AMERICAN DIABETES ASSOCIATION agents. These individuals therefore do
not require insulin. Other individuals
who have some residual insulin secretion
but require exogenous insulin for ade-
DEFINITION AND cardiovascular symptoms and sexual dys-
quate glycemic control can survive with-
DESCRIPTION OF DIABETES function. Patients with diabetes have an
out it. Individuals with extensive b-cell
MELLITUSdDiabetes is a group of increased incidence of atherosclerotic car-
destruction and therefore no residual in-
metabolic diseases characterized by hy- diovascular, peripheral arterial, and cere-
sulin secretion require insulin for survival.
perglycemia resulting from defects in in- brovascular disease. Hypertension and
The severity of the metabolic abnormality
sulin secretion, insulin action, or both. abnormalities of lipoprotein metabolism
can progress, regress, or stay the same.
The chronic hyperglycemia of diabetes is are often found in people with diabetes.
Thus, the degree of hyperglycemia reflects
associated with long-term damage, dys- The vast majority of cases of diabetes
the severity of the underlying metabolic
function, and failure of different organs, fall into two broad etiopathogenetic cate-
process and its treatment more than the
especially the eyes, kidneys, nerves, heart, gories (discussed in greater detail below).
nature of the process itself.
and blood vessels. In one category, type 1 diabetes, the cause
Several pathogenic processes are in- is an absolute deficiency of insulin secre-
CLASSIFICATION OF
volved in the development of diabetes. tion. Individuals at increased risk of de-
DIABETES MELLITUS AND
These range from autoimmune destruc- veloping this type of diabetes can often be
OTHER CATEGORIES
tion of the b-cells of the pancreas with identified by serological evidence of an
OF GLUCOSE
consequent insulin deficiency to abnor- autoimmune pathologic process occurring
REGULATIONdAssigning a type of
malities that result in resistance to insulin in the pancreatic islets and by genetic
diabetes to an individual often depends
action. The basis of the abnormalities in markers. In the other, much more preva-
on the circumstances present at the time
carbohydrate, fat, and protein metabo- lent category, type 2 diabetes, the cause is a
of diagnosis, and many diabetic individ-
lism in diabetes is deficient action of in- combination of resistance to insulin action
uals do not easily fit into a single class. For
sulin on target tissues. Deficient insulin and an inadequate compensatory insulin
example, a person diagnosed with gesta-
action results from inadequate insulin se- secretory response. In the latter category, a
tional diabetes mellitus (GDM) may con-
cretion and/or diminished tissue respon- degree of hyperglycemia sufficient to cause
tinue to be hyperglycemic after delivery
ses to insulin at one or more points in the pathologic and functional changes in var-
and may be determined to have, in fact,
complex pathways of hormone action. ious target tissues, but without clinical
type 2 diabetes. Alternatively, a person
Impairment of insulin secretion and de- symptoms, may be present for a long
who acquires diabetes because of large
fects in insulin action frequently coexist in period of time before diabetes is detected.
doses of exogenous steroids may become
the same patient, and it is often unclear During this asymptomatic period, it is
normoglycemic once the glucocorticoids
which abnormality, if either alone, is the possible to demonstrate an abnormality in
are discontinued, but then may develop
primary cause of the hyperglycemia. carbohydrate metabolism by measurement
diabetes many years later after recurrent
Symptoms of marked hyperglycemia in- of plasma glucose in the fasting state or
episodes of pancreatitis. Another example
clude polyuria, polydipsia,weight loss,some- after a challenge with an oral glucose load
would be a person treated with thiazides
times with polyphagia, and blurred vision. or by A1C.
who develops diabetes years later. Because
Impairment of growth and susceptibility to The degree of hyperglycemia (if any)
thiazides in themselves seldom cause severe
certain infections may also accompany may change over time, depending on the
hyperglycemia, such individuals probably
chronic hyperglycemia. Acute, life-threaten- extent of the underlying disease process
have type 2 diabetes that is exacerbated by
ing consequences of uncontrolled diabetes (Fig. 1). A disease process may be present
the drug. Thus, for the clinician and patient,
are hyperglycemia with ketoacidosis or the but may not have progressed far enough
it is less important to label the particular
nonketotic hyperosmolar syndrome. to cause hyperglycemia. The same disease
type of diabetes than it is to understand the
Long-term complications of diabetes process can cause impaired fasting glu-
pathogenesis of the hyperglycemia and to
include retinopathy with potential loss cose (IFG) and/or impaired glucose toler-
treat it effectively.
of vision; nephropathy leading to renal ance (IGT) without fulfilling the criteria
failure; peripheral neuropathy with risk for the diagnosis of diabetes. In some indi- Type 1 diabetes (b-cell destruction,
of foot ulcers, amputations, and Charcot viduals with diabetes, adequate glycemic usually leading to absolute insulin
joints; and autonomic neuropathy caus- control can be achieved with weight reduc- deficiency)
ing gastrointestinal, genitourinary, and tion, exercise, and/or oral glucose-lowering Immune-mediated diabetes. This form
of diabetes, which accounts for only
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
5–10% of those with diabetes, previously
Updated Fall 2012. encompassed by the terms insulin-
DOI: 10.2337/dc13-S067
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly
dependent diabetes or juvenile-onset di-
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ abetes, results from a cellular-mediated
licenses/by-nc-nd/3.0/ for details. autoimmune destruction of the b-cells of

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S67


Position Statement

Figure 1dDisorders of glycemia: etiologic types and stages. *Even after presenting in ketoacidosis, these patients can briefly return to normo-
glycemia without requiring continuous therapy (i.e., “honeymoon” remission); **in rare instances, patients in these categories (e.g., Vacor toxicity,
type 1 diabetes presenting in pregnancy) may require insulin for survival.

the pancreas. Markers of the immune de- commonly occurs in childhood and ado- Type 2 diabetes (ranging from
struction of the b-cell include islet cell au- lescence, but it can occur at any age, even predominantly insulin resistance
toantibodies, autoantibodies to insulin, in the 8th and 9th decades of life. with relative insulin deficiency to
autoantibodies to GAD (GAD65), and auto- Autoimmune destruction of b-cells predominantly an insulin secretory
antibodies to the tyrosine phosphatases has multiple genetic predispositions and defect with insulin resistance)
IA-2 and IA-2b. One and usually more of is also related to environmental factors This form of diabetes, which accounts for
these autoantibodies are present in 85– that are still poorly defined. Although pa- ;90–95% of those with diabetes, previ-
90% of individuals when fasting hyper- tients are rarely obese when they present ously referred to as non–insulin-depen-
glycemia is initially detected. Also, the with this type of diabetes, the presence of dent diabetes, type 2 diabetes, or adult-
disease has strong HLA associations, obesity is not incompatible with the diag- onset diabetes, encompasses individuals
with linkage to the DQA and DQB genes, nosis. These patients are also prone to who have insulin resistance and usually
and it is influenced by the DRB genes. other autoimmune disorders such as have relative (rather than absolute) insu-
These HLA-DR/DQ alleles can be either Graves’ disease, Hashimoto’s thyroiditis, lin deficiency At least initially, and often
predisposing or protective. Addison’s disease, vitiligo, celiac sprue, throughout their lifetime, these individu-
In this form of diabetes, the rate of autoimmune hepatitis, myasthenia gravis, als do not need insulin treatment to sur-
b-cell destruction is quite variable, being and pernicious anemia. vive. There are probably many different
rapid in some individuals (mainly infants Idiopathic diabetes. Some forms of type causes of this form of diabetes. Although
and children) and slow in others (mainly 1 diabetes have no known etiologies. the specific etiologies are not known, au-
adults). Some patients, particularly chil- Some of these patients have permanent toimmune destruction of b-cells does not
dren and adolescents, may present with insulinopenia and are prone to ketoaci- occur, and patients do not have any of the
ketoacidosis as the first manifestation of dosis, but have no evidence of autoim- other causes of diabetes listed above or
the disease. Others have modest fasting munity. Although only a minority of below.
hyperglycemia that can rapidly change patients with type 1 diabetes fall into this Most patients with this form of di-
to severe hyperglycemia and/or ketoaci- category, of those who do, most are of abetes are obese, and obesity itself causes
dosis in the presence of infection or other African or Asian ancestry. Individuals some degree of insulin resistance. Patients
stress. Still others, particularly adults, with this form of diabetes suffer from who are not obese by traditional weight
may retain residual b-cell function suffi- episodic ketoacidosis and exhibit vary- criteria may have an increased percentage
cient to prevent ketoacidosis for many ing degrees of insulin deficiency be- of body fat distributed predominantly in
years; such individuals eventually be- tween episodes. This form of diabetes the abdominal region. Ketoacidosis sel-
come dependent on insulin for survival is strongly inherited, lacks immunolog- dom occurs spontaneously in this type of
and are at risk for ketoacidosis. At this ical evidence for b-cell autoimmunity, diabetes; when seen, it usually arises in
latter stage of the disease, there is little and is not HLA associated. An absolute association with the stress of another
or no insulin secretion, as manifested by requirement for insulin replacement illness such as infection. This form of
low or undetectable levels of plasma therapy in affected patients may come diabetes frequently goes undiagnosed for
C-peptide. Immune-mediated diabetes and go. many years because the hyperglycemia

S68 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

develops gradually and at earlier stages is forms result from mutations in other tran- associated with abnormalities of teeth and
often not severe enough for the patient to scription factors, including HNF-4a, nails and pineal gland hyperplasia.
notice any of the classic symptoms of HNF-1b, insulin promoter factor (IPF)- Alterations in the structure and func-
diabetes. Nevertheless, such patients are 1, and NeuroD1. tion of the insulin receptor cannot be
at increased risk of developing macro- Diabetes diagnosed in the first 6 demonstrated in patients with insulin-
vascular and microvascular complica- months of life has been shown not to be resistant lipoatrophic diabetes. Therefore,
tions. Whereas patients with this form of typical autoimmune type 1 diabetes. This it is assumed that the lesion(s) must reside
diabetes may have insulin levels that so-called neonatal diabetes can either be in the postreceptor signal transduction
appear normal or elevated, the higher transient or permanent. The most com- pathways.
blood glucose levels in these diabetic mon genetic defect causing transient Diseases of the exocrine pancreas. Any
patients would be expected to result in disease is a defect on ZAC/HYAMI im- process that diffusely injures the pancreas
even higher insulin values had their b-cell printing, whereas permanent neonatal can cause diabetes. Acquired processes
function been normal. Thus, insulin se- diabetes is most commonly a defect in the include pancreatitis, trauma, infection, pan-
cretion is defective in these patients and gene encoding the Kir6.2 subunit of the createctomy, and pancreatic carcinoma.
insufficient to compensate for insulin re- b-cell KATP channel. Diagnosing the latter With the exception of that caused by
sistance. Insulin resistance may improve has implications, since such children can cancer, damage to the pancreas must be
with weight reduction and/or pharmaco- be well managed with sulfonylureas. extensive for diabetes to occur; adreno-
logical treatment of hyperglycemia but is Point mutations in mitochondrial carcinomas that involve only a small
seldom restored to normal. The risk of DNA have been found to be associated portion of the pancreas have been associ-
developing this form of diabetes increases with diabetes and deafness The most ated with diabetes. This implies a mech-
with age, obesity, and lack of physical ac- common mutation occurs at position anism other than simple reduction in
tivity. It occurs more frequently in women 3,243 in the tRNA leucine gene, leading b-cell mass. If extensive enough, cystic fi-
with prior GDM and in individuals with to an A-to-G transition. An identical brosis and hemochromatosis will also
hypertension or dyslipidemia, and its fre- lesion occurs in the MELAS syndrome damage b-cells and impair insulin secre-
quency varies in different racial/ethnic sub- (mitochondrial myopathy, encephalop- tion. Fibrocalculous pancreatopathy may
groups. It is often associated with a strong athy, lactic acidosis, and stroke-like syn- be accompanied by abdominal pain radi-
genetic predisposition, more so than is the drome); however, diabetes is not part ating to the back and pancreatic calcifica-
autoimmune form of type 1 diabetes. How- of this syndrome, suggesting different tions identified on X-ray examination.
ever, the genetics of this form of diabetes phenotypic expressions of this genetic Pancreatic fibrosis and calcium stones
are complex and not fully defined. lesion. in the exocrine ducts have been found at
Genetic abnormalities that result in autopsy.
Other specific types of diabetes the inability to convert proinsulin to in- Endocrinopathies. Several hormones
Genetic defects of the b-cell. Several sulin have been identified in a few fami- (e.g., growth hormone, cortisol, gluca-
forms of diabetes are associated with lies, and such traits are inherited in an gon, epinephrine) antagonize insulin ac-
monogenetic defects in b-cell function. autosomal dominant pattern. The resul- tion. Excess amounts of these hormones
These forms of diabetes are frequently tant glucose intolerance is mild. Similarly, (e.g., acromegaly, Cushing’s syndrome,
characterized by onset of hyperglycemia the production of mutant insulin mole- glucagonoma, pheochromocytoma, re-
at an early age (generally before age 25 cules with resultant impaired receptor spectively) can cause diabetes. This gen-
years). They are referred to as maturity- binding has also been identified in a few erally occurs in individuals with
onset diabetes of the young (MODY) and families and is associated with an autoso- preexisting defects in insulin secretion,
are characterized by impaired insulin se- mal inheritance and only mildly impaired and hyperglycemia typically resolves
cretion with minimal or no defects in in- or even normal glucose metabolism. when the hormone excess is resolved.
sulin action. They are inherited in an Genetic defects in insulin action. There Somatostatinomas, and aldostero-
autosomal dominant pattern. Abnormali- are unusual causes of diabetes that result noma-induced hypokalemia, can cause
ties at six genetic loci on different chro- from genetically determined abnormali- diabetes, at least in part, by inhibiting
mosomes have been identified to date. ties of insulin action. The metabolic ab- insulin secretion. Hyperglycemia gener-
The most common form is associated normalities associated with mutations of ally resolves after successful removal of
with mutations on chromosome 12 in a the insulin receptor may range from the tumor.
hepatic transcription factor referred to as hyperinsulinemia and modest hyperglyce- Drug- or chemical-induced diabetes.
hepatocyte nuclear factor (HNF)-1a. A mia to severe diabetes. Some individuals Many drugs can impair insulin secretion.
second form is associated with mutations with these mutations may have acanthosis These drugs may not cause diabetes by
in the glucokinase gene on chromosome nigricans. Women may be virilized and themselves, but they may precipitate di-
7p and results in a defective glucokinase have enlarged, cystic ovaries. In the past, abetes in individuals with insulin resis-
molecule. Glucokinase converts glucose this syndrome was termed type A insulin tance. In such cases, the classification is
to glucose-6-phosphate, the metabolism resistance. Leprechaunism and the Rabson- unclear because the sequence or relative
of which, in turn, stimulates insulin secre- Mendenhall syndrome are two pediatric importance of b-cell dysfunction and in-
tion by the b-cell. Thus, glucokinase syndromes that have mutations in the sulin resistance is unknown. Certain tox-
serves as the “glucose sensor” for the insulin receptor gene with subsequent ins such as Vacor (a rat poison) and
b-cell. Because of defects in the glucoki- alterations in insulin receptor function intravenous pentamidine can perma-
nase gene, increased plasma levels of glu- and extreme insulin resistance. The former nently destroy pancreatic b-cells. Such
cose are necessary to elicit normal levels has characteristic facial features and is drug reactions fortunately are rare. There
of insulin secretion. The less common usually fatal in infancy, while the latter is are also many drugs and hormones that

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S69


Position Statement

can impair insulin action. Examples in- Table 1dEtiologic classification of diabetes mellitus
clude nicotinic acid and glucocorticoids.
I. Type 1 diabetes (b-cell destruction, usually leading to absolute insulin deficiency)
Patients receiving a-interferon have been A. Immune mediated
reported to develop diabetes associated B. Idiopathic
with islet cell antibodies and, in certain II. Type 2 diabetes (may range from predominantly insulin resistance with relative insulin deficiency
instances, severe insulin deficiency. The to a predominantly secretory defect with insulin resistance)
III. Other specific types
list shown in Table 1 is not all-inclusive, A. Genetic defects of b-cell function
but reflects the more commonly recog- 1. MODY 3 (Chromosome 12, HNF-1a)
nized drug-, hormone-, or toxin-induced 2. MODY 1 (Chromosome 20, HNF-4a)
forms of diabetes. 3. MODY 2 (Chromosome 7, glucokinase)
Infections. Certain viruses have been as- 4. Other very rare forms of MODY (e.g., MODY 4: Chromosome 13, insulin promoter factor-1;
MODY 6: Chromosome 2, NeuroD1; MODY 7: Chromosome 9, carboxyl ester lipase)
sociated with b-cell destruction. Diabetes 5. Transient neonatal diabetes (most commonly ZAC/HYAMI imprinting defect on 6q24)
occurs in patients with congenital rubella, 6. Permanent neonatal diabetes (most commonly KCNJ11 gene encoding Kir6.2 subunit of b-cell
although most of these patients have HLA KATP channel)
and immune markers characteristic of type 7. Mitochondrial DNA
8. Others
1 diabetes. In addition, coxsackievirus B, B. Genetic defects in insulin action
cytomegalovirus, adenovirus, and mumps 1. Type A insulin resistance
have been implicated in inducing certain 2. Leprechaunism
cases of the disease. 3. Rabson-Mendenhall syndrome
Uncommon forms of immune-mediated 4. Lipoatrophic diabetes
5. Others
diabetes. In this category, there are two C. Diseases of the exocrine pancreas
known conditions, and others are likely 1. Pancreatitis
to occur. The stiff-man syndrome is an 2. Trauma/pancreatectomy
autoimmune disorder of the central ner- 3. Neoplasia
4. Cystic fibrosis
vous system characterized by stiffness of 5. Hemochromatosis
the axial muscles with painful spasms. 6. Fibrocalculous pancreatopathy
Patients usually have high titers of the 7. Others
GAD autoantibodies, and approximately D. Endocrinopathies
one-third will develop diabetes. 1. Acromegaly
2. Cushing’s syndrome
Anti-insulin receptor antibodies can 3. Glucagonoma
cause diabetes by binding to the insulin 4. Pheochromocytoma
receptor, thereby blocking the binding of 5. Hyperthyroidism
insulin to its receptor in target tissues. 6. Somatostatinoma
7. Aldosteronoma
However, in some cases, these antibodies 8. Others
can act as an insulin agonist after binding to E. Drug or chemical induced
the receptor and can thereby cause hypo- 1. Vacor
glycemia. Anti-insulin receptor antibodies 2. Pentamidine
are occasionally found in patients with 3. Nicotinic acid
4. Glucocorticoids
systemic lupus erythematosus and other 5. Thyroid hormone
autoimmune diseases. As in other states of 6. Diazoxide
extreme insulin resistance, patients with 7. b-Adrenergic agonists
anti-insulin receptor antibodies often have 8. Thiazides
9. Dilantin
acanthosis nigricans. In the past, this syn- 10. g-Interferon
drome was termed type B insulin resistance. 11. Others
Other genetic syndromes sometimes F. Infections
associated with diabetes. Many genetic 1. Congenital rubella
syndromes are accompanied by an in- 2. Cytomegalovirus
3. Others
creased incidence of diabetes. These in- G. Uncommon forms of immune-mediated diabetes
clude the chromosomal abnormalities of 1. “Stiff-man” syndrome
Down syndrome, Klinefelter syndrome, 2. Anti-insulin receptor antibodies
and Turner syndrome. Wolfram syn- 3. Others
H. Other genetic syndromes sometimes associated with diabetes
drome is an autosomal recessive disorder 1. Down syndrome
characterized by insulin-deficient diabe- 2. Klinefelter syndrome
tes and the absence of b-cells at autopsy. 3. Turner syndrome
Additional manifestations include diabetes 4. Wolfram syndrome
insipidus, hypogonadism, optic atrophy, 5. Friedreich ataxia
6. Huntington chorea
and neural deafness. Other syndromes are 7. Laurence-Moon-Biedl syndrome
listed in Table 1. 8. Myotonic dystrophy
9. Porphyria
GDM 10. Prader-Willi syndrome
11. Others
For many years, GDM has been defined as IV. Gestational diabetes mellitus
any degree of glucose intolerance with
Patients with any form of diabetes may require insulin treatment at some stage of their disease. Such use of
insulin does not, of itself, classify the patient.
S70 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org
Position Statement

onset or first recognition during preg- with high triglycerides and/or low HDL the Diabetes Prevention Program (DPP),
nancy. Although most cases resolve with cholesterol, and hypertension. Structured wherein the mean A1C was 5.9% (SD
delivery, the definition applied whether lifestyle intervention, aimed at increasing 0.5%), indicates that preventive interven-
or not the condition persisted after preg- physical activity and producing 5–10% tions are effective in groups of people with
nancy and did not exclude the possibility loss of body weight, and certain pharma- A1C levels both below and above 5.9%
that unrecognized glucose intolerance cological agents have been demonstrated (9). For these reasons, the most appropri-
may have antedated or begun concomi- to prevent or delay the development of ate A1C level above which to initiate pre-
tantly with the pregnancy. This definition diabetes in people with IGT; the potential ventive interventions is likely to be
facilitated a uniform strategy for detection impact of such interventions to reduce somewhere in the range of 5.5–6%.
and classification of GDM, but its limi- mortality or the incidence of cardiovascu- As was the case with FPG and 2-h PG,
tations were recognized for many years. lar disease has not been demonstrated to defining a lower limit of an intermediate
As the ongoing epidemic of obesity and date. It should be noted that the 2003 category of A1C is somewhat arbitrary,
diabetes has led to more type 2 diabetes in ADA Expert Committee report reduced as the risk of diabetes with any measure
women of childbearing age, the number of the lower FPG cut point to define IFG or surrogate of glycemia is a continuum,
pregnant women with undiagnosed type 2 from 110 mg/dl (6.1 mmol/l) to 100 mg/dl extending well into the normal ranges. To
diabetes has increased. (5.6 mmol/l), in part to ensure that prev- maximize equity and efficiency of pre-
After deliberations in 2008–2009, the alence of IFG was similar to that of IGT. ventive interventions, such an A1C cut
International Association of Diabetes and However, the World Health Organization point should balance the costs of “false
Pregnancy Study Groups (IADPSG), an (WHO) and many other diabetes organi- negatives” (failing to identify those who
international consensus group with rep- zations did not adopt this change in the are going to develop diabetes) against
resentatives from multiple obstetrical and definition of IFG. the costs of “false positives” (falsely iden-
diabetes organizations, including the As A1C is used more commonly to tifying and then spending intervention re-
American Diabetes Association (ADA), diagnose diabetes in individuals with risk sources on those who were not going to
recommended that high-risk women factors, it will also identify those at higher develop diabetes anyway).
found to have diabetes at their initial pre- risk for developing diabetes in the future. As is the case with the glucose mea-
natal visit, using standard criteria (Table When recommending the use of the A1C sures, several prospective studies that used
3), receive a diagnosis of overt, not gesta- to diagnose diabetes in its 2009 report, A1C to predict the progression to diabetes
tional, diabetes. Approximately 7% of all the International Expert Committee (3) demonstrated a strong, continuous asso-
pregnancies (ranging from 1 to 14%, de- stressed the continuum of risk for diabe- ciation between A1C and subsequent di-
pending on the population studied and tes with all glycemic measures and did not abetes. In a systematic review of 44,203
the diagnostic tests employed) are com- formally identify an equivalent intermedi- individuals from 16 cohort studies with
plicated by GDM, resulting in more than ate category for A1C. The group did note a follow-up interval averaging 5.6 years
200,000 cases annually. that those with A1C levels above the lab- (range 2.8–12 years), those with an A1C
oratory “normal” range but below the di- between 5.5 and 6.0% had a substantially
CATEGORIES OF INCREASED agnostic cut point for diabetes (6.0 to increased risk of diabetes with 5-year
RISK FOR DIABETESdIn 1997 and ,6.5%) are at very high risk of develop- incidences ranging from 9 to 25%. An
2003, the Expert Committee on Diagno- ing diabetes. Indeed, incidence of diabe- A1C range of 6.0–6.5% had a 5-year risk
sis and Classification of Diabetes Mellitus tes in people with A1C levels in this range of developing diabetes between 25 and
(1,2) recognized an intermediate group of is more than 10 times that of people with 50% and relative risk 20 times higher
individuals whose glucose levels do not lower levels (4–7). However, the 6.0 to compared with an A1C of 5.0% (10). In
meet criteria for diabetes, yet are higher ,6.5% range fails to identify a substantial a community-based study of black and
than those considered normal. These peo- number of patients who have IFG and/or white adults without diabetes, baseline
ple were defined as having impaired fast- IGT. Prospective studies indicate that A1C was a stronger predictor of subse-
ing glucose (IFG) [fasting plasma glucose people within the A1C range of 5.5– quent diabetes and cardiovascular events
(FPG) levels 100 mg/dl (5.6 mmol/l) to 6.0% have a 5-year cumulative incidence than was fasting glucose (11). Other anal-
125 mg/dl (6.9 mmol/l)], or impaired glu- of diabetes that ranges from 12 to 25% yses suggest that an A1C of 5.7% is asso-
cose tolerance (IGT) [2-h values in the (4–7), which is appreciably (three- to ciated with similar diabetes risk to the
oral glucose tolerance test (OGTT) of eightfold) higher than incidence in the high-risk participants in the DPP (12).
140 mg/dl (7.8 mmol/l) to 199 mg/dl U.S. population as a whole (8). Analyses Hence, it is reasonable to consider an
(11.0 mmol/l)]. of nationally representative data from the A1C range of 5.7–6.4% as identifying in-
Individuals with IFG and/or IGT have National Health and Nutrition Examina- dividuals with high risk for future diabe-
been referred to as having prediabetes, tion Survey (NHANES) indicate that the tes, to whom the term prediabetes may be
indicating the relatively high risk for the A1C value that most accurately identifies applied.
future development of diabetes. IFG and people with IFG or IGT falls between 5.5 Individuals with an A1C of 5.7–6.4%
IGT should not be viewed as clinical and 6.0%. In addition, linear regression should be informed of their increased risk
entities in their own right but rather risk analyses of these data indicate that among for diabetes as well as cardiovascular dis-
factors for diabetes as well as cardiovas- the nondiabetic adult population, an FPG ease and counseled about effective strate-
cular disease. They can be observed as of 110 mg/dl (6.1 mmol/l) corresponds gies, such as weight loss and physical
intermediate stages in any of the disease to an A1C of 5.6%, while an FPG of 100 activity, to lower their risks. As with glu-
processes listed in Table 1. IFG and IGT mg/dl (5.6 mmol/l) corresponds to an cose measurements, the continuum of risk
are associated with obesity (especially ab- A1C of 5.4% (R.T. Ackerman, personal is curvilinear, so that as A1C rises, the risk
dominal or visceral obesity), dyslipidemia communication). Finally, evidence from of diabetes rises disproportionately.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S71


Position Statement

Accordingly, interventions should be which retinopathy increased were similar correlation between A1C and average
most intensive and follow-up should be among the populations. These analyses glucose in certain individuals. In addi-
particularly vigilant for those with A1C confirmed the long-standing diagnostic 2-h tion, the A1C can be misleading in pa-
levels above 6.0%, who should be consid- PG value of $200 mg/dl (11.1 mmol/l). tients with certain forms of anemia and
ered to be at very high risk. However, just However, the older FPG diagnostic cut hemoglobinopathies, which may also
as an individual with a fasting glucose of point of 140 mg/dl (7.8 mmol/l) was noted have unique ethnic or geographic distri-
98 mg/dl (5.4 mmol/l) may not be at neg- to identify far fewer individuals with dia- butions. For patients with a hemoglobin-
ligible risk for diabetes, individuals with betes than the 2-h PG cut point. The FPG opathy but normal red cell turnover, such
A1C levels below 5.7% may still be at diagnostic cut point was reduced to as sickle cell trait, an A1C assay without
risk, depending on level of A1C and pres- $126 mg/dl (7.0 mmol/l). interference from abnormal hemoglobins
ence of other risk factors, such as obesity A1C is a widely used marker of should be used (an updated list is avail-
and family history. chronic glycemia, reflecting average able at http://www.ngsp.org/interf.asp).
Table 2 summarizes the categories of blood glucose levels over a 2- to 3-month For conditions with abnormal red cell
increased risk for diabetes. Evaluation of period of time. The test plays a critical role turnover, such as anemias from hemolysis
patients at risk should incorporate a in the management of the patient with and iron deficiency, the diagnosis of
global risk factor assessment for both di- diabetes, since it correlates well with both diabetes must employ glucose criteria
abetes and cardiovascular disease. Screen- microvascular and, to a lesser extent, exclusively.
ing for and counseling about risk of macrovascular complications and is The established glucose criteria for
diabetes should always be in the prag- widely used as the standard biomarker the diagnosis of diabetes remain valid.
matic context of the patient’s comorbidi- for the adequacy of glycemic manage- These include the FPG and 2-h PG.
ties, life expectancy, personal capacity to ment. Prior Expert Committees have not Additionally, patients with severe hyper-
engage in lifestyle change, and overall recommended use of the A1C for diag- glycemia such as those who present with
health goals. nosis of diabetes, in part due to lack of severe classic hyperglycemic symptoms
standardization of the assay. However, or hyperglycemic crisis can continue to be
DIAGNOSTIC CRITERIA FOR A1C assays are now highly standardized diagnosed when a random (or casual)
DIABETES MELLITUSdFor deca- so that their results can be uniformly plasma glucose of $200 mg/dl (11.1
des, the diagnosis of diabetes has been applied both temporally and across pop- mmol/l) is found. It is likely that in such
based on glucose criteria, either the FPG ulations. In their recent report (3), an In- cases the health care professional would
or the 75-g OGTT. In 1997, the first ternational Expert Committee, after an also measure an A1C test as part of the
Expert Committee on the Diagnosis and extensive review of both established and initial assessment of the severity of the di-
Classification of Diabetes Mellitus revised emerging epidemiological evidence, rec- abetes and that it would (in most cases) be
the diagnostic criteria, using the observed ommended the use of the A1C test to di- above the diagnostic cut point for diabe-
association between FPG levels and pres- agnose diabetes, with a threshold of tes. However, in rapidly evolving diabe-
ence of retinopathy as the key factor with $6.5%, and ADA affirms this decision. tes, such as the development of type 1
which to identify threshold glucose level. The diagnostic A1C cut point of 6.5% is diabetes in some children, A1C may not
The Committee examined data from three associated with an inflection point for ret- be significantly elevated despite frank
cross-sectional epidemiologic studies that inopathy prevalence, as are the diagnostic diabetes.
assessed retinopathy with fundus pho- thresholds for FPG and 2-h PG (3). The Just as there is less than 100% con-
tography or direct ophthalmoscopy and diagnostic test should be performed cordance between the FPG and 2-h PG
measured glycemia as FPG, 2-h PG, and using a method that is certified by the Na- tests, there is not full concordance be-
A1C. These studies demonstrated glyce- tional Glycohemoglobin Standardization tween A1C and either glucose-based
mic levels below which there was little Program (NGSP) and standardized or test. Analyses of NHANES data indicate
prevalent retinopathy and above which traceable to the Diabetes Control and that, assuming universal screening of the
the prevalence of retinopathy increased in Complications Trial reference assay. undiagnosed, the A1C cut point of
an apparently linear fashion. The deciles Point-of-care A1C assays are not suffi- $6.5% identifies one-third fewer cases
of the three measures at which retinopa- ciently accurate at this time to use for di- of undiagnosed diabetes than a fasting
thy began to increase were the same for agnostic purposes. glucose cut point of $126 mg/dl (7.0
each measure within each population. There is an inherent logic to using a mmol/l) (www.cdc.gov/diabetes/pubs/
Moreover, the glycemic values above more chronic versus an acute marker of factsheet11/tables1_2.htm). However, in
dysglycemia, particularly since the A1C is practice, a large portion of the population
already widely familiar to clinicians as a with type 2 diabetes remains unaware of
Table 2dCategories of increased risk for marker of glycemic control. Moreover, their condition. Thus, it is conceivable
diabetes (prediabetes)* the A1C has several advantages to the that the lower sensitivity of A1C at the
FPG, including greater convenience, designated cut point will be offset by the
FPG 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9
since fasting is not required, evidence to test’s greater practicality, and that wider
mmol/l) [IFG]
suggest greater preanalytical stability, and application of a more convenient test
2-h PG in the 75-g OGTT 140 mg/dl (7.8
less day-to-day perturbations during pe- (A1C) may actually increase the number
mmol/l) to 199 mg/dl (11.0 mmol/l) [IGT]
riods of stress and illness. These advan- of diagnoses made.
A1C 5.7–6.4%
tages, however, must be balanced by Further research is needed to better
*For all three tests, risk is continuous, extending
below the lower limit of the range and becoming
greater cost, the limited availability of characterize those patients whose glyce-
disproportionately greater at higher ends of the A1C testing in certain regions of the mic status might be categorized differ-
range. developing world, and the incomplete ently by two different tests (e.g., FPG and

S72 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

A1C), obtained in close temporal approx- “nondiabetic” test is likely to be in a range normal for pregnancy. For most compli-
imation. Such discordance may arise from very close to the threshold that defines di- cations, there was no threshold for risk.
measurement variability, change over abetes. These results have led to careful reconsid-
time, or because A1C, FPG, and post- Since there is preanalytic and analytic eration of the diagnostic criteria for GDM.
challenge glucose each measure different variability of all the tests, it is also possible After deliberations in 2008–2009, the
physiological processes. In the setting of that when a test whose result was above IADPSG, an international consensus
an elevated A1C but “nondiabetic” FPG, the diagnostic threshold is repeated, the group with representatives from multiple
the likelihood of greater postprandial glu- second value will be below the diagnostic obstetrical and diabetes organizations, in-
cose levels or increased glycation rates cut point. This is least likely for A1C, cluding ADA, developed revised recom-
for a given degree of hyperglycemia may somewhat more likely for FPG, and most mendations for diagnosing GDM. The
be present. In the opposite scenario (high likely for the 2-h PG. Barring a laboratory group recommended that all women not
FPG yet A1C below the diabetes cut error, such patients are likely to have test known to have diabetes undergo a 75-g
point), augmented hepatic glucose pro- results near the margins of the threshold OGTT at 24–28 weeks of gestation. Ad-
duction or reduced glycation rates may for a diagnosis. The healthcare profes- ditionally, the group developed diagnos-
be present. sional might opt to follow the patient tic cut points for the fasting, 1-h, and 2-h
As with most diagnostic tests, a test closely and repeat the testing in 3–6 plasma glucose measurements that con-
result diagnostic of diabetes should be months. veyed an odds ratio for adverse outcomes
repeated to rule out laboratory error, The decision about which test to use of at least 1.75 compared with women
unless the diagnosis is clear on clinical to assess a specific patient for diabetes with mean glucose levels in the HAPO
grounds, such as a patient with classic should be at the discretion of the health study. Current screening and diagnostic
symptoms of hyperglycemia or hypergly- care professional, taking into account the strategies, based on the IADPSG state-
cemic crisis. It is preferable that the same availability and practicality of testing an ment (14), are outlined in Table 4.
test be repeated for confirmation, since individual patient or groups of patients. These new criteria will significantly
there will be a greater likelihood of con- Perhaps more important than which di- increase the prevalence of GDM, primar-
currence in this case. For example, if the agnostic test is used, is that the testing for ily because only one abnormal value, not
A1C is 7.0% and a repeat result is 6.8%, diabetes be performed when indicated. two, is sufficient to make the diagnosis.
the diagnosis of diabetes is confirmed. There is discouraging evidence indicating The ADA recognizes the anticipated sig-
However, there are scenarios in which re- that many at-risk patients still do not re- nificant increase in the incidence of GDM
sults of two different tests (e.g., FPG and ceive adequate testing and counseling for to be diagnosed by these criteria and is
A1C) are available for the same patient. In this increasingly common disease, or for its sensitive to concerns about the “medical-
this situation, if the two different tests are frequently accompanying cardiovascular ization” of pregnancies previously catego-
both above the diagnostic thresholds, the risk factors. The current diagnostic criteria rized as normal. These diagnostic criteria
diagnosis of diabetes is confirmed. for diabetes are summarized in Table 3. changes are being made in the context of
On the other hand, when two differ- worrisome worldwide increases in obe-
ent tests are available in an individual and Diagnosis of GDM sity and diabetes rates, with the intent of
the results are discordant, the test whose GDM carries risks for the mother and optimizing gestational outcomes for
result is above the diagnostic cut point neonate. The Hyperglycemia and Adverse women and their babies.
should be repeated, and the diagnosis is Pregnancy Outcomes (HAPO) study Admittedly, there are few data from
made on the basis of the confirmed test. (13), a large-scale (;25,000 pregnant randomized clinical trials regarding ther-
That is, if a patient meets the diabetes women) multinational epidemiologic apeutic interventions in women who will
criterion of the A1C (two results $6.5%) study, demonstrated that risk of adverse now be diagnosed with GDM based on
but not the FPG (,126 mg/dl or 7.0 maternal, fetal, and neonatal outcomes only one blood glucose value above the
mmol/l), or vice versa, that person continuously increased as a function of specified cut points (in contrast to the
should be considered to have diabetes. Ad- maternal glycemia at 24–28 weeks, even older criteria that stipulated at least two
mittedly, in most circumstance the within ranges previously considered

Table 4dScreening for and diagnosis of


GDM
Table 3dCriteria for the diagnosis of diabetes
Perform a 75-g OGTT, with plasma glucose
A1C $6.5%. The test should be performed in a laboratory using a method that is NGSP certified measurement fasting and at 1 and 2 h, at
and standardized to the DCCT assay.* 24–28 weeks of gestation in women not
OR previously diagnosed with overt diabetes.
FPG $126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for at least 8 h.* The OGTT should be performed in the
OR morning after an overnight fast of at least
2-h plasma glucose $200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as 8 h.
described by the World Health Organization, using a glucose load containing the equivalent of The diagnosis of GDM is made when any of the
75 g anhydrous glucose dissolved in water.* following plasma glucose values are
OR exceeded:
In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma c Fasting: $92 mg/dl (5.1 mmol/l)
glucose $200 mg/dl (11.1 mmol/l). c 1 h: $180 mg/dl (10.0 mmol/l)

*In the absence of unequivocal hyperglycemia, criteria 1–3 should be confirmed by repeat testing. c 2 h: $153 mg/dl (8.5 mmol/l)

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S73


Position Statement

abnormal values). Expected benefits to role of the A1C assay in the diagnosis of 11. Selvin E, Steffes MW, Zhu H, Matsushita
their pregnancies and offspring is inferred diabetes. Diabetes Care 2009;32:1327– K, Wagenknecht L, Pankow J, Coresh J,
from intervention trials that focused on 1334 Brancati FL. Glycated hemoglobin, di-
women with more mild hyperglycemia 4. Edelman D, Olsen MK, Dudley TK, Harris abetes, and cardiovascular risk in non-
than identified using older GDM diag- AC, Oddone EZ. Utility of hemoglobin diabetic adults. N Engl J Med 2010;362:
A1c in predicting diabetes risk. J Gen In- 800–811
nostic criteria and that found modest tern Med 2004;19:1175–1180 12. Ackermann RT, Cheng YJ, Williamson
benefits (15,16). The frequency of their 5. Pradhan AD, Rifai N, Buring JE, Ridker DF, Gregg EW. Identifying adults at high
follow-up and blood glucose monitoring PM. Hemoglobin A1c predicts diabetes risk for diabetes and cardiovascular dis-
is not yet clear but likely to be less inten- but not cardiovascular disease in non- ease using hemoglobin A1c National
sive than women diagnosed by the older diabetic women. Am J Med 2007;120: Health and Nutrition Examination Survey
criteria. Additional well-designed clinical 720–727 2005–2006. Am J Prev Med 2011;40:
studies are needed to determine the op- 6. Sato KK, Hayashi T, Harita N, Yoneda T, 11–17
timal intensity of monitoring and treat- Nakamura Y, Endo G, Kambe H. Com- 13. Metzger BE, Lowe LP, Dyer AR, Trimble
ment of women with GDM diagnosed bined measurement of fasting plasma ER, Chaovarindr U, Coustan DR, Hadden
by the new criteria (that would not glucose and A1C is effective for the pre- DR, McCance DR, Hod M, McIntyre HD,
diction of type 2 diabetes: the Kansai Oats JJ, Persson B, Rogers MS, Sacks DA.
have met the prior definition of GDM).
Healthcare Study. Diabetes Care 2009;32: Hyperglycemia and adverse pregnancy
It is important to note that 80–90% of 644–646
women in both of the mild GDM studies outcomes. N Engl J Med 2008;358:1991–
7. Shimazaki T, Kadowaki T, Ohyama Y,
(whose glucose values overlapped with 2002
Ohe K, Kubota K. Hemoglobin A1c
the thresholds recommended herein) 14. Metzger BE, Gabbe SG, Persson B,
(HbA1c) predicts future drug treatment
could be managed with lifestyle therapy Buchanan TA, Catalano PA, Damm P,
for diabetes mellitus: a follow-up study
Dyer AR, Leiva A, Hod M, Kitzmiler JL,
alone. using routine clinical data in a Japanese
Lowe LP, McIntyre HD, Oats JJ, Omori Y,
university hospital. Translational Re-
search 2007;149:196–204 Schmidt MI. International Association of
8. Geiss LS, Pan L, Cadwell B, Gregg EW, Diabetes and Pregnancy Study Groups
References
Benjamin SM, Engelgau MM. Changes in recommendations on the diagnosis and
1. Expert Committee on the Diagnosis and
Classification of Diabetes Mellitus. Report incidence of diabetes in U.S. adults, classification of hyperglycemia in preg-
of the Expert Committee on the Diagnosis 1997–2003. Am J Prev Med 2006;30: nancy. Diabetes Care 2010;33:676–682
and Classification of Diabetes Mellitus. 371–377 15. Landon MB, Spong CY, Thom E,
Diabetes Care 1997;20:1183–1197 9. Knowler WC, Barrett-Connor E, Fowler Carpenter MW, Ramin SM, Casey B,
2. Genuth S, Alberti KG, Bennett P, Buse J, SE, Hamman RF, Lachin JM, Walker EA, Wapner RJ, Varner MW, Rouse DJ, Thorp
DeFronzo R, Kahn R, Kitzmiller J, Knowler Nathan DM, Diabetes Prevention Program JM, Jr., Sciscione A, Catalano P, Harper M,
WC, Lebovitz H, Lernmark A, Nathan D, Research Group. Reduction in the in- Saade G, Lain KY, Sorokin Y, Peaceman
Palmer J, Rizza R, Saudek C, Shaw J, Steffes cidence of type 2 diabetes with lifestyle AM, Tolosa JE, Anderson GB. A multi-
M, Stern M, Tuomilehto J, Zimmet P, Ex- intervention or metformin. N Engl J Med center, randomized trial of treatment for
pert Committee on the Diagnosis and 2002;346:393–403 mild gestational diabetes. N Engl J Med
Classification of Diabetes Mellitus. Follow- 10. Zhang X, Gregg EW, Williamson DF, 2009;361:1339–1348
up report on the diagnosis of diabetes Barker LE, Thomas W, Bullard KW, 16. Crowther CA, Hiller JE, Moss JR, McPhee
mellitus. Diabetes Care 2003;26:3160– Imperatore G, Williams DE, Albright AL. AJ, Jeffries WS, Robinson JS. Effect of
3167 A1C level and future risk of diabetes: treatment of gestational diabetes mellitus
3. International Expert Committee. Inter- a systematic review. Diabetes Care 2010; on pregnancy outcomes. N Engl J Med
national Expert Committee report on the 33:1665–1673 2005;352:2477–2486

S74 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


P O S I T I O N S T A T E M E N T

]
Diabetes Care in the School and Day Care
Setting
AMERICAN DIABETES ASSOCIATION

D
iabetes is one of the most common the child full participation in all school Knowledgeable trained personnel are es-
chronic diseases of childhood (1). activities (8,9). sential if the student is to avoid the imme-
There are ;215,000 individu- Despite these protections, children in diate health risks of low blood glucose and
als ,20 years of age with diabetes in the school and day care setting still face to achieve the metabolic control required
the U.S. (2). The majority of these young discrimination. For example, some day to decrease risks for later development of
people attend school and/or some type care centers may refuse admission to diabetes complications (3,20). Studies
of day care and need knowledgeable children with diabetes, and children in have shown that the majority of school
staff to provide a safe school environ- the classroom may not be provided the personnel have an inadequate under-
ment. Both parents and the health care assistance necessary to monitor blood standing of diabetes (21,22). Conse-
team should work together to provide glucose and administer insulin and may quently, diabetes education must be
school systems and day care providers be prohibited from eating needed snacks. targeted toward day care providers, teach-
with the information necessary to allow The American Diabetes Association works ers, and other school personnel who in-
children with diabetes to participate to ensure the safe and fair treatment of teract with the child, including school
fully and safely in the school experience children with diabetes in the school and administrators, school nurses, coaches,
(3,4). day care setting (10–15) (www.diabetes. health aides, bus drivers, secretaries, etc.
org/schooldiscrimination). (3,20). Current recommendations and
DIABETES AND up-to-date resources regarding appropri-
THE LAWdFederal laws that protect Diabetes care in schools ate care for children with diabetes in the
children with diabetes include Section Appropriate diabetes care in the school and school are universally available to all
504 of the Rehabilitation Act of 1973 day care setting is necessary for the child’s school personnel (3,23).
(5), the Individuals with Disabilities Edu- immediate safety, long-term well-being, The purpose of this position statement
cation Act (originally the Education for and optimal academic performance. The is to provide recommendations for the
All Handicapped Children Act of 1975) Diabetes Control and Complications Trial management of children with diabetes in
(6), and the Americans with Disabilities showed a significant link between blood the school and day care setting.
Act (7). Under these laws, diabetes has glucose control and later development of
been considered to be a disability, and it diabetes complications, with improved
is illegal for schools and/or day care cen- glycemic control decreasing the risk of
ters to discriminate against children with these complications (16,17). To achieve
disabilities. In addition, any school that glycemic control, a child must check blood GENERAL GUIDELINES FOR
receives federal funding or any facility glucose frequently, monitor food intake, THE CARE OF THE CHILD IN
THE SCHOOL AND DAY CARE
considered open to the public must rea- take medications, and engage in regular
SETTING
sonably accommodate the special needs physical activity. Insulin is usually taken
of children with diabetes. Indeed, federal in multiple daily injections or through an
I. Diabetes Medical Management
law requires an individualized assessment infusion pump. Crucial to achieving glyce-
of any child with diabetes. The required mic control is an understanding of the ef- Plan
An individualized Diabetes Medical Man-
accommodations should be documented fects of physical activity, nutrition therapy,
agement Plan (DMMP) should be devel-
in a written plan developed under the ap- and insulin on blood glucose levels.
oped by the student’s personal diabetes
plicable federal law such as a Section 504 To facilitate the appropriate care of
health care team with input from the
Plan or Individualized Education Pro- the student with diabetes, the school
parent/guardian. Inherent in this process
gram (IEP). The needs of a student with nurse as well as other school and day care
are delineated responsibilities assumed by
diabetes should be provided for within personnel must have an understanding
all parties, including the parent/guardian,
the child’s usual school setting with as of diabetes and must be trained in its
the school personnel, and the student
little disruption to the school’s and the management and in the treatment of dia-
(3,24,25). These responsibilities are out-
child’s routine as possible and allowing betes emergencies (3,18,19,20,34,36).
lined in this position statement. In addi-
tion, the DMMP should be used as the
basis for the development of written edu-
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
cation plans such as the Section 504 Plan
Originally approved 1998. Revised 2008. or the IEP. The DMMP should address the
DOI: 10.2337/dc13-S075
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly specific needs of the child and provide
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ specific instructions for each of the fol-
licenses/by-nc-nd/3.0/ for details. lowing:

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S75


Position Statement

1. Blood glucose monitoring, including to ensure proper disposal of materials. help; level 2 training for school staff
the frequency and circumstances re- A separate logbook should be kept at members who have responsibility
quiring blood glucose checks, and use school with the diabetes supplies for for a student or students with di-
of continuous glucose monitoring if the staff or student to record blood abetes, which includes all content
utilized. glucose and ketone results; blood glu- from level 1 plus recognition and
2. Insulin administration (if necessary), cose values should be transmitted to treatment of hypoglycemia and hy-
including doses/injection times pre- the parent/guardian for review as often perglycemia and required accom-
scribed for specific blood glucose val- as requested. Some students maintain a modations for those students; and
ues and for carbohydrate intake, the record of blood glucose results in me- level 3 training for a small group of
storage of insulin, and, when appro- ter memory rather than recording in a school staff members who will per-
priate, physician authorization of par- logbook, especially if the same meter is form student-specific routine and
ent/guardian adjustments to insulin used at home and at school. emergency care tasks such as blood
dosage. 2. The DMMP completed and signed by glucose monitoring, insulin adminis-
3. Meals and snacks, including food con- the student’s personal diabetes health tration, and glucagon administration
tent, amounts, and timing. care team. when a school nurse is not available
4. Symptoms and treatment of hypogly- 3. Supplies to treat hypoglycemia, in- to perform these tasks and which will
cemia (low blood glucose), including cluding a source of glucose and a glu- include level 1 and 2 training as well.
the administration of glucagon if rec- cagon emergency kit, if indicated in 3. Immediate accessibility to the treat-
ommended by the student’s treating the DMMP. ment of hypoglycemia by a knowl-
physician. 4. Information about diabetes and the edgeable adult. The student should
5. Symptoms and treatment of hypergly- performance of diabetes-related remain supervised until appropriate
cemia (high blood glucose). tasks. treatment has been administered,
6. Checking for ketones and appropriate 5. Emergency phone numbers for the and the treatment should be available
actions to take for abnormal ketone parent/guardian and the diabetes as close to where the student is as
levels, if requested by the student’s health care team so that the school possible.
health care provider. can contact these individuals with 4. Accessibility to scheduled insulin at
7. Participation in physical activity. diabetes-related questions and/or dur- times set out in the student’s DMMP
8. Emergency evacuation/school lock- ing emergencies. as well as immediate accessibility to
down instructions. 6. Information about the student’s meal/ treatment for hyperglycemia including
snack schedule. The parent should insulin administration as set out by the
A sample DMMP (http://professional. work with the school during the student’s DMMP.
diabetes.org/DMMP) may be accessed teacher preparation period before the 5. A location in the school that provides
online and customized for each individ- beginning of the school year or before privacy during blood glucose moni-
ual student. For detailed information on the student returns to school after di- toring and insulin administration, if
the symptoms and treatment of hypogly- agnosis to coordinate this schedule desired by the student and family, or
cemia and hyperglycemia, refer to Medi- with that of the other students as closely permission for the student to check
cal Management of Type 1 Diabetes (26). A as possible. For young children, in- his or her blood glucose level and
brief description of diabetes targeted to structions should be given for when take appropriate action to treat hy-
school and day care personnel is included food is provided during school parties poglycemia in the classroom or any-
in the APPENDIX; it may be helpful to in- and other activities. where the student is in conjunction
clude this information as an introduction 7. In most locations, and increasingly, a with a school activity, if indicated in
to the DMMP. signed release of confidentiality from the student’s DMMP.
the legal guardian will be required so 6. School nurse and back-up trained
II. Responsibilities of the various that the health care team can com- school personnel who can check
care providers municate with the school. Copies blood glucose and ketones and ad-
should be retained both at the school minister insulin, glucagon, and other
A. The parent/guardian should provide and in the health care professionals’ medications as indicated by the stu-
the school or day care provider with offices. dent’s DMMP.
the following: 7. School nurse and back-up trained
B. The school or day care provider school personnel responsible for the
1. All materials, equipment, insulin, should provide the following: student who will know the schedule
and other medication necessary for of the student’s meals and snacks and
diabetes care tasks, including blood 1. Opportunities for the appropriate work with the parent/guardian to
glucose monitoring, insulin admin- level of ongoing training and diabetes coordinate this schedule with that of
istration (if needed), and urine or education for the school nurse. the other students as closely as pos-
blood ketone monitoring. The par- 2. Training for school personnel as fol- sible. This individual will also notify
ent/guardian is responsible for the lows: level 1 training for all school the parent/guardian in advance of
maintenance of the blood glucose staff members, which includes a basic any expected changes in the school
monitoring equipment (i.e., cleaning overview of diabetes, typical needs schedule that affect the student’s
and performing controlled testing of a student with diabetes, recogni- meal times or exercise routine and
per the manufacturer’s instructions) tion of hypoglycemia and hyper- will remind young children of snack
and must provide materials necessary glycemia, and who to contact for times.

S76 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

Table 1dResources for teachers, child care providers, parents, and health professionals number of school staff on diabetes-related
Helping the Student with Diabetes Succeed: A Guide for School Personnel. National Diabetes Education
tasks and in the treatment of diabetes
Program, 2010. Available at http://ndep.nih.gov/publications/PublicationDetail.aspx?PubId=97#main
emergencies. This training should be pro-
Diabetes Care Tasks at School: What Key Personnel Need to Know. Alexandria, VA, American
vided by the school nurse or another
Diabetes Association, 2008. Available at http://shopdiabetes.org/58-diabetes-care-tasks-at-
qualified health care professional with ex-
school-what-key-personnel-need-to-know-2010-edition.aspx
pertise in diabetes. Members of the stu-
Your School & Your Rights: Protecting Children with Diabetes Against Discrimination in Schools and
dent’s diabetes health care team should
Day Care Centers. Alexandria, VA, American Diabetes Association, 2005 (brochure). Available
provide school personnel and parents/
at http://www.diabetes.org/assets/pdfs/schools/your-school-your-right-2010.pdf*
guardians with educational materials
Children with Diabetes: Information for School and Child Care Providers. Alexandria, VA, American
from the American Diabetes Association
Diabetes Association, 2004 (brochure). Available at http://shopdiabetes.org/42-children-with-
and other sources targeted to school per-
diabetes-information-for-school-and-child-care-providers.aspx*
sonnel and/or parents. Table 1 includes a
ADA’s Safe at School campaign and information on how to keep children with diabetes safe at
listing of appropriate resources.
school. Call 1-800-DIABETES and go to http://www.diabetes.org/living-with-diabetes/
parents-and-kids/diabetes-care-at-school/
III. Expectations of the student in
American Diabetes Association: Complete Guide to Diabetes. Alexandria, VA, American Diabetes
diabetes care
Association, 2011. Available at http://www.shopdiabetes.org/551-American-Diabetes-
Children and youth should be allowed to
Association-Complete-Guide-to-Diabetes-5th-Edition.aspx
provide their own diabetes care at school
American Diabetes Association: Guide to Raising a Child With Diabetes, 3rd ed. Alexandria, VA,
to the extent that is appropriate based on
American Diabetes Association, 2011. Available at http://www.shopdiabetes.org/548-ADA-
the student’s development and his or her
Guide-to-Raising-a-Child-with-Diabetes-3rd-Edition.aspx
experience with diabetes. The extent of
Clarke W: Advocating for the child with diabetes. Diabetes Spectrum 12:230–236, 1999
the student’s ability to participate in di-
School Discrimination Resources. Alexandria, VA, American Diabetes Association, 2006. Available
abetes care should be agreed upon by the
at http://www.diabetes.org/living-with-diabetes/know-your-rights/discrimination/school-
school personnel, the parent/guardian,
discrimination/*
and the health care team, as necessary.
Every Day Wisdom: A Kit for Kids with Diabetes (and their parents). Alexandria, VA, American
The ages at which children are able to
Diabetes Association, 2000. Available at http://www.diabetes.org/living-with-diabetes/parents-
perform self-care tasks are variable and
and-kids/everyday-wisdom-kit-nov-dec-2012.html?loc=rightrail1_wisdomkit_evergreen
depend on the individual, and a child’s
ADA’s Planet D, online information for children and youth with diabetes. Available at http://
capabilities and willingness to provide
www.diabetes.org/living-with-diabetes/parents-and-kids/planet-d/
self-care should be respected (18).
*Available in the American Diabetes Association’s Education Discrimination Packet by calling 1-800-
DIABETES. 1. Toddlers and preschool-aged children:
unable to perform diabetes tasks in-
dependently and will need an adult to
provide all aspects of diabetes care.
8. Permission for self-sufficient and ca- 14. A plan for the disposal of sharps Many of these younger children will
pable students to carry equipment, based upon an agreement with the have difficulty in recognizing hypo-
supplies, medication, and snacks; to student’s family, local ordinances, glycemia, so it is important that school
perform diabetes management tasks; and Universal Precaution Standards. personnel are able to recognize and
and to have cell phone access to reach 15. Information on serving size and ca- provide prompt treatment. However,
parent/guardian and health care loric, carbohydrate, and fat content children in this age range can usually
provider. of foods served in the school (27). determine which finger to prick, can
9. Permission for the student to see the choose an injection site, and are gen-
school nurse and other trained The school nurse should be the key co- erally cooperative.
school personnel upon request. ordinator and provider of care and should 2. Elementary school–aged children: de-
10. Permission for the student to eat a coordinate the training of an adequate pending on the length of diagnosis
snack anywhere, including the class- number of school personnel as specified and level of maturity, may be able to
room or the school bus, if necessary to above and ensure that if the school nurse is perform their own blood glucose
prevent or treat hypoglycemia. not present at least one adult is present checks, but usually will require su-
11. Permission to miss school without who is trained to perform these proce- pervision. Older elementary school–
consequences for illness and required dures in a timely manner while the aged children are generally beginning
medical appointments to monitor the student is at school, on field trips, par- to self-administer insulin with super-
student’s diabetes management. This ticipating in school-sponsored extracur- vision and understand the effect of
should be an excused absence with a ricular activities, and on transportation insulin, physical activity, and nutrition
doctor’s note, if required by usual provided by the school or day care on blood glucose levels. Unless the
school policy. facility. This is needed in order to enable child has hypoglycemic unawareness,
12. Permission for the student to use the full participation in school activities he or she should usually be able to let
restroom and have access to fluids (3,18,20). These school personnel an adult know when experiencing hy-
(i.e., water) as necessary. need not be health care professionals poglycemia.
13. An appropriate location for insulin (3,9,20,28,33,35). 3. Middle school– and high school–aged
and/or glucagon storage, if neces- It is the school’s responsibility to pro- children: usually able to provide self-
sary. vide appropriate training of an adequate care depending on the length of

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S77


Position Statement

diagnosis and level of maturity but APPENDIX High blood glucose (hyperglycemia)
will always need help when experi- occurs when the body gets too little insulin,
encing severe hypoglycemia. Inde- Background information on too much food, or too little exercise; it may
pendence in older children should be diabetes for school personnel also be caused by stress or an illness such
encouraged to enable the child to Diabetes is a serious, chronic disease that as a cold. The most common symptoms
make his or her decisions about his or impairs the body’s ability to use food. of hyperglycemia are thirst, frequent uri-
her own care. Insulin, a hormone produced by the nation, and blurry vision. If untreated
pancreas, helps the body convert food over a period of days, hyperglycemia and
Students’ competence and capability into energy. In people with diabetes, ei- insufficient insulin can lead to a serious
for performing diabetes-related tasks are ther the pancreas does not make insulin condition called diabetic ketoacidosis
set out in the DMMP and then adapted to or the body cannot use insulin properly. (DKA), which is characterized by nausea,
the school setting by the school health Without insulin, the body’s main energy vomiting, and a high level of ketones in the
team and the parent/guardian. At all ages, sourcedglucosedcannot be used as fuel. blood and urine. For students using insulin
individuals with diabetes may require Rather, glucose builds up in the blood. infusion pumps, lack of insulin supply may
help to perform a blood glucose check Over many years, high blood glucose lead to DKA more rapidly. DKA can be life-
when the blood glucose is low. In addi- levels can cause damage to the eyes, kid- threatening and thus requires immediate
tion, many individuals require a reminder neys, nerves, heart, and blood vessels. medical attention (32).
to eat or drink during hypoglycemia and The majority of school-aged youth
should not be left unsupervised until such with diabetes have type 1 diabetes. People
treatment has taken place and the blood with type 1 diabetes do not produce in-
glucose value has returned to the normal AcknowledgmentsdThe American Diabetes
sulin and must receive insulin through Association thanks the members of the Health
range. Ultimately, each person with di- either injections or an insulin pump. In-
abetes becomes responsible for all aspects Care Professional Volunteer Writing Group for
sulin taken in this manner does not cure this updated statement: William Clarke, MD;
of routine care, and it is important for diabetes and may cause the student’s Larry C. Deeb, MD; Paula Jameson, MSN,
school personnel to facilitate a student in
blood glucose level to become danger- ARNP, CDE; Francine Kaufman, MD; Geor-
reaching this goal. However, regardless geanna Klingensmith, MD; Desmond Schatz,
ously low. Type 2 diabetes, the most
of a student’s ability to provide self-care, MD; Janet H. Silverstein, MD; and Linda M.
common form of the disease, typically
help will always be needed in the event Siminerio, RN, PhD, CDE.
afflicting obese adults, has been shown to
of a diabetes emergency.
be increasing in youth. This may be due
to the increase in obesity and decrease in
MONITORING BLOOD References
physical activity in young people. Stu-
GLUCOSE IN THE 1. American Diabetes Association: American
CLASSROOMdIt is best for a stu- dents with type 2 diabetes may be able to Diabetes Association Complete Guide to Di-
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quickly and conveniently as possible. cations and/or insulin injections. All 2. Centers for Disease Control and Pre-
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This is important to avoid medical prob-
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Accordingly, as stated earlier, a student Low blood glucose (hypoglycemia) is 3. National Institutes of Health: Helping the
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In summary, with proper planning with this degree of hypoglycemia will Act, 20 U.S.C. 1400 et seq., implementing
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adolescents with insulin-dependent diabetes School Campaign Statement of Principles of the Council on Science and Public
mellitus. J Pediatr 125: 177–188, 1994 endorsed by American Academy of Pedi- Health (A-08): Ensuring the Best In-School
18. American Diabetes Association: Care of atrics, American Association of Clinical Care for Children with Diabetes [article
children and adolescents with type 1 di- Endocrinologists, American Association online], June 2008. Available from http://
abetes (Position Statement). Diabetes Care of Diabetes Educators, American Dia- www.ama-assn.org/resources/doc/csaph/
28: 186–212, 2005 betes Association, American Dietetic csaph4a08.pdf

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P O S I T I O N S T A T E M E N T

Diabetes and Driving


AMERICAN DIABETES ASSOCIATION identified, which people are medically eval-
uated, and what restrictions are placed on
people who have experienced hypoglyce-
mia or other problems related to diabetes

O
f the nearly 19 million people in the LICENSING all vary from state to state.
U.S. with diagnosed diabetes (1), a REQUIREMENTSdPeople with dia- States identify drivers with diabetes
large percentage will seek or cur- betes are currently subject to a great variety in a number of ways. In at least 23 states,
rently hold a license to drive. For many, a of licensing requirements and restrictions. drivers are either asked directly if they
driver’s license is essential to work; taking These licensing decisions occur at several have diabetes or are otherwise required to
care of family; securing access to public and points and involve different levels and self-identify if they have diabetes. In other
private facilities, services, and institutions; types of review, depending on the type of states drivers are asked some variation of a
interacting with friends; attending classes; driving. Some states and local jurisdictions question about whether they have a con-
and/or performing many other functions of impose no special requirements for people dition that is likely to cause altered percep-
daily life. Indeed, in many communities with diabetes. Other jurisdictions ask driv- tion or loss of consciousness while driving.
and areas of the U.S. the use of an automo- ers with diabetes various questions about In most states, when the answer to either
bile is the only (or the only feasible or af- their condition, including their manage- question is yes, the driver is required to
fordable) means of transportation available. ment regimen and whether they have ex- submit to a medical evaluation before he
There has been considerable debate perienced any diabetes-related problems or she will be issued a license.
whether, and the extent to which, diabetes that could affect their ability to safely oper-
may be a relevant factor in determining ate a motor vehicle. In some instances, Medical evaluation
driver ability and eligibility for a license. answers to these questions result in restric- Drivers whose medical conditions can lead
This position statement addresses such tions being placed on a person’s license, in- to significantly impaired consciousness are
issues in light of current scientific and cluding restrictions on the type of vehicle evaluated for their fitness to continue to
medical evidence. they may operate and/or where they may op- drive. For people with diabetes, this typi-
Sometimes people with a strong in- erate that vehicle. In addition, the rules for cally occurs when a person has experienced
terest in road safety, including motor vehi- operating a commercial motor vehicle, and hypoglycemia (3) behind the wheel, even if
cle administrators, pedestrians, drivers, for obtaining related license endorsements this did not result in a motor vehicle acci-
other road users, and employers, associate (such as rules restricting operation of a school dent. In some states this occurs as a result
all diabetes with unsafe driving when in bus or transport of passengers or hazardous of a policy to evaluate all people with di-
fact most people with diabetes safely oper- materials) are quite different and in many abetes, even if there has been no triggering
ate motor vehicles without creating any ways more cumbersome for people with di- event. It can also occur when a person ex-
meaningful risk of injury to themselves abetes, especially those who use insulin. periences severe hypoglycemia while not
or others. When legitimate questions arise With the exception of commercial driving and a physician reports the episode
about the medical fitness of a person with driving in interstate commerce (Interstate to the licensing authority. In a handful of
diabetes to drive, an individual assessment of commercial driving is defined as trade, states, such reporting by physicians is man-
that person’s diabetes managementdwith traffic or transportation in the United States datory. In most other states physicians are
particular emphasis on demonstrated abil- between a place in a state and a place permitted to make reports but are given
ity to detect and appropriately treat poten- outside of such a state, between two places discretion to determine when such reports
tial hypoglycemiadis necessary in order in a state through another state or a place are necessary. Some states specify that
to determine any appropriate restrictions. outside of the United States, or between physicians may voluntarily report those pa-
The diagnosis of diabetes is not sufficient two places in a state as part of trade, traffic tients who pose an imminent threat to pub-
to make any judgments about individual or transportation originating or terminat- lic safety because they are driving against
driver capacity. ing outside the state or the United States medical advice. Physicians and others re-
This document provides an overview [2]), which is subject to uniform federal quired to make reports to the licensing au-
of existing licensing rules for people with regulation, both private and commercial thority are usually provided with immunity
diabetes, addresses the factors that impact driving are subject to rules determined by from civil and criminal actions resulting
driving for this population, and identifies individual states. These rules vary widely, from the report.
general guidelines for assessing driver fit- with each state taking its own approach to When licensing authorities learn
ness and determining appropriate licensing determining medical fitness to drive and that a driver has experienced an episode
restrictions. the issuance of licenses. How diabetes is of hypoglycemia that potentially affected
the ability to drive, that driver is referred
for a medical evaluation and in many
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
cases will lose driving privileges for a period
Peer reviewed by the Professional Practice Committee, September 2011, and approved by the Executive of time until cleared by the licensing au-
Committee of the American Diabetes Association, November 2011. thority. This period can range from 3 to 6
DOI: 10.2337/dc13-S080
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly months or longer. Some state laws allow for
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ waivers of the rules when the episode is a
licenses/by-nc-nd/3.0/ for details. one-time event not likely to recur, for

S80 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

example because of a change in medication risk of incurring driving mishaps, such as ratio of ;4 (14), whereas those with sleep
or episodes that occur only during sleep. unstable coronary heart disease, obstruc- apnea have a relative risk of ;2.4 (15). If
Medical evaluation procedures vary tive sleep apnea, epilepsy, Parkinson’s society tolerates these conditions, it would
and range from a simple confirmation of disease, or alcohol and substance abuse, be unjustified to restrict the driving priv-
the person’s diabetes from a physician to a there are also some drivers with diabetes ileges of an entire class of individuals who
more elaborate process involving a state that have a higher risk for driving mis- are at much lower risk, such as drivers
medical advisory board, hearings, and haps. The challenges are to identify high- with diabetes.
presentation and assessment of medical risk individuals and develop measures to The most significant subgroup of
evidence. Some states convene medical assist them to lower their risk for driving persons with diabetes for whom a greater
advisory boards with nurses and physi- mishaps. degree of restrictions is often applied is
cians of different specialties who review drivers managing their diabetes with in-
and make recommendations concerning Understanding the risk of diabetes sulin. Yet, when the type of diabetes is
the licensing of people with diabetes and and driving controlled for, insulin therapy per se has
other medical conditions. In other states, In a recent Scottish study, only 62% of not been found to be associated with in-
licensing decisions are made by adminis- health care professionals suggested that creased driving risk (3,16,17). While im-
trative staff with little or no medical train- insulin-treated drivers should test their paired awareness of hypoglycemia has
ing and with little or no review by a blood glucose before driving; 13% of health been found to relate to increased incidence
medical review board or by a physician care professionals thought it safe to drive of motor vehicle crashes in some studies
or physicians with any relevant expertise with blood glucose ,72 mg/dL (4 mmol/L), (12), it has not been found to be a relevant
concerning medical conditions presented and 8% did not know that impaired aware- variable in other studies (4,7,23). The sin-
by individual applicants. ness of hypoglycemia might be a contrain- gle most significant factor associated with
The medical evaluation process for dication to driving (5). It is important that driving collisions for drivers with diabetes
commercial drivers occurs at predeter- health care professionals be knowledgeable appears to be a recent history of severe hy-
mined intervals, typically every 2 years. and take the lead in discussing risk reduc- poglycemia, regardless of the type of diabe-
Unlike noncommercial licenses, these tion for their patients at risk for hypoglyce- tes or the treatment used (1,3,18–21).
regular evaluations are not linked to mia. In a large international study, nearly The American Diabetes Association
episodes of severe hypoglycemia but are half of drivers with type 1 diabetes and Workgroup on Hypoglycemia defined se-
part of an ongoing fitness evaluation for three-quarters of those with type 2 diabetes vere hypoglycemia as low blood glucose
jobs requiring commercial driving. The fed- had never discussed driving guidelines with resulting in neuroglycopenia that disrupts
eral government has no diabetes-specific their physician (8). cognitive motor function and requires the
restrictions for individuals who manage A meta-analysis of 15 studies sug- assistance of another to actively administer
their disease with diet, exercise, and/or gested that the relative risk of having a carbohydrate, glucagon, or other resuscita-
oral medication. It offers an exemption motor vehicle accident for people with tive actions (22). In a prospective multicen-
program for insulin-using interstate com- diabetes as a whole, i.e., without differen- ter study of 452 drivers with type 1 diabetes
mercial drivers and issues medical certifi- tiating those with a significant risk from followed monthly for 12 months, 185 par-
cates to qualified drivers. Factors in the those with little or no risk, as compared ticipants (41%) reported a total of 503 epi-
federal commercial driving medical evalu- with the general population ranges be- sodes of moderate hypoglycemia (where
ation include a review of diabetes history, tween 1.126 and 1.19, a 12–19% in- the driver could still treat him/herself but
medications, hospitalizations, blood glu- creased risk (6). Some published studies could no longer drive safely) and 23 partic-
cose history, and tests for various com- indicated that drivers with type 1 diabetes ipants (5%) reported 31 episodes of severe
plications and an assessment of driver have a slightly higher risk, with a relative hypoglycemia (where the driver was unable
understanding of diabetes and willingness risk ratio of ;2 (7,8,9), but this was not to treat him/herself) while driving (21).
to monitor their condition. confirmed by other studies (10). Two stud- Conversely, the Diabetes Control and Com-
ies even suggested that there is no increased plications Trial (DCCT) group reported 11
SCIENCE OF DIABETES AND risk associated with insulin-treated diabe- motor vehicle accidents in 714 episodes of
DRIVINGdHypoglycemia indicating tes (11,12), but the methodologies used severe hypoglycemia, a rate of 1.5% (23).
an impaired ability to drive, retinopathy have been criticized (13). The significant impact of moderate
or cataract formation impairing the vision This increased risk of collisions must hypoglycemia while driving is supported
needed to operate a motor vehicle, and be interpreted in the light of society’s tol- by multiple studies demonstrating that
neuropathy affecting the ability to feel foot erance of other and much higher–risk moderate hypoglycemia significantly and
pedals can each impact driving safety (4). conditions. For example, 16-year-old consistently impairs driving safety (24–26)
However, the incidence of these conditions males have 42 times more collisions than and judgment (27,28) as to whether to con-
is not sufficiently extensive to justify re- 35- to 45-year-old women. If the heaviest tinue to drive or to self-treat (29,30) under
striction of driving privileges for all drivers car collides with the lightest car, the driver such metabolic conditions. In one study,
with diabetes. Driving mishaps related to of the latter is 20 times more likely to be 25% of respondents thought it was safe to
diabetes are relatively infrequent for most killed than the driver of the former. The drive even when blood glucose was ,70
drivers with diabetes and occur at a lower most dangerous rural highways are 9.2 mg/dL (3.9 mmol/L) (31).
rate than mishaps of many other drivers times more dangerous than the safest urban While significant hyperglycemia may
with conditions that affect driving perfor- highways. Driving at 1:00 A.M. on Sunday is impair cognitive, motor, and perceptual
mance and that are tolerated by society. 142 times more dangerous than driving at functioning (32–35), there is only one re-
However, just as there are some pa- 11:00 A.M. (7). Drivers with attention deficit/ port suggesting extreme hyperglycemia
tients with conditions that increase their hyperactivity disorder have a relative risk can impact driving safety (36). Thus,

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S81


Position Statement

efforts to equate hyperglycemia with driv- can be effectively delivered over the inter- evaluation to determine whether restric-
ing impairment are currently not scientif- net (46). Diabetes Driving (diabetesdriv- tions on the license or mechanical mod-
ically justified. ing.com), a program funded by the ifications to the vehicle (e.g., hand
National Institutes of Health, is another controls for people with an insensate
Individual differences internet-based tool to help assess the foot) are necessary to ensure public safety.
Eighty percent of episodes of severe hy- risk of driving mishaps and assist high- It is ill-advised to determine risk for
poglycemia affect about 20% of people risk drivers to avoid hypoglycemia while driving mishaps based on a driver’s gly-
with type 1 diabetes (37–39). Available driving and to better detect and manage cosylated hemoglobin because episodic
data suggest that a small subgroup of driv- hypoglycemia if it occurs while driving. transitions into hypoglycemia, not average
ers with type 1 diabetes account for the blood glucose, increases risk of driving
majority of hypoglycemia-related colli- RECOMMENDATIONS mishaps.
sions (9,30,40). When 452 drivers with Evaluation of drivers with diabetes
type 1 diabetes were followed prospec- Identifying and evaluating diabetes must include an assessment by the treat-
tively for a year, baseline reports of prior in drivers ing physician or another diabetes special-
episodes of mild symptomatic hypoglyce- Individuals whose diabetes poses a sig- ist who can review recent diabetes history
mia while driving or severe hypoglycemia nificantly elevated risk to safe driving and provide to the licensing agency a
while driving, hypoglycemia-related driv- must be identified and evaluated prior to recommendation about whether the
ing mishaps, or hypoglycemia-related getting behind the wheel. Because people driver has a condition that impairs his
collisions were associated with a higher with diabetes are diverse in terms of the or her ability to safely operate a motor
risk of driving mishaps in the following nature of their condition, the symptoms vehicle. The treating physician or another
12 months by 3, 6, 6, and 20%, respec- they experience, and the measures they physician who is knowledgeable about
tively. Risk increased exponentially with take to manage their diabetes, it is impor- diabetes is the best source of information
additional reported episodes: If individu- tant that identification and evaluation pro- concerning the driver’s diabetes manage-
als had two episodes of severe hypoglyce- cesses be appropriate, individualized, and ment and history. The input of such a
mia in the preceding 12 months their risk based not solely on a diagnosis of diabetes physician is essential to assess a person’s
increased to 12%, and two collisions in but rather on concrete evidence of actual diabetes management and determine
the previous 2 years increased their risk risk. Laws that require all people with whether operation of a motor vehicle is
by 40%. The strongest predictors in- diabetes (or all people with insulin-treated safe and practicable. If questions arise
volved a history of hypoglycemia while diabetes) to be medically evaluated as a concerning the safe driving ability of a
driving (21). Laboratory studies that com- condition of licensure are ill advised be- person with chronic complications of di-
pared drivers with type 1 diabetes who cause they combine people with diabetes abetes (e.g., retinopathy or neuropathy),
had no history of hypoglycemia-related into one group rather than identifying the individual should be referred to a spe-
driving mishap in the past year to those those drivers who may be at increased risk cialist with expertise in evaluating the
who had more than one mishap found due to potential difficulties in avoiding diabetes-related problem for specific rec-
that those with a history of mishaps: 1) hypoglycemia or the presence of compli- ommendations.
drove significantly worse during progres- cations. In addition, the logistics of regis- Physicians should be requested to
sive mild hypoglycemia (70–50 mg/dL, tering and evaluating millions of people provide the following information: 1)
3.9–2.8 mmol/L) but drove equally well with diabetes who wish to drive presents whether the driver has had an episode of
when blood glucose was normal (euglyce- an enormous administrative and fiscal bur- severe hypoglycemia requiring interven-
mia); 2) had a lower epinephrine response den to licensing agencies. States that require tion from another person within the pre-
while driving during hypoglycemia, 3) drivers to identify diabetes should limit vious 2 years (and when this happened);
were more insulin sensitive, and 4) demon- the identification to reports of diabetes- 2) whether there was an explanation for
strated greater difficulties with working related problems. the hypoglycemia; 3) whether the driver is
memory and information processing speed To identify potentially at-risk drivers, a at increased risk of severe hypoglycemia;
during euglycemia and hypoglycemia short questionnaire can be used to find 4) whether the driver has the ability to
(24,40,41). Thus, a history of mishaps those drivers who may require further recognize incipient hypoglycemia and
should be used as a basis for identifying evaluation. The questionnaire should ask knows how to take appropriate corrective
insulin-managed drivers with elevated whether the driver has, within the past 12 action; 5) whether the driver provides ev-
risk of future mishaps. Such individuals months, lost consciousness due to hypo- idence of sufficient self-monitoring of
are appropriately subjected to additional glycemia, experienced hypoglycemia that blood glucose; 6) whether the driver has
screening requirements. required intervention from another per- any diabetes-related complications affect-
Four studies have demonstrated that son to treat or that interfered with driving, ing safe driving that need further assess-
Blood Glucose Awareness Training or experienced hypoglycemia that devel- ment; and 7) whether the driver has a
(BGAT) reduces the occurrence of colli- oped without warning. The questionnaire good understanding of diabetes and its
sions and moving vehicle violations while should also query about loss of visual treatment, has been educated on the
improving judgment about whether to acuity or peripheral vision and loss of avoidance of hypoglycemia while driving,
drive while hypoglycemic (42–45). BGAT feeling in the right foot. Inasmuch as and is willing to follow a suggested treat-
is an 8-week psycho-educational training obstructive sleep apnea is more common ment plan.
program designed to assist individuals in people with type 2 diabetes than in the When evaluating a driver with a history
with type 1 diabetes to better anticipate, nondiabetic population, patients should of severe hypoglycemia, impaired hypogly-
prevent, recognize, and treat extreme be queried about falling asleep during the cemia awareness, or a diabetes-related mo-
blood glucose events. This intervention day. Any positive answer should trigger an tor vehicle accident, it is necessary to

S82 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

investigate the reasons for the hypoglyce- Generally, severe hypoglycemia that glucose monitoring may also be beneficial,
mia and to determine whether it is a occurs during sleep should not disqualify particularly when noting the direction of
function of the driver’s treatment regimen a person from driving. Hypoglycemia that the glucose trend. If this technology is
or lifestyle, a psychological reaction to the occurs while the person is not driving should used, the person using the device needs
management of their diabetes, or the nor- be examined to determine if it is indicative to appreciate that any action taken (e.g.,
mal course of diabetes. Appropriate clini- of a larger problem or an event that is not additional carbohydrate consumption)
cal interventions should be instituted. likely to recur while the person is behind needs to be based on a blood glucose mea-
the wheel of a car (e.g., hypoglycemia that surement.
Licensing decisions following occurs during an intense bout of exercise). The determination of which disquali-
evaluation Some episodes of severe hypoglycemia can fied drivers should be reevaluated and
Drivers with diabetes should only have a be explained and corrected with the assis- when this should be done should be made
license suspended or restricted if doing so tance of a diabetes health care professional, on an individual basis considering factors
is the only practical way to address an e.g., episodes that occur because of a such as the circumstances of the disqual-
established safety risk. Licensing deci- change in medication. However, recurrent ifying event and changes in medication
sions should reflect deference to the pro- episodes of severe hypoglycemia, defined and behavior that have been implemented
fessional judgment of the evaluating as two or more episodes in a year, may by the driver. When an assessment deter-
physician with regard to diabetes, while indicate that a person is not able to safely mines that the driver should be evaluated
also balancing the licensing agency’s need operate a motor vehicle. at some point in the future, the driver’s
to keep the roads and the public safe. States whose licensing rules lead to a physician should be consulted to deter-
States should have medical advisory suspension of a driver’s license following mine the length of the reevaluation pe-
boards whose role is to assess potential an episode of hypoglycemia should allow riod. A driver with diabetes should not
driving risks based on continually up- for waiver of these rules when the hypo- be kept in an endless cycle of reevaluation
dated medical information, to ensure glycemia can be explained and addressed if there is no longer a significantly ele-
that licensing agency staff is prepared to by the treating physician and is not likely vated safety risk.
handle diabetes licensing issues, and to to recur. For example, waivers may be ap- The determination of medical fitness
make recommendations relevant to indi- propriate following hypoglycemia that to drive should be a clinical one, weighing
vidual drivers. State medical advisory happens as a result of a change in medi- the various factors noted above. Decisions
boards should have representation by cation or during or concurrent with ill- about whether licensing restrictions are
health care professionals with expertise ness or pregnancy. Licensing agencies necessary to ensure safety of the traveling
in treating diabetes, in addition to the in- may request documentation from the public are ultimately determined by the
formation provided by the driver’s treating physician attesting that the patient meets licensing agency, taking into account the
physician, prior to making licensing deci- the conditions for a waiver (which may clinical determination of medical fitness.
sions for people with diabetes. Where the include, among other requirements, edu-
medical advisory board does not have a cation on diabetes management and Physician reporting
permanent member with expertise in di- avoidance of hypoglycemia). Although the concept behind mandatory
abetes, such an expert should be consulted Drivers with a suspended license be- physician reporting laws is to keep roads
in cases involving restrictions on a driver cause of factors related to diabetes should safe by eliminating unacceptable risk
with diabetes. be eligible to have their driver’s license re- from impaired driving, such laws have
As discussed above, a history of hy- instated following a sufficient period of the unintended consequence of discour-
poglycemia does not mean an individual time (usually no more than 6 months) aging people with diabetes from discus-
cannot be a safe driver. Rather, when upon advice from the treating physician sing their condition frankly with a
there is evidence of a history of severe that the driver has made appropriate ad- physician when there is a problem that
hypoglycemia, an appropriate evaluation justments and is adhering to a regimen needs correction due to fear of losing their
should be undertaken to determine the that has resulted in correction of the prob- license. Patients who are not candid with
cause of the low blood glucose, the cir- lems that led to the license suspension. Fol- their physicians are likely to receive in-
cumstances of the episode, whether it was lowing reinstatement of driving privileges, ferior treatment and therefore may expe-
an isolated incident, whether adjustment periodic follow-up evaluation is necessary rience complications that present a
to the insulin regimen may mitigate the to ensure that the person remains safely driving risk. In addition to the negative
risk, and the likelihood of such an episode able to operate a motor vehicle. effect that mandatory reporting has on the
recurring. It is important that licensing People who experience progressive physician-patient relationship, there is
decisions take into consideration contrib- impairment of their awareness of hypo- no evidence that mandatory physician
utory factors that may mitigate a potential glycemia should consult a health care reporting reduces the crash rate or im-
risk, and that licensing agencies do not provider to determine whether it is safe proves public safety (47).
adopt a “one strike” approach to licensing to continue driving with proper measures Physicians should be permitted to
people with diabetes. Drivers with diabe- to avoid disruptive hypoglycemia (such as exercise professional judgment in decid-
tes must be individually assessed to deter- testing blood glucose before driving and ing whether and when to report a patient
mine whether their diabetes poses a safety at regular intervals in the course of a to the licensing agency for review of
risk. The mere fact that a person’s diabetes journey lasting more than 30–60 min). If driving privileges. States that allow physi-
has come to the attention of the licensing the driver is able to make adjustments to cians to make such reports should focus
agencydwhether by a report or because improve awareness or prevent disruptive on whether the driver’s mental or physical
of an accidentdshould not itself pre- hypoglycemia while driving, there should condition impairs the patient’s ability to
determine a licensing decision. not be license restrictions. Continuous exercise safe control over a motor vehicle.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S83


Position Statement

Reports based solely on a diagnosis of di- high or low blood glucose levels and what CONCLUSIONdIn summary, people
abetes, or tied to a characterization that the patient did to treat those levels. Allow- with diabetes should be assessed individ-
the driver has a condition involving lapses ing health care professionals to exercise ually, taking into account each individu-
of consciousness, are too broad and do professional judgment about the informa- al’s medical history as well as the potential
not adequately measure individual risk. tion they learn in these patient conversa- related risks associated with driving.
Ultimately, reports must be left to the dis- tions will encourage candid sharing of
cretion of the physician, using profes- information and lead to improved patient
sional judgment about whether the health and road safety. AcknowledgmentsdThe American Diabetes
patient poses a safety risk. Further, in or- Clinical interventions in response to Association thanks the members of the writing
der to protect the physician-patient rela- hypoglycemia vary by individual but may group for developing this statement: Daniel
tionship and ensure the open and honest include strategies for the frequency and Lorber, MD, FACP, CDE (Chair); John
communication that ultimately promotes timing of blood glucose monitoring, Anderson, MD; Shereen Arent, JD; Daniel J.
safety, it is important that physicians be medication dosage changes, and estab- Cox, PhD, ABPP; Brian M. Frier, BSc, MD,
immunized from liability, both for mak- lishing more conservative glucose targets FRCPE, FRCPG; Michael A. Greene, JD;
ing reports and not making reports. if there is a history of severe hypo- John W. Griffin, Jr., JD; Gary Gross, JD;
Katie Hathaway, JD; Irl Hirsch, MD; Daniel
glycemia. Certain people who have a
B. Kohrman, JD; David G. Marrero, PhD;
Patient education and clinical history of severe hypoglycemia may be Thomas J. Songer, PhD; and Alan L. Yatvin, JD.
interventions encouraged by their health care provider
It is important that health care professio- to use continuous glucose monitoring
nals be knowledgeable and take the lead in systems that enable them to detect a References
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for those patients at increased risk for prevent hypoglycemia while operating any Atlanta, GA, U.S. Department of Health
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Control and Prevention, 2011
most important aspect of encouraging peo- those with type 2 diabetes who are at risk for
2. Code of Federal Regulation. Title 49:
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intake are not, and alcohol exacerbates the People with diabetes who are at risk mouth Meeting, Pennsylvania, ECRI, 2011
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When a patient has complications of dia- (e.g., cheese crackers), in their vehicle; mens. J Intern Med 2002;252:352–360
betes, it is important for the physician to 2) never begin an extended drive with 9. Cox DJ, Penberthy JK, Zrebiec J, et al. Di-
discuss with the driver the effect of those low normal blood glucose (e.g., 70–90 abetes and driving mishaps: frequency and
complications, if any, on driving ability. mg/dL) without prophylactic carbohy- correlations from a multinational survey.
Physicians and other health care pro- drate consumption to avoid a fall in blood Diabetes Care 2003;26:2329–2334
10. Stork ADM, van Haeften TW, Veneman
fessionals who treat people with diabetes glucose during the drive; 3) stop the ve-
TF. Diabetes and driving: desired data,
should regularly discuss the risk of driving hicle as soon any of the symptoms of low research methods and their pitfalls, cur-
with low blood glucose with their patients. blood glucose are experienced and mea- rent knowledge, and future research. Di-
Clinical visits should include review of sure and treat the blood glucose level; and abetes Care 2006;29:1942–1949
blood glucose logs and questions to the 4) not resume driving until their blood 11. Lonnen KF, Powell RJ, Taylor D, Shore AC,
patient about symptoms associated with glucose and cognition have recovered. MacLeod KM. Road traffic accidents and

S84 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

diabetes: insulin use does not determine driving performance during moderate 37. Pedersen-Bjergaard U, Pramming S,
risk. Diabet Med 2008;25:578–584 hypoglycemia in adults with IDDM. Di- Heller SR, et al. Severe hypoglycaemia in
12. Eadington DW, Frier BM. Type 1 diabetes abetes Care 1994;17:1367–1368 1076 adult patients with type 1 diabetes:
and driving experience: an eight-year co- 26. Cox DJ, Gonder-Frederick LA, Kovatchev influence of risk markers and selection.
hort study. Diabet Med 1989;6:137–141 BP, Julian DM, Clarke WL. Progressive Diabetes Metab Res Rev 2004;20:479–
13. Major HG, Rees SDR, Frier BM. Driving hypoglycemia’s impact on driving simula- 486
and diabetes: DVLA response to Lonnen tion performance: occurrence, awareness 38. Bognetti F, Brunelli A, Meschi F, Viscardi
et al. Diabet Med 2009;26:191 and correction. Diabetes Care 2000;23: M, Bonfanti R, Chiumello G. Frequency
14. Jerome L, Habinski L, Segal A. Attention- 163–170 and correlates of severe hypoglycaemia in
deficit/hyperactivity disorder (ADHD) and 27. Weinger K, Kinsley BT, Levy CJ, et al. The children and adolescents with diabetes
driving risk: a review of the literature and a perception of safe driving ability during hy- mellitus. Eur J Pediatr 1997;156:589–591
methodological critique. Curr Psychiatry poglycemia in patients with type 1 diabetes 39. Rewers A, Chase HP, Mackenzie T, et al.
Rep 2006;8:416–426 mellitus. Am J Med 1999;107:246–253 Predictors of acute complications in chil-
15. Tregear S, Reston J, Schoelles K, Phillips 28. Clarke WL, Cox DJ, Gonder-Frederick dren with type 1 diabetes. JAMA 2002;
B. Obstructive sleep apnea and risk of LA, Kovatchev BP. Hypoglycemia and the 287:2511–2518
motor vehicle crash: systematic review decision to drive a motor vehicle by per- 40. Campbell LK, Gonder-Frederick LA,
and meta-analysis. J Clin Sleep Med 2009; sons with diabetes. JAMA 1999;282:750– Broshek DK, et al. Neurocognitive differ-
5:573–581 754 ences between drivers with type 1 diabetes
16. Laberge-Nadeau C, Dionne G, Ekoé JM, 29. Cox DJ, Gonder-Frederick LA, Kovatchev with and without a recent history of re-
et al. Impact of diabetes on crash risks of BP, Clarke WL. Self-treatment of hypo- current driving mishaps. Int J Diabetes
truck-permit holders and commercial glycemia while driving. Diabetes Res Clin Mellit 2010;2:73–77
drivers. Diabetes Care 2000;23:612–617 Pract 2001;54:17–26 41. Cox DJ, Kovatchev BP, Gonder-Frederick
17. Tregear SJ, Rizzo M, Tiller M, et al. Diabetes 30. Cox DJ, Kovatchev BP, Anderson SM, LA, Clarke WL. Physiological and perfor-
and motor vehicle crashes: a systematic Clarke WL, Gonder-Frederick LA. Type 1 mance differences between drivers with
evidence-based review and meta-analysis. diabetic drivers with and without a history Type 1 Diabetes Mellitus (T1DM) with and
In Proceedings of the Fourth International of recurrent hypoglycemia-related driving without a recent history of driving mishaps:
Driving Symposium on Human Factors in mishaps: physiological and performance An exploratory study. Can J Diabetes 2003;
Driver Assessment, Training and Vehicle De- differences during euglycemia and the 27:23–29
sign. Iowa City, Iowa, The University of induction of hypoglycemia. Diabetes Care 42. Cox DJ, Gonder-Frederick LA, Julian DM,
Iowa, 2007, p. 343–350 2010;33:2430–2435 Clarke W. Long-term follow-up evalua-
18. Songer TJ. Low blood sugar and motor 31. Graveling AJ, Warren RE, Frier BM. Hy- tion of blood glucose awareness training.
vehicle crashes in persons with type 1 poglycaemia and driving in people with Diabetes Care 1994;17:1–5
diabetes. Annu Proc Assoc Adv Automot insulin-treated diabetes: adherence to 43. Cox DJ, Gonder-Frederick LA, Polonsky
Med 2002;46:424–427 recommendations for avoidance. Diabet W, Schlundt D, Julian D, Clarke W.
19. Songer TJ, Dorsey RR. High risk charac- Med 2004;21:1014–1019 A multicenter evaluation of blood glucose
teristics for motor vehicle crashes in per- 32. Kovatchev BP, Cox DJ, Summers KH, awareness training-II. Diabetes Care 1995;
sons with diabetes by age. Annu Proc Assoc Gonder-Frederick LA, Clarke WL. Post- 18:523–528
Adv Automot Med 2006;50:335–351 prandial glucose dynamics and associated 44. Cox DJ, Gonder-Frederick LA, Polonsky
20. Redelmeier DA, Kenshole AB, Ray JG. symptoms in type 2 diabetes mellitus. J W, Schlundt D, Kovatchev B, Clarke W.
Motor vehicle crashes in diabetic patients Appl Res 2003;3:449–458 Blood glucose awareness training (BGAT-
with tight glycemic control: a population- 33. Sommerfield AJ, Deary IJ, Frier BM. Acute 2): long-term benefits. Diabetes Care
based case control analysis. PLoS Med hyperglycemia alters mood state and im- 2001;24:637–642
2009;6:e1000192 pairs cognitive performance in people 45. Broers S, le Cessie S, van Vliet KP,
21. Cox DJ, Ford D, Gonder-Frederick LG, with type 2 diabetes. Diabetes Care 2004; Spinhoven P, van der Ven NC, Radder JK.
et al. Driving mishaps among individuals 27:2335–2340 Blood glucose awareness training in
with type 1 diabetes: a prospective study. 34. Cox DJ, McCall A, Kovatchev BP, Sarwat Dutch Type 1 diabetes patients. Short-
Diabetes Care 2009;32:2177–2180 S, Ilag LL, Tan MH. Effects of blood glu- term evaluation of individual and group
22. American Diabetes Association. Defining cose rate of changes on perceived mood training. Diabet Med 2002;19:157–161
and reporting hypoglycemia in diabetes: and cognitive symptoms in insulin-treated 46. Cox DJ, Ritterband L, Magee J, Clarke W,
a report from the American Diabetes As- type 2 diabetes. Diabetes Care 2007;30: Gonder-Frederick L. Blood glucose aware-
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23. The DCCT Research Group. Epidemiol- Bauchowitz AU, et al. Cognitive function 47. McLachlan RS, Starreveld E, Lee MA.
ogy of severe hypoglycemia in the diabetes is disrupted by both hypo- and hyper- Impact of mandatory physician reporting
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1991;90:450–459 type 1 diabetes: a field study. Diabetes 2007;48:1500–1505
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WL. Driving decrements in type I diabetes 36. Cox D, Ford D, Ritterband L, Singh H, DA, Thomas PW, Kerr D. Influence of
during moderate hypoglycemia. Diabetes Gonder-Frederick L. Disruptive effects of alcohol on cognitive performance during
1993;42:239–243 hyperglycemia on driving in adults with mild hypoglycaemia: implications for
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P O S I T I O N S T A T E M E N T

Diabetes Management in Correctional


Institutions
AMERICAN DIABETES ASSOCIATION and physical examination by a licensed
health care provider with prescriptive au-
thority in a timely manner. If one is not

A
t any given time, over 2 million peo- with diabetes is also likely to reduce available on site, one should be consulted
ple are incarcerated in prisons and short-term risks for acute complications re- by those performing reception screening.
jails in the U.S (1). It is estimated quiring transfer out of the facility, thus im- The purposes of this history and physical
that nearly 80,000 of these inmates have proving security. examination are to determine the type of
diabetes, a prevalence of 4.8% (2). In ad- This document provides a general set diabetes, current therapy, alcohol use, and
dition, many more people pass through of guidelines for diabetes care in correc- behavioral health issues, as well as to screen
the corrections system in a given year. In tional institutions. It is not designed to be a for the presence of diabetes-related com-
1998 alone, over 11 million people were diabetes management manual. More de- plications. The evaluation should review
released from prison to the community tailed information on the management of the previous treatment and the past history
(1). The current estimated prevalence of diabetes and related disorders can be found of both glycemic control and diabetes
diabetes in correctional institutions is in the American Diabetes Association complications. It is essential that medica-
somewhat lower than the overall U.S. prev- (ADA) Clinical Practice Recommendations, tion and medical nutrition therapy (MNT)
alence of diabetes, perhaps because the in- published each year in January as the first be continued without interruption upon
carcerated population is younger than the supplement to Diabetes Care, as well as the entry into the correctional system, as a
general population. The prevalence of di- “Standards of Medical Care in Diabetes” (4) hiatus in either medication or appropriate
abetes and its related comorbidities and contained therein. This discussion will fo- nutrition may lead to either severe hypo- or
complications, however, will continue to cus on those areas where the care of people hyperglycemia that can rapidly progress to
increase in the prison population as current with diabetes in correctional facilities may irreversible complications, even death.
sentencing guidelines continue to increase differ, and specific recommendations are
the number of aging prisoners and the in- made at the end of each section.
Intake physical examination and
cidence of diabetes in young people con-
laboratory
tinues to increase. INTAKE MEDICAL
All potential elements of the initial med-
People with diabetes in correctional ASSESSMENT
ical evaluation are included in Table 7 of
facilities should receive care that meets
the ADA’s “Standards of Medical Care in
national standards. Correctional institu- Reception screening
Diabetes,” referred to hereafter as the
tions have unique circumstances that Reception screening should emphasize
“Standards of Care” (4). The essential
need to be considered so that all standards patient safety. In particular, rapid identi-
components of the initial history and
of care may be achieved (3). Correctional fication of all insulin-treated persons with
physical examination are detailed in Fig.
institutions should have written policies diabetes is essential in order to identify
1. Referrals should be made immediately
and procedures for the management of those at highest risk for hypo- and hyper-
if the patient with diabetes is pregnant.
diabetes and for training of medical and glycemia and diabetic ketoacidosis
correctional staff in diabetes care practices. (DKA). All insulin-treated patients should Recommendations
These policies must take into consideration have a capillary blood glucose (CBG) c Patients with a diagnosis of diabetes
issues such as security needs, transfer from determination within 1–2 h of arrival. should have a complete medical history
one facility to another, and access to med- Signs and symptoms of hypo- or hyper- and undergo an intake physical exam-
ical personnel and equipment, so that all glycemia can often be confused with in- ination by a licensed health pro-
appropriate levels of care are provided. Ide- toxication or withdrawal from drugs or fessional in a timely manner. (E)
ally, these policies should encourage or at alcohol. Individuals with diabetes exhib- c Insulin-treated patients should have a
least allow patients to self-manage their di- iting signs and symptoms consistent with CBG determination within 1–2 h of
abetes. Ultimately, diabetes management is hypoglycemia, particularly altered mental arrival. (E)
dependent upon having access to needed status, agitation, combativeness, and dia- c Medications and MNT should be con-
medical personnel and equipment. Ongo- phoresis, should have finger-stick blood tinued without interruption upon entry
ing diabetes therapy is important in order glucose levels measured immediately. into the correctional environment. (E)
to reduce the risk of later complications,
including cardiovascular events, visual Intake screening
loss, renal failure, and amputation. Early Patients with a diagnosis of diabetes SCREENING FOR DIABETESd
identification and intervention for people should have a complete medical history Consistent with the ADA Standards of
Care, patients should be evaluated for
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
diabetes risk factors at the intake physical
Originally approved 1989. Most recent revision, 2008. and at appropriate times thereafter. Those
DOI: 10.2337/dc13-S086
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly who are at high risk should be considered
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ for blood glucose screening. If pregnant, a
licenses/by-nc-nd/3.0/ for details. risk assessment for gestational diabetes

S86 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

Figure 1dEssential components of the initial history and physical examination. Alb/Cr ratio, albumin-to-creatinine ratio; ALT, alanine amino-
transferase; AST, aspartate aminotransferase.

mellitus (GDM) should be undertaken at and communicated to all persons in- tentially provides an opportunity for di-
the first prenatal visit. Patients with clin- volved in his/her care, including security abetes self-management education to be
ical characteristics consistent with a high staff. Table 1, taken from the ADA Stand- reinforced by fellow patients.
risk for GDM should undergo glucose ards of Care, provides a summary of rec-
testing as soon as possible. High-risk ommendations for setting glycemic NUTRITION AND FOOD
women not found to have GDM at the control goals for adults with diabetes. SERVICESdNutrition counseling and
initial screening and average-risk women People with diabetes should ideally menu planning are an integral part of the
should be tested between 24 and 28 receive medical care from a physician- multidisciplinary approach to diabetes
weeks of gestation. For more detailed coordinated team. Such teams include, management in correctional facilities. A
information on screening for both type 2 but are not limited to, physicians, nurses, combination of education, interdisciplin-
and gestational diabetes, see the ADA dietitians, and mental health professio- ary communication, and monitoring food
Position Statement “Screening for Type nals with expertise and a special interest intake aids patients in understanding
2 Diabetes” (5) and the Standards of in diabetes. It is essential in this collabo- their medical nutritional needs and can
Care (4). rative and integrated team approach that facilitate diabetes control during and after
individuals with diabetes assume as incarceration.
MANAGEMENT PLANdGlycemic active a role in their care as possible. Nutrition counseling for patients
control is fundamental to the manage- Diabetes self-management education is an with diabetes is considered an essential
ment of diabetes. A management plan to integral component of care. Patient self- component of diabetes self-management.
achieve normal or near-normal glycemia management should be emphasized, and People with diabetes should receive indi-
with an A1C goal of ,7% should be de- the plan should encourage the involve- vidualized MNT as needed to achieve
veloped for diabetes management at the ment of the patient in problem solving as treatment goals, preferably provided by a
time of initial medical evaluation. Goals much as possible. registered dietitian familiar with the com-
should be individualized (4), and less strin- It is helpful to house insulin-treated ponents of MNT for persons with diabetes.
gent treatment goals may be appropriate for patients in a common unit, if this is Educating the patient, individually or
patients with a history of severe hypoglyce- possible, safe, and consistent with pro- in a group setting, about how carbohy-
mia, patients with limited life expectancies, viding access to other programs at the drates and food choices directly affect
elderly adults, and individuals with co- correctional institution. Common hous- diabetes control is the first step in facili-
morbid conditions (4). This plan should ing not only can facilitate mealtimes and tating self-management. This education
be documented in the patient’s record medication administration, but also po- enables the patient to identify better food

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S87


Position Statement

Table 1dSummary of recommendations for ate medical care to minimize risk of future treatment. Patients must have immediate
glycemic, blood pressure, and lipid control decompensation. access to glucose tablets or other glucose-
for most adults with diabetes Institutions should implement a pol- containing foods. Hypoglycemia can gen-
A1C ,7.0%*
icy requiring staff to notify a physician of erally be treated by the patient with oral
all CBG results outside of a specified carbohydrates. If the patient cannot be
Blood pressure ,140/80 mmHg† range, as determined by the treating relied on to keep hypoglycemia treatment
Lipids ,100 mg/dL physician (e.g., ,50 or .350 mg/dL). on his/her person, staff members should
LDL cholesterol (,2.6 mmol/L)‡ have ready access to glucose tablets or
*More or less stringent glycemic goals may be ap- Hyperglycemia equivalent. In general, 15–20 g oral glu-
propriate for individual patients. Goals should be Severe hyperglycemia in a person with cose will be adequate to treat hypoglyce-
individualized based on duration of diabetes, age/life
expectancy, comorbid conditions, known CVD or diabetes may be the result of intercurrent mic events. CBG and treatment should be
advanced microvascular complications, hypoglycemia illness, missed or inadequate medication, repeated at 15-min intervals until blood
unawareness, individual and patient considerations. or corticosteroid therapy. Correctional glucose levels return to normal (.70 mg/
†Based on patient characteristics and response to institutions should have systems in place dL).
therapy, lower SBP targets may be appropriate. ‡In
individuals with overt CVD, a lower LDL cholesterol
to identify and refer to medical staff all Staff should have glucagon for intra-
goal of ,70 mg/dL (1.8 mmol/L), using a high dose patients with consistently elevated blood muscular injection or glucose for intra-
of a statin, is an option. glucose as well as intercurrent illness. venous infusion available to treat severe
The stress of illness in those with type hypoglycemia without requiring trans-
1 diabetes frequently aggravates glycemic port of the hypoglycemic patient to an
selections from those available in the control and necessitates more frequent outside facility. Any episode of severe
dining hall and commissary. Such an monitoring of blood glucose (e.g., every hypoglycemia or recurrent episodes of
approach is more realistic in a facility 4–6 h). Marked hyperglycemia requires mild to moderate hypoglycemia require
where the patient has the opportunity to temporary adjustment of the treatment reevaluation of the diabetes management
make food choices. program and, if accompanied by ketosis, plan by the medical staff. In certain cases
The easiest and most cost-effective interaction with the diabetes care team. of unexplained or recurrent severe hypo-
means to facilitate good outcomes in pa- Adequate fluid and caloric intake must glycemia, it may be appropriate to admit
tients with diabetes is instituting a heart- be ensured. Nausea or vomiting accom- the patient to the medical unit for obser-
healthy diet as the master menu (6). There panied with hyperglycemia may indicate vation and stabilization of diabetes man-
should be consistent carbohydrate content DKA, a life-threatening condition that re- agement.
at each meal, as well as a means to identify quires immediate medical care to prevent Correctional institutions should have
the carbohydrate content of each food se- complications and death. Correctional in- systems in place to identify the patients at
lection. Providing carbohydrate content of stitutions should identify patients with greater risk for hypoglycemia (i.e., those
food selections and/or providing education type 1 diabetes who are at risk for DKA, on insulin or sulfonylurea therapy) and to
in assessing carbohydrate content enables particularly those with a prior history of ensure the early detection and treatment
patients to meet the requirements of their frequent episodes of DKA. For further in- of hypoglycemia. If possible, patients at
individual MNT goals. Commissaries formation see “Hyperglycemic Crisis in greater risk of severe hypoglycemia (e.g.,
should also help in dietary management Diabetes” (8). those with a prior episode of severe
by offering healthy choices and listing the hypoglycemia) may be housed in units
carbohydrate content of foods. Hypoglycemia closer to the medical unit in order to
The use of insulin or oral medications Hypoglycemia is defined as a blood glu- minimize delay in treatment.
may necessitate snacks in order to avoid cose level ,70 mg/dL. Severe hypoglyce-
hypoglycemia. These snacks are a part of mia is a medical emergency defined as Recommendations
such patients’ medical treatment plans hypoglycemia requiring assistance of a c Train correctional staff in the recogni-
and should be prescribed by medical staff. third party and is often associated with tion, treatment, and appropriate re-
Timing of meals and snacks must be mental status changes that may include ferral for hypo- and hyperglycemia. (E)
coordinated with medication administra- confusion, incoherence, combativeness, c Train appropriate staff to administer
tion as needed to minimize the risk of somnolence, lethargy, seizures, or coma. glucagon. (E)
hypoglycemia, as discussed more fully in Signs and symptoms of severe hypogly- c Train staff to recognize symptoms and
the MEDICATION section of this document. cemia can be confused with intoxication signs of serious metabolic decompensa-
For further information, see the ADA Posi- or withdrawal. Individuals with diabetes tion, and immediately refer the patient
tion Statement “Nutrition Recommenda- exhibiting signs and symptoms consistent for appropriate medical care. (E)
tions and Interventions for Diabetes” (7). with hypoglycemia, particularly altered c Institutions should implement a policy
mental status, agitation, and diaphoresis, requiring staff to notify a physician of
URGENT AND EMERGENCY should have their CBG levels checked all CBG results outside of a specified
ISSUESdAll patients must have access immediately. range, as determined by the treating
to prompt treatment of hypo- and hyper- Security staff who supervise patients physician (e.g., ,50 or .350 mg/dL).
glycemia. Correctional staff should be at risk for hypoglycemia (i.e., those on (E)
trained in the recognition and treatment insulin or oral hypoglycemic agents) c Identify patients with type 1 diabetes
of hypo- and hyperglycemia, and appro- should be educated in the emergency re- who are at high risk for DKA. (E)
priate staff should be trained to adminis- sponse protocol for recognition and treat-
ter glucagon. After such emergency care, ment of hypoglycemia. Every attempt MEDICATIONdFormularies should
patients should be referred for appropri- should be made to document CBG before provide access to usual and customary

S88 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

oral medications and insulins necessary to management with the goal of achieving c Foot care: Recommendations for foot
treat diabetes and related conditions. near-normal levels of blood glucose (9). care for patients with diabetes and no
While not every brand name of insulin While the use of these modalities may be history of an open foot lesion are de-
and oral medication needs to be available, difficult in correctional institutions, every scribed in the ADA Standards of Care.
individual patient care requires access to effort should be made to continue multi- A comprehensive foot examination is
short-, medium-, and long-acting insulins ple daily insulin injection or continuous recommended annually for all patients
and the various classes of oral medica- subcutaneous insulin infusion in people with diabetes to identify risk factors
tions (e.g., insulin secretagogues, bigua- who were using this therapy before incar- predictive of ulcers and amputations.
nides, a-glucosidase inhibitors, and ceration or to institute these therapies as Persons with an insensate foot, an open
thiazolidinediones) necessary for current indicated in order to achieve blood glu- foot lesion, or a history of such a lesion
diabetes management. cose targets. should be referred for evaluation by an
Patients at all levels of custody should It is essential that transport of patients appropriate licensed health professional
have access to medication at dosing fre- from jails or prisons to off-site appoint- (e.g., podiatrist or vascular surgeon).
quencies that are consistent with their ments, such as medical visits or court Special shoes should be provided as
treatment plan and medical direction. If appearances, does not cause significant recommended by licensed health pro-
feasible and consistent with security con- disruption in medication or meal timing. fessionals to aid healing of foot lesions and
cerns, patients on multiple doses of short- Correctional institutions and police lock- to prevent development of new lesions.
acting oral medications should be placed ups should implement policies and pro- c Retinopathy: Annual retinal examina-
in a “keep on person” program. In other cedures to diminish the risk of hypo- and tions by a licensed eye care professional
situations, patients should be permitted hyperglycemia by, for example, providing should be performed for all patients
to self-inject insulin when consistent carry-along meals and medication for with diabetes, as recommended in the
with security needs. Medical department patients traveling to off-site appointments ADA Standards of Care. Visual changes
nurses should determine whether patients or changing the insulin regimen for that that cannot be accounted for by acute
have the necessary skill and responsible be- day. The availability of prefilled insulin changes in glycemic control require
havior to be allowed self-administration “pens” provides an alternative for off-site prompt evaluation by an eye care pro-
and the degree of supervision necessary. insulin delivery. fessional.
When needed, this skill should be a part c Nephropathy: An annual spot urine
of patient education. Reasonable syringe test for determination of microalbumin-
control systems should be established. Recommendations to-creatinine ratio should be performed.
In the past, the recommendation that c Formularies should provide access to The use of ACE inhibitors or angiotensin
regular insulin be injected 30–45 min be- usual and customary oral medications receptor blockers is recommended for
fore meals presented a significant prob- and insulins to treat diabetes and re- all patients with albuminuria. Blood
lem when “lock downs” or other lated conditions. (E) pressure should be controlled to ,140/
disruptions to the normal schedule of c Patients should have access to medi- 80 mmHg.
meals and medications occurred. The cation at dosing frequencies that are c Cardiac: People with type 2 diabetes
use of multiple-dose insulin regimens us- consistent with their treatment plan are at a particularly high risk of coro-
ing rapid-acting analogs can decrease the and medical direction. (E) nary artery disease. Cardiovascular
disruption caused by such changes in c Correctional institutions and police disease (CVD) risk factor management
schedule. Correctional institutions lock-ups should implement policies is of demonstrated benefit in reducing
should have systems in place to ensure and procedures to diminish the risk of this complication in patients with di-
that rapid-acting insulin analogs and hypo- and hyperglycemia during off- abetes. Blood pressure should be mea-
oral agents are given immediately before site travel (e.g., court appearances). (E) sured at every routine diabetes visit. In
meals if this is part of the patient’s medical adult patients, test for lipid disorders at
plan. It should be noted however that least annually and as needed to achieve
even modest delays in meal consumption ROUTINE SCREENING FOR AND goals with treatment. Use aspirin ther-
with these agents can be associated with MANAGEMENT OF DIABETES apy (75–162 mg/day) in all adult pa-
hypoglycemia. If consistent access to food COMPLICATIONSdAll patients tients with diabetes and cardiovascular
within 10 min cannot be ensured, rapid- with a diagnosis of diabetes should re- risk factors or known macrovascular
acting insulin analogs and oral agents are ceive routine screening for diabetes-related disease. Current national standards for
approved for administration during or complications, as detailed in the ADA adults with diabetes call for treatment
immediately after meals. Should circum- Standards of Care (4). Interval chronic of lipids to goals of LDL #100, HDL
stances arise that delay patient access to disease clinics for persons with diabetes .40, triglycerides ,150 mg/dL, and
regular meals following medication ad- provide an efficient mechanism to monitor blood pressure to a level of ,140/80
ministration, policies and procedures patients for complications of diabetes. In mmHg.
must be implemented to ensure the pa- this way, appropriate referrals to consul-
tient receives appropriate nutrition to tant specialists, such as optometrists/ MONITORING/TESTS OF
prevent hypoglycemia. ophthalmologists, nephrologists, and GLYCEMIAdMonitoring of CBG is a
Both continuous subcutaneous insu- cardiologists, can be made on an as-needed strategy that allows caregivers and people
lin infusion and multiple daily insulin basis and interval laboratory testing can with diabetes to evaluate diabetes man-
injection therapy (consisting of three or be done. agement regimens. The frequency of
more injections a day) can be effective The following complications should monitoring will vary by patients’ glycemic
means of implementing intensive diabetes be considered: control and diabetes regimens. Patients

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S89


Position Statement

with type 1 diabetes are at risk for hypo- c A1C should be checked every 3–6 c risk factors
glycemia and should have their CBG months. (E) c signs and symptoms of, and emergency
monitored three or more times daily. Pa- response to, hypo- and hyperglycemia
tients with type 2 diabetes on insulin need c glucose monitoring
to monitor at least once daily and more SELF-MANAGEMENT c medications
frequently based on their medical plan. EDUCATIONdSelf-management ed- c exercise
Patients treated with oral agents should ucation is the cornerstone of treatment c nutrition issues including timing of
have CBG monitored with sufficient fre- for all people with diabetes. The health meals and access to snacks
quency to facilitate the goals of glycemic staff must advocate for patients to partic-
control, assuming that there is a program ipate in self-management as much as Recommendations
for medical review of these data on an possible. Individuals with diabetes who c Include diabetes in correctional staff
ongoing basis to drive changes in medica- learn self-management skills and make education programs. (E)
tions. Patients whose diabetes is poorly lifestyle changes can more effectively
controlled or whose therapy is changing manage their diabetes and avoid or delay ALCOHOL AND DRUGSdPatients
should have more frequent monitoring. complications associated with diabetes. with diabetes who are withdrawing from
Unexplained hyperglycemia in a patient In the development of a diabetes self- drugs and alcohol need special consider-
with type 1 diabetes may suggest impend- management education program in the ation. This issue particularly affects initial
ing DKA, and monitoring of ketones correctional environment, the unique cir- police custody and jails. At an intake
should therefore be performed. cumstances of the patient should be facility, proper initial identification and
Glycated hemoglobin (A1C) is a mea- considered while still providing, to the assessment of these patients are critical.
sure of long-term (2- to 3-month) glyce- greatest extent possible, the elements The presence of diabetes may complicate
mic control. Perform the A1C test at least of the “National Standards for Diabetes detoxification. Patients in need of com-
two times a year in patients who are Self-Management Education and Sup- plicated detoxification should be referred
meeting treatment goals (and who have port” (11). A staged approach may be to a facility equipped to deal with high-
stable glycemic control) and quarterly in used depending on the needs assess- risk detoxification. Patients with diabetes
patients whose therapy has changed or ment and the length of incarceration. should be educated in the risks involved
who are not meeting glycemic goals. Table 2 sets out the major components with smoking. All inmates should be
Discrepancies between CBG monitor- of diabetes self-management education. advised not to smoke. Assistance in
ing results and A1C may indicate a he- Survival skills should be addressed as smoking cessation should be provided
moglobinopathy, hemolysis, or need for soon as possible; other aspects of edu- as practical.
evaluation of CBG monitoring technique cation may be provided as part of an on-
and equipment or initiation of more going education program.
frequent CBG monitoring to identify Ideally, self-management education TRANSFER AND
when glycemic excursions are occurring is coordinated by a certified diabetes DISCHARGEdPatients in jails may be
and which facet of the diabetes regimen is educator who works with the facility to housed for a short period of time before
changing. develop polices, procedures, and proto- being transferred or released, and it is not
In the correctional setting, policies cols to ensure that nationally recognized unusual for patients in prison to be trans-
and procedures need to be developed and education guidelines are implemented. ferred within the system several times
implemented regarding CBG monitoring The educator is also able to identify during their incarceration. One of the many
that address the following: patients who need diabetes self-manage- challenges that health care providers face
ment education, including an assessment working in the correctional system is how
c infection control of the patients’ medical, social, and di- to best collect and communicate important
c education of staff and patients abetes histories; diabetes knowledge, health care information in a timely manner
c proper choice of meter skills, and behaviors; and readiness to when a patient is in initial police custody, is
c disposal of testing lancets change. jailed short term, or is transferred from
c quality control programs facility to facility. The importance of this
c access to health services communication becomes critical when the
c size of the blood sample STAFF EDUCATIONdPolicies and patient has a chronic illness such as di-
c patient performance skills procedures should be implemented to abetes.
c documentation and interpretation of ensure that the health care staff has Transferring a patient with diabetes
test results adequate knowledge and skills to direct from one correctional facility to another
c availability of test results for the health the management and education of per- requires a coordinated effort. To
care provider (10) sons with diabetes. The health care staff facilitate a thorough review of medical
needs to be involved in the development information and completion of a trans-
of the correctional officers’ training pro- fer summary, it is critical for custody
Recommendations gram. The staff education program personnel to provide medical staff with
c In the correctional setting, policies and should be at a lay level. Training should sufficient notice before movement of the
procedures need to be developed and be offered at least biannually, and the patient.
implemented to enable CBG monitoring curriculum should cover the following: Before the transfer, the health care
to occur at the frequency necessitated by staff should review the patient’s medical
the individual patient’s glycemic control c what diabetes is record and complete a medical transfer
and diabetes regimen. (E) c signs and symptoms of diabetes summary that includes the patient’s

S90 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

Table 2dMajor components of diabetes self-management education care and facilitate entry into commu-
Survival skills Daily management issues
nity diabetes care. (E)
c hypo-/hyperglycemia c disease process
c sick day management c nutritional management SHARING OF MEDICAL
c medication c physical activity INFORMATION AND
RECORDSdPractical considerations
c monitoring c medications
may prohibit obtaining medical records
c foot care c monitoring
from providers who treated the patient
c acute complications before arrest. Intake facilities should im-
c risk reduction plement policies that 1) define the cir-
c goal setting/problem solving cumstances under which prior medical
c psychosocial adjustment records are obtained (e.g., for patients
c preconception care/pregnancy/gestational who have an extensive history of treat-
diabetes management ment for complications); 2) identify per-
son(s) responsible for contacting the prior
provider; and 3) establish procedures for
current health care issues. At a mini- care provider upon arrival at the receiving tracking requests.
mum, the summary should include the institution. Facilities that use outside medical
following: Planning for patients’ discharge from providers should implement policies
prisons should include instruction in the and procedures for ensuring that key
c the patient’s current medication long-term complications of diabetes, the information (e.g., test results, diagnoses,
schedule and dosages necessary lifestyle changes and examina- physicians’ orders, appointment dates) is
c the date and time of the last medication tions required to prevent these complica- received from the provider and incorpo-
administration tions, and, if possible, where patients may rated into the patient’s medical chart after
c any recent monitoring results (e.g., obtain regular follow-up medical care. A each outside appointment. The proce-
CBG and A1C) quarterly meeting to educate patients dure should include, at a minimum, a
c other factors that indicate a need for with upcoming discharges about commu- means to highlight when key information
immediate treatment or management at nity resources can be valuable. Inviting has not been received and designation of a
the receiving facility (e.g., recent epi- community agencies to speak at these person responsible for contacting the
sodes of hypoglycemia, history of se- meetings and/or provide written materials outside provider for this information.
vere hypoglycemia or frequent DKA, can help strengthen the community link All medical charts should contain
concurrent illnesses, presence of di- for patients discharging from correctional CBG test results in a specified, readily
abetes complications) facilities. accessible section and should be reviewed
c information on scheduled treatment/ Discharge planning for the patients on a regular basis.
appointments if the receiving facility is with diabetes should begin 1 month
responsible for transporting the patient before discharge. During this time, ap- CHILDREN AND ADOLESCENTS
to that appointment plication for appropriate entitlements WITH DIABETESdChildren and
c name and telephone/fax number of a should be initiated. Any gaps in the adolescents with diabetes present special
contact person at the transferring fa- patient’s knowledge of diabetes care problems in disease management, even
cility who can provide additional in- need to be identified and addressed. It outside the setting of a correctional in-
formation, if needed is helpful if the patient is given a di- stitution. Children and adolescents with
rectory or list of community resources diabetes should have initial and follow-up
The medical transfer summary, which and if an appointment for follow-up care care with physicians who are experienced
acts as a quick medical reference for the with a community provider is made. A in their care. Confinement increases the
receiving facility, should be transferred supply of medication adequate to last difficulty in managing diabetes in chil-
along with the patient. To supplement the until the first postrelease medical ap- dren and adolescents, as it does in adults
flow of information and to increase the pointment should be provided to the with diabetes. Correctional authorities
probability that medications are correctly patient upon release. The patient should also have different legal obligations for
identified at the receiving institution, be provided with a written summary of children and adolescents.
sending institutions are encouraged to his/her current health care issues, in-
provide each patient with a medication cluding medications and doses, recent Nutrition and activity
card to be carried by the patient that A1C values, etc. Growing children and adolescents have
contains information concerning diagno- greater caloric/nutritional needs than
ses, medication names, dosages, and fre- Recommendations adults. The provision of an adequate
quency. Diabetes supplies, including c For all interinstitutional transfers, amount of calories and nutrients for
diabetes medication, should accompany complete a medical transfer summary adolescents is critical to maintaining
the patient. to be transferred with the patient. (E) good nutritional status. Physical activity
The sending facility must be mindful c Diabetes supplies and medication should be provided at the same time each
of the transfer time in order to provide the should accompany the patient during day. If increased physical activity occurs,
patient with medication and food if transfer. (E) additional CBG monitoring is necessary
needed. The transfer summary or medical c Begin discharge planning with ade- and additional carbohydrate snacks may
record should be reviewed by a health quate lead time to insure continuity of be required.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S91


Position Statement

Medical management and follow-up with the prison staff. It is critical for 6. Krauss RM, Eckel RH, Howard B, Appel
Children and adolescents who are incar- correctional institutions to identify par- LJ, Daniels SR, Deckelbaum RJ, Erdman
cerated for extended periods should have ticularly high-risk patients in need of JW Jr, Kris-Etherton P, Goldberg IJ,
follow-up visits at least every 3 months more intensive evaluation and therapy, Kotchen TA, Lichtenstein AH, Mitch WE,
Mullis R, Robinson K, Wylie-Rosett J, St
with individuals who are experienced in including pregnant women, patients with
Jeor S, Suttie J, Tribble DL, Bazzarre TL:
the care of children and adolescents with advanced complications, a history of re- American Heart Association Dietary
diabetes. Thyroid function tests and fast- peated severe hypoglycemia, or recurrent Guidelines: revision 2000: a statement
ing lipid and microalbumin measure- DKA. for healthcare professionals from the
ments should be performed according to A comprehensive, multidisciplinary Nutrition Committee of the American
recognized standards for children and approach to the care of people with di- Heart Association. Stroke 31:2751–2766,
adolescents (12) in order to monitor for abetes can be an effective mechanism to 2000
autoimmune thyroid disease and compli- improve overall health and delay or pre- 7. American Diabetes Association: Nutrition
cations and comorbidities of diabetes. vent the acute and chronic complications recommendations and interventions for
Children and adolescents with diabe- of this disease. diabetes (Position Statement). Diabetes
Care 31 (Suppl. 1):S61–S78, 2008
tes exhibiting unusual behavior should
8. American Diabetes Association: Hyper-
have their CBG checked at that time. glycemic crisis in diabetes (Position
Because children and adolescents are AcknowledgmentsdThe following members Statement). Diabetes Care 27 (Suppl. 1):
reported to have higher rates of nocturnal of the American Diabetes Association/National S94–S102, 2004
hypoglycemia (13), consideration should Commission on Correctional Health Care 9. American Diabetes Association: Continu-
be given regarding the use of episodic Joint Working Group on Diabetes Guidelines ous subcutaneous insulin infusion (Posi-
overnight blood glucose monitoring in for Correctional Institutions contributed to tion Statement). Diabetes Care 27 (Suppl.
these patients. In particular, this should the revision of this document: Daniel L. 1):S110, 2004
be considered in children and adolescents Lorber, MD, FACP, CDE (chair); R. Scott 10. American Diabetes Association: Tests of
Chavez, MPA, PA-C; Joanne Dorman, RN, glycemia in diabetes (Position Statement).
who have recently had their overnight in-
CDE, CCHP-A; Lynda K. Fisher, MD; Diabetes Care 27 (Suppl. 1):S91–S93,
sulin dose changed. Stephanie Guerken, RD, CDE; Linda B. Haas, 2004
CDE, RN; Joan V. Hill, CDE, RD; David Ken- 11. Haas L, Maryniuk M, Beck J, Cox CE,
PREGNANCYdPregnancy in a dall, MD; Michael Puisis, DO; Kathy Salo- Duker P, Edwards L, Fisher EB, Hanson L,
woman with diabetes is by definition a mone, CDE, MSW, APRN; Ronald M. Kent D, Kolb L, McLaughlin S, Orzeck E,
high-risk pregnancy. Every effort should Shansky, MD, MPH; and Barbara Wakeen, Piette JD, Rhinehart AS, Rothman R,
be made to ensure that treatment of the RD, LD. Sklaroff S, Tomky D, Youssef G, on be-
pregnant woman with diabetes meets half of the 2012 Standards Revision Task
accepted standards (14,15). It should be Force: National standards for diabetes
noted that glycemic standards are more References self-management education and support.
stringent, the details of dietary manage- 1. National Commission on Correctional Diabetes Care 36 (Suppl. 1):S100–S108, 2013
ment are more complex and exacting, in- Health Care: The Health Status of Soon-to- 12. International Society for Pediatric and
Be Released Inmates: A Report to Congress. Adolescent Diabetes: Consensus Guidelines
sulin is the only antidiabetic agent 2000: ISPAD Consensus Guidelines for the
Vol. 1. Chicago, NCCHC, 2002
approved for use in pregnancy, and a 2. Hornung CA, Greifinger RB, Gadre S: A Management of Type 1 Diabetes Mellitus in
number of medications used in the man- Projection Model of the Prevalence of Se- Children and Adolescents. Zeist, Nether-
agement of diabetic comorbidities are lected Chronic Diseases in the Inmate Pop- lands, Medical Forum International, 2000,
known to be teratogenic and must be dis- ulation. Vol. 2. Chicago, NCCHC, 2002, p. 116, 118
continued in the setting of pregnancy. p. 39–56 13. Kaufman FR, Austin J, Neinstein A, Jeng L,
3. Puisis M: Challenges of improving quality Halyorson M, Devoe DJ, Pitukcheewanont
SUMMARY AND KEY in the correctional setting. In Clinical P: Nocturnal hypoglycemia detected with
POINTSdPeople with diabetes should Practice in Correctional Medicine. St. Louis, the continuous glucose monitoring system
receive care that meets national stand- MO, Mosby-Yearbook, 1998, p. 16–18 in pediatric patients with type 1 diabetes.
4. American Diabetes Association: Standards J Pediatr 141:625–630, 2002
ards. Being incarcerated does not change 14. American Diabetes Association: Gestational
of medical care in diabetesd2013 (Posi-
these standards. Patients must have access tion Statement). Diabetes Care 36 (Suppl. 1): diabetes mellitus (Position Statement). Di-
to medication and nutrition needed to S11–S66, 2013 abetes Care 27 (Suppl. 1):S88–S90, 2004
manage their disease. In patients who do 5. American Diabetes Association: Screening 15. Jovanovic L (Ed.): Medical Management of
not meet treatment targets, medical and for type 2 diabetes (Position Statement). Pregnancy Complicated by Diabetes. 4th ed.
behavioral plans should be adjusted by Diabetes Care 27 (Suppl. 1):S11–S14, Alexandria, VA, American Diabetes Asso-
health care professionals in collaboration 2004 ciation, 2009

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P O S I T I O N S T A T E M E N T

Diabetes and Employment


AMERICAN DIABETES ASSOCIATION

A
s of 2010, nearly 26 million Amer- medications used to the tools used to individualized assessment of the candi-
icans have diabetes (1), most of administer them and to monitor blood date or employee with diabetes.
whom are or wish to be participat- glucose levels.
ing members of the workforce. Diabetes Employment decisions should not
usually has no impact on an individual’s be based on generalizations or stereo- Role of diabetes health care
ability to do a particular job, and indeed types regarding the effects of diabetes. professionals
an employer may not even know that a The impact of diabetes and its manage- When questions arise about the medical
given employee has diabetes. In 1984, ment varies widely among individuals. fitness of a person with diabetes for a
the American Diabetes Association Therefore, a proper assessment of in- particular job, a health care professional
adopted the following position on em- dividual candidates for employment or with expertise in treating diabetes should
ployment: current employees must take this vari- perform an individualized assessment.
ability into account. The involvement of the diabetes health
Any person with diabetes, whether insulin In addition, federal and state laws care professional should occur before any
[treated] or non–insulin [treated], should be require employers to make decisions adverse employment decision, such as
eligible for any employment for which he/she
is otherwise qualified. that are based on assessment of the failure to hire or promote or termination.
circumstances and capabilities of the A health professional who is familiar with
individual with diabetes for the particu- the person with diabetes and who has
Questions are sometimes raised by em-
lar job in question (2,3). Application of expertise in treating diabetes is best able
ployers about the safety and effectiveness
blanket policies to individuals with di- to perform such an assessment. In some
of individuals with diabetes in a given job.
abetes results in people with diabetes be- situations and in complex cases, an
When such questions are legitimately
ing denied employment for which they endocrinologist or a physician who spe-
raised, a person with diabetes should
are well qualified and fully capable of cializes in treating diabetes or its compli-
be individually assessed to determine
performing effectively and safely. It cations is the best qualified health
whether or not that person can safely
should be noted that, as a result of professional to assume this responsibility
and effectively perform the particular (4). The individual’s treating physician is
duties of the job in question. This docu- amendments to the Americans with Dis-
abilities Act, which became effective on generally the health care professional
ment provides a general set of guidelines
1 January 2009, all persons with diabe- with the best knowledge of an individ-
for evaluating individuals with diabetes
for employment, including how an as- tes are considered to have a “disability” ual’s diabetes. Thus, even when the em-
within the meaning of that law. This is ployer utilizes its own physician to
sessment should be performed and what
because, among other reasons, diabetes perform the evaluation, the opinions of
changes (accommodations) in the work-
constitutes a substantial limitation on the treating physician and other health
place may be needed for an individual
endocrine system functioningdthe Act care professionals with clinical expertise
with diabetes.
was amended to extend its coverage to in diabetes should be sought out and
persons with a substantial limitation in, carefully considered. In situations where
I. EVALUATING among other things, a major bodily there is disagreement between the opin-
INDIVIDUALS WITH function, such as the endocrine system. ion of the employee’s treating physician
DIABETES FOR Therefore, persons with diabetes are and that of the employer’s physician, the
EMPLOYMENTdIt was once com- protected from discrimination in em- evaluation should be handed over to an
mon practice to restrict individuals with ployment and other areas. The amend- independent health care professional
diabetes from certain jobs or classes of ments overturned a series of Supreme with significant clinical expertise in
employment solely because of the diag- Court decisions that had severely nar- diabetes.
nosis of diabetes or the use of insulin, rowed who was covered by the law and
without regard to an individual’s abilities resulted in many people with diabetes
or circumstances. Such “blanket bans” and other chronic illnesses being denied Individual assessment
are medically inappropriate and ignore protection from discrimination. This A medical evaluation of an individual
the many advancements in diabetes man- section provides an overview of the fac- with diabetes may occur only in limited
agement that range from the types of tors relevant to a medically appropriate circumstances (3). Employers may not in-
quire about an individual’s health statusd
directly or indirectly and regardless of
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
the type of jobdbefore making a job of-
Revised Fall 2009. fer, but may require a medical examina-
DOI: 10.2337/dc13-S093
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly tion or make a medical inquiry once an
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ offer of employment has been extended
licenses/by-nc-nd/3.0/ for details. and before the individual begins the job.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S93


Position Statement

The job offer may be conditioned on the to be considered. Only health care profes- medical data and should never be
results of the medical inquiry or examina- sionals tasked with such evaluations made based solely on one piece of
tion. An employer may withdraw an offer should have access to employee medical data. (E)
from an applicant with diabetes only if it information, and this information must be c Screening guidelines and protocols can
becomes clear that he or she cannot do the kept separate from personnel records (3). be useful tools in making decisions
essential functions of the job or would about employment if they are used in
pose a direct threat (i.e., a significant Screening guidelines an objective way and based on the latest
risk of substantial harm) to health or A number of screening guidelines for scientific knowledge about diabetes
safety and such threat could not be elim- evaluating individuals with diabetes in and its management. (E)
inated with an accommodation (a work- various types of high risk jobs have been
place change that enables a worker with a developed in recent years. Examples in- II. EVALUATING THE
disability to safely and effectively perform clude the American College of Occupa- SAFETY RISK OF
job duties). Another situation in which tional and Environmental Medicine’s EMPLOYEES WITH
a medical evaluation is permissible is National Consensus Guideline for the DIABETESdEmployers who deny job
when a problem potentially related to Medical Evaluation of Law Enforcement opportunities because they perceive all
the employee’s diabetes arises on the job Officers, the National Fire Protection people with diabetes to be a safety risk
and such problem could affect job perfor- Association’s Standard on Comprehen- do so based on misconceptions, misin-
mance and/or safety. In this situation, a sive Occupational Medical Program for formation, or a lack of current information
physician may be asked to evaluate the Fire Departments, the U.S. Department about diabetes. The following guidelines
employee’s fitness to remain on the job of Transportation’s Federal Motor Car- provide information for evaluating an in-
and/or his or her ability to safely perform rier Safety Administration’s Diabetes dividual with diabetes who works or seeks
the job. Exemption Program, and the U.S. Marshall to work in what may be considered a safety-
Employers also may obtain medical Service and Federal Occupational Health sensitive position.
information about an employee when the Law Enforcement Program Diabetes
employee has requested an accomoda- Protocol. Safety concerns
tion and his or her disability or need for Such guidelines and protocols can be The first step in evaluating safety con-
accommodation is not obvious. An em- useful tools in making decisions about cerns is to determine whether the con-
ployer should not rely on a medical individual candidates or employees if cerns are reasonable in light of the job
evaluation to deny an employment op- they are used in an objective way and duties the individual must perform. For
portunity to an individual with diabetes based on the latest scientific knowledge most types of employment (such as jobs
unless it is conducted by a health care about diabetes and its management. in an office, retail, or food service envi-
professional with expertise in diabetes and These protocols should be regularly reeval- ronment) there is no reason to believe that
based on sufficient and appropriate med- uated and updated to reflect changes in the individual’s diabetes will put employ-
ical data. The information sought and diabetes knowledge and evidence and ees or the public at risk. In other types of
assessed must be properly limited to data should be developed and reviewed by employment (such as jobs where the
relevant to the individual’s diabetes and health care professionals with significant individual must carry a firearm or oper-
job performance (3). The data needed will experience in diabetes and its treatment. ate dangerous machinery) the safety con-
vary depending on the type of job and the Individuals who do not meet the standards cern is whether the employee will
reason for the evaluation, but an evalu- set forth in such protocols should be given become suddenly disoriented or inca-
ation should never be made based only the opportunity to demonstrate excep- pacitated. Such episodes, which are usu-
on one piece of data, such as a single blood tional circumstances that would justify ally due to severely low blood glucose
glucose result or A1C result. Since diabetes deviating from the guidelines. Such guide- (hypoglycemia), occur only in people
is a chronic disease in which health status lines or protocols are not absolute criteria receiving certain treatments such as in-
and management requirements naturally but rather the framework for a thorough sulin or secretagogues such as sulfonyl-
change over time, it is inappropriated individualized assessment. ureas and even then occur infrequently.
and medically unnecessarydfor exam- Workplace accommodations can be
iners to collect all past laboratory values Recommendations made that are minimal yet effective in
or information regarding office visits c People with diabetes should be in- helping the individual to manage his or
whether or not related to diabetes. dividually considered for employment her diabetes on the job and avoid severe
Only medical information relevant to based on the requirements of the spe- hypoglycemia.
evaluating an individual’s current capac- cific job and the individual’s medical
ity for safe performance of the particular condition, treatment regimen, and Hypoglycemia
job at issue should be collected. For ex- medical history. (E) Hypoglycemia is defined as a blood
ample, in some circumstances a review of c When questions arise about the medical glucose level ,70 mg/dL (4,6). It is a
an individual’s hypoglycemia history may fitness of a person with diabetes for a potential side effect of some diabetes
be relevant to the evaluation and should particular job, a health care professional treatments, including insulin and sul-
be collected. with expertise in treating diabetes fonlyureas. It can usually be effectively
Information about the individual’s should perform an individualized as- self-treated by ingestion of glucose (carbo-
diabetes management (such as the current sessment; input from the treating phy- hydrate) and is not often associated with
treatment regimen, medications, and sician should always be included. (E) loss of consciousness or a seizure. Severe
blood glucose logs), job duties, and c Employment evaluations should be hypoglycemia, requiring the assistance of
work environment are all relevant factors based on sufficient and appropriate another person, is a medical emergency.

S94 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

Symptoms of severe hypoglycemia may complications to the nerves (neuropa- be able to lessen this risk with careful
include confusion or, rarely, seizure or thy), eyes (retinopathy), kidneys (ne- changes to their diabetes management
loss of consciousness (6). Most individu- phropathy), or heart, not all individuals regimen (for example, more frequent
als with diabetes never experience an ep- with diabetes develop these long-term blood glucose testing or frequent meals).
isode of severe hypoglycemia because complications. Such complications be- Presence of diabetes-related complica-
either they are not on medication that come relevant in employment decisions tions. Chronic complications that may
causes it or they recognize the early warn- only when they are established and in- result from long-term diabetes involve the
ing signs and can quickly self-treat the terfere with the performance of the actual blood vessels and nerves. These compli-
problem by drinking or eating. Also, job being considered. Evaluations should cations may involve nerve (neuropathy),
with self-monitoring of blood glucose not be based on speculation as to what eye (retinopathy), kidney (nephropathy),
levels, most people with diabetes can might occur in the future. Job evaluations and heart disease. In turn, these problems
manage their condition in such a manner should take high blood glucose levels into can lead to amputation, blindness or other
that there is minimal risk of incapacita- account only if they have already caused vision problems, including vision loss,
tion from hypoglycemia because mildly long-term complications such as visual kidney failure, stroke, or heart attack. As
low glucose levels can be easily detected impairment that interfere with perfor- these complications could potentially affect
and treated (4,7). mance of the specific job. job performance and safety, such compli-
A single episode of severe hypoglyce- cations should be evaluated by a specialist
mia should not per se disqualify an in- Aspects of a safety assessment in the specific area related to the compli-
dividual from employment. Rather, an When an individual with diabetes is cation. If complications are not present,
appropriate evaluation should be under- assessed for safety risk there are several their possible future development should
taken by a health care professional with aspects that must be considered. not be addressed, both because of laws
expertise in diabetes to determine the Blood glucose test results. A single prohibiting such consideration and be-
cause of the low blood glucose, the cir- blood glucose test result only gives infor- cause with medical monitoring and thera-
cumstances of the episode, whether it was mation about an individual’s blood glucose pies, long-term complications can now
an isolated incident, whether adjustment level at one particular point in time. Be- often be avoided or delayed. Thus, many
to the insulin regimen may mitigate this cause blood glucose levels fluctuate people with diabetes never develop any of
risk, and the likelihood of such an episode throughout the day (this is also true for these complications, and those that do
happening again. Some episodes of severe people without diabetes), one test result is generally develop them over a period of
hypoglycemia can be explained and cor- of no use in assessing the overall health of a years.
rected with the assistance of a diabetes person with diabetes. The results of a series
health care professional. of self-monitored blood glucose measure- Inappropriate assessments
However, recurrent episodes of se- ments over a period of time, however, can The following tools and terms do not
vere hypoglycemia may indicate that an give valuable information about an indi- accurately reflect the current state of di-
individual may in fact not be able to safely vidual’s diabetes health. Blood glucose re- abetes treatment and should be avoided
perform a job, particularly jobs or tasks cords should be assessed by a health care in an assessment of whether an individual
involving significant risk of harm to em- professional with expertise in diabetes (7). with diabetes is able to safely and effec-
ployees or the public, especially when History of severe hypoglycemia. Of- tively perform a particular job.
these episodes cannot be explained. The ten, a key factor in assessing employment Urine glucose tests. Urine glucose re-
person’s medical history and details of safety and risk is documentation of in- sults are no longer considered to be an
any history of severe hypoglycemia cidents of severe hypoglycemia. An in- appropriate and accurate methodology
should be examined closely to determine dividual who has managed his or her for assessing diabetes control (8). Before
whether it is likely that such episodes will diabetes over an extended period of time the mid-1970s, urine glucose tests were
recur on the job. In all cases, job duties without experiencing severe hypoglyce- the best available method of monitoring
should be carefully examined to deter- mia is unlikely to experience this condi- blood glucose levels. However, the urine
mine whether there are ways to minimize tion in the future. Conversely, multiple test is not a reliable or accurate indicator
the risk of severe hypoglycemia (such as incidents of severe hypoglycemia may of blood glucose levels and is a poor mea-
adjustment of the insulin regimen or in some situations be disqualifying for sure of the individual’s current health sta-
providing additional breaks to check high-risk occupations. However, the tus. Blood glucose monitoring is a more
blood glucose levels). circumstances of each incident should accurate and timely means to measure
be examined, as some incidents can be glycemic control. Urine glucose tests
Hyperglycemia explained due to changes in insulin dos- should never be used to evaluate the em-
In contrast to hypoglycemia, high blood age, illness, or other factors and thus will ployability of a person with diabetes.
glucose levels (hyperglycemia) can cause be unlikely to recur or have already been A1C and estimated average glucose.
long-term complications over years or de- addressed by the individual through Hemoglobin A1C (A1C) test results re-
cades but does not normally lead to any changes to his or her diabetes treatment flect average glycemia over several
adverse effect on job performance. The regimen or education. months and correlate with mean plasma
symptoms of hyperglycemia generally de- Hypoglycemia unawareness. Some in- glucose levels (4). Estimated average glu-
velop over hours or days and do not occur dividuals over time lose the ability to cose (eAG) is directly related to A1C and
suddenly. Therefore, hyperglycemia does recognize the early warning signs of hypo- also provides an individual with an esti-
not pose an immediate risk of sudden in- glycemia. These individuals are at increased mate of average blood glucose over a pe-
capacitation. While over years or decades, risk for a sudden episode of severe hypo- riod of time, but it uses the same values
high blood glucose may cause long-term glycemia. Some of these individuals may and units that are observed when using a

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S95


Position Statement

glucose meter or recording a fasting glu- are relevant in employment decisions care tasks that should be provided when-
cose value on a lab report (5). A1C/eAG only when they are established and ever feasible.
values provide health care providers with interfere with the performance of the Administering insulin. Employees may
important information about the effec- actual job being considered. (E) need short breaks during the workday to
tiveness of an individual’s treatment regi- c Proper safety assessments should in- administer insulin when it is needed.
men (4) but are often misused in assessing clude review of blood glucose test re- Insulin can be safely administered wher-
whether an individual can safely sults, history of severe hypoglycemia, ever the employee happens to be. The
perform a job. Because they identify presence of hypoglycemia unawareness, employee may also need a place to store
only averages and not whether the person and presence of diabetes-related com- insulin and other supplies if work con-
had severe extreme blood glucose read- plications and should not include urine ditions (such as extreme temperatures)
ings, A1C/eAG results are of no value in glucose or AIC/eAG tests or be based prevent the supplies from being carried
predicting short-term complications of on a general assessment of level of con- on the person (10).
diabetes and thus have no use in evaluat- trol. (E) Food and drink. Employees may need
ing individuals in employment situations. access to food and/or beverages during
The American Diabetes Association the workday. This is particularly impor-
III. ACCOMMODATING
recommends that in most patients A1C tant in the event that the employee needs
EMPLOYEES WITH
levels be kept below 7% (4), or eAG below to quickly respond to low blood glucose
DIABETESdIndividuals with diabetes
154 mg/dL. This recommendation sets a levels or maintain hydration if glucose
may need certain changes or accommo-
target in order to lessen the chances of levels are high. Employees should be
dations on the job in order to perform
long-term complications of high blood permitted to consume food or beverages
their work responsibilities effectively and
glucose levels but does not provide useful as needed at their desk or work station
safely. Federal and state laws require the
information on whether the individual is (except in an extremely rare situation in
provision of “reasonable accommodations”
at significant risk for hypoglycemia or which this would pose a hazard and
to help an employee with diabetes to per-
suboptimal job performance and is not a create a safety issue, and if this is the case,
measure of “compliance” with therapy. form the essential functions of the job (3). an alternative site should be provided).
Additional laws provide for leave for an em-
An A1C or eAG cut off score is not med- Leave. Employees may need leave or a
ployee to deal with his or her medical needs
ically justified in employment evaluations flexible work schedule to accommodate
and should never be a determinative fac- or those of a family member (9). Although medical appointments or other diabetes
there are some typical accommodations
tor in employment. care needs. Occasionally, employees may
that many people with diabetes use, the
“Uncontrolled” or “brittle” diabetes. need to miss work due to unanticipated
need for accommodations must be as-
Sometimes an individual’s diabetes is de- events (severe hypoglycemic episode) or
sessed on an individualized basis (2).
scribed as “uncontrolled,” “poorly con- illness.
trolled,” or “brittle.” These terms are not Work schedules. Certain types of work
well defined and are not relevant to job Accommodating daily diabetes schedules, such as rotating or split shifts,
evaluations. As such, giving an opinion management needs can make it especially difficult for some
on the level of “control” an individual Many of the accommodations that em- individuals to manage diabetes effec-
has over diabetes is not the same as assess- ployees with diabetes need on a day-to- tively.
ing whether that individual is qualified to day basis are those that allow them to
perform a particular job and can do so manage their diabetes in the workplace as Accommodating complications of
safely. Such an individual assessment is they would elsewhere. They are usually diabetes
the only relevant evaluation. simple accommodations, can be provided In addition to accommodating the day-to-
without any cost to the employer, and day management of diabetes in the work-
Recommendations should cause little or no disruption in the place, for some individuals it is also
c Evaluating the safety risk of employees workplace. Most employers are required necessary to seek modifications for long-
with diabetes includes determining to provide accommodations unless those term diabetes-related complications.
whether the concerns are reasonable in accommodations would create an undue Such people can remain productive em-
light of the job duties the individual burden (3). Some accommodations that ployees if appropriate accommodations
must perform. (E) may be needed include the following. are implemented.
c Most people with diabetes can manage Testing blood glucose. Breaks may be For example, an employee with di-
their condition in such a manner that needed to allow an individual to test abetic retinopathy or other vision impair-
there is no or minimal risk of incapaci- blood glucose levels when needed. Such ments may benefit from using a big screen
tation from hypoglycemia at work. A checks only take minutes to complete. computer or other visual aids, while an
single episode of severe hypoglycemia Some individuals use continuous glucose employee with nerve pain may benefit
should not per se disqualify an individ- monitors but will still need an opportu- from reduced walking distances or having
ual from employment, but an individual nity to check blood glucose with a meter. the ability to sit down on the job. Indi-
with recurrent episodes of severe hypo- Blood glucose can be checked wherever viduals with kidney problems may need
glycemia may be unable to safely per- the employee is without putting other to have flexibility to take time off work for
form certain jobs, especially when those employees at risk, and employers should dialysis treatment.
episodes cannot be explained. (E) not limit where employees with diabetes It is impossible to provide an exhaus-
c Hyperglycemia does not pose an imme- are permitted to manage their diabetes. tive list of potential accommodations. The
diate risk of sudden incapacitation on Some employees may prefer to have a pri- key message in accommodating an em-
the job, and long-term complications vate location for testing or other diabetes ployee with diabetes is to ensure that

S96 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

accommodations are tailored to the in- jobs. The therapies for, and effects of, 2. Equal Employment Opportunity Com-
dividual and effective in helping the in- diabetes vary greatly from person to per- mission: Questions and Answers About
dividual perform his or her job. Input son, so employers must consider each Diabetes in the Workplace and the
from health care professionals who spe- person’s capacities and needs on an in- Americans with Disabilities Act (ADA),
Oct. 29, 2003. Available from http://www
cialize in the particular complication, or dividual basis. People with diabetes
.eeoc.gov/facts/diabetes.html. Accessed 26
from vocational rehabilitation specialists should always be evaluated individually May 2008
or organizations, may help identify appro- with the assistance of experienced dia- 3. Americans with Disabilities Act of 1990,
priate accommodations. betes health care professionals. The re- 42 U.S.C. x12101 et seq.
quirements of the specific job and the 4. American Diabetes Association: Standards
Recommendations individual’s ability to perform that job, of medical care in diabetesd2013 (Posi-
with or without reasonable accommoda- tion Statement). Diabetes Care 2013;36
c Individuals with diabetes may need
tions, always need to be considered. (Suppl. 1): S11–S66
accommodations on the job in order 5. Nathan DM, Kuenen J, Borg R, Zheng H,
to perform their work responsibilities Schoenfeld D, Heine R: Translating the
effectively and safely; these include A1C assay into estimated average glucose
accommodating daily diabetes needs AcknowledgmentsdThe American Diabetes values. Diabetes Care 31: 1473–1478, 2008
Association thanks the members of the vol-
and, when present, the complications unteer writing group for this updated state-
6. American Diabetes Association: Defining
of diabetes. All such accommodations and reporting hypoglycemia in diabetes,
ment: John E. Anderson, MD; Michael A. a report from the American Diabetes As-
must be tailored to the individual and Greene, JD; John W. Griffin, Jr., JD; Daniel B.
effective in helping the individual per- sociation Workgroup on Hypoglycemia.
Kohrman, JD; Daniel Lorber, MD, FACP, CDE; Diabetes Care 28: 1245–1249, 2005
form his or her job. (E) Christopher D. Saudek, MD; Desmond Schatz, 7. American Diabetes Association: Self-
MD; and Linda Siminerio, RN, PhD, CDE. monitoring of blood glucose (Consensus
CONCLUSIONdIndividuals with di- Statement). Diabetes Care 17: 81–86, 1994
abetes can and do serve as highly pro- 8. American Diabetes Association: Tests of
ductive members of the workforce. While References glycemia in diabetes (Position Statement).
1. Centers for Disease Control and Pre- Diabetes Care 27 (Suppl. 1): S91–S93,
not every individual with diabetes will
vention: National Diabetes Fact Sheet: 2004
be qualified for, nor can perform, every General Information and National Estimates 9. Family Medical Leave Act of 1993, 29 U.S.C.
available job, reasonable accommoda- on Diabetes and Prediabetes in the U.S., 2011. x2601 et seq.
tions can readily be made that allow the Atlanta, GA, U.S. Department of Health and 10. American Diabetes Association: Insulin ad-
vast majority of people with diabetes to Human Services, Centers for Disease Con- ministration (Position Statement). Diabetes
effectively perform the vast majority of trol and Prevention, 2011 Care 27 (Suppl. 1): S106–S109, 2004

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S97


P O S I T I O N S T A T E M E N T

Third-Party Reimbursement for Diabetes


Care, Self-Management Education,
and Supplies
AMERICAN DIABETES ASSOCIATION health care costs, individuals with dia-
betes must have access to the integral
components of diabetes care, such as

D
iabetes is a chronic disease that af- outlines appropriate medical care for peo- health care visits, diabetes supplies, self-
fects nearly 26 million Americans ple with diabetes (5). management education, and diabetes med-
(1) and is characterized by serious, An integral component of diabetes ications. As such, insurers must reimburse
costly, and often fatal complications. The care is self-management education (in- for diabetes-related medical treatment as
total cost of diagnosed diabetes in the U.S. patient and/or outpatient) delivered by an well as for self-management education
in 2007 was estimated to be $174 billion interdisciplinary team. Self-management programs that have met accepted stand-
(2). To prevent or delay costly diabetes training helps people with diabetes adjust ards, such as the American Diabetes Asso-
complications and to enable people with their daily regimen to improve glycemic ciation’s National Standards for Diabetes
diabetes to lead healthy, productive lives, control. Diabetes self-management edu- Self-Management Education and Support.
appropriate medical care based on current cation teaches individuals with diabetes Furthermore, third-party payers must also
standards of practice, self-management to assess the interplay among medical reimburse for medications and supplies
education, and medication and supplies nutrition therapy, physical activity, emo- related to the daily care of diabetes. These
must be available to everyone with diabe- tional/physical stress, and medications, same standards should also apply to or-
tes. This article is based on technical re- and then to respond appropriately and ganizations that purchase health care ben-
views titled “Diabetes Self-Management continually to those factors to achieve and efits for their members or employees, as
Education” (3) and “National Standards maintain optimal glucose control. well as managed care organizations that
for Diabetes Self-Management Education Today, self-management education is provide services to participants.
Programs” (4). understood to be such a critical part of It is recognized that the use of formu-
The goal of medical care for people diabetes care that medical treatment of di- laries, prior authorization, competitive
with diabetes is to optimize glycemic con- abetes without systematic self-management bidding, and related provisions (hereafter
trol and minimize complications. The Di- education is regarded as inadequate. The referred to as “controls”) can manage pro-
abetes Control and Complications Trial National Standards for Diabetes Self- vider practices and costs to the potential
(DCCT) demonstrated that treatment that Management Education and Support estab- benefit of payors and patients. Social Se-
maintains blood glucose levels near nor- lish specific criteria against which diabetes curity Act Title XIX, section 1927, states
mal in type 1 diabetes delays the onset education programs can be measured, that excluded medications should not
and reduces the progression of microvas- and a quality assurance program has been have “a significant clinically meaningful
cular complications. The UK Prospective developed and subsequently revised (6). therapeutic advantage in terms of safety,
Diabetes Study (UKPDS) documented Treatments and therapies that im- effectiveness or clinical outcomes of such
that optimal glycemic control can also prove glycemic control and reduce the treatment of such population.” A variety of
benefit most individuals with type 2 dia- complications of diabetes will also signif- laws, regulations, and executive orders
betes. To achieve optimal glucose control, icantly reduce health care costs (7,8). Nu- also provide guidance on the use of such
the person with diabetes must be able to merous studies have demonstrated that controls to oversee the purchase and use
access health care providers who have ex- self-management education leads to re- of durable medical equipment (hereafter
pertise in the field of diabetes. Treatment ductions in the costs associated with all referred to as “equipment”) and single-
plans must also include self-management types of diabetes. Participants in self- use medical supplies (hereafter referred
training and tools, regular and timely lab- management education programs have to as “supplies”) associated with the man-
oratory evaluations, medical nutrition been found to have decreased lower- agement of diabetes.
therapy, appropriately prescribed medi- extremity amputation rates, reduced Certain principles should guide the
cation(s), and regular self-monitoring of medication costs, and fewer emergency creation and enforcement of controls in
blood glucose levels. The American Dia- room visits and hospitalizations. order to insure that they meet the com-
betes Association position statement To achieve optimal glycemic control, prehensive medical needs of people living
“Standards of Medical Care in Diabetes” thus achieving long-term reduction in with diabetes. A wide array of medications
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c and supplies are correlated with improved
The recommendations in this article are based on the evidence reviewed in the following publications: Diabetes glycemic outcomes and a reduction in the
self-management education (Technical Review). Diabetes Care 18:1204–1214, 1995, and National stand- risk of diabetes-related complications. Be-
ards for diabetes self-management education and support. Diabetes Care 35:2393–2401, 2012. cause no single diabetes treatment regimen
Approved 1995. Revised 2008. is appropriate for all people with diabetes,
DOI: 10.2337/dc13-S098
© 2013 by the American Diabetes Association. Readers may use this article as long as the work is properly
providers and patients should have access
cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/ to a broad array of medications and supplies
licenses/by-nc-nd/3.0/ for details. to develop an effective treatment modality.

S98 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statement

However, the Association also recognizes variable circumstances encountered in information on diabetes and prediabetes in the
that there may be a number of medica- daily life. These protections should guar- U.S., 2011. Atlanta, GA, U.S. Department of
tions and/or supplies within any given antee access to an acceptable range and Health and Human Services, Centers for
class. As such, any controls should ensure all classes of antidiabetic medications, Disease Control and Prevention, 2011
that all classes of antidiabetic agents with equipment, and supplies. Furthermore, 2. American Diabetes Association: Economic
costs of diabetes in the U.S. in 2007. Di-
unique mechanisms of action are avail- fair and reasonable appeals processes
abetes Care 31: 596–615, 2008
able to facilitate achieving glycemic goals should ensure that diabetic patients and 3. Clement S: Diabetes self-management ed-
to reduce the risk of complications. Sim- their medical care practitioners can obtain ucation (Technical Review). Diabetes Care
ilar issues operate in the management of medications, equipment, and supplies 18: 1204–1214, 1995
lipid disorders, hypertension, and other that are not contained within existent 4. Funnell MM, Haas LB: National standards
cardiovascular risk factors, as well as for controls. for diabetes self-management education
other diabetes complications. Further- Diabetes management needs individu- programs (Technical Review). Diabetes
more, any controls should ensure that alization in order for patients to reach Care 18: 100–116, 1995
all classes of equipment and supplies glycemic targets. Because there is diversity 5. American Diabetes Association: Standards
designed for use with such equipment are in the manifestations of the disease and in of medical care in diabetesd2013 (Position
available to facilitate achieving glycemic the impact of other medical conditions Statement). Diabetes Care 36 (Suppl. 1):
goals to reduce the risk of complications. upon diabetes, it is common that practi- S11–S66, 2013
6. Haas L, Maryniuk M, Beck J, Cox CE,
It is important to note that medical ad- tioners will need to uniquely tailor treat-
Duker P, Edwards L, Fisher EB, Hanson L,
vances are rapidly changing the landscape ment for their patients. To reach diabetes Kent D, Kolb L, McLaughlin S, Orzeck E,
of diabetes medications and supplies. To treatment goals, practitioners should Piette JD, Rhinehart AS, Rothman R,
ensure that patients with diabetes have have access to all classes of antidiabetic Sklaroff S, Tomky D, Youssef G, on behalf
access to beneficial updates in treatment medications, equipment, and supplies of the 2012 Standards Revision Task
modalities, systems of controls must em- without undue controls. Without appro- Force: National standards for diabetes
ploy efficient mechanisms through which priate safeguards, these controls could self-management education and support.
to introduce and approve new products. constitute an obstruction of effective care. Diabetes Care 35: 2393–2401, 2012
Though it can seem appropriate for The value of self-management edu- 7. Herman WH, Dasbach DJ, Songer TJ,
controls to restrict certain items in chronic cation and provision of diabetes supplies Thompson DE, Crofford OB: Assessing
disease management, particularly with a has been acknowledged by the passage the impact of intensive insulin therapy on
complex disorder such as diabetes, it of the Balanced Budget Act of 1997 (9) the health care system. Diabetes Rev 2: 384–
should be recognized that adherence is a and by stated medical policy on both di- 388, 1994
8. Wagner EH, Sandu N, Newton KM,
major barrier to achieving targets. Any abetes education and medical nutrition McCullock DK, Ramsey SD, Grothaus LC:
controls should take into account the therapy. Effects of improved glycemic control on
huge mental and physical burden that in- health care costs and utilization. JAMA 285:
tensive disease management exerts upon 182–189, 2001
patients with diabetes. Protections should References 9. Balanced Budget Act of 1997. U.S. Govt.
ensure that patients with diabetes can 1. Centers for Disease Control and Preven- Printing Office, 1997, p. 115–116 (publ.
readily comply with therapy in the widely tion: National estimates and general no. 869-033-00034-1)

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S99


N A T I O N A L S T A N D A R D S

National Standards for Diabetes


Self-Management Education and
Support
LINDA HAAS, PHC, RN, CDE (CHAIR)1 SUE MCLAUGHLIN, BS, RD, CDE, CPT11 Because of the dynamic nature of
MELINDA MARYNIUK, MED, RD, CDE (CHAIR)2 ERIC ORZECK, MD, FACE, CDE12 health care and diabetes-related research,
JONI BECK, PHARMD, CDE, BC-ADM3 JOHN D. PIETTE, PHD13 the Standards are reviewed and revised
CARLA E. COX, PHD, RD, CDE, CSSD4 ANDREW S. RHINEHART, MD, FACP, CDE14 approximately every 5 years by key stake-
PAULINA DUKER, MPH, RN, BC-ADM, CDE5 RUSSELL ROTHMAN, MD, MPP15
LAURA EDWARDS, RN, MPA6 SARA SKLAROFF16 holders and experts within the diabetes
EDWIN B. FISHER, PHD7 DONNA TOMKY, MSN, RN, C-NP, CDE, FAADE17 education community. In the fall of
LENITA HANSON, MD, CDE, FACE, FACP8 GRETCHEN YOUSSEF, MS, RD, CDE18 2011, a Task Force was jointly convened
DANIEL KENT, PHARMD, BS, CDE9 ON BEHALF OF THE 2012 STANDARDS by the American Association of Diabetes
LESLIE KOLB, RN, BSN, MBA10 REVISION TASK FORCE Educators (AADE) and the American Di-
abetes Association (ADA). Members of the
Task Force included experts from the
areas of public health, underserved pop-

B
y the most recent estimates, 18.8 mil- The National Standards for Diabetes Self- ulations including rural primary care and
lion people in the U.S. have been di- Management Education are designed other rural health services, individual
agnosed with diabetes and an to define quality DSME and support and practices, large urban specialty practices,
additional 7 million are believed to be liv- to assist diabetes educators in provid- and urban hospitals. They also included
ing with undiagnosed diabetes. At the same ing evidence-based education and self- individuals with diabetes, diabetes research-
time, 79 million people are estimated to management support. The Standards ers, certified diabetes educators, registered
have blood glucose levels in the range of are applicable to educators in solo prac- nurses, registered dietitians, physicians,
prediabetes or categories of increased risk tice as well as those in large multicenter pharmacists, and a psychologist. The Task
for diabetes. Thus, more than 100 million programsdand everyone in between. Force was charged with reviewing the
Americans are at risk for developing the There are many good models for the pro- current National Standards for Diabetes
devastating complications of diabetes (1). vision of diabetes education and support. Self-Management Education for their ap-
Diabetes self-management education The Standards do not endorse any one ap- propriateness, relevance, and scientific basis
(DSME) is a critical element of care for all proach, but rather seek to delineate the and updating them based on the available
people with diabetes and those at risk for commonalities among effective and excel- evidence and expert consensus.
developing the disease. It is necessary in lent self-management education strate- The Task Force made the decision to
order to prevent or delay the complications gies. These are the standards used in change the name of the Standards from
of diabetes (2–6) and has elements re- the field for recognition and accred- the National Standards for Diabetes Self-
lated to lifestyle changes that are also es- itation. They also serve as a guide for non- Management Education to the National
sential for individuals with prediabetes as accredited and nonrecognized providers Standards for Diabetes Self-Management
part of efforts to prevent the disease (7,8). and programs. Education and Support. This name change
is intended to codify the significance of
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c ongoing support for people with diabetes
From the 1VA Puget Sound Health Care System Hospital and Specialty Medicine, Seattle, Washington; the and those at risk for developing the disease,
2
Joslin Diabetes Center, Boston, Massachusetts; 3Pediatric Diabetes and Endocrinology, The University of particularly to encourage behavior change,
Oklahoma Health Sciences Center College of Medicine, Edmond, Oklahoma; the 4Western Montana Clinic, the maintenance of healthy diabetes-related
Missoula, Montana; the 5Diabetes Education/Clinical Programs, American Diabetes Association, Alexan-
dria, Virginia; the 6Center for Healthy North Carolina, Apex, North Carolina; 7Peers for Progress, American
behaviors, and to address psychosocial
Academy of Family Physicians Foundation and Department of Health Behavior, Gillings School of Global concerns. Given that self-management
Public Health, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; 8Ultracare does not stop when a patient leaves the
Endocrine and Diabetes Consultants, Venice, Florida; the 9Group Health Central Specialty Clinic, Seattle, educator’s office, self-management support
Washington; the 10Diabetes Education Accreditation Program, American Association of Diabetes Educators, must be an ongoing process.
Chicago, Illinois; 11On Site Health and Wellness, LLC, Omaha, Nebraska; 12Endocrinology Associates, Main
Medical Plaza, Houston, Texas; the 13VA Center for Clinical Management Research and the University of Although the term “diabetes” is used
Michigan Health System, Ann Arbor, Michigan; 14Johnston Memorial Diabetes Care Center, Abingdon, predominantly, the Standards should also
Virginia; the 15Center for Health Services Research, Vanderbilt University Medical Center, Nashville, Ten- be understood to apply to the education
nessee; 16Technical Writer, Washington, DC; the 17Department of Endocrinology and Diabetes, ABQ Health and support of people with prediabetes.
Partners, Albuquerque, New Mexico; and 18MedStar Diabetes Institute/MedStar Health, Washington, DC.
Corresponding authors: Linda Haas, linda.haas@va.gov, and Melinda Maryniuk, melinda.maryniuk@joslin Currently, there are significant barriers
.harvard.edu. to the provision of education and support
DOI: 10.2337/dc13-S100 to those with prediabetes. And yet, the
The previous version of this article “National Standards for Diabetes Self-Management Education” was pub- strategies for supporting successful be-
lished in Diabetes Care 2007;30:1630–1637. This version received final approval in July 2012.
© 2013 by the American Diabetes Association and the American Association of Diabetes Educators. Readers havior change and the healthy behaviors
may use this article as long as the work is properly cited, the use is educational and not for profit, and the recommended for people with prediabe-
work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details. tes are largely identical to those for

S100 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


National Standards

individuals with diabetes. As barriers to and life experiences of the person with care programs and disease management
care are overcome, providers of DSME diabetes or prediabetes and is guided by services, including “Supporting Self-
and diabetes self-management support evidence-based standards. The overall ob- Management” (18).
(DSMS), given their training and experi- jectives of DSME are to support informed
ence, are particularly well equipped to as- decision making, self-care behaviors, pro- STANDARD 2
sist individuals with prediabetes in blem solving, and active collaboration
developing and maintaining behaviors with the health care team and to improve External input
that can prevent or delay the onset of di- clinical outcomes, health status, and qual- The provider(s) of DSME will seek ongoing
abetes. ity of life. input from external stakeholders and experts
Many people with diabetes have or DSMS: Activities that assist the person in order to promote program quality.
are at risk for developing comorbidities, with prediabetes or diabetes in imple- For both individual and group pro-
including both diabetes-related compli- menting and sustaining the behaviors viders of DSME and DSMS, external input
cations and conditions (e.g., heart dis- needed to manage his or her condition is vital to maintaining an up-to-date,
ease, lipid abnormalities, nerve damage, on an ongoing basis beyond or outside of effective program. Broad participation of
hypertension, and depression) and other formal self-management training. The community stakeholders, including indi-
medical problems that may interfere with type of support provided can be behav- viduals with diabetes, health professio-
self-care (e.g., emphysema, arthritis, and ioral, educational, psychosocial, or clini- nals, and community interest groups, will
alcoholism). In addition, the diagnosis, cal (11–15). increase the program’s knowledge of the
progression, and daily work of managing local population and allow the provider to
the disease can take a major emotional toll STANDARD 1 better serve the community. Often, but not
on people with diabetes that makes self- always, this external input is best achieved
care even more difficult (9). The Stand- Internal structure by the establishment of a formal advisory
ards encourage providers of DSME and The provider(s) of DSME will document an board. The DSME and DSMS provider(s)
DSMS to address the entire panorama of organizational structure, mission statement, must have a documented plan for seeking
each participant’s clinical profile. Regular and goals. For those providers working outside input and acting on it.
communication among the members of within a larger organization, that organiza- The goal of external input and dis-
participant’s health care teams is essential tion will recognize and support quality cussion in the program planning process
to ensure high-quality, effective educa- DSME as an integral component of diabetes is to foster ideas that will enhance the
tion and support for people with diabetes care. quality of the DSME and/or DSMS being
and prediabetes. Documentation of an organizational provided, while building bridges to key
In the course of its work on the structure, mission statement, and goals stakeholders (19). The result is effective,
Standards, the Task Force identified areas can lead to efficient and effective pro- dynamic DSME that is patient centered,
in which there is currently an insufficient vision of DSME and DSMS. In the busi- more responsive to consumer-identified
amount of research. In particular, there ness literature, case studies and case needs and the needs of the community,
are three areas in which the Task Force report investigations of successful man- more culturally relevant, and more ap-
recommends additional research: agement strategies emphasize the impor- pealing to consumers (17,19,20).
tance of clear goals and objectives,
1. What is the influence of organizational defined relationships and roles, and man- STANDARD 3
structure on the effectiveness of the agerial support. Business and health pol-
provision of DSME and DSMS? icy experts and organizations emphasize Access
2. What is the impact of using a struc- written commitments, policies, support, The provider(s) of DSME will determine who
tured curriculum in DSME? and the importance of outcomes report- to serve, how best to deliver diabetes educa-
3. What training should be required for ing to maintain ongoing support or com- tion to that population, and what resources
those community, lay, or peer workers mitment (16,17). can provide ongoing support for that popu-
without training in health or diabetes Documentation of an organizational lation.
who are to participate in the provision structure that delineates channels of com- Currently, the majority of people
of DSME and to provide DSMS? munication and represents institutional with diabetes and prediabetes do not
commitment to the educational entity is receive any structured diabetes education
Finally, the Standards emphasize that critical for success. According to The Joint (19,20). While there are many barriers to
the person with diabetes is at the center Commission, this type of documentation DSME, one crucial issue is access (21).
of the entire diabetes education and sup- is equally important for both small and Providers of DSME can help address this
port process. It is the individuals with large health care organizations (18). issue by:
diabetes who do the hard work of man- Health care and business experts over-
aging their condition, day in and day out. whelmingly agree that documentation c Clarifying the specific population to be
The educator’s role, first and foremost, is of the process of providing services is a served. Understanding the community,
to make that work easier (10). critical factor in clear communication service area, or regional demographics is
and provides a solid basis from which to crucial to ensuring that as many people
DEFINITIONS deliver quality diabetes education. In as possible are being reached, including
DSME: The ongoing process of facilitat- 2010, The Joint Commission published those who do not frequently attend
ing the knowledge, skill, and ability nec- the Disease-Specific Care Certification clinical appointments (9,17,22–24).
essary for prediabetes and diabetes self-care. Manual, which outlines standards and c Determining that population’s self-
This process incorporates the needs, goals, performance measurements for chronic management education and support

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needs. Different individuals, their fam- experience with program and/or clinical Assistants), case managers, lay health
ilies, and communities need different management (56–59). In some cases, par- and community workers (76–83), and
types of education and support (25). ticularly in solo or other small practices, the peer counselors or educators (84,85)
The provider(s) of DSME and DSMS coordinator may also provide DSME and/ have been shown to contribute effec-
needs to work to ensure that the or DSMS. tively as part of the DSME team and in
necessary education alternatives are providing DSMS. While DSME and
available (25–27). This means under- STANDARD 5 DSMS are often provided within the
standing the population’s demogra- framework of a collaborative and integrated
phic characteristics, such as ethnic/ Instructional staff team approach, it is crucial that the indi-
cultural background, sex, and age, as One or more instructors will provide vidual with diabetes is viewed as central to
well as levels of formal education, lit- DSME and, when applicable, DSMS. At the team and that he or she takes an active
eracy, and numeracy (28–31). It may least one of the instructors responsible for role.
also entail identifying resources out- designing and planning DSME and DSMS Certification as a diabetes educator
side of the provider’s practice that can will be a registered nurse, registered dieti- (CDE) by the National Certification
assist in the ongoing support of the tian, or pharmacist with training and ex- Board for Diabetes Educators (NCBDE)
participant. perience pertinent to DSME, or another is one way a health professional can
c Identifying access issues and working professional with certification in diabetes demonstrate mastery of a specific body
to overcome them. It is essential to care and education, such as a CDE or of knowledge, and this certification has
determine factors that prevent in- BC-ADM. Other health workers can con- become an accepted credential in the
dividuals with diabetes from receiving tribute to DSME and provide DSMS with diabetes community (86). An additional
self-management education and sup- appropriate training in diabetes and with credential that indicates specialized train-
port. The assessment process includes supervision and support. ing beyond basic preparation is board
the identification of these barriers to Historically, nurses and dietitians were certification in Advanced Diabetes Man-
access (32–34). These barriers may in- the main providers of diabetes education agement (BC-ADM) offered by the AADE,
clude the socioeconomic or cultural (3,4,60–64). In recent years, the role of the which is available for nurses, dietitians,
factors mentioned above, as well as, for diabetes educator has expanded to other pharmacists, physicians, and physician
example, health insurance shortfalls disciplines, particularly pharmacists (65– assistants (68,74,87).
and the lack of encouragement from 67). Reviews comparing the effectiveness Individuals who serve as lay health and
other health providers to seek diabetes of different disciplines for education have community workers and peer counselors
education (35,36). not identified clear differences in the qual- or educators may contribute to the pro-
ity of services delivered by different profes- vision of DSME instruction and provide
STANDARD 4 sionals (3–5). However, the literature DSMS if they have received training in
favors the registered nurse, registered die- diabetes management, the teaching of self-
Program coordination titian, and pharmacist serving both as the management skills, group facilitation, and
A coordinator will be designated to oversee key primary instructors for diabetes educa- emotional support. For these individuals, a
the DSME program. The coordinator will tion and as members of the multidisciplin- system must be in place that ensures
have oversight responsibility for the plan- ary team responsible for designing the supervision of the services they provide
ning, implementation, and evaluation of ed- curriculum and assisting in the delivery of by a diabetes educator or other health care
ucation services. DSME (1–7,68). Expert consensus sup- professional and professional back-up to
Coordination is essential to ensure ports the need for specialized diabetes address clinical problems or questions
that quality diabetes self-management and educational training beyond academic beyond their training (88–90).
education and support is delivered preparation for the primary instructors on For services outside the expertise of
through an organized, systematic process the diabetes team (69–72). Professionals any provider(s) of DSME and DSMS, a
(37,38). As the field of DSME continues to serving as instructors must document ap- mechanism must be in place to ensure
evolve, the coordinator plays a pivotal propriate continuing education or compa- that the individual with diabetes is con-
role in ensuring accountability and conti- rable activities to ensure their continuing nected with appropriately trained and
nuity in the education program (39–41). competence to serve in their instructional, credentialed providers.
The coordinator’s role may be viewed as training, and oversight roles (73).
that of coordinating the program (or ed- Reflecting the evolving health care STANDARD 6
ucation process) and/or as supporting the environment, a number of studies have
coordination of the many aspects of self- endorsed a multidisciplinary team ap- Curriculum
management in the continuum of diabe- proach to diabetes care, education, and A written curriculum reflecting current evi-
tes and related conditions when feasible support. The disciplines that may be in- dence and practice guidelines, with criteria
(42–49). This oversight includes design- volved include, but are not limited to, for evaluating outcomes, will serve as the
ing an education program or service that physicians, psychologists and other men- framework for the provision of DSME. The
helps the participant access needed re- tal health specialists, physical activity needs of the individual participant will de-
sources and assists him or her in navigat- specialists (including physical therapists, termine which parts of the curriculum will be
ing the health care system (37,50–55). occupational therapists, and exercise provided to that individual.
The individual serving as the coordi- physiologists), optometrists, and podia- Individuals with prediabetes and di-
nator will have knowledge of the lifelong trists (68,74,75). More recently, health abetes and their families and caregivers
process of managing a chronic disease and educators (e.g., Certified Health Educa- have much to learn to become effective
facilitating behavior change, in addition to tion Specialists and Certified Medical self-managers of their condition. DSME

S102 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


National Standards

can provide this education via an up-to- making and meaningful behavior change documented in the education/health re-
date, evidence-based, and flexible curric- and addressing psychosocial concerns cord. Documentation of participant en-
ulum (8,91). (114,115). counters will guide the education process,
The curriculum is a coordinated set of provide evidence of communication among
courses and educational experiences. It STANDARD 7 instructional staff and other members of the
also specifies learning outcomes and ef- participant’s health care team, prevent du-
fective teaching strategies (92,93). The Individualization plication of services, and demonstrate ad-
curriculum must be dynamic and reflect The diabetes self-management, education, herence to guidelines (117,135,142,143).
current evidence and practice guidelines and support needs of each participant will Providing information to other members
(93–97). Recent education research en- be assessed by one or more instructors. The of the participant’s health care team
dorses the inclusion of practical problem- participant and instructor(s) will then together through documentation of educational
solving approaches, collaborative care, develop an individualized education and sup- objectives and personal behavioral goals
psychosocial issues, behavior change, and port plan focused on behavior change. increases the likelihood that all the mem-
strategies to sustain self-management Research has demonstrated the im- bers will work in collaboration (86,143).
efforts (12,13,19,74,86,98–101). portance of individualizing diabetes edu- Evidence suggests that the development of
The following core topics are com- cation to each participant’s needs (116). standardized procedures for documenta-
monly part of the curriculum taught in The assessment process is used to identify tion, training health professionals to docu-
comprehensive programs that have what those needs are and to facilitate ment appropriately, and the use of
demonstrated successful outcomes the selection of appropriate educational structured standardized forms based on
(2,3,5,91,102–104): and behavioral interventions and self- current practice guidelines can improve
management support strategies, guided documentation and may ultimately im-
c Describing the diabetes disease process by evidence (2,63,116–118). The assess- prove quality of care (135,143–145).
and treatment options ment must garner information about
c Incorporating nutritional management the individual’s medical history, age, cul- STANDARD 8
into lifestyle tural influences, health beliefs and atti-
c Incorporating physical activity into tudes, diabetes knowledge, diabetes Ongoing support
lifestyle self-management skills and behaviors, The participant and instructor(s) will to-
c Using medication(s) safely and for emotional response to diabetes, readiness gether develop a personalized follow-up
maximum therapeutic effectiveness to learn, literacy level (including health plan for ongoing self-management support.
c Monitoring blood glucose and other literacy and numeracy), physical limita- The participant’s outcomes and goals and the
parameters and interpreting and using tions, family support, and financial status plan for ongoing self-management support
the results for self-management de- (11,106,108,117,119–128). will be communicated to other members of
cision making The education and support plan that the health care team.
c Preventing, detecting, and treating the participant and instructor(s) develop While DSME is necessary and effec-
acute complications will be rooted in evidence-based ap- tive, it does not in itself guarantee a
c Preventing, detecting, and treating proaches to effective health communica- lifetime of effective diabetes self-care
chronic complications tion and education while taking into (113). Initial improvements in partici-
c Developing personal strategies to ad- consideration participant barriers, abili- pants’ metabolic and other outcomes
dress psychosocial issues and concerns ties, and expectations. The instructor will have been found to diminish after ap-
c Developing personal strategies to pro- use clear health communication principles, proximately 6 months (3). To sustain
mote health and behavior change avoiding jargon, making information cul- the level of self-management needed to
turally relevant, using language- and literacy- effectively manage prediabetes and diabe-
While the content areas listed above appropriate education materials, and using tes over the long term, most participants
provide a solid outline for a diabetes interpreter services when indicated need ongoing DSMS (15).
education and support curriculum, it is (107,129–131). Evidence-based commu- The type of support provided can be
crucial that the content be tailored to nication strategies such as collaborative behavioral, educational, psychosocial, or
match each individual’s needs and be goal setting, motivational interviewing, clinical (11–14). A variety of strategies are
adapted as necessary for age, type of di- cognitive behavior change strategies, available for providing DSMS both within
abetes (including prediabetes and diabe- problem solving, self-efficacy enhance- and outside the DSME organization. Some
tes in pregnancy), cultural factors, health ment, and relapse prevention strategies patients benefit from working with a nurse
literacy and numeracy, and comorbidities are also effective (101,132–134). Peri- case manager (6,86,146). Case manage-
(14,105–108). The content areas will be odic reassessment can determine whether ment for DSMS can include reminders
able to be adapted for all practice settings. there is need for additional or different about needed follow-up care and tests,
Approaches to education that are in- interventions and future reassessment medication management, education, be-
teractive and patient centered have been (6,72,134–137). A variety of assessment havioral goal setting, psychosocial support,
shown to be effective (12,13,109–112). Also modalities, including telephone follow-up and connection to community resources.
crucial is the development of action-oriented and other information technologies (e.g., The effectiveness of providing DSMS
behavioral goals and objectives (12– Web based, text messaging, or automated through disease management programs,
14,113). Creative, patient-centered, expe- phone calls), may augment face-to-face as- trained peers and community health
rience-based delivery methodsdbeyond sessments (72,87,138–141). workers, community-based programs, in-
the mere acquisition of knowledgedare ef- The assessment and education plan, formation technology, ongoing education,
fective for supporting informed decision intervention, and outcomes will be support groups, and medical nutrition

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S103


National Standards

therapy has also been established (7– health beliefs, and culture as well as their actually leading to improvement), while
11,86,88–90,142,147–150). emotional response to diabetes can have a process measures provide information
While the primary responsibility for di- significant impact on how participants about what caused those results
abetes education belongs to the provider(s) understand their illness and engage in (144,150). Process measures are often tar-
of DSME, participants benefit by receiv- self-management. DSME providers who geted to those processes that typically im-
ing reinforcement of content and behav- account for these differences when collab- pact the most important outcomes.
ioral goals from their entire health care orating with participants on the design of
team (135). Additionally, many patients personalized DSME or DSMS programs
receive DSMS through their primary can improve participant outcomes AcknowledgmentsdNo potential conflicts of
care provider. Thus, communication (147,148). interest relevant to this article were reported.
among the team regarding the patient’s Assessments of participant outcomes The Task Force acknowledges Paulina
educational outcomes, goals, and DSMS must occur at appropriate intervals. The Duker, ADA Staff Facilitator; Leslie Kolb,
plan is essential to ensure that people interval depends on the nature of the AADE Staff Facilitator; Karen Fitzner, PhD,
with diabetes receive support that meets outcome itself and the time frame speci- meeting facilitator (FH Consultants, Chicago,
Illinois); and Sara Sklaroff for technical writing
their needs and is reinforced and con- fied based on the participant’s personal
assistance.
sistent among the health care team goals. For some areas, the indicators,
members. measures, and time frames will be based
Because self-management takes place on guidelines from professional organiza-
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Professional Practice Committee for the
2013 Clinical Practice Recommendations
Committee members disclosed the following financial or other conflicts of interest covering the period 1 November 2011–31 October 2012.

Member Employment Research grant Other research support


Roger Austin, MS, RPH, CDE Henry Ford Health System, None None
Sterling Heights, MI
Nathaniel G. Clark, MD, RD Diabetes Center of Cape Cod, None None
Hyannis, MA
Cyrus V. Desouza, MD University of Nebraska REATA Research Trial#, None
Medical Center and Omaha VA Novo Nordisk#
Medical Center, Omaha, NE
Martha Funnell, MSN, University of Michigan, Ann None None
RN, CDE Arbor, MI
Allison B. Goldfine, MD Joslin Diabetes Center, Boston, MA NIDDK#, NHLBI# Research supplies from Caraco
Pharmaceuticals#, LifeScan#,
Mercodia#, Nestle#, Amneal#
Richard Grant, MD, MPH Division of Research, Kaiser AHRQ#, NIDDK# None
Permanente, Oakland, CA
James Lenhard, MD Christiana Care Health System, NIH# None
Wilmington, DE
Jennifer B. Marks, MD VA Diabetes Management Team, Lilly#, NIH#, Leona M. and NIDDK
Miami, FL, and Diabetes Research Harry B. Helmsley Charitable
Institute, University of Miami Trust (T1D Exchange Clinic
School of Medicine, Miami, FL Registry)#
Anthony L. McCall, MD, PhD University of Virginia, Aventis#, Eli Lilly#, NIDDK None
Charlottesville, VA
Janis R. McWilliams, RN, MSN, Consultant, Pittsburgh, PA None None
CDE, BC-ADM
R. Harsha Rao, MD University of Pittsburgh Medical None None
Center, Pittsburgh, PA, and VA
Pittsburgh Healthcare System,
Pittsburgh, PA
Andrew Rhinehart, MD, Mountain States Health Alliance, Diabetes Impact Grant#, None
CDE, BC-ADM, FACP Abingdon, VA Health Wagon Grant#
Henry Rodriguez, MD University of South Florida, NIH#, Bristol-Myers Squibb#, None
Tampa, FL Daiichi Sankyo#, Novartis#,
Merck#, Leona M. and Harry
B. Helmsley Charitable Trust
(T1D Exchange Clinic Registry)#
Debra L. Simmons, MD, MS University of Utah, VA Salt Lake NHLBI#, Novo Nordisk# None
City, Salt Lake City, UT, and
University of Arkansas for
Medical Sciences and Central
Arkansas Veterans Healthcare
System, Little Rock, AR
Patricia Urbanski, Consultant, Cloquet, MN None None
MEd, RD, LD, CDE
Carol Wysham, MD (Chair) Rockwood Clinic, Spokane, WA NIH#, Leona M. and Harry B. None
Helmsley Charitable Trust
(T1D Exchange Clinic Registry)#

Judy Fradkin, MD NIDDK, Bethesda, MD None None


(Ex officio)
Stephanie Dunbar, RD, American Diabetes Association, None None
MPH (Staff) Alexandria, VA
Sue Kirkman, MD (Staff) American Diabetes Association, None None
Alexandria, VA

*$$10,000 per year from company to individual; #grant or contract is to university or other employer.

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 S109


Professional Practice Committee

Member Speakers’ bureau/honoraria Ownership interest Consultant/advisory board Other


R.A. Johnson & Johnson None None None
Diabetes Institute
(wife Mary Austin)
N.G.C. Novo Nordisk, Amylin None None Clinical Diabetes, Editorial Board
C.V.D. None None Novo Nordisk, Takeda None
M.F. None None Eli Lilly, Boehringer Ingelheim, None
Halozyme Therapeutics,
Merck Pharmaceutical,
Bristol-Myers Squibb/
AstraZeneca, UCLA
Center for Health Policy
Research, Animas/LifeScan
Glucose Meter, Bristol-
Myers Squibb Nurse
Practitioner, Bayer Health
Care Diabetes Care, Novo
Nordisk Pen Devices
A.B.G. None Pending patents: JDP–106 None Special Government Employee, FDA
(SAZ–T2D), JDP–109 (invited participant for Endocrine and
(SAZ–CUD), JDP–129 (SRF) Metabolic Advisory Committee)
R.G. None None None None
J.L. Boehringer Ingelheim, None None Expert witness for variety of legal
sanofi-aventis firms. No cases involved in the last
12 months concerned drugs, devices,
or pharmaceutical companies
J.B.M. ADA, Diabetes Research None Amgen None
Institute Foundation
A.L.M. None None None Clinical Science Chair, The Endocrine
Society Annual Meeting & Expo 2012
J.R.M. Roche (Creative Coaching None None None
Workshop), VMS
(Steady Start Educator
Network), Healthy
Interactions
R.H.R. None Co-inventor of GENIE. No None None
commercial agreements
or collaborations. (U.S.
patent application
number 12464344 filed
by VA Technology
Transfer Program, DC01-
#145823-v1-066072-
0050 Automated System
and Method of Diabetes
Control (Rao RH,
Perreiah PL,
Cunningham CA,
Inventors)
A.R. Forest Laboratories*, None sanofi-aventis*, Amylin Board Member and President, Appalachian
Abbott Laboratories, Diabetes Foundation
Eli Lilly, Novo
Nordisk*, sanofi-
aventis*, Boehringer
Ingelheim, Amylin
H.R. Eli Lilly* None Eli Lilly*, Roche Diagnostics Diabetes Forecast, Associate Editor
D.L.S. None None None None
P.U. Eli Lilly None Eli Lilly, sanofi-aventis, Clinical Diabetes, Editorial Board
Halozyme Therapeutics,
Medtronic
C.W. Amylin Pharmaceuticals*, None Amylin Pharmaceuticals*, None
Eli Lilly*, Merck, Novo Boehringer Ingelheim,
Nordisk*, sanofi- Johnson & Johnson,
aventis*, Boehringer sanofi-aventis*
Ingelheim
J.F. None None None None
S.D. None None None None

S.K. None None None None

S110 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Systematic Reviews

A systematic review provides a scientific published. Listed below are recent and William S. Yancy Jr.
rationale for a position statement and reviews. Diabetes Care 35:434–445, 2012
undergoes critical peer review before Macronutrients, Food Groups, and
submission to the Professional Practice Eating Patterns in the Management Cost-Effectiveness of Interventions
Committee for approval. Effective Janu- of Diabetes: A Systematic Review of to Prevent and Control Diabetes
ary 2010, technical reports were re- the Literature, 2010 Mellitus: A Systematic Review
placed with systematic reviews, for Madelyn L. Wheeler, Stephanie A. Dunbar, Rui Li, Ping Zhang, Lawrence E. Barker,
which a priori search and inclusion/ Lindsay M. Jaacks, Wahida Karmally, Farah M. Chowdhury, and Xuanping Zhang
exclusion criteria are developed and Elizabeth J. Mayer-Davis, Judith Wylie-Rosett, Diabetes Care 33:1872–1894, 2010

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 e1


Consensus Reports

Effective January 2010, prior reports of the types listed below were renamed “consensus reports.” Listed below are recent consensus
reports.
EXPERT COMMITTEE REPORTS American Association of Clinical Endo- Managing Preexisting Diabetes for
International Expert Committee Re- crinologists and American Diabetes As- Pregnancy: Summary of Evidence
port on the Role of the A1C Assay in sociation Consensus Statement on and Consensus Recommendations
the Diagnosis of Diabetes Inpatient Glycemic Control for Care
International Expert Committee Etie S. Moghissi, Mary T. Korytkowski, John L. Kitzmiller, Jennifer M. Block,
Diabetes Care 32:1327–1334, 2009 Monica DiNardo, Daniel Einhorn, Ri- Florence M. Brown, Patrick M. Catalano,
chard Hellman, Irl B. Hirsch, Silvio E. Deborah L. Conway, Donald R. Coustan,
Inzucchi, Faramarz Ismail-Beigi, M. Sue Erica P. Gunderson, William H. Herman,
CONSENSUS REPORTS
Kirkman, and Guillermo E. Umpierrez Lisa D. Hoffman, Maribeth Inturrisi, Lois
Diabetes in Older Adults Diabetes Care 32:1119–1131, 2009 B. Jovanovic, Siri I. Kjos, Robert H. Knopp,
M. Sue Kirkman, Vanessa Jones Briscoe, Martin N. Montoro, Edward S. Ogata,
Nathaniel Clark, Hermes Florez, Linda B. Hyperglycemic Crises in Adult Pa- Pathmaja Paramsothy, Diane M. Reader,
Haas, Jeffrey B. Halter, Elbert S. Huang, tients With Diabetes Barak M. Rosenn, Alyce M. Thomas, and
Mary T. Korytkowski, Medha N. Munshi, Abbas E. Kitabchi, Guillermo E. Umpierrez, M. Sue Kirkman
Peggy Soule Odegard, Richard E. Pratley, John M. Miles, and Joseph N. Fisher Diabetes Care 31:1060–1079, 2008
and Carrie S. Swift Diabetes Care 32:1335–1343, 2009
Diabetes Care 35:2650–2664, 2012
How Do We Define Cure of Diabetes? Influence of Race, Ethnicity, and
The Charcot Foot in Diabetes John B. Buse, Sonia Caprio, William T. Culture on Childhood Obesity: Implica-
Lee C. Rogers, Robert G. Frykberg, David Cefalu, Antonio Ceriello, Stefano Del tions for Prevention and Treatment:
G. Armstrong, Andrew J.M. Boulton, Prato, Silvio E. Inzucchi, Sue McLaughlin, A Consensus Statement of Shaping
Michael Edmonds, Georges Ha Van, Gordon L. Phillips II, R. Paul Robertson, America’s Health and the Obesity
Agnes Hartemann, Frances Game, William Francesco Rubino, Richard Kahn, and M. Society
Jeffcoate, Alexandra Jirkovska, Edward Jude, Sue Kirkman Sonia Caprio, Stephen R. Daniels, Adam
Drewnowski, Francine R. Kaufman, Law-
Stephan Morbach, William B. Morrison, Diabetes Care 32:2133–2135, 2009
rence A. Palinkas, Arlan L. Rosenbloom,
Michael Pinzur, Dario Pitocco, Lee Sanders,
Dane K. Wukich, and Luigi Uccioli and Jeffrey B. Schwimmer
Lipoprotein Management in Patients Diabetes Care 31:2211–2221, 2008
Diabetes Care 34:2123–2129, 2011 With Cardiometabolic Risk: Consen-
sus Statement From the American Di-
Diabetes and Cancer abetes Association and the American Screening for Coronary Artery
Edward Giovannucci, David M. Harlan, College of Cardiology Foundation Disease in Patients With Diabetes
Michael C. Archer, Richard M. Bergenstal, John D. Brunzell, Michael Davidson, Curt Jeroen J. Bax, Lawrence H. Young,
Susan M. Gapstur, Laurel A. Habel, Mi- D. Furberg, Ronald B. Goldberg, Barbara Robert L. Frye, Robert O. Bonow,
chael Pollak, Judith G. Regensteiner, and V. Howard, James H. Stein, and Joseph L. Helmut O. Steinberg, and Eugene J.
Douglas Yee Witztum Barrett
Diabetes Care 33:1674–1685, 2010 Diabetes Care 31:811–822, 2008 Diabetes Care 30:2729–2736, 2007

e2 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org


Position Statements

A position statement is an official point Diabetes Care for Emerging Adults: Medicine and the American Diabetes
of view or belief of the ADA. Position Recommendations for Transition Association: Joint Position
statements are issued on scientific or From Pediatric to Adult Diabetes Statement
medical issues related to diabetes. They Care Systems. A Position Statement Sheri R. Colberg, Ronald J. Sigal, Bo Fern-
may be authored or unauthored and are of the American Diabetes hall, Judith G. Regensteiner, Bryan J.
published in ADA journals and other Association, With Representation by Blissmer, Richard R. Rubin, Lisa Chasan-
scientific/medical publications as appro- the American College of Osteopathic Taber, Ann L. Albright, and Barry Braun
priate. Position statements must be re- Family Physicians, the American Diabetes Care 33:e147–e167, 2010
viewed and approved by the Professional Academy of Pediatrics, the
Practice Committee and, subsequently, American Association of Clinical Clinical Care Guidelines for Cystic
by the Executive Committee of the Board Endocrinologists, the American Fibrosis–Related Diabetes: A
of Directors. ADA position statements are Osteopathic Association, the Position Statement of the American
typically based on a technical review or Centers for Disease Control and Diabetes Association and a Clinical
other review of published literature. They Prevention, Children with Diabetes, Practice Guideline of the Cystic
are reviewed on an annual basis and upda- The Endocrine Society, the Fibrosis Foundation, Endorsed by
ted as needed. In addition to those pub- International Society for Pediatric the Pediatric Endocrine Society
lished in this supplement, listed below are and Adolescent Diabetes, Juvenile Antoinette Moran, Carol Brunzell, Richard
recent position statements. Diabetes Research Foundation C. Cohen, Marcia Katz, Bruce C. Marshall,
International, the National Diabetes Gary Onady, Karen A. Robinson, Kathryn A.
Diabetes Management at Camps for Education Program, and the Sabadosa, Arlene Stecenko, Bonnie Slovis,
Children With Diabetes Pediatric Endocrine Society (formerly and the CFRD Guidelines Committee
American Diabetes Association Lawson Wilkins Pediatric Endocrine Diabetes Care 33:2697–2708, 2010
Diabetes Care 35 (Suppl. 1):S72–S75, Society)
2012 Anne Peters, Lori Laffel, and the American Intensive Glycemic Control and the
Diabetes Association Transitions Work- Prevention of Cardiovascular Events:
Management of Hyperglycemia in ing Group Implications of the ACCORD,
Type 2 Diabetes: A Patient-Centered Diabetes Care 34:2477–2485, 2011 ADVANCE, and VA Diabetes Trials.
Approach. Position Statement of the A Position Statement of the
American Diabetes Association Aspirin for Primary Prevention of American Diabetes Association and
(ADA) and the European Association Cardiovascular Events in People a Scientific Statement of the
for the Study of Diabetes (EASD) With Diabetes: A Position Statement American College of Cardiology
Silvio E. Inzucchi, Richard M. Bergenstal, of the American Diabetes Foundation and the American Heart
John B. Buse, Michaela Diamant, Ele Association, a Scientific Statement Association
Ferrannini, Michael Nauck, Anne L. of the American Heart Association, Jay S. Skyler, Richard Bergenstal, Robert
Peters, Apostolos Tsapas, Richard and an Expert Consensus Document O. Bonow, John Buse, Prakash Deedwania,
Wender, and David R. Matthews of the American College of Edwin A.M. Gale, Barbara V. Howard,
Diabetes Care 35:1364–1379, 2012 Cardiology Foundation M. Sue Kirkman, Mikhail Kosiborod, Peter
Michael Pignone, Mark J. Alberts, John A. Reaven, and Robert S. Sherwin
Guidelines and Recommendations for Colwell, Mary Cushman, Silvio E. Inzuc- Diabetes Care 32:187–192, 2009
Laboratory Analysis in the Diagnosis chi, Debabrata Mukherjee, Robert S.
and Management of Diabetes Mellitus Rosenson, Craig D. Williams, Peter W. Nutrition Recommendations and
David B. Sacks, Mark Arnold, George L. Wilson, and M. Sue Kirkman Interventions for Diabetes: A Position
Bakris, David E. Bruns, Andrea Rita Diabetes Care 33:1395–1402, 2010 Statement of the American Diabetes
Horvath, M. Sue Kirkman, Ake Lernmark, Association
Boyd E. Metzger, and David M. Nathan Exercise and Type 2 Diabetes. American Diabetes Association
Diabetes Care 34:e61–e99, 2011 The American College of Sports Diabetes Care 31 (Suppl. 1):S61–S78, 2008

care.diabetesjournals.org DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 e3


Scientific Statements

A scientific statement is a scholarly syn- American Heart Association and the Group of the American Diabetes
opsis of a topic related to diabetes, which American Diabetes Association Association, With Endorsement by
may or may not contain clinical or research Christopher Gardner, Judith Wylie- the American Association of Clinical
recommendations. Any recommenda- Rosett, Samuel S. Gidding, Lyn M. Steffen, Endocrinologists
tions included represent the official Rachel K. Johnson, Diane Reader, and Andrew J.M. Boulton, David G. Armstrong,
point of view or belief of the ADA. Alice H. Lichtenstein, on behalf of the Stephen F. Albert, Robert G. Frykberg,
Work Group Reports and Task Force American Heart Association Nutrition Richard Hellman, M. Sue Kirkman,
Reports fall into this category. Scientific Committee of the Council on Nutrition, Lawrence A. Lavery, Joseph W. LeMaster,
statements must be reviewed and ap- Physical Activity and Metabolism, Coun- Joseph L. Mills, Sr., Michael J. Mueller,
proved by the Professional Practice cil on Arteriosclerosis, Thrombosis and Peter Sheehan, and Dane K. Wukich
Committee and, subsequently, by the Vascular Biology, Council on Cardiovas- Diabetes Care 31:1679–1685, 2008
Executive Committee of the Board of cular Disease in the Young, and the
Directors. Listed below are recent scien- American Diabetes Association American Diabetes Association
tific statements. Diabetes Care 35:1798–1808, 2012 Statement on Emergency and
Disaster Preparedness: A Report of
Nonnutritive Sweeteners: Current Comprehensive Foot Examination the Disaster Response Task Force
Use and Health Perspectives. A and Risk Assessment: A Report of the The Disaster Response Task Force
Scientific Statement From the Task Force of the Foot Care Interest Diabetes Care 30:2395–2398, 2007

e4 DIABETES CARE, VOLUME 36, SUPPLEMENT 1, JANUARY 2013 care.diabetesjournals.org

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