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Introduction

T
he American Diabetes Association They are reviewed on an annual basis and Professional Practice Committee. The
(ADA) has been actively involved in updated as needed. A list of recent posi- Associations Professional Practice
the development and dissemination tion statements is included on p. e114 of Committee is responsible for reviewing
of diabetes care standards, guidelines, and this supplement. ADA systematic reviews and position
related documents for many years. These statements, as well as for overseeing
statements are published in one or more Systematic review. A balanced review revisions of the latter as needed. Ap-
of the Associations professional journals. and analysis of the literature on a scien- pointment to the Professional Practice
This supplement contains the latest up- tic or medical topic related to diabetes. Committee is based on excellence in
date of ADAs major position statement, Effective January 2010, technical reviews clinical practice and/or research. The
Standards of Medical Care in Diabetes, are replaced with systematic reviews, for committee comprises physicians, diabe-
which contains all of the Associations key which a priori search and inclusion/ tes educators, registered dietitians, and
recommendations. In addition, contained exclusion criteria are developed and pub- others who have expertise in a range of
herein are selected position statements on lished. The systematic review provides a areas, including adult and pediatric
certain topics not adequately covered in scientic rationale for a position state- endocrinology, epidemiology, and pub-
the Standards. ADA hopes that this is a ment and undergoes critical peer review lic health, lipid research, hypertension,
convenient and important resource for all before submission to the Professional and preconception and pregnancy care.
health care professionals who care for Practice Committee for approval. A list All members of the Professional Practice
people with diabetes. of past technical reviews is included on Committee are required to disclose po-
ADA Clinical Practice Recommenda- page e110 of this supplement. tential conicts of interest (listed on
tions consist of position statements that page S109).
represent ofcial ADA opinion as denoted Consensus report. A comprehensive ex-
by formal review and approval by the amination by a panel of experts (i.e., con- Grading of scientic evidence. There
Professional Practice Committee and the sensus panel) of a scientic or medical has been considerable evolution in the
Executive Committee of the Board of issue related to diabetes. Effective January evaluation of scientic evidence and in
Directors. Consensus reports and system- 2010, consensus statements were re- the development of evidence-based
atic reviews are not ofcial ADA recom- named consensus reports. The category guidelines since the ADA rst began
mendations; however, they are produced now also includes task force, workgroup, publishing practice guidelines. Accord-
under the auspices of the Association by and expert committee reports. Consensus ingly, we developed a classication sys-
invited experts. These publications may reports do not have the Associations tem to grade the quality of scientic
be used by the Professional Practice Com- name included in the title or subtitle and evidence supporting ADA recommenda-
mittee as source documents to update the include a disclaimer in the introduction tions for all new and revised ADA position
Standards. stating that any recommendations are not statements.
ADA has adopted the following def- ADA position. A consensus report is typi- Recommendations are assigned rat-
initions for its clinically related reports. cally developed immediately following a ings of A, B, or C, depending on the
consensus conference at which presenta- quality of evidence (Table 1). Expert
ADA position statement. An ofcial tions are made on the issue under review. opinion (E) is a separate category for
point of view or belief of the ADA. The statement represents the panels col- recommendations in which there is as
Position statements are issued on scien- lective analysis, evaluation, and opinion at yet no evidence from clinical trials, in
tic or medical issues related to diabetes. that point in time based in part on the which clinical trials may be impractical,
They may be authored or unauthored and conference proceedings. The need for a or in which there is conicting evidence.
are published in ADA journals and other consensus report arises when clinicians or Recommendations with an A rating
scientic/medical publications as appro- scientists desire guidance on a subject for are based on large well-designed clinical
priate. Position statements must be re- which the evidence is contradictory or in- trials or well-done meta-analyses. Gen-
viewed and approved by the Professional complete. Once written by the panel, a erally, these recommendations have the
Practice Committee and, subsequently, consensus report is not subject to subse- best chance of improving outcomes
by the Executive Committee of the Board quent review or approval and does not when applied to the population to
of Directors. ADA position statements are represent ofcial Association opinion. A which they are appropriate. Recommen-
typically based on a systematic review list of recent consensus reports is included dations with lower levels of evidence
or other review of published literature. on p. e112 of this supplement. may be equally important but are not
as well supported. The level of evidence
supporting a given recommendation is
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c noted either as a heading for a group of
recommendations or in parentheses
DOI: 10.2337/dc12-s001.
2012 by the American Diabetes Association. Readers may use this article as long as the work is properly after a given recommendation.
cited, the use is educational and not for prot, and the work is not altered. See http://creativecommons.org/ Of course, evidence is only one compo-
licenses/by-nc-nd/3.0/ for details. nent of clinical decision-making. Clinicians

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S1


Introduction

Table 1dADA evidence-grading system for clinical practice recommendations care for patients, not populations;
guidelines must always be interpreted
Level of with the needs of the individual patient
evidence Description in mind. Individual circumstances,
such as comorbid and coexisting dis-
A Clear evidence from well-conducted, generalizable, randomized controlled trials eases, age, education, disability, and,
that are adequately powered, including: above all, patients values and prefer-
c Evidence from a well-conducted multicenter trial ences, must also be considered and may
c Evidence from a meta-analysis that incorporated quality ratings in the lead to different treatment targets and
analysis strategies. Also, conventional evidence
Compelling nonexperimental evidence, i.e., the all or none rule developed by hierarchies, such as the one adapted by
the Centre for Evidence-Based Medicine at Oxford the ADA, may miss some nuances that
Supportive evidence from well-conducted randomized controlled trials that are are important in diabetes care. For
adequately powered, including: example, while there is excellent evi-
c Evidence from a well-conducted trial at one or more institutions dence from clinical trials supporting the
c Evidence from a meta-analysis that incorporated quality ratings in the importance of achieving glycemic con-
analysis trol, the optimal way to achieve this
B Supportive evidence from well-conducted cohort studies, including: result is less clear. It is difcult to assess
c Evidence from a well-conducted prospective cohort study or registry each component of such a complex
c Evidence from a well-conducted meta-analysis of cohort studies intervention.
Supportive evidence from a well-conducted case-control study ADA will continue to improve and
C Supportive evidence from poorly controlled or uncontrolled studies, including: update the Clinical Practice Recommen-
c Evidence from randomized clinical trials with one or more major or three or more dations to ensure that clinicians, health
minor methodological aws that could invalidate the results plans, and policymakers can continue to
c Evidence from observational studies with high potential for bias (such as case rely on them as the most authoritative and
series with comparison to historical controls) current guidelines for diabetes care. Our
c Evidence from case series or case reports Clinical Practice Recommendations are
Conicting evidence with the weight of evidence supporting the recommendation also available on the Associations website
E Expert consensus or clinical experience at www.diabetes.org/diabetescare.

S2 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


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

Summary of Revisions for the 2012


Clinical Practice Recommendations

Additions to the Standards to clarify recommendations, the follow- c Section X. Strategies for Improving
of Medical Care in ing sections have undergone major Diabetes Care was revised to reect
Diabetesd2012 changes: growing evidence for the effectiveness
c A section on driving and diabetes has of restructuring systems of chronic care
been added. c The Introduction was revised to more delivery.
c A section and table on common co- clearly describe processes for system-
morbidities of diabetes has been added. atic evidence review, to link to the ev-
c A table listing properties of noninsulin idence table for changes since 2011, Revised Position Statement
therapies for hyperglycemia in type 2 and to link to opportunities for public cA revised position statement, Diabetes
diabetes has been added. comment on the Standards of Medical Management at Camps for Children
Care in Diabetesd2012. with Diabetes, has been added.
Revisions to the Standards c Section V.D.2. Therapy for Type 2 Di-
of Medical Care in abetes was revised to include more spe-
Diabetesd2012 cic recommendations for starting and New Position Statement
In addition to many small changes related advancing pharmacotherapy for hyper- c A new position statement, Driving and
to new evidence since the prior year, and glycemia. Diabetes, has been added.

c c c c c c c c c c c c c c c c c c c c c c c c c 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/dc12-s003
2012 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 prot, and the work is not altered. See http://creativecommons.org/
licenses/by-nc-nd/3.0/ for details.

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S3


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

Executive Summary: Standards of


Medical Care in Diabetesd2012

Current criteria for the c In those identied with increased risk those with IGT (A), IFG (E), or an A1C of
diagnosis of diabetes for future diabetes, identify and, if ap- 5.76.4% (E), especially for those with
c A1C $6.5%. The test should be per- propriate, treat other cardiovascular dis- BMI .35 kg/m2, those aged ,60 years,
formed in a laboratory using a method ease (CVD) risk factors. (B) and those with prior GDM. (A)
that is National Glycohemoglobin Stan- c At least annual monitoring for the de-
dardization Program (NGSP)-certied Detection and diagnosis of velopment of diabetes in those with
and standardized to the Diabetes Con- gestational diabetes prediabetes is suggested. (E)
trol and Complications Trial (DCCT) mellitus (GDM)
assay; or c Screen for undiagnosed type 2 diabetes Glucose monitoring
c fasting plasma glucose (FPG) $126 at the rst prenatal visit in those with c Self-monitoring of blood glucose (SMBG)
mg/dL (7.0 mmol/l). Fasting is de- risk factors, using standard diagnostic should be carried out three or more
ned as no caloric intake for at least criteria. (B) times daily for patients using multiple
8 h; or c In pregnant women not previously insulin injections or insulin pump ther-
c 2-h plasma glucose $200 mg/dL (11.1 known to have diabetes, screen for apy. (B)
mmol/l) during an oral glucose toler- GDM at 24-28 weeks gestation, using a c For patients using less frequent insulin
ance test (OGTT). The test should be 75-g 2-h OGTT and the diagnostic injections, noninsulin therapies, or med-
performed as described by the World cutpoints in Table 6 of the Standards ical nutrition therapy (MNT) alone,
Health Organization, using a glucose of Medical Care in Diabetesd2012. SMBG may be useful as a guide to man-
load containing the equivalent of 75 g (B) agement. (E)
anhydrous glucose dissolved in wa- c Screen women with GDM for persistent c To achieve postprandial glucose tar-
ter; or diabetes at 612 weeks postpartum, gets, postprandial SMBG may be ap-
c in a patient with classic symptoms of using a test other than A1C. (E) propriate. (E)
hyperglycemia or hyperglycemic crisis, c Women with a history of GDM should c When prescribing SMBG, ensure that
a random plasma glucose $200 mg/dL have lifelong screening for the devel- patients receive initial instruction in,
(11.1 mmol/l); opment of diabetes or prediabetes at and routine follow-up evaluation of,
c in the absence of unequivocal hypergly- least every 3 years. (B) SMBG technique and their ability to
cemia, the result should be conrmed by c Women with a history of GDM found use data to adjust therapy. (E)
repeat testing. to have prediabetes should receive c Continuous glucose monitoring (CGM)
lifestyle interventions or metformin to in conjunction with intensive insulin
prevent diabetes. (A) regimens can be a useful tool to lower
Testing for diabetes in A1C in selected adults (age $25 years)
asymptomatic patients Prevention/delay of type 2 with type 1 diabetes. (A)
c Testing to detect type 2 diabetes and to diabetes c Although the evidence for A1C-lowering
assess risk for future diabetes in asymp- c Patients with IGT (A), IFG (E), or an is less strong in children, teens, and
tomatic people should be considered in A1C of 5.76.4% (E) should be re- younger adults, CGM may be helpful in
adults of any age who are overweight or ferred to an effective ongoing sup- these groups. Success correlates with
obese (BMI $25 kg/m2) and who have port program targeting weight loss of adherence to ongoing use of the de-
one or more additional risk factors for 7% of body weight and increasing vice. (C)
diabetes (see Table 4 of the Standards physical activity to at least 150 min c CGM may be a supplemental tool to
of Medical Care in Diabetesd2012). In per week of moderate activity such as SMBG in those with hypoglycemia un-
those without these risk factors, testing walking. awareness and/or frequent hypoglyce-
should begin at age 45 years. (B) c Follow-up counseling appears to be mic episodes. (E)
c If tests are normal, repeat testing at important for success. (B)
least at 3-year intervals is reasonable. c Based on the cost-effectiveness of dia- A1C
(E) betes prevention, such programs should c Perform the A1C test at least two times
c To test for diabetes or to assess risk of be covered by third-party payers. (B) a year in patients who are meeting treat-
future diabetes, A1C, FPG, or 2-h 75-g c Metformin therapy for prevention of ment goals (and who have stable glyce-
OGTT are appropriate. (B) type 2 diabetes may be considered in mic control). (E)
c Perform the A1C test quarterly in pa-

c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c tients whose therapy has changed or


who are not meeting glycemic goals. (E)
DOI: 10.2337/dc12-s004
c Use of point-of-care testing for A1C
2012 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 prot, and the work is not altered. See http://creativecommons.org/ provides the opportunity for more timely
licenses/by-nc-nd/3.0/ for details. treatment changes. (E)

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Executive Summary

Glycemic goals in adults Recommendations for energy moderate amount (one drink per day or
c Lowering A1C to below or around 7% balance, overweight, and obesity less for adult women and two drinks per
has been shown to reduce microvascular c Weight loss is recommended for all day or less for adult men) and should
complications of diabetes, and if im- overweight or obese individuals who take extra precautions to prevent hypo-
plemented soon after the diagnosis of have or are at risk for diabetes. (A) glycemia. (E)
diabetes is associated with long-term c For weight loss, either low-carbohydrate, c Routine supplementation with anti-
reduction in macrovascular disease. low-fat calorie-restricted, or Mediterra- oxidants, such as vitamins E and C and
Therefore, a reasonable A1C goal for nean diets may be effective in the short carotene, is not advised because of lack
many nonpregnant adults is ,7%. (B) term (up to 2 years). (A) of evidence of efcacy and concern re-
c Providers might reasonably suggest more c For patients on low-carbohydrate di- lated to long-term safety. (A)
stringent A1C goals (such as ,6.5%) for ets, monitor lipid proles, renal func- c It is recommended that individualized
selected individual patients, if this can tion, and protein intake (in those with meal planning include optimization of
be achieved without signicant hypo- nephropathy) and adjust hypoglyce- food choices to meet recommended
glycemia or other adverse effects of mic therapy as needed. (E) daily allowance (RDA)/dietary reference
treatment. Appropriate patients might c Physical activity and behavior modi- intake (DRI) for all micronutrients. (E)
include those with short duration of cation are important components of
diabetes, long life expectancy, and no weight loss programs and are most help- Diabetes self-management
signicant CVD. (C) ful in maintenance of weight loss. (B) education (DSME)
c Less stringent A1C goals (such as c People with diabetes should receive
,8%) may be appropriate for patients Recommendations for primary DSME according to national standards
with a history of severe hypoglycemia, prevention of diabetes and diabetes self-management support
limited life expectancy, advanced micro- c Among individuals at high risk for de- at the time their diabetes is diagnosed
vascular or macrovascular complications, veloping type 2 diabetes, structured pro- and as needed thereafter. (B)
and extensive comorbid conditions and grams that emphasize lifestyle changes c Effective self-management and quality
for those with longstanding diabetes that include moderate weight loss (7% of life are the key outcomes of DSME
in whom the general goal is difcult to body weight) and regular physical ac- and should be measured and moni-
attain despite diabetes self-management tivity (150 min/week), with dietary tored as part of care. (C)
education, appropriate glucose moni- strategies that include reduced calories c DSME should address psychosocial is-
toring, and effective doses of multiple and reduced intake of dietary fat, can sues, since emotional wellbeing is associ-
glucose-lowering agents including in- reduce the risk for developing diabetes ated with positive diabetes outcomes. (C)
sulin. (B) and are therefore recommended. (A) c Because DSME can result in cost-savings
c Individuals at risk for type 2 diabetes and improved outcomes (B), DSME
Therapy for type 2 diabetes should be encouraged to achieve the U.S. should be adequately reimbursed by
c At the time of type 2 diabetes diagnosis, Department of Agriculture (USDA) rec- third-party payers. (E)
initiate metformin therapy along with ommendation for dietary ber (14 g ber/
lifestyle interventions, unless metformin 1,000 kcal) and foods containing whole Physical activity
is contraindicated. (A) grains (one-half of grain intake). (B) c People with diabetes should be advised
c In newly diagnosed type 2 diabetic c Individuals at risk for type 2 diabetes to perform at least 150 min/week of
patients with markedly symptomatic should be encouraged to limit their moderate-intensity aerobic physical ac-
and/or elevated blood glucose levels or intake of sugar-sweetened beverages. (B) tivity (5070% of maximum heart rate),
A1C, consider insulin therapy, with or spread over at least 3 days per week with
without additional agents, from the out- Recommendations for management no more than 2 consecutive days with-
set. (E) of diabetes out exercise. (A)
c If noninsulin monotherapy at maxi- Macronutrients in diabetes management c In the absence of contraindications,
mal tolerated dose does not achieve c The mix of carbohydrate, protein, and people with type 2 diabetes should be
or maintain the A1C target over 36 fat may be adjusted to meet the meta- encouraged to perform resistance train-
months, add a second oral agent, a GLP-1 bolic goals and individual preferences ing at least twice per week. (A)
receptor agonist, or insulin. (E) of the person with diabetes. (C)
c Monitoring carbohydrate intake, whether Psychosocial assessment
Medical nutrition therapy by carbohydrate counting, choices, or and care
(MNT) experience-based estimation, remains a c It is reasonable to include assessment
General Recommendations key strategy in achieving glycemic con- of the patients psychological and so-
c Individuals who have prediabetes or trol. (B) cial situation as an ongoing part of the
diabetes should receive individualized c Saturated fat intake should be ,7% of medical management of diabetes. (E)
MNT as needed to achieve treatment total calories. (B) c Psychosocial screening and follow-up
goals, preferably provided by a regis- c Reducing intake of trans fat lowers LDL may include, but is not limited to, atti-
tered dietitian familiar with the com- cholesterol and increases HDL choles- tudes about the illness, expectations for
ponents of diabetes MNT. (A) terol (A); therefore intake of trans fat medical management and outcomes,
c Because MNT can result in cost-savings should be minimized. (E) affect/mood, general and diabetes-related
and improved outcomes (B), MNT should Other nutrition recommendations. quality of life, resources (nancial, so-
be adequately covered by insurance c If adults with diabetes choose to use cial, and emotional), and psychiatric
and other payers. (E) alcohol, they should limit intake to a history. (E)

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S5


Executive Summary

c Consider screening for psychosocial prob- c Administer pneumococcal polysaccharide c Patients with diabetes and hypertension
lems such as depression and diabetes- vaccine to all diabetic patients $2 years should be treated with a pharmacologic
related distress, anxiety, eating disorders, of age. A one-time revaccination is rec- therapy regimen that includes either an
and cognitive impairment when self- ommended for individuals .64 years of ACE inhibitor or an ARB). If one class is
management is poor. (C) age previously immunized when they not tolerated, the other should be
were ,65 years of age if the vaccine substituted. (C)
Hypoglycemia was administered .5 years ago. Other c Multiple drug therapy (two or more
c Glucose (1520 g) is the preferred treat- indications for repeat vaccination in- agents at maximal doses) is generally
ment for the conscious individual with clude nephrotic syndrome, chronic renal required to achieve blood pressure tar-
hypoglycemia, although any form of car- disease, and other immunocompro- gets. (B)
bohydrate that contains glucose may be mised states, such as after transplan- c Administer one or more antihyperten-
used. If SMBG 15 min after treatment tation. (C) sive medications at bedtime. (A)
shows continued hypoglycemia, the treat- c Administer hepatitis B vaccination to c If ACE inhibitors, ARBs, or diuretics are
ment should be repeated. Once SMBG adults with diabetes as per Centers for used, kidney function and serum potas-
glucose returns to normal, the individual Disease Control and Prevention (CDC) sium levels should be monitored. (E)
should consume a meal or snack to pre- recommendations. (C) c In pregnant patients with diabetes and
vent recurrence of hypoglycemia. (E) chronic hypertension, blood pressure tar-
c Glucagon should be prescribed for all Hypertension/blood get goals of 110129/6579 mmHg are
individuals at signicant risk of severe pressure control suggested in the interest of long-term
hypoglycemia, and caregivers or family Screening and diagnosis maternal health and minimizing impaired
members of these individuals should be c Blood pressure should be measured at fetal growth. ACE inhibitors and ARBs
instructed in its administration. Gluca- every routine diabetes visit. Patients found are contraindicated during pregnancy. (E)
gon administration is not limited to to have systolic blood pressure $130
health care professionals. (E) mmHg or diastolic blood pressure $80 Dyslipidemia/lipid
c Individuals with hypoglycemia un- mmHg should have blood pressure management
awareness or one or more episodes of conrmed on a separate day. Repeat Screening
severe hypoglycemia should be advised systolic blood pressure $130 mmHg or c In most adult patients, measure fasting
to raise their glycemic targets to strictly diastolic blood pressure $80 mmHg lipid prole at least annually. In adults
avoid further hypoglycemia for at least conrms a diagnosis of hypertension. (C) with low-risk lipid values (LDL choles-
several weeks, to partially reverse hy- terol ,100 mg/dL, HDL cholesterol .50
poglycemia unawareness and reduce Goals mg/dL, and triglycerides ,150 mg/dL),
risk of future episodes. (B) c A goal systolic blood pressure ,130 lipid assessments may be repeated every
mmHg is appropriate for most patients 2 years. (E)
Bariatric surgery with diabetes. (C)
c Bariatric surgery may be considered for c Based on patient characteristics and Treatment recommendations
adults with BMI .35 kg/m2 and type 2 response to therapy, higher or lower and goals
diabetes, especially if the diabetes or systolic blood pressure targets may be c Lifestyle modication focusing on the
associated comorbidities are difcult to appropriate. (B) reduction of saturated fat, trans fat, and
control with lifestyle and pharmaco- c Patients with diabetes should be trea- cholesterol intake; increase of n-3 fatty
logic therapy. (B) ted to a diastolic blood pressure ,80 acids, viscous ber and plant stanols/
c Patients with type 2 diabetes who have mmHg. (B) sterols; weight loss (if indicated); and
undergone bariatric surgery need life- increased physical activity should be
long lifestyle support and medical mon- Treatment recommended to improve the lipid
itoring. (B) c Patients with a systolic blood pressure prole in patients with diabetes. (A)
c Although small trials have shown glyce- of 130139 mmHg or a diastolic blood c Statin therapy should be added to life-
mic benet of bariatric surgery in patients pressure of 8089 mmHg may be given style therapy, regardless of baseline lipid
with type 2 diabetes and BMI of 30 lifestyle therapy alone for a maximum levels, for diabetic patients:
35 kg/m2, there is currently insufcient of 3 months and then, if targets are not
c with overt CVD. (A)
evidence to generally recommend sur- achieved, may be treated with the ad-
c without CVD who are over the age of
gery in patients with BMI ,35 kg/m2 dition of pharmacological agents. (E)
40 years and have one or more other
outside of a research protocol. (E) c Patients with more severe hypertension
CVD risk factors. (A)
c The long-term benets, cost-effectiveness, (systolic blood pressure $140 or di-
and risks of bariatric surgery in indi- astolic blood pressure $90 mmHg) at c For lower-risk patients than the above
viduals with type 2 diabetes should be diagnosis or follow-up should receive (e.g., without overt CVD and under the
studied in well-designed controlled trials pharmacologic therapy in addition to age of 40 years), statin therapy should
with optimal medical and lifestyle ther- lifestyle therapy. (A) be considered in addition to lifestyle
apy as the comparator. (E) c Lifestyle therapy for hypertension con- therapy if LDL cholesterol remains .100
sists of weight loss, if overweight; DASH- mg/dL or in those with multiple CVD
Immunization style dietary pattern, including reducing risk factors. (E)
c Annually provide an inuenza vaccine sodium and increasing potassium in- c In individuals without overt CVD, the
to all diabetic patients $6 months of take; moderation of alcohol intake; and primary goal is LDL cholesterol ,100
age. (C) increased physical activity. (B) mg/dL (2.6 mmol/l). (A)

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Executive Summary

c In individuals with overt CVD, a lower c Include smoking cessation counsel- either ACE inhibitors or ARBs should be
LDL cholesterol goal of ,70 mg/dL ing and other forms of treatment as used. (A)
(1.8 mmol/l), using a high dose of a a routine component of diabetes care. c If one class is not tolerated, the other
statin, is an option. (B) (B) should be substituted. (E)
c If drug-treated patients do not reach c Reduction of protein intake to 0.81.0
the above targets on maximal tolerated Coronary heart disease (CHD) g z kg body wt21 z day21 in individuals
statin therapy, a reduction in LDL cho- screening and treatment with diabetes and the earlier stages of
lesterol of ;3040% from baseline is an Screening CKD and to 0.8 g z kg body wt21 z day21
alternative therapeutic goal. (A) c In asymptomatic patients, routine screen- in the later stages of CKD may improve
c Triglycerides levels ,150 mg/dL (1.7 ing for coronary artery disease (CAD) is measures of renal function (UAE rate,
mmol/l) and HDL cholesterol .40 mg/ not recommended, as it does not im- GFR) and is recommended. (B)
dL (1.0 mmol/l) in men and .50 mg/dL prove outcomes as long as CVD risk c When ACE inhibitors, ARBs, or diuretics
(1.3 mmol/l) in women, are desirable. factors are treated. (A) are used, monitor serum creatinine
However, LDL cholesteroltargeted statin and potassium levels for the develop-
therapy remains the preferred strategy. (C) Treatment ment of increased creatinine and hy-
c If targets are not reached on maximally c In patients with known CVD, consider perkalemia. (E)
tolerated doses of statins, combination ACE inhibitor therapy (C) and use as- c Continued monitoring of UAE to assess
therapy using statins and other lipid- pirin and statin therapy (A) (if not both response to therapy and pro-
lowering agents may be considered to contraindicated) to reduce the risk of gression of disease is reasonable. (E)
achieve lipid targets but has not been cardiovascular events. In patients with a c When estimated GFR (eGFR) is ,60
evaluated in outcome studies for either prior myocardial infarction, b-blockers ml z min/1.73 m2, evaluate and manage
CVD outcomes or safety. (E) should be continued for at least 2 years potential complications of CKD. (E)
c Statin therapy is contraindicated in after the event. (B) c Consider referral to a physician ex-
pregnancy. (B) c Longer-term use of b-blockers in the perienced in the care of kidney dis-
absence of hypertension is reasonable if ease for uncertainty about the etiology
Antiplatelet agents well tolerated, but data are lacking. (E) of kidney disease, difcult manage-
c Consider aspirin therapy (75162 mg/ c Avoid TZD treatment in patients with ment issues, or advanced kidney dis-
day) as a primary prevention strategy in symptomatic heart failure. (C) ease. (B)
those with type 1 or type 2 diabetes at c Metformin may be used in patients with
increased cardiovascular risk (10-year stable congestive heart failure (CHF) if
risk .10%). This includes most men renal function is normal. It should be Retinopathy screening and
.50 years of age or women .60 years avoided in unstable or hospitalized pa- treatment
of age who have at least one additional tients with CHF. (C) General recommendations
major risk factor (family history of c To reduce the risk or slow the pro-
CVD, hypertension, smoking, dyslipi- Nephropathy screening gression of retinopathy, optimize gly-
demia, or albuminuria). (C) and treatment cemic control. (A)
c Aspirin should not be recommended c To reduce the risk or slow the progres-
General recommendations
for CVD prevention for adults with c To reduce the risk or slow the progres-
sion of retinopathy, optimize blood pres-
diabetes at low CVD risk (10-year CVD sion of nephropathy, optimize glucose sure control. (A)
risk ,5%, such as in men ,50 years control. (A)
and women ,60 years of age with no c To reduce the risk or slow the progres- Screening
major additional CVD risk factors), sion of nephropathy, optimize blood c Adults and children aged 10 years or
since the potential adverse effects from pressure control. (A) older with type 1 diabetes should have
bleeding likely offset the potential an initial dilated and comprehensive
benets. (C) eye examination by an ophthalmologist
c In patients in these age-groups with
Screening or optometrist within 5 years after the
c Perform an annual test to assess urine
multiple other risk factors (e.g., 10-year onset of diabetes. (B)
risk 510%), clinical judgment is re- albumin excretion (UAE) in type 1 di- c Patients with type 2 diabetes should
quired. (E) abetic patients with diabetes duration have an initial dilated and comprehen-
c Use aspirin therapy (75162 mg/day) as a
of $5 years and in all type 2 diabetic sive eye examination by an ophthalmol-
secondary prevention strategy in those patients starting at diagnosis. (B) ogist or optometrist shortly after the
c Measure serum creatinine at least annu-
with diabetes with a history of CVD. (A) diagnosis of diabetes. (B)
c For patients with CVD and documented
ally in all adults with diabetes regardless c Subsequent examinations for type 1
aspirin allergy, clopidogrel (75 mg/day) of the degree of UAE. The serum creati- and type 2 diabetic patients should be
should be used. (B) nine should be used to estimate glo- repeated annually by an ophthalmolo-
c Combination therapy with ASA (75
merular ltration rate (GFR) and stage gist or optometrist. Less-frequent exams
162 mg/day) and clopidogrel (75 mg/ the level of chronic kidney disease (every 23 years) may be considered
day) is reasonable for up to a year after (CKD), if present. (E) following one or more normal eye exams.
an acute coronary syndrome. (B) Examinations will be required more fre-
Treatment quently if retinopathy is progressing. (B)
Smoking cessation c In the treatment of the nonpregnant pa- c High-quality fundus photographs can de-
c Advise all patients not to smoke. (A) tient with micro- or macroalbuminuria, tect most clinically signicant diabetic

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S7


Executive Summary

retinopathy. Interpretation of the im- Foot care years of age and has had diabetes for 5
ages should be performed by a trained eye c For all patients with diabetes, perform years. (B)
care provider. While retinal photogra- an annual comprehensive foot exami- c Treatment with an ACE inhibitor, titrated
phy may serve as a screening tool for nation to identify risk factors predictive to normalization of albumin excretion,
retinopathy, it is not a substitute for a of ulcers and amputations. The foot should be considered when elevated
comprehensive eye exam, which should examination should include inspec- ACR is subsequently conrmed on
be performed at least initially and at in- tion, assessment of foot pulses, and two additional specimens from differ-
tervals thereafter as recommended by testing for loss of protective sensation ent days. (E)
an eye care professional. (E) (10-g monolament plus testing any
c Women with preexisting diabetes who one of the following: vibration using Hypertension
are planning pregnancy or who have 128-Hz tuning fork, pinprick sensa- c Initial treatment of high-normal blood
become pregnant should have a com- tion, ankle reexes, or vibration per- pressure (systolic or diastolic blood
prehensive eye examination and should ception threshold). (B) pressure consistently above the 90th per-
be counseled on the risk of development c Provide general foot self-care education centile for age, sex, and height) includes
and/or progression of diabetic retinopa- to all patients with diabetes. (B) dietary intervention and exercise, aimed
thy. Eye examination should occur in c A multidisciplinary approach is rec- at weight control and increased phys-
the rst trimester with close follow-up ommended for individuals with foot ical activity, if appropriate. If target
throughout pregnancy and for 1 year ulcers and high-risk feet, especially blood pressure is not reached with 36
postpartum. (B) those with a history of prior ulcer or months of lifestyle intervention, phar-
amputation. (B) macologic treatment should be consid-
c Refer patients who smoke, have loss of ered. (E)
Treatment
c Promptly refer patients with any level
protective sensation and structural ab- c Pharmacologic treatment of hyper-
normalities, or have history of prior tension (systolic or diastolic blood
of macular edema, severe nonproli-
lower-extremity complications to foot pressure consistently above the 95th
ferative diabetic retinopathy (NPDR),
care specialists for ongoing preventive percentile for age, sex, and height or
or any PDR to an ophthalmologist
who is knowledgeable and experienced
care and life-long surveillance. (C) consistently .130/80 mmHg, if 95%
c Initial screening for peripheral arterial exceeds that value) should be consid-
in the management and treatment of
disease (PAD) should include a history ered as soon as the diagnosis is con-
diabetic retinopathy. (A)
c Laser photocoagulation therapy is in-
for claudication and an assessment of rmed. (E)
the pedal pulses. Consider obtaining c ACE inhibitors should be considered
dicated to reduce the risk of vision loss
an ankle-brachial index (ABI), as many for the initial treatment of hyperten-
in patients with high-risk PDR, clini-
cally signicant macular edema, and patients with PAD are asymptomatic. (C) sion, following appropriate reproduc-
c Refer patients with signicant claudi- tive counseling due to the potential
some cases of severe NPDR. (A)
cation or a positive ABI for further vas- teratogenic effects. (E)
c The presence of retinopathy is not a
contraindication to aspirin therapy for cular assessment and consider exercise, c The goal of treatment is a blood pres-
cardioprotection, as this therapy does
medications, and surgical options. (C) sure consistently ,130/80 or below the
not increase the risk of retinal hemor- 90th percentile for age, sex, and height,
rhage. (A) Assessment of common whichever is lower. (E)
comorbid conditions
Neuropathy screening and Dyslipidemia
c For patients with risk factors, signs or
treatement Screening
c All patients should be screened for
symptoms, consider assessment and treat- c If there is a family history of hyper-
ment for common diabetes-associated
distal symmetric polyneuropathy (DPN) cholesterolemia or a cardiovascular
conditions (see Table 15 of the Stand-
starting at diagnosis of type 2 diabetes event before age 55 years, or if family
ards of Medical Care in Diabetesd
and 5 years after the diagnosis of type 1 history is unknown, then consider
2012). (B)
diabetes and at least annually thereafter, obtaining a fasting lipid prole on
using simple clinical tests. (B) children .2 years of age soon after
c Electrophysiological testing is rarely Children and adolescents diagnosis (after glucose control has
needed, except in situations where the Glycemic control been established). If family history is
clinical features are atypical. (E) c Consider age when setting glycemic goals not of concern, then consider the rst
c Screening for signs and symptoms of in children and adolescents with type 1 lipid screening at puberty ($10 years).
cardiovascular autonomic neuropathy diabetes. (E) For children diagnosed with diabetes
should be instituted at diagnosis of type at or after puberty, consider obtaining
2 diabetes and 5 years after the diagnosis Screening and management a fasting lipid prole soon after dia-
of type 1 diabetes. Special testing is of chronic complications in gnosis (after glucose control has been
rarely needed and may not affect man- children and adolescents established). (E)
agement or outcomes. (E) with type 1 diabetes c For both age-groups, if lipids are abnor-
c Medications for the relief of specic Nephropathy mal, annual monitoring is reasonable. If
symptoms related to painful DPN and c Annual screening for microalbuminuria, LDL cholesterol values are within the
autonomic neuropathy are recom- with a random spot urine sample for accepted risk levels (,100 mg/dL [2.6
mended, as they improve the quality of albumin-to-creatinine ratio (ACR), should mmol/l]), a lipid prole repeated every
life of the patient. (E) be considered once the child is 10 5 years is reasonable. (E)

S8 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Executive Summary

Treatment if the patient develops symptoms of may benet those with life expectancy at
c Initial therapy may consist of optimi- thyroid dysfunction, thyromegaly, or least equal to the time frame of primary or
zation of glucose control and MNT an abnormal growth rate. (E) secondary prevention trials. (E)
using a Step 2 American Heart Associ- c Screening for diabetes complications
ation Diet aimed at a decrease in the Transition from pediatric to adult care should be individualized in older adults,
amount of saturated fat in the diet. (E) c As teens transition into emerging adult- but particular attention should be paid to
c After the age of 10 years, the addition hood, health care providers and families complications that would lead to func-
of a statin in patients who, after MNT must recognize their many vulnerabi- tional impairment. (E)
and lifestyle changes, have LDL cho- lities (B) and prepare the developing
lesterol .160 mg/dL (4.1 mmol/l), or teen, beginning in early to mid adoles- Cystic brosisrelated
LDL cholesterol . 30 mg/dL (3.4 cence and at least one year prior to the diabetes (CFRD)
mmol/l) and one or more CVD risk transition. (E) c Annual screening for CFRD with OGTT
factors, is reasonable. (E) c Both pediatricians and adult health care should begin by age 10 years in all pa-
c The goal of therapy is an LDL choles- providers should assist in providing sup- tients with CF who do not have CFRD
terol value ,100 mg/dL (2.6 mmol/l). (E) port and links to resources for the teen (B). Use of A1C as a screening test for
and emerging adult. (B) CFRD is not recommended. (B)
Retinopathy c During a period of stable health the
c The rst ophthalmologic examination Preconception care diagnosis of CFRD can be made in CF
should be obtained once the child is c A1C levels should be as close to normal as patients according to usual diagnostic
$10 years of age and has had diabetes possible (,7%) in an individual patient criteria. (E)
for 35 years. (B) before conception is attempted. (B) c Patients with CFRD should be treated
c After the initial examination, annual c Starting at puberty, preconception coun- with insulin to attain individualized gly-
routine follow-up is generally recom- seling should be incorporated in the cemic goals. (A)
mended. Less-frequent examinations routine diabetes clinic visit for all women c Annual monitoring for complications
may be acceptable on the advice of an of childbearing potential. (C) of diabetes is recommended, beginning
eye care professional. (E) c Women with diabetes who are contem- 5 years after the diagnosis of CFRD. (E)
plating pregnancy should be evaluated
Celiac disease and, if indicated, treated for diabetic
c Consider screening children with type 1 retinopathy, nephropathy, neuropathy, Diabetes care in the hospital
c All patients with diabetes admitted to the
diabetes for celiac disease by measur- and CVD. (B)
ing tissue transglutaminase or antiendo- c Medications used by such women should
hospital should have their diabetes clearly
mysial antibodies, with documentation be evaluated prior to conception, since identied in the medical record. (E)
c All patients with diabetes should have
of normal total serum IgA levels, soon drugs commonly used to treat diabetes
after the diagnosis of diabetes. (E) and its complications may be contra- an order for blood glucose monitoring,
c Testing should be considered in chil- indicated or not recommended in preg- with results available to all members
dren with growth failure, failure to gain nancy, including statins, ACE inhibitors, of the health care team. (E)
c Goals for blood glucose levels:
weight, weight loss, diarrhea, atulence, ARBs, and most noninsulin therapies. (E)
abdominal pain, or signs of malabsorp- c Since many pregnancies are unplanned, Critically ill patients: Insulin ther-
tion, or in children with frequent un- consider the potential risks and benets apy should be initiated for treatment
explained hypoglycemia or deterioration of medications that are contraindicated of persistent hyperglycemia starting
in glycemic control. (E) in pregnancy in all women of childbear- at a threshold of no greater than 180
c Consider referral to a gastroenterolo- ing potential, and counsel women using mg/dL (10 mmol/L). Once insulin
gist for evaluation with endoscopy and such medications accordingly. (E) therapy is started, a glucose range of
biopsy for conrmation of celiac disease 140180 mg/dL (7.8 to 10 mmol/L) is
in asymptomatic children with positive Older adults recommended for the majority of
antibodies. (E) c Older adults who are functional, cog- critically ill patients. (A)
c Children with biopsy-conrmed celiac nitively intact, and have signicant life More stringent goals, such as 110
disease should be placed on a gluten- expectancy should receive diabetes care 140 mg/dL (6.17.8 mmol/l) may be
free diet and have consultation with a using goals developed for younger appropriate for selected patients, as
dietitian experienced in managing both adults. (E) long as this can be achieved without
diabetes and celiac disease. (B) c Glycemic goals for older adults not signicant hypoglycemia. (C)
meeting the above criteria may be re- Critically ill patients require an in-
Hypothyroidism laxed using individual criteria, but hy- travenous insulin protocol that has
c Consider screening children with type 1 perglycemia leading to symptoms or risk demonstrated efcacy and safety in
diabetes for thyroid disease using thyroid of acute hyperglycemic complications achieving the desired glucose range
peroxidase and thyroglobulin antibodies should be avoided in all patients. (E) without increasing risk for severe
soon after diagnosis. (E) c Other cardiovascular risk factors should hypoglycemia. (E)
c Measuring TSH concentrations soon be treated in older adults with consid- Noncritically ill patients: There is
after diagnosis of type 1 diabetes, after eration of the time frame of benet and no clear evidence for specic blood
metabolic control has been established, the individual patient. Treatment of hy- glucose goals. If treated with in-
is reasonable. If normal, consider re- pertension is indicated in virtually all sulin, premeal blood glucose targets
checking every 12 years, especially older adults, and lipid and aspirin therapy generally ,140 mg/dL (7.8 mmol/l)

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S9


Executive Summary

with random blood glucose ,180 octreotide or immunosuppressive medi- Strategies for improving care
mg/dL (10.0 mmol/l) are reasonable, cations. (B) If hyperglycemia is docu- c Care should be aligned with compo-
provided these targets can be safely mented and persistent, consider treating nents of the Chronic Care Model to
achieved. More stringent targets such patients to the same glycemic goals ensure productive interactions be-
may be appropriate in stable pa- as patients with known diabetes. (E) tween a prepared proactive practice
tients with previous tight glycemic c A hypoglycemia management protocol team and an informed activated pa-
control. Less stringent targets may be should be adopted and implemented tient. (A)
appropriate in those with severe co- by each hospital or hospital system. A c When feasible, care systems should
morbidites. (E) plan for preventing and treating hy- support team-based care, community
poglycemia should be established for involvement, patient registries, and
c Scheduled subcutaneous insulin with each patient. Episodes of hypoglycemia embedded decision support tools to
basal, nutritional, and correction com- in the hospital should be documented meet patient needs. (B)
ponents is the preferred method for in the medial record and tracked. (E) c Treatment decisions should be timely
achieving and maintaining glucose con- c Consider obtaining an A1C on patients and based on evidence-based guidelines
trol in noncritically ill patients. with diabetes admitted to the hospital that are tailored to individual patient
c Glucose monitoring should be initi- if the result of testing in the previous preferences, prognoses, and comorbid-
ated in any patient not known to be 23 months is not available. (E) ities. (B)
diabetic who receives therapy associ- c Patients with hyperglycemia in the c A patient centered communication style
ated with high-risk for hyperglycemia, hospital who do not have a prior di- should be employed that incorporates
including high-dose glucocorticoid agnosis of diabetes should have ap- patient preferences, assesses literacy and
therapy, initiation of enteral or parenteral propriate plans for follow-up testing numeracy, and addresses cultural bar-
nutrition, or other medications such as and care documented at discharge. (E) riers to care. (B)

S10 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 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


Diabetesd2012

D
iabetes mellitus is a chronic illness new evidence. For the current revision, c Type 1 diabetes (results from b-cell
that requires continuing medical care committee members systematically searched destruction, usually leading to absolute
and ongoing patient self-management Medline for human studies related to each insulin deciency)
education and support to prevent acute subsection and published since 1 January c Type 2 diabetes (results from a pro-
complications and to reduce the risk of 2010. Recommendations (bulleted at the gressive insulin secretory defect on the
long-term complications. Diabetes care is beginning of each subsection and also listed background of insulin resistance)
complex and requires that many issues, in the Executive Summary: Standards of c Other specic types of diabetes due to
beyond glycemic control, be addressed. Medical Care in Diabetesd2012) were re- other causes, e.g., genetic defects in b-cell
A large body of evidence exists that sup- vised based on new evidence or, in some function, genetic defects in insulin action,
ports a range of interventions to improve cases, to clarify the prior recommendation diseases of the exocrine pancreas (such as
diabetes outcomes. or match the strength of the wording to cystic brosis), and drug- or chemical-
These standards of care are intended the strength of the evidence. A table link- induced (such as in the treatment of HIV/
to provide clinicians, patients, researchers, ing the changes in recommendations to AIDS or after organ transplantation)
payers, and other interested individuals new evidence can be reviewed at http:// c Gestational diabetes mellitus (GDM)
with the components of diabetes care, professional.diabetes.org/CPR_Search. (diabetes diagnosed during pregnancy
general treatment goals, and tools to eval- aspx. Subsequently, as is the case for all that is not clearly overt diabetes)
uate the quality of care. While individual Position Statements, the standards of care
preferences, comorbidities, and other pa- were reviewed and approved by the Execu- Some patients cannot be clearly clas-
tient factors may require modication of tive Committee of ADAs Board of Directors, sied as having type 1 or type 2 diabetes.
goals, targets that are desirable for most which includes health care professionals, Clinical presentation and disease progres-
patients with diabetes are provided. Spe- scientists, and lay people. sion vary considerably in both types of
cically titled sections of the standards Feedback from the larger clinical com- diabetes. Occasionally, patients who oth-
address children with diabetes, pregnant munity was valuable for the 2012 revision erwise have type 2 diabetes may present
women, and people with prediabetes. These of the standards. Readers who wish to with ketoacidosis. Similarly, patients with
standards are not intended to preclude comment on the Standards of Medical type 1 may have a late onset and slow (but
clinical judgment or more extensive eval- Care in Diabetesd2012 are invited to do relentless) progression of disease despite
uation and management of the patient by so at http://professional.diabetes.org/ having features of autoimmune disease.
other specialists as needed. For more de- CPR_Search.aspx. Such difculties in diagnosis may occur
tailed information about management of Members of the Professional Practice in children, adolescents, and adults. The
diabetes, refer to references 13. Committee disclose all potential nancial true diagnosis may become more obvious
The recommendations included are conicts of interest with industry. These over time.
screening, diagnostic, and therapeutic ac- disclosures were discussed at the onset of
tions that are known or believed to favor- the standards revision meeting. Members of B. Diagnosis of diabetes
ably affect health outcomes of patients with the committee, their employer, and their Recommendations
diabetes. A large number of these interven- disclosed conicts of interest are listed in the For decades, the diagnosis of diabetes was
tions have been shown to be cost-effective Professional Practice Committee Members based on plasma glucose criteria, either
(4). A grading system (Table 1), developed table (see pg. S109). The American Diabetes the fasting plasma glucose (FPG) or the
by the American Diabetes Association Association funds development of the 2-h value in the 75-g oral glucose toler-
(ADA) and modeled after existing methods, standards and all its position statements ance test (OGTT) (5).
was utilized to clarify and codify the evi- out of its general revenues and does not uti- In 2009, an International Expert Com-
dence that forms the basis for the recom- lize industry support for these purposes. mittee that included representatives of the
mendations. The level of evidence that American Diabetes Association (ADA), the
supports each recommendation is listed af- I. CLASSIFICATION AND International Diabetes Federation (IDF),
ter each recommendation using the letters DIAGNOSIS and the European Association for the Study
A, B, C, or E. of Diabetes (EASD) recommended the use
These standards of care are revised an- A. Classication of the A1C test to diagnose diabetes,
nually by the ADAs multidisciplinary Pro- The classication of diabetes includes four with a threshold of $6.5% (6), and ADA
fessional Practice Committee, incorporating clinical classes: adopted this criterion in 2010 (5). The di-
agnostic test should be performed using a
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
method that is certied by the National
Originally approved 1988. Most recent review/revision October 2011. Glycohemoglobin Standardization Pro-
DOI: 10.2337/dc12-s011
2012 by the American Diabetes Association. Readers may use this article as long as the work is properly gram (NGSP) and standardized or traceable
cited, the use is educational and not for prot, and the work is not altered. See http://creativecommons.org/ to the Diabetes Control and Complications
licenses/by-nc-nd/3.0/ for details. Trial (DCCT) reference assay. Point-of-care

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S11


Position Statement

Table 1dADA evidence grading system for clinical practice recommendations Table 2dCriteria for the diagnosis of
diabetes
Level of A1C $6.5%. The test should be performed
evidence Description in a laboratory using a method that is NGSP
certied and standardized to the DCCT
A Clear evidence from well-conducted, generalizable, RCTs that are adequately assay.*
powered, including: OR
c Evidence from a well-conducted multicenter trial
FPG $126 mg/dL (7.0 mmol/L). Fasting is
c Evidence from a meta-analysis that incorporated quality ratings in the analysis dened as no caloric intake for at least 8 h.*
Compelling nonexperimental evidence, i.e., all or none rule developed OR
by Center for Evidence Based Medicine at Oxford 2-h plasma glucose $200 mg/dL (11.1 mmol/L)
Supportive evidence from well-conducted randomized controlled trials that during an OGTT. The test should be
are adequately powered, including: performed as described by the WHO, using
c Evidence from a well-conducted trial at one or more institutions a glucose load containing the equivalent of
c Evidence from a meta-analysis that incorporated quality ratings in 75 g anhydrous glucose dissolved in water.*
the analysis OR
B Supportive evidence from well-conducted cohort studies In a patient with classic symptoms of
c Evidence from a well-conducted prospective cohort study or registry
hyperglycemia or hyperglycemic crisis,
a random plasma glucose $200 mg/dL
c Evidence from a well-conducted meta-analysis of cohort studies
(11.1 mmol/L)
Supportive evidence from a well-conducted case-control study
C *In the absence of unequivocal hyperglycemia, re-
Supportive evidence from poorly controlled or uncontrolled studies sult should be conrmed by repeat testing.
c Evidence from RCTs with one or more major or three or more
minor methodological aws that could invalidate the results
c Evidence from observational studies with high potential for bias of undiagnosed diabetes than a fasting
(such as case series with comparison with historical controls) glucose cut point of $126 mg/dL (7.0
c Evidence from case series or case reports
mmol/L) (11). However, in practice, a
Conicting evidence with the weight of evidence supporting the recommendation large portion of the diabetic population
E Expert consensus or clinical experience remains unaware of their condition.
Thus, the lower sensitivity of A1C at the
designated cut point may well be offset by
A1C assays, for which prociency testing is postprandially) may be higher (9). Epide- the tests greater practicality, and wider
not mandated, are not sufciently accurate miologic studies forming the framework application of a more convenient test
at this time to use for diagnostic purposes. for recommending use of the A1C to diag- (A1C) may actually increase the number
Epidemiologic datasets show a similar nose diabetes have all been in adult popu- of diagnoses made.
relationship between A1C and risk of lations. Whether the cut point would be As with most diagnostic tests, a test
retinopathy as has been shown for the the same to diagnose children with type 2 result diagnostic of diabetes should be
corresponding FPG and 2-h PG thresholds. diabetes is an area of uncertainty (10). A1C repeated to rule out laboratory error, unless
The A1C has several advantages to the FPG inaccurately reects glycemia with certain the diagnosis is clear on clinical grounds,
and OGTT, including greater convenience anemias and hemoglobinopathies. For pa- such as a patient with a hyperglycemic
(since fasting is not required), evidence to tients with an abnormal hemoglobin but crisis or classic symptoms of hyperglycemia
suggest greater preanalytical stability, and normal red cell turnover, such as sickle cell and a random plasma glucose $200 mg/dL.
less day-to-day perturbations during pe- trait, an A1C assay without interference from It is preferable that the same test be repeated
riods of stress and illness. These advan- abnormal hemoglobins should be used (an for conrmation, since there will be a greater
tages must be balanced by greater cost, updated list is available at www.ngsp.org/ likelihood of concurrence in this case. For
the limited availability of A1C testing in npsp.org/interf.asp). For conditions with ab- example, if the A1C is 7.0% and a repeat
certain regions of the developing world, normal red cell turnover, such as pregnancy, result is 6.8%, the diagnosis of diabetes is
and the incomplete correlation between recent blood loss or transfusion, or some conrmed. However, if two different tests
A1C and average glucose in certain indi- anemias, the diagnosis of diabetes must em- (such as A1C and FPG) are both above the
viduals. In addition, HbA1c levels may vary ploy glucose criteria exclusively. diagnostic thresholds, the diagnosis of dia-
with patients race/ethnicity (7,8). Some The established glucose criteria for betes is also conrmed.
have posited that glycation rates differ by the diagnosis of diabetes (FPG and 2-h On the other hand, if two different
race (with, for example, African Americans PG) remain valid as well (Table 2). Just as tests are available in an individual and
having higher rates of glycation), but this there is less than 100% concordance be- the results are discordant, the test whose
is controversial. A recent epidemiologic tween the FPG and 2-h PG tests, there is result is above the diagnostic cut point
study found that, when matched for FPG, not perfect concordance between A1C should be repeated, and the diagnosis is
African Americans (with and without di- and either glucose-based test. Analyses made on the basis of the conrmed test.
abetes) indeed had higher A1C than of National Health and Nutrition Exami- That is, if a patient meets the diabetes
whites, but also had higher levels of fruc- nation Survey (NHANES) data indicate criterion of the A1C (two results $6.5%)
tosamine and glycated albumin and lower that, assuming universal screening of but not the FPG (,126 mg/dL or 7.0
levels of 1,5-anhydroglucitol, suggesting the undiagnosed, the A1C cut point of mmol/L), or vice versa, that person should
that their glycemic burden (particularly $6.5% identies one-third fewer cases be considered to have diabetes.

S12 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Since there is preanalytic and analytic with an A1C of 5.0% (14). In a community- Table 3dCategories of increased risk for
variability of all the tests, it is also possible based study of black and white adults with- diabetes (prediabetes)*
that when a test whose result was above out diabetes, baseline A1C was a stronger FPG 100 mg/dL (5.6 mmol/L) to 125 mg/dL
the diagnostic threshold is repeated, the predictor of subsequent diabetes and car- (6.9 mmol/L) (IFG)
second value will be below the diagnostic diovascular events than fasting glucose OR
cut point. This is least likely for A1C, (15). Other analyses suggest that an A1C 2-h plasma glucose in the 75-g OGTT
somewhat more likely for FPG, and most of 5.7% is associated with diabetes risk sim- 140 mg/dL (7.8 mmol/L) to 199 mg/dL
likely for the 2-h PG. Barring a laboratory ilar to that of the high-risk participants in (11.0 mmol/L) (IGT)
error, such patients are likely to have test the Diabetes Prevention Program (DPP). OR
results near the margins of the threshold Hence, it is reasonable to consider an A1C 5.76.4%
for a diagnosis. The health care professional A1C range of 5.7 to 6.4% as identifying
*For all three tests, risk is continuous, extending
might opt to follow the patient closely and individuals with high risk for future below the lower limit of the range and becoming
repeat the testing in 36 months. The cur- diabetes, a state that may be referred to disproportionately greater at higher ends of the range.
rent diagnostic criteria for diabetes are as prediabetes (5). As is the case for indi-
summarized in Table 2. viduals found to have IFG and IGT, indi-
viduals with an A1C of 5.76.4% should the provider tests because of high suspicion
C. Categories of increased risk for be informed of their increased risk for di- of diabetes, to the symptomatic patient.
diabetes (prediabetes) abetes as well as CVD and counseled The discussion herein is primarily framed
In 1997 and 2003, The Expert Committee about effective strategies to lower their as testing for diabetes in those without
on Diagnosis and Classication of Diabetes risks (see section IV. PREVENTION/ symptoms. The same assays used for test-
Mellitus (12,13) recognized an interme- DELAY OF TYPE 2 DIABETES). As with ing for diabetes will also detect individuals
diate group of individuals whose glucose glucose measurements, the continuum of with prediabetes.
levels, although not meeting criteria for risk is curvilinear, so that as A1C rises the
diabetes, are nevertheless too high to be risk of diabetes rises disproportionately A. Testing for type 2 diabetes and
considered normal. These persons were (14). Accordingly, interventions should risk of future diabetes in adults
dened as having impaired fasting glu- be most intensive and follow-up should Prediabetes and diabetes meet established
cose (IFG) (FPG levels 100 mg/dL [5.6 be particularly vigilant for those with criteria for conditions in which early de-
mmol/L] to 125 mg/dL [6.9 mmol/L]), A1Cs .6.0%, who should be considered tection is appropriate. Both conditions are
or impaired glucose tolerance (IGT) (2-h to be at very high risk. Table 3 summarizes common, increasing in prevalence, and
values in the OGTT of 140 mg/dL [7.8 the categories of increased risk for diabetes. impose signicant public health burdens.
mmol/L] to 199 mg/dL [11.0 mmol/L]). It There is a long presymptomatic phase
should be noted that the World Health II. TESTING FOR DIABETES IN before the diagnosis of type 2 diabetes is
Organization (WHO) and a number of ASYMPTOMATIC PATIENTS usually made. Relatively simple tests are
other diabetes organizations dene the cut- available to detect preclinical disease. Ad-
off for IFG at 110 mg/dL (6.1 mmol/L). Recommendations ditionally, the duration of glycemic burden
Individuals with IFG and/or IGT have c Testing to detect type 2 diabetes and is a strong predictor of adverse outcomes,
been referred to as having prediabetes, assess risk for future diabetes in asymp- and effective interventions exist to prevent
indicating the relatively high risk for the tomatic people should be considered in progression of prediabetes to diabetes (see
future development of diabetes. IFG and adults of any age who are overweight or section IV. PREVENTION/DELAY OF
IGT should not be viewed as clinical obese (BMI $25 kg/m2) and who have TYPE 2 DIABETES) and to reduce risk of
entities in their own right but rather risk one or more additional risk factors for complications of diabetes (see section V.I.
factors for diabetes as well as cardiovascular diabetes (Table 4). In those without PREVENTION AND MANAGEMENT OF
disease (CVD). IFG and IGT are associated these risk factors, testing should begin at DIABETES COMPLICATIONS).
with obesity (especially abdominal or vis- age 45 years. (B) Type 2 diabetes is frequently not
ceral obesity), dyslipidemia with high tri- c If tests are normal, repeat testing at least diagnosed until complications appear,
glycerides and/or low HDL cholesterol, and at 3-year intervals is reasonable. (E) and approximately one-fourth of all people
hypertension. c To test for diabetes or to assess risk with diabetes in the U.S. may be undiag-
As is the case with the glucose meas- of future diabetes, the A1C, FPG, or 2-h nosed. The effectiveness of early identica-
ures, several prospective studies that used 75-g OGTT are appropriate. (B) tion of prediabetes and diabetes through
A1C to predict the progression to diabetes c In those identied with increased risk mass testing of asymptomatic individuals
demonstrated a strong, continuous asso- for future diabetes, identify and, if appro- has not been proven denitively, and
ciation between A1C and subsequent di- priate, treat other CVD risk factors. (B) rigorous trials to provide such proof are
abetes. In a systematic review of 44,203 unlikely to occur. In a large randomized
individuals from 16 cohort studies with a For many illnesses, there is a major controlled trial (RCT) in Europe, general
follow-up interval averaging 5.6 years distinction between screening and diag- practice patients between the ages of 40
(range 2.8-12 years), those with an A1C nostic testing. However, for diabetes, the and 69 years were screened for diabetes
between 5.5 and 6.0% had a substantially same tests would be used for screening and then randomized by practice to routine
increased risk of diabetes with 5-year in- as for diagnosis. Diabetes may be identied care of diabetes or intensive treatment of
cidences ranging from 925%. An A1C anywhere along a spectrum of clinical sce- multiple risk factors. After 5.3 years of
range of 6.0 to 6.5% had a 5-year risk of narios ranging from a seemingly low-risk follow-up, CVD risk factors were modestly
developing diabetes between 25 to 50% individual who happens to have glucose but signicantly more improved with in-
and relative risk 20 times higher compared testing, to a higher-risk individual whom tensive treatment. Incidence of rst CVD

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Position Statement

Table 4dCriteria for testing for diabetes in asymptomatic adult individuals Because of the need for follow-up and
discussion of abnormal results, testing
1. Testing should be considered in all adults who are overweight (BMI $25 kg/m2*) and who
should be carried out within the health
have one or more additional risk factors:
care setting. Community screening outside
c physical inactivity
a health care setting is not recommended
c rst-degree relative with diabetes
because people with positive tests may not
c high-risk race/ethnicity (e.g., African American, Latino, Native American, Asian American, seek, or have access to, appropriate follow-
Pacic Islander) up testing and care. Conversely, there may
c women who delivered a baby weighing .9 lb or who were diagnosed with GDM be failure to ensure appropriate repeat
c hypertension (blood pressure $140/90 mmHg or on therapy for hypertension) testing for individuals who test negative.
c HDL cholesterol level ,35 mg/dL (0.90 mmol/L) and/or a triglyceride level .250 mg/dL Community screening may also be poorly
(2.82 mmol/L) targeted, i.e., it may fail to reach the groups
c women with PCOS
most at risk and inappropriately test those
at low risk (the worried well) or even those
c A1C $5.7%, IGT, or IFG on previous testing
already diagnosed.
c other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis
nigricans)
B. Testing for type 2 diabetes
c history of CVD
in children
2. In the absence of the above criteria, testing for diabetes should begin at age 45 years The incidence of type 2 diabetes in ado-
3. If results are normal, testing should be repeated at least at 3-year intervals, with consideration lescents has increased dramatically in the
of more-frequent testing depending on initial results (e.g., those with prediabetes should be last decade, especially in minority popu-
tested yearly) and risk status. lations (28), although the disease remains
*At-risk BMI may be lower in some ethnic groups. PCOS, polycystic ovary syndrome. rare in the general pediatric population
(29). Consistent with recommendations
event and mortality rates were not signi- Either A1C, FPG, or the 2-h OGTT is for adults, children and youth at in-
cantly different between groups (16). This appropriate for testing. It should be noted creased risk for the presence or the devel-
study would seem to add support for early that the tests do not necessarily detect opment of type 2 diabetes should be
treatment of screen-detected diabetes, as diabetes in the same individuals. The ef- tested within the healthcare setting (30).
risk factor control was excellent even in cacy of interventions for primary pre- The recommendations of the ADA con-
the routine treatment arm and both groups vention of type 2 diabetes (2026) has sensus statement on Type 2 Diabetes in
had lower event rates than predicted. The primarily been demonstrated among in- Children and Youth, with some modica-
absence of a control unscreened arm limits dividuals with IGT, not for individuals tions, are summarized in Table 5 (30).
the ability to denitely prove that screening with isolated IFG or for individuals with
impacts outcomes. Mathematical modeling specic A1C levels. C. Screening for type 1 diabetes
studies suggest that screening independent The appropriate interval between Generally, people with type 1 diabetes
of risk factors beginning at age 30 or age 45 tests is not known (27). The rationale present with acute symptoms of diabetes
years is highly cost-effective (,$11,000 for the 3-year interval is that false nega- and markedly elevated blood glucose
per quality-adjusted life-year gained) (17). tives will be repeated before substantial levels, and most cases are diagnosed soon
Recommendations for testing for di- time elapses, and there is little likelihood after the onset of hyperglycemia. However,
abetes in asymptomatic, undiagnosed that an individual will develop signicant evidence from type 1 prevention studies
adults are listed in Table 4. Testing should complications of diabetes within 3 years suggests that measurement of islet auto-
be considered in adults of any age with of a negative test result. In the modeling antibodies identies individuals who are at
BMI $25 kg/m2 and one or more of the study, repeat screening every 3 or 5 years risk for developing type 1 diabetes. Such
known risk factors for diabetes. There is was cost-effective (17). testing may be appropriate in high-risk
compelling evidence that lower BMI cut
points suggest diabetes risk in some racial
and ethnic groups. In a large multiethnic Table 5dTesting for type 2 diabetes in asymptomatic children
cohort study, for an equivalent incidence Criteria
rate of diabetes conferred by a BMI of 30 c Overweight (BMI .85th percentile for age and sex, weight for height .85th
kg/m2 in whites, the BMI cutoff value was percentile, or weight .120% of ideal for height
24 kg/m2 in South Asians, 25 kg/m2 in
Plus any two of the following risk factors:
Chinese, and 26 kg/m2 African Americans
c Family history of type 2 diabetes in rst- or second-degree relative
(18).Disparities in screening rates, not ex-
c Race/ethnicity (Native American, African American, Latino, Asian American,
plainable by insurance status, are high-
lighted by evidence that despite much Pacic Islander)
higher prevalence of type 2 diabetes, c Signs of insulin resistance or conditions associated with insulin resistance

non-Caucasians in an insured population (acanthosis nigricans, hypertension, dyslipidemia, PCOS, or birth weight small for
are no more likely than Caucasians to be gestational age birthweight)
screened for diabetes (19). Because age c Maternal history of diabetes or GDM during the childs gestation

is a major risk factor for diabetes, testing Age of initiation: 10 years or at onset of puberty, if puberty occurs at a younger age
of those without other risk factors should Frequency: every 3 years
begin no later than age 45 years. PCOS, polycystic ovary syndrome

S14 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

individuals, such as those with prior tran- onset or rst recognition during preg- pregnancies previously categorized as
sient hyperglycemia or those who have nancy (12), whether or not the condition normal. These diagnostic criteria changes
relatives with type 1 diabetes, in the context persisted after pregnancy, and not exclud- are being made in the context of worri-
of clinical research studies (see, e.g., http:// ing the possibility that unrecognized glu- some worldwide increases in obesity and
www2.diabetestrialnet.org). Widespread cose intolerance may have antedated or diabetes rates, with the intent of optimiz-
clinical testing of asymptomatic low-risk in- begun concomitantly with the pregnancy. ing gestational outcomes for women and
dividuals cannot currently be recommended, This denition facilitated a uniform strat- their babies.
as it would identify very few individuals in egy for detection and classication of GDM, Admittedly, there are few data from
the general population who are at risk. In- but its limitations were recognized for randomized clinical trials regarding ther-
dividuals who screen positive should be many years. As the ongoing epidemic of apeutic interventions in women who will
counseled about their risk of developing di- obesity and diabetes has led to more type now be diagnosed with GDM based on
abetes. Clinical studies are being conducted 2 diabetes in women of childbearing age, only one blood glucose value above the
to test various methods of preventing type 1 the number of pregnant women with un- specied cut points (in contrast to the
diabetes, or reversing early type 1 diabetes, diagnosed type 2 diabetes has increased older criteria that stipulated at least two
in those with evidence of autoimmunity. (31). Because of this, it is reasonable to abnormal values). However, there is emerg-
screen women with risk factors for type 2 ing observational and retrospective evi-
III. DETECTION AND diabetes (Table 4) for diabetes at their initial dence that women diagnosed with the
DIAGNOSIS OF GESTATIONAL prenatal visit, using standard diagnostic new criteria (even if they would not have
DIABETES MELLITUS (GDM) criteria (Table 2). Women found to have been diagnosed with older criteria) have
diabetes at this visit should receive a di- increased rates of poor pregnancy outcomes
Recommendations agnosis of overt, not gestational, diabetes. similar to those of women with GDM by
c Screen for undiagnosed type 2 diabetes GDM carries risks for the mother and prior criteria (34,35). Expected benets
at the rst prenatal visit in those with risk neonate. The Hyperglycemia and Adverse to these pregnancies and offspring is infer-
factors, using standard diagnostic crite- Pregnancy Outcomes (HAPO) study (32), a red from intervention trials that focused on
ria. (B) large-scale (;25,000 pregnant women) women with more mild hyperglycemia
c In pregnant women not previously multinational epidemiologic study, dem- than identied using older GDM diagnostic
known to have diabetes, screen for GDM onstrated that risk of adverse maternal, fe- criteria and that found modest benets
at 2428 weeks gestation, using a 75-g tal, and neonatal outcomes continuously (36,37). The frequency of follow-up and
2-h OGTT and the diagnostic cut points increased as a function of maternal glyce- blood glucose monitoring for these women
in Table 6. (B) mia at 2428 weeks, even within ranges is not yet clear but likely to be less intensive
c Screen women with GDM for persistent previously considered normal for preg- than for women diagnosed by the older cri-
diabetes at 612 weeks postpartum, nancy. For most complications, there was teria. It is important to note that 8090% of
using a test other than A1C. (E) no threshold for risk. These results have led women in both of the mild GDM studies
c Women with a history of GDM should to careful reconsideration of the diagnostic (whose glucose values overlapped with the
have lifelong screening for the devel- criteria for GDM. After deliberations in thresholds recommended herein) could be
opment of diabetes or prediabetes at 20082009, the International Association managed with lifestyle therapy alone.
least every 3 years. (B) of Diabetes and Pregnancy Study Groups The American College of Obstetrics
c Women with a history of GDM found (IADPSG), an international consensus and Gynecology announced in 2011 that
to have prediabetes should receive life- group with representatives from multiple they continue to recommend use of prior
style interventions or metformin to pre- obstetrical and diabetes organizations, in- diagnostic criteria for GDM (38). Several
vent diabetes. (A) cluding ADA, developed revised recom- other countries have adopted the new cri-
mendations for diagnosing GDM. The teria, and a report from the WHO on this
For many years, GDM was dened as group recommended that all women not topic is pending at the time of the publi-
any degree of glucose intolerance with known to have prior diabetes undergo a cation of these standards.
75-g OGTT at 2428 weeks of gestation. Because some cases of GDM may rep-
Additionally, the group developed diag- resent preexisting undiagnosed type 2
Table 6dScreening for and diagnosis of nostic cut points for the fasting, 1-h, and diabetes, women with a history of GDM
GDM 2-h plasma glucose measurements that should be screened for diabetes 612
Perform a 75-g OGTT, with plasma glucose conveyed an odds ratio for adverse out- weeks postpartum, using nonpregnant
measurement fasting and at 1 and 2 h, at comes of at least 1.75 compared with OGTT criteria. Because of their prepartum
2428 weeks gestation in women not women with the mean glucose levels in treatment for hyperglycemia, use of the
previously diagnosed with overt diabetes. the HAPO study. Current screening and A1C for diagnosis of persistent diabetes at
diagnostic strategies, based on the IADPSG the postpartum visit is not recommended
The OGTT should be performed in the
statement (33), are outlined in Table 6. (39). Women with a history of GDM have a
morning after an overnight fast of at least
These new criteria will signicantly greatly increased subsequent risk for diabe-
8 h.
increase the prevalence of GDM, primar- tes (40) and should be followed up with
The diagnosis of GDM is made when any of ily because only one abnormal value, not subsequent screening for the development
the following plasma glucose values are two, is sufcient to make the diagnosis. of diabetes or prediabetes, as outlined in
exceeded: ADA recognizes the anticipated signi- section II. TESTING FOR DIABETES IN
c Fasting $92 mg/dL (5.1 mmol/L)
cant increase in the incidence of GDM ASYMPTOMATIC PATIENTS.
c 1 h $180 mg/dL (10.0 mmol/L) diagnosed by these criteria and is sensitive Lifestyle interventions or metformin
c 2 h $153 mg/dL (8.5 mmol/L) to concerns about the medicalization of should be offered to women with a history

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S15


Position Statement

of GDM who develop prediabetes, as Based on the results of clinical trials The management plan should be
discussed in section IV. PREVENTION/ and the known risks of progression of formulated as a collaborative therapeutic
DELAY OF TYPE 2 DIABETES. prediabetes to diabetes, persons with an alliance among the patient and family,
A1C of 5.76.4%, IGT, or IFG should be the physician, and other members of the
IV. PREVENTION/DELAY counseled on lifestyle changes with goals health care team. A variety of strategies
OF TYPE 2 DIABETES similar to those of the DPP (7% weight and techniques should be used to provide
loss and moderate physical activity of at adequate education and development
Recommendations least 150 min per week). Regarding drug of problem-solving skills in the various
c Patients with IGT (A), IFG (E), or an A1C therapy for diabetes prevention, a consen- aspects of diabetes management. Imple-
of 5.76.4% (E) should be referred to an sus panel felt that metformin should be mentation of the management plan re-
effective ongoing support program tar- the only drug considered (47). For other quires that each aspect is understood and
geting weight loss of 7% of body weight drugs, issues of cost, side effects, and lack agreed to by the patient and the care
and increasing physical activity to at least of persistence of effect in some studies providers and that the goals and treatment
150 min per week of moderate activity (48) require consideration. Metformin plan are reasonable. Any plan should rec-
such as walking. was less effective than lifestyle interven- ognize diabetes self-management education
c Follow-up counseling appears to be im- tion in the DPP and DPPOS but may be (DSME) and on-going diabetes support as
portant for success. (B) cost-saving over a 10-year period (45). It an integral component of care. In develop-
c Based on the cost-effectiveness of dia- was as effective as lifestyle in participants ing the plan, consideration should be given
betes prevention, such programs should with a BMI of at least 35 kg/m2 (20), and to the patients age, school or work schedule
be covered by third-party payers. (B) in women with a history of GDM, metfor- and conditions, physical activity, eating
c Metformin therapy for prevention of min and intensive lifestyle led to an equiv- patterns, social situation and cultural fac-
type 2 diabetes may be considered in alent 50% reduction in the risk of diabetes tors, and presence of complications of
those with IGT (A), IFG (E), or an A1C (49). Metformin therefore might reason- diabetes or other medical conditions.
of 5.76.4% (E), especially for those with ably be recommended for very-high-risk
BMI .35 kg/m2, age ,60 years, and individuals (those with a history of GDM,
C. Glycemic control
women with prior GDM. (A) the very obese, and/or those with more
1. Assessment of glycemic control. Two
c At least annual monitoring for the de- severe or progressive hyperglycemia). Of
primary techniques are available for health
velopment of diabetes in those with note in the DPP, metformin was not sig-
providers and patients to assess the ef-
prediabetes is suggested. (E) nicantly better than placebo in those
fectiveness of the management plan on
over age 60 years.
glycemic control: patient self-monitoring of
RCTs have shown that individuals at
blood glucose (SMBG) or interstitial glu-
high risk for developing type 2 diabetes V. DIABETES CARE cose, and A1C.
(those with IFG, IGT, or both) can signif-
icantly decrease the rate of onset of diabetes a. Glucose monitoring
A. Initial evaluation
with particular interventions (2026). A complete medical evaluation should be Recommendations
These include intensive lifestyle modica- c SMBG should be carried out three or
performed to classify the diabetes, detect
tion programs that have been shown to more times daily for patients using mul-
the presence of diabetes complications,
be very effective (;58% reduction after tiple insulin injections or insulin pump
review previous treatment and glycemic
3 years) and use of the pharmacologic therapy. (B)
control in patients with established diabetes,
agents metformin, a glucosidase inhibi- c For patients using less-frequent in-
assist in formulating a management plan,
tors, orlistat, and thiazolidinediones, sulin injections, noninsulin therapies,
and provide a basis for continuing care.
each of which has been shown to decrease or medical nutrition therapy (MNT)
Laboratory tests appropriate to the evalua-
incident diabetes to various degrees. Follow- alone, SMBG may be useful as a guide
tion of each patients medical condition
up of three large studies of lifestyle inter- to management. (E)
should be performed. A focus on the com-
vention has shown sustained reduction in ponents of comprehensive care (Table 7) c To achieve postprandial glucose targets,
the rate of conversion to type 2 diabetes, postprandial SMBG may be appropriate.
will assist the health care team to ensure
with 43% reduction at 20 years in the Da (E)
optimal management of the patient with
Qing study (41), 43% reduction at 7 years c When prescribing SMBG, ensure that
diabetes.
in the Finnish Diabetes Prevention Study patients receive initial instruction in,
(DPS) (42), and 34% reduction at 10 and routine follow-up evaluation of,
years in the U.S. Diabetes Prevention Pro- B. Management SMBG technique and their ability to use
gram Outcome Study (DPPOS) (43). A People with diabetes should receive med- data to adjust therapy. (E)
cost-effectiveness model suggested that ical care from a physician-coordinated c Continuous glucose monitoring (CGM)
lifestyle interventions as delivered in the team. Such teams may include, but are in conjunction with intensive insulin
DPP are cost-effective (44), and actual not limited to, physicians, nurse practition- regimens can be a useful tool to lower
cost data from the DPP and DPPOS con- ers, physicians assistants, nurses, dietitians, A1C in selected adults (age $25 years)
rm that lifestyle interventions are highly pharmacists, and mental health professio- with type 1 diabetes. (A)
cost-effective (45). Group delivery of the nals with expertise and a special interest in c Although the evidence for A1C-lowering
DPP intervention in community settings diabetes. It is essential in this collaborative is less strong in children, teens, and
has the potential to be signicantly less and integrated team approach that individ- younger adults, CGM may be helpful in
expensive while still achieving similar uals with diabetes assume an active role in these groups. Success correlates with ad-
weight loss (46). their care. herence to ongoing use of the device. (C)

S16 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Table 7dComponents of the comprehensive diabetes evaluation and goals of the patient. SMBG is espe-
Medical history
cially important for patients treated with
c Age and characteristics of onset of diabetes (e.g., DKA, asymptomatic laboratory nding)
insulin to monitor for and prevent asymp-
tomatic hypoglycemia and hyperglycemia.
c Eating patterns, physical activity habits, nutritional status, and weight history;
For most patients with type 1 diabetes and
growth and development in children and adolescents
pregnant women taking insulin, SMBG is
c Diabetes education history
recommended three or more times daily.
c Review of previous treatment regimens and response to therapy (A1C records) For these populations, signicantly more
c Current treatment of diabetes, including medications and medication adherence, frequent testing may be required to reach
meal plan, physical activity patterns, and readiness for behavior change A1C targets safely without hypoglycemia
c Results of glucose monitoring and patients use of data and for hypoglycemia detection prior to
c DKA frequency, severity, and cause critical tasks such as driving. In a large
c Hypoglycemic episodes
database study of almost 27,000 children
and adolescents with type 1 diabetes, after
Hypoglycemia awareness
adjustment for multiple confounders, in-
Any severe hypoglycemia: frequency and cause
creased daily frequency of SMBG was
c History of diabetes-related complications
signicantly associated with lower A1C
Microvascular: retinopathy, nephropathy, neuropathy (sensory, including history
(20.2% per additional test per day, level-
of foot lesions; autonomic, including sexual dysfunction and gastroparesis) ing off at 5 tests per day) and with fewer
Macrovascular: CHD, cerebrovascular disease, PAD
acute complications (50). The optimal fre-
Other: psychosocial problems,* dental disease*
quency and timing of SMBG for patients
Physical examination with type 2 diabetes on noninsulin therapy
c Height, weight, BMI
is unclear. A meta-analysis of SMBG in
c Blood pressure determination, including orthostatic measurements when indicated noninsulin-treated patients with type 2
c Fundoscopic examination* diabetes concluded that some regimens of
c Thyroid palpation SMBG were associated with a reduction in
c Skin examination (for acanthosis nigricans and insulin injection sites) A1C of 20.4%. However, many of the
c Comprehensive foot examination
studies in this analysis also included patient
education with diet and exercise counsel-
Inspection
ing and, in some cases, pharmacologic in-
Palpation of dorsalis pedis and posterior tibial pulses
tervention, making it difcult to assess the
Presence/absence of patellar and Achilles reexes
contribution of SMBG alone to improved
Determination of proprioception, vibration, and monolament sensation
control (51). Several randomized trials
Laboratory evaluation
have called into question the clinical utility
c A1C, if results not available within past 23 months
and cost-effectiveness of routine SMBG in
c If not performed/available within past year:
noninsulin-treated patients (5254).
Fasting lipid prole, including total, LDL, and HDL cholesterol and triglycerides Because the accuracy of SMBG is
Liver function tests instrument and user dependent (55), it
Test for UAE with spot urine albumin-to-creatinine ratio is important to evaluate each patients
Serum creatinine and calculated GFR monitoring technique, both initially and
Thyroid-stimulating hormone in type 1 diabetes, dyslipidemia, or women over at regular intervals thereafter. In addition,
age 50 years optimal use of SMBG requires proper in-
Referrals terpretation of the data. Patients should be
c Eye care professional for annual dilated eye exam taught how to use the data to adjust food
c Family planning for women of reproductive age intake, exercise, or pharmacological ther-
c Registered dietitian for MNT apy to achieve specic glycemic goals,
c DMSE
and these skills should be reevaluated pe-
c Dentist for comprehensive periodontal examination
riodically.
Real-time CGM through the measure-
c Mental health professional, if needed
ment of interstitial glucose (which corre-
*See appropriate referrals for these categories. lates well with plasma glucose) is available.
These sensors require calibration with
c CGM may be a supplemental tool to that SMBG is a component of effective SMBG, and the latter are still recommended
SMBG in those with hypoglycemia therapy. SMBG allows patients to evaluate for making acute treatment decisions.
unawareness and/or frequent hypogly- their individual response to therapy and CGM devices have alarms for hypo- and
cemic episodes. (E) assess whether glycemic targets are being hyperglycemic excursions. Small studies
achieved. Results of SMBG can be useful in selected patients with type 1 diabetes
Major clinical trials of insulin-treated in preventing hypoglycemia and adjusting have suggested that CGM use reduces the
patients that demonstrated the benets medications (particularly prandial insulin time spent in hypo- and hyperglycemic
of intensive glycemic control on diabetes doses), MNT, and physical activity. ranges and may modestly improve glycemic
complications have included SMBG as part The frequency and timing of SMBG control. A 26-week randomized trial of 322
of multifactorial interventions, suggesting should be dictated by the particular needs type 1 patients showed that adults age 25

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S17


Position Statement

years and older using intensive insulin diabetes complications (61,62), A1C test- Table 8dCorrelation of A1C with average
therapy and CGM experienced a 0.5% re- ing should be performed routinely in all glucose
duction in A1C (from ;7.67.1%) com- patients with diabetes, at initial assessment
pared with usual intensive insulin therapy and then as part of continuing care. Mea- Mean plasma glucose
with SMBG (56). Sensor use in children, surement approximately every 3 months
teens, and adults to age 24 years did not determines whether a patients glycemic A1C (%) mg/dL mmol/L
result in signicant A1C lowering, and there targets have been reached and maintained. 6 126 7.0
was no signicant difference in hypoglyce- For any individual patient, the frequency of 7 154 8.6
mia in any group. Importantly, the greatest A1C testing should be dependent on the 8 183 10.2
predictor of A1C lowering in this study for clinical situation, the treatment regimen 9 212 11.8
all age-groups was frequency of sensor use, used, and the judgment of the clinician. 10 240 13.4
which was lower in younger age-groups. Some patients with stable glycemia well 11 269 14.9
In a smaller RCT of 129 adults and children within target may do well with testing 12 298 16.5
with baseline A1C ,7.0%, outcomes com- only twice per year, while unstable or These estimates are based on ADAG data of ;2,700
bining A1C and hypoglycemia favored the highly intensively managed patients glucose measurements over 3 months per A1C mea-
group utilizing CGM, suggesting that CGM (e.g., pregnant type 1 women) may be surement in 507 adults with type 1, type 2, and no
is also benecial for individuals with type 1 tested more frequently than every 3 diabetes. The correlation between A1C and average
diabetes who have already achieved excel- months. The availability of the A1C result glucose was 0.92 (ref. 67). A calculator for converting
A1C results into eAG, in either mg/dL or mmol/L, is
lent control (57). at the time that the patient is seen (POC available at http://professional.diabetes.org/eAG.
A recent RCT of 120 children and testing) has been reported in small studies
adults with type 1 diabetes with baseline to result in increased intensication of
A1C ,7.5% showed that real-time CGM therapy and improvement in glycemic primarily Caucasian type 1 participants in
was associated with reduced time spent in control (63,64). However, two recent sys- the DCCT (68). Clinicians should note that
hypoglycemia and a small but signicant tematic reviews and meta-analyses found the numbers in the table are now different,
decrease in A1C compared with blinded no signicant difference in A1C between as they are based on ;2,800 readings per
CGM (58). A trial comparing CGM plus POC and laboratory A1C usage (65,66). A1C in the ADAG trial.
insulin pump to SMBG plus multiple in- The A1C test is subject to certain In the ADAG study, there were no sig-
jections of insulin in adults and children limitations. Conditions that affect eryth- nicant differences among racial and ethnic
with type 1 diabetes showed signicantly rocyte turnover (hemolysis, blood loss) groups in the regression lines between A1C
greater improvements in A1C with sen- and hemoglobin variants must be consid- and mean glucose, although there was a
sor augmented pump therapy (59,60), ered, particularly when the A1C result trend toward a difference between African/
but this trial did not isolate the effect of does not correlate with the patients clinical African American and Caucasian partici-
CGM itself. Although CGM is an evolving situation (55). In addition, A1C does not pants. A small study comparing A1C to
technology, these data suggest that, in ap- provide a measure of glycemic variability or CGM data in type 1 children found a
propriately selected patients who are mo- hypoglycemia. For patients prone to glyce- highly statistically signicant correlation
tivated to wear it most of the time, it may mic variability (especially type 1 patients, between A1C and mean blood glucose,
offer benet. CGM may be particularly or type 2 patients with severe insulin de- although the correlation (r 5 0.7) was sig-
useful in those with hypoglycemia un- ciency), glycemic control is best judged by nicantly lower than in the ADAG trial (69).
awareness and/or frequent episodes of hy- the combination of results of SMBG testing Whether there are signicant differences in
poglycemia, and studies in this area are and the A1C. The A1C may also serve as a how A1C relates to average glucose in chil-
ongoing. CGM forms the underpinning check on the accuracy of the patients meter dren or in African American patients is an
for the development of pumps that sus- (or the patients reported SMBG results) area for further study. For the time being,
pend insulin delivery when hypoglycemia and the adequacy of the SMBG testing the question has not led to different recom-
is developing as well as for the burgeoning schedule. mendations about testing A1C or to differ-
work on articial pancreas systems. Table 8 contains the correlation be- ent interpretations of the clinical meaning
tween A1C levels and mean plasma glucose of given levels of A1C in those populations.
b. A1C levels based on data from the international For patients in whom A1C/eAG and
Recommendations A1C-Derived Average Glucose (ADAG) tri- measured blood glucose appear discrep-
c Perform the A1C test at least two times a al utilizing frequent SMBG and CGM in ant, clinicians should consider the possi-
year in patients who are meeting treat- 507 adults (83% Caucasian) with type 1, bilities of hemoglobinopathy or altered
ment goals (and who have stable glyce- type 2, and no diabetes (67). ADA and the red cell turnover, and the options of more
mic control). (E) American Association of Clinical Chemists frequent and/or different timing of SMBG
c Perform the A1C test quarterly in pa- have determined that the correlation (r 5 or use of CGM. Other measures of chronic
tients whose therapy has changed or 0.92) is strong enough to justify reporting glycemia such as fructosamine are avail-
who are not meeting glycemic goals. (E) both an A1C result and an estimated aver- able, but their linkage to average glucose
c Use of point-of-care (POC) testing for age glucose (eAG) result when a clinician and their prognostic signicance are not
A1C provides the opportunity for more orders the A1C test. The table in pre-2009 as clear as for A1C.
timely treatment changes. (E) versions of the Standards of Medical Care
in Diabetes describing the correlation be- 2. Glycemic goals in adults
Because A1C is thought to reect tween A1C and mean glucose was derived Recommendations
average glycemia over several months from relatively sparse data (one 7-point c Lowering A1C to below or around 7%
(55), and has strong predictive value for prole over 1 day per A1C reading) in the has been shown to reduce microvascular

S18 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

complications of diabetes, and if im- progression of microvascular complica- events with intensive control, and in 9-year
plemented soon after the diagnosis of tions. The Veterans Affairs Diabetes Trial post-DCCT follow-up of the EDIC cohort
diabetes is associated with long-term (VADT) showed signicant reductions in participants previously randomized to the
reduction in macrovascular disease. albuminuria with intensive (achieved me- intensive arm had a signicant 42% re-
Therefore, a reasonable A1C goal for dian A1C 6.9%) compared with standard duction in CVD outcomes and a signicant
many nonpregnant adults is ,7%. (B) glycemic control but no difference in reti- 57% reduction in the risk of nonfatal
c Providers might reasonably suggest more nopathy and neuropathy (76,77). The Ac- myocardial infarction (MI), stroke, or
stringent A1C goals (such as ,6.5%) for tion in Diabetes and Vascular Disease: CVD death compared with those previ-
selected individual patients, if this can be Preterax and Diamicron Modied Release ously in the standard arm (82). The benet
achieved without signicant hypogly- Controlled Evaluation (ADVANCE) study of intensive glycemic control in this type 1
cemia or other adverse effects of treat- of intensive versus standard glycemic con- cohort has recently been shown to persist
ment. Appropriate patients might include trol in type 2 diabetes found a statistically for several decades (83).
those with short duration of diabetes, signicant reduction in albuminuria, but In type 2 diabetes, there is evidence
long life expectancy, and no signicant not neuropathy or retinopathy, with an that more-intensive treatment of glycemia
CVD. (C) A1C target of ,6.5% (achieved median in newly diagnosed patients may reduce
c Less-stringent A1C goals (such as ,8%) A1C 6.3%) compared with standard ther- long-term CVD rates. During the UKPDS
may be appropriate for patients with a apy achieving a median A1C of 7.0% trial, there was a 16% reduction in cardio-
history of severe hypoglycemia, limited (78). Recent analyses from the Action vascular events (combined fatal or nonfatal
life expectancy, advanced microvascular to Control Cardiovascular Risk in Diabe- MI and sudden death) in the intensive
or macrovascular complications, exten- tes (ACCORD) trial have shown lower glycemic control arm, although this differ-
sive comorbid conditions, and those with rates of onset or progression of early- ence was not statistically signicant (P 5
longstanding diabetes in whom the stage microvascular complications in 0.052), and there was no suggestion of ben-
general goal is difcult to attain despite the intensive glycemic control arm com- et on other CVD outcomes such as stroke.
DSME, appropriate glucose monitoring, pared with the standard arm (79,80). However, after 10 years of follow-up, those
and effective doses of multiple glucose- Epidemiological analyses of the DCCT originally randomized to intensive glyce-
lowering agents including insulin. (B) and UKPDS (61,62) demonstrate a curvi- mic control had signicant long-term re-
linear relationship between A1C and mi- ductions in MI (15% with sulfonylurea or
Hyperglycemia denes diabetes, and crovascular complications. Such analyses insulin as initial pharmacotherapy, 33%
glycemic control is fundamental to the suggest that, on a population level, the with metformin as initial pharmacother-
management of diabetes. The DCCT study greatest number of complications will be apy) and in all-cause mortality (13 and
(61), a prospective RCT of intensive versus averted by taking patients from very poor 27%, respectively) (75).
standard glycemic control in patients with control to fair or good control. These anal- However, results of three more-recent
relatively recently diagnosed type 1 diabe- yses also suggest that further lowering of large trials (ACCORD, ADVANCE, and
tes, showed denitively that improved A1C from 7 to 6% is associated with further VADT) suggest no signicant reduction
glycemic control is associated with signif- reduction in the risk of microvascular com- in CVD outcomes with intensive glycemic
icantly decreased rates of microvascular plications, albeit the absolute risk reduc- control in these populations, who had more
(retinopathy and nephropathy) and neu- tions become much smaller. Given the advanced diabetes than UKPDS partici-
ropathic complications. Follow-up of the substantially increased risk of hypoglyce- pants. All three of these trials were conduc-
DCCT cohorts in the Epidemiology of Di- mia (particularly in those with type 1 dia- ted in participants with more-long-standing
abetes Interventions and Complications betes, but also in the recent type 2 trials), diabetes (mean duration 811 years) and
(EDIC) study (70,71) demonstrated persis- the concerning mortality ndings in the either known CVD or multiple cardiovas-
tence of these microvascular benets in ACCORD trial (81), and the relatively cular risk factors. Details of these three
previously intensively treated subjects, much greater effort required to achieve studies are reviewed extensively in an
even though their glycemic control approx- near-normoglycemia, the risks of lower gly- ADA position statement (84).
imated that of previous standard arm sub- cemic targets may outweigh the potential The ACCORD study enrolled partic-
jects during follow-up. benets on microvascular complications ipants with either known CVD or two or
The Kumamoto Study (72) and U.K. on a population level. However, selected more major CV risk factors and random-
Prospective Diabetes Study (UKPDS) individual patients, especially those with ized them to intensive glycemic control
(73,74) conrmed that intensive glycemic little comorbidity and long life expectancy (goal A1C ,6%) or standard glycemic
control was associated with signicantly (who may reap the benets of further low- control (goal A1C 78%). The glycemic
decreased rates of microvascular and neu- ering of glycemia below 7%) may, based on control arm of ACCORD was halted early
ropathic complications in patients with provider judgment and patient preferences, due to the nding of an increased rate of
type 2 diabetes. Long-term follow-up of adopt more-intensive glycemic targets (for mortality in the intensive arm compared
the UKPDS cohorts showed persistence of example, an A1C target ,6.5%) as long with the standard arm (1.41 vs. 1.14% per
the effect of early glycemic control on as signicant hypoglycemia does not year; HR 1.22, 95% CI 1.011.46), with a
most microvascular complications (75). become a barrier. similar increase in cardiovascular deaths.
Subsequent trials in patients with CVD, a more common cause of death This increase in mortality in the intensive
more-long-standing type 2 diabetes, de- in populations with diabetes than micro- glycemic control arm was seen in all pre-
signed primarily to look at the role of vascular complications, is less clearly im- specied patient subgroups. The primary
intensive glycemic control on cardiovas- pacted by levels of hyperglycemia or outcome of ACCORD (MI, stroke, or car-
cular outcomes, also conrmed a bene- intensity of glycemic control. In the DCCT, diovascular death) was nonsignicantly
t, although more modest, on onset or there was a trend toward lower risk of CVD lower in the intensive glycemic control

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S19


Position Statement

group, due to a reduction in nonfatal MI, insulin or maximal-dose oral agents as those with very long duration of diabe-
both when the glycemic control interven- (median entry A1C 9.4%) to a strategy tes, known history of severe hypoglycemia,
tion was halted (81) and at completion of of intensive glycemic control (goal A1C advanced atherosclerosis, and advanced
the planned follow-up (85). ,6.0%) or standard glycemic control, age/ frailty. Certainly, providers should be
Exploratory analyses of the mortality with a planned A1C separation of at least vigilant in preventing severe hypoglycemia
ndings of ACCORD (evaluating variables 1.5%. The primary outcome of VADT in patients with advanced disease and
including weight gain, use of any specic was a composite of CVD events. The cu- should not aggressively attempt to achieve
drug or drug combination, and hypogly- mulative primary outcome was nonsig- near-normal A1C levels in patients in
cemia) were reportedly unable to identify a nicantly lower in the intensive arm whom such a target cannot be reasonably
clear explanation for the excess mortality in (76). An ancillary study of VADT demon- easily and safely achieved. Severe or fre-
the intensive arm (81). The ACCORD in- strated that intensive glycemic control quent hypoglycemia is an absolute indica-
vestigators subsequently published addi- was quite effective in reducing CVD tion for the modication of treatment
tional epidemiologic analyses showing no events in individuals with less atheroscle- regimens, including setting higher glyce-
increase in mortality in either the intensive rosis at baseline (assessed by coronary mic goals. Many factors, including patient
arm participants who achieved A1C levels calcium) but not in those with more ex- preferences, should be taken into account
,7% or those who lowered their A1C tensive baseline atherosclerosis (88). when developing a patients individualized
quickly after trial enrollment. In fact, al- The evidence for a cardiovascular goals (89a).
though there was no A1C level at which benet of intensive glycemic control pri- Recommended glycemic goals for
intensive arm participants had signicantly marily rests on long-term follow-up of many nonpregnant adults are shown in
lower mortality than standard arm partici- study cohorts treated early in the course Table 9. The recommendations are based
pants, the highest risk for mortality was of type 1 and type 2 diabetes and subset on those for A1C values, with listed blood
observed in intensive arm participants analyses of ACCORD, ADVANCE, and glucose levels that appear to correlate with
with the highest A1C levels (86). VADT. A recent group-level meta-analysis achievement of an A1C of ,7%. The issue
The role of hypoglycemia in the ex- of the latter three trials suggests that of pre- versus postprandial SMBG targets is
cess mortality ndings was also complex. glucose lowering has a modest (9%) but complex (90). Elevated postchallenge (2-h
Severe hypoglycemia was signicantly statistically signicant reduction in major OGTT) glucose values have been associated
more likely in participants randomized CVD outcomes, primarily nonfatal MI, with increased cardiovascular risk indepen-
to the intensive glycemic control arm. with no signicant effect on mortality. dent of FPG in some epidemiological stud-
However, excess mortality in the intensive However, heterogeneity of the mortality ies. In diabetic subjects, some surrogate
versus standard arms was only signicant effects across studies was noted, precluding measures of vascular pathology, such as en-
for participants with no severe hypoglyce- rm summary measures of the mortality dothelial dysfunction, are negatively af-
mia, and not for those with one or more effects. A prespecied subgroup analysis fected by postprandial hyperglycemia
episodes. Severe hypoglycemia was associ- suggested that major CVD outcome reduc- (91). It is clear that postprandial hypergly-
ated with excess mortality in either arm, tion occurred in patients without known cemia, like preprandial hyperglycemia,
but the association was stronger in those CVD at baseline (HR 0.84, 95% CI 0.74 contributes to elevated A1C levels, with
randomized to the standard glycemic con- 0.94) (89). Conversely, the mortality nd- its relative contribution being higher at
trol arm (87). Unlike the case with the ings in ACCORD and subgroup analyses of A1C levels that are closer to 7%. However,
DCCT, where lower achieved A1C levels VADT suggest that the potential risks of outcome studies have clearly shown A1C
were related to signicantly increased rates very intensive glycemic control may out- to be the primary predictor of complica-
of severe hypoglycemia, in ACCORD every weigh its benets in some patients, such tions, and landmark glycemic control trials
1% decline in A1C from baseline to 4
months into the trial was associated
with a signicant decrease in the rate of Table 9dSummary of glycemic recommendations for many nonpregnant adults
severe hypoglycemia in both arms (86). with diabetes
The primary outcome of ADVANCE
was a combination of microvascular events
A1C ,7.0%*
(nephropathy and retinopathy) and major Preprandial capillary plasma glucose 70130 mg/dL* (3.97.2 mmol/L)
adverse cardiovascular events (MI, stroke, Peak postprandial capillary plasma glucose ,180 mg/dL* (,10.0 mmol/L)
and cardiovascular death). Intensive glyce- c Goals should be individualized based on*

mic control (to a goal A1C ,6.5% vs. treat- duration of diabetes
ment to local standards) signicantly age/life expectancy
reduced the primary end point. However, comorbid conditions
this was due to a signicant reduction in known CVD or advanced microvascular
the microvascular outcome, primarily de- complications
velopment of macroalbuminuria, with no hypoglycemia unawareness
signicant reduction in the macrovascular individual patient considerations
outcome. There was no difference in overall c More- or less-stringent glycemic goals may be
or cardiovascular mortality between the in- appropriate for individual patients
tensive compared with the standard glyce- c Postprandial glucose may be targeted if A1C goals are
mic control arms (78). not met despite reaching preprandial glucose goals
VADT randomized participants with Postprandial glucose measurements should be made 12 h after the beginning of the meal, generally peak
type 2 diabetes who were uncontrolled on levels in patients with diabetes.

S20 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

such as the DCCT and UKPDS relied over- hypoglycemia with equal A1C-lowering to safely achieve and maintain glycemic
whelmingly on preprandial SMBG. Addi- in type 1 diabetes (95,96). control and to change interventions when
tionally, an RCT in patients with known Therefore, recommended therapy for therapeutic goals are not being met.
CVD found no CVD benet of insulin regi- type 1 diabetes consists of the following ADA and EASD have partnered on
mens targeting postprandial glucose com- components: 1) use of multiple-dose in- new guidance for individualization of use
pared with those targeting preprandial sulin injections (three to four injections of medication classes and combinations
glucose (92). For individuals who have pre- per day of basal and prandial insulin) or in patients with type 2 diabetes. These
meal glucose values within target but who CSII therapy; 2) matching prandial insu- guidelines, to be published in early 2012,
have A1C values above target, monitoring lin to carbohydrate intake, premeal blood will be less prescriptive than prior algo-
postprandial plasma glucose (PPG) 12 h glucose, and anticipated activity; and 3) rithms, and will discuss advantages and
after the start of the meal and treatment for many patients (especially if hypogly- disadvantages of the available medication
aimed at reducing PPG values to ,180 cemia is a problem), use of insulin ana- classes as well as considerations for their
mg/dL may help lower A1C and is a reason- logs. There are excellent reviews available use. For information about currently ap-
able recommendation for postprandial test- that guide the initiation and management proved classes of medications for treat-
ing and targets. Glycemic goals for children of insulin therapy to achieve desired gly- ing hyperglycemia in type 2 diabetes, see
are provided in section VII.A.1.a. Glycemic cemic goals (3,95,97). Table 10.
Control. Because of the increased frequency of
As regards goals for glycemic control other autoimmune diseases in type 1 di- E. Medical nutrition therapy (MNT)
for women with GDM, recommendations abetes, screening for thyroid dysfunction, General recommendations
from the Fifth International Workshop- vitamin B12 deciency, or celiac disease c Individuals who have prediabetes or
Conference on Gestational Diabetes (93) should be considered based on signs and diabetes should receive individualized
are to target maternal capillary glucose symptoms. Periodic screening in absence MNT as needed to achieve treatment
concentrations of: of symptoms has been recommended, but goals, preferably provided by a regis-
the effectiveness and optimal frequency are tered dietitian familiar with the compo-
c preprandial: #95 mg/dL (5.3 mmol/L), unclear. nents of diabetes MNT. (A)
and either: c Because MNT can result in cost-savings
c 1-h postmeal: #140 mg/dL (7.8 mmol/L) 2. Therapy for type 2 diabetes and improved outcomes (B), MNT should
or Recommendations be adequately covered by insurance and
c 2-h postmeal: #120 mg/dL (6.7 mmol/L) c At the time of type 2 diabetes diagnosis, other payers. (E)
initiate metformin therapy along with Energy balance, overweight, and obesity
For women with preexisting type 1 or lifestyle interventions, unless metfor- c Weight loss is recommended for all
type 2 diabetes who become pregnant, a min is contraindicated. (A) overweight or obese individuals who
recent consensus statement (94) recom- c In newly diagnosed type 2 diabetic pa- have or are at risk for diabetes. (A)
mended the following as optimal glycemic tients with markedly symptomatic and/ c For weight loss, either low-carbohydrate,
goals, if they can be achieved without ex- or elevated blood glucose levels or A1C, low-fat calorie-restricted, or Mediterra-
cessive hypoglycemia: consider insulin therapy, with or with- nean diets may be effective in the short-
out additional agents, from the outset. (E) term (up to 2 years). (A)
c premeal, bedtime, and overnight glucose c If noninsulin monotherapy at maximal c For patients on low-carbohydrate diets,
6099 mg/dL (3.35.4 mmol/L) tolerated dose does not achieve or main- monitor lipid proles, renal function,
c peak postprandial glucose 100129 tain the A1C target over 36 months, and protein intake (in those with ne-
mg/dL (5.47.1 mmol/L) add a second oral agent, a GLP-1 receptor phropathy), and adjust hypoglycemic
c A1C ,6.0% agonist, or insulin. (E) therapy as needed. (E)
c Physical activity and behavior modi-
D. Pharmacologic and overall Prior expert consensus statements cation are important components of
approaches to treatment have suggested approaches to manage- weight loss programs and are most helpful
1. Therapy for type 1 diabetes. The ment of hyperglycemia in individuals in maintenance of weight loss. (B)
DCCT clearly showed that intensive in- with type 2 diabetes (98). Highlights in- Recommendations for primary prevention
sulin therapy (three or more injections per clude intervention at the time of diagnosis of diabetes
day of insulin, continuous subcutaneous with metformin in combination with life- c Among individuals at high risk for de-
insulin infusion [CSII], or insulin pump style changes (MNT and exercise) and con- veloping type 2 diabetes, structured
therapy) was a key part of improved tinuing timely augmentation of therapy programs that emphasize lifestyle changes
glycemia and better outcomes (61,82). At with additional agents (including early ini- that include moderate weight loss (7%
the time of the study, therapy was carried tiation of insulin therapy) as a means of body weight) and regular physical ac-
out with short- and intermediate-acting hu- achieving and maintaining recommended tivity (150 min/week), with dietary
man insulins. Despite better microvascular levels of glycemic control (i.e., A1C ,7% strategies including reduced calories and
outcomes, intensive insulin therapy was as- for most patients). As A1C targets are not reduced intake of dietary fat, can reduce
sociated with a high rate in severe hypogly- achieved, treatment intensication is based the risk for developing diabetes and are
cemia (62 episodes per 100 patient-years of on the addition of another agent from a therefore recommended. (A)
therapy). Since the time of the DCCT, a different class. Meta-analyses (98a) suggest c Individuals at risk for type 2 diabetes
number of rapid-acting and long-acting that overall, each new class of noninsulin should be encouraged to achieve the
insulin analogs have been developed. agents added to initial therapy lowers A1C U.S. Department of Agriculture (USDA)
These analogs are associated with less around 0.91.1%. The overall objective is recommendation for dietary ber (14 g

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S21


Table 10dNoninsulin therapies for hyperglycemia in type 2 diabetes: properties of selected glucose-lowering drugs that may guide individualization of therapy

S22
Class Compound(s) Mechanism Action(s) Advantages Disadvantages Cost
Biguanides Metformin Activates AMP-kinase c Hepatic glucose c No weight gain c Gastrointestinal side effects Low
production c No hypoglycemia (diarrhea, abdominal
Position Statement

c Intestinal glucose c Reduction in cramping)


absorption c Lactic acidosis (rare)
cardiovascular
c Insulin action events and c Vitamin B12 deciency
mortality c Contraindications: reduced
(UKPDS f/u) kidney function
Sulfonylureas c Glibenclamide/ Closes KATP c Insulin secretion c Generally well c Relatively glucose-independent Low
(2nd generation) Glyburide channels on b-cell tolerated stimulation of insulin secretion:
c Glipizide plasma membranes c Reduction in Hypoglycemia, including
c Gliclazide cardiovascular episodes necessitating hospital
c Glimepiride events and admission and causing death
mortality c Weight gain
(UKPDS f/u) c May blunt myocardial ischemic

DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012


preconditioning
c Low durability
Meglitinides c Repaglinide Closes KATP Insulin secretion Accentuated effects c Hypoglycemia, weight gain, Medium
c Nateglinide channels on b-cell around meal
c May blunt myocardial ischemic
plasma membranes ingestion
preconditioning
c Dosing frequency
Thiazolidinediones c Pioglitazone Activates the nuclear c Peripheral insulin c No hypoglycemia c Weight gain High
(Glitazones) transcription sensitivity c HDL cholesterol c Edema
factor PPAR-g
c Triglycerides c Heart failure

c Bone fractures

c Rosiglitazone As above As above No hypoglycemia c LDL cholesterol High


c Weight gain

c Edema

c Heart failure

c Bone fractures

c Increased cardiovascular events


(mixed evidence)
c FDA warnings on cardiovascular
safety
c Contraindicated in patients with
heart disease
a-Glucosidase c Acarbose Inhibits intestinal Intestinal carbohydrate c Nonsystemic c Gastrointestinal side effects (gas, Medium
inhibitors c Miglitol a-glucosidase digestion (and, medication atulence, diarrhea)
consecutively, c Postprandial c Dosing frequency
absorption) slowed

care.diabetesjournals.org
glucose
Position Statement

ber/1,000 kcal) and foods containing

Medium
Cost whole grains (one-half of grain intake).
High

High

High
(B)
c Individuals at risk for type 2 diabetes
should be encouraged to limit their in-
take of sugar-sweetened beverages. (B)

thyroid tumors in animals (liraglutide)


Gastrointestinal side effects (nausea,

Cases of acute pancreatitis observed

Recommendations for management of

Occasional reports of urticaria/

Cases of pancreatitis observed

May interfere with absorption


diabetes
C-cell hyperplasia/ medullary

Long-term safety unknown

Long-term safety unknown

Long-term safety unknown


Disadvantages

Macronutrients in diabetes management


c The mix of carbohydrate, protein, and

of other medications
vomiting, diarrhea)

fat may be adjusted to meet the meta-

Dizziness/syncope
bolic goals and individual preferences

Triglycerides
Constipation
of the person with diabetes. (C)
angioedema

c Monitoring carbohydrate, whether by


Injectable

Rhinitis
Fatigue
Nausea
carbohydrate counting, choices, or ex-
perience-based estimation, remains a key
strategy in achieving glycemic control. (B)
c

c
c Saturated fat intake should be ,7% of
total calories. (B)
Weight neutrality

c Reducing intake of trans fat lowers LDL


LDL cholesterol
Weight reduction

No hypoglycemia

No hypoglycemia
improved b-cell

No hypoglycemia
cholesterol and increases HDL choles-
Advantages

mass/function

terol (A), therefore intake of trans fat


Potential for

should be minimized. (E)


Other nutrition recommendations
c If adults with diabetes choose to use
alcohol, they should limit intake to a
c

moderate amount (one drink per day or


less for adult women and two drinks per
regulation of metabolism

Adapted with permission from Silvio Inzucchi, Yale University. PPAR, peroxisome proliferatoractivated receptor.
Slows gastric emptying

day or less for adult men) and should


Glucagon secretion

Glucagon secretion
(glucose-dependent)

(glucose-dependent)

Alters hypothalamic

Insulin sensitivity

take extra precautions to prevent hypo-


Insulin secretion

Insulin secretion

glycemia. (E)
Action(s)

concentration

concentration

c Routine supplementation with anti-


Active GLP-1

Active GIP

oxidants, such as vitamins E and C and


Unknown
Satiety

carotene, is not advised because of lack


of evidence of efcacy and concern re-
lated to long-term safety. (A)
c

c It is recommended that individualized


meal planning include optimization of
Activates dopaminergic
Inhibits DPP-4 activity,

endogenously released

food choices to meet recommended


endocrine pancreas;

prolongs survival of

daily allowance (RDA)/dietary reference


brain/autonomous

incretin hormones
receptors (b-cells/
Mechanism

nervous system)

Binds bile acids/

intake (DRI) for all micronutrients. (E)


Activates GLP-1

cholesterol

MNT is an integral component of


receptors

diabetes prevention, management, and


self-management education. In addition
to its role in preventing and controlling
diabetes, ADA recognizes the importance
of nutrition as an essential component of
Compound(s)

Bromocriptine

an overall healthy lifestyle. A full review of


Vildagliptin
Saxagliptin
Linagliptin
Liraglutide

Colesevelam
Sitagliptin
Exenatide

the evidence regarding nutrition in pre-


venting and controlling diabetes and its
complications and additional nutrition-
related recommendations can be found in
c

the ADA position statement Nutrition


Table 10dContinued

Recommendations and Interventions for


Diabetes, published in 2007 and updated
DPP-4 inhibitors
GLP-1 receptor

sequestrants

in 2008 (100). Achieving nutrition-related


enhancers)

Dopamine-2
mimetics)

goals requires a coordinated team effort


(incretin

(incretin
agonists

agonists
Bile acid

that includes the active involvement of


Class

the person with prediabetes or diabetes.


Because of the complexity of nutrition

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S23


Position Statement

issues, it is recommended that a registered of sugar-sweetened beverages have coin- Although brain fuel needs can be met on
dietitian who is knowledgeable and skilled cided with the epidemics of obesity and lower-carbohydrate diets, long-term meta-
in implementing nutrition therapy into di- type 2 diabetes. In a meta-analysis of eight bolic effects of very-low-carbohydrate
abetes management and education be the prospective cohort studies (N 5 310,819), a diets are unclear, and such diets eliminate
team member who provides MNT. diet high in consumption of sugar-sweetened many foods that are important sources of
Clinical trials/outcome studies of beverages was associated with the devel- energy, ber, vitamins, and minerals and
MNT have reported decreases in A1C at opment of type 2 diabetes (n 5 15,043). that are important in dietary palatability
36 months ranging from 0.25 to 2.9% Individuals in the highest versus the low- (129).
with higher reductions seen in type 2 di- est quantile of sugar-sweetened beverage Saturated and trans fatty acids are the
abetes of shorter duration. Multiple studies intake had a 26% greater risk of develop- principal dietary determinants of plasma
have demonstrated sustained improve- ing diabetes (119). LDL cholesterol. There is a lack of evidence
ments in A1C at 12 months and longer For individuals with type 2 diabetes, on the effects of specic fatty acids on peo-
when an registered dietitian provided studies have demonstrated that moderate ple with diabetes; the recommended goals
follow-up visits ranging from monthly to weight loss (5% of body weight) is asso- are therefore consistent with those for indi-
three sessions per year (101108). Studies ciated with decreased insulin resistance, viduals with CVD (109,130).
in nondiabetic suggest that MNT reduces improved measures of glycemia and lipe-
LDL cholesterol by 1525 mg/dL up to mia, and reduced blood pressure (120); Reimbursement for MNT
16% (109) and support a role for life- longer-term studies ($52 weeks) showed MNT, when delivered by a registered
style modication in treating hypertension mixed effects on A1C in adults with type 2 dietitian according to nutrition practice
(109,110). diabetes (121123), and in some studies guidelines, is reimbursed as part of the
While the importance of weight loss results were confounded by pharmaco- Medicare program as overseen by the
for overweight and obese individuals is logic weight loss therapy. Look AHEAD Centers for Medicare and Medicaid Serv-
well documented, an optimal macronu- (Action for Health in Diabetes) is a large ices (CMS) (www.cms.gov).
trient distribution and dietary pattern of clinical trial designed to determine whether
weight loss diets has not been established. long-term weight loss will improve glyce- F. Diabetes self-management
A systematic review of 80 weight loss mia and prevent cardiovascular events in education (DSME)
studies of $1 year duration demonstrated subjects with type 2 diabetes. One-year re- Recommendations
that moderate weight loss achieved through sults of the intensive lifestyle intervention c People with diabetes should receive
diet alone, diet and exercise, and meal re- in this trial show an average 8.6% weight DSME according to national standards
placements can be achieved and main- loss, signicant reduction of A1C, and re- and diabetes self-management support
tained (4.88% weight loss at 12 months) duction in several CVD risk factors (124), when their diabetes is diagnosed and as
(111). Both low-fat low-carbohydrate and with benets sustained at 4 years (125). needed thereafter. (B)
Mediterranean style eating patterns have When completed, the Look AHEAD trial c Effective self-management and quality
been shown to promote weight loss with should provide insight into the effects of of life are the key outcomes of DSME
similar results after 1 to 2 years of follow-up long-term weight loss on important clinical and should be measured and monitored
(112115). A meta-analysis showed that outcomes. as part of care. (C)
at 6 months, low-carbohydrate diets were Although numerous studies have at- c DSME should address psychosocial
associated with greater improvements in tempted to identify the optimal mix of issues, since emotional well-being is
triglyceride and HDL cholesterol concen- macronutrients for meal plans of people associated with positive diabetes out-
trations than low-fat diets; however, LDL with diabetes, it is unlikely that one such comes. (C)
cholesterol was signicantly higher on the combination of macronutrients exists. The c Because DSME can result in cost-savings
low-carbohydrate diets (116). best mix of carbohydrate, protein, and fat and improved outcomes (B), DSME
Because of the effects of obesity on appears to vary depending on individual should be adequately reimbursed by
insulin resistance, weight loss is an impor- circumstances. It must be clearly recog- third-party payers. (E)
tant therapeutic objective for overweight or nized that regardless of the macronutrient
obese individuals who are at risk for di- mix, total caloric intake must be appropri- DSME is an essential element of di-
abetes (117). The multifactorial intensive ate to weight management goal. Further, abetes care (131136), and national
lifestyle intervention employed in the individualization of the macronutrient standards for DSME (137) are based on
DPP, which included reduced intake of composition will depend on the metabolic evidence for its benets. Education helps
fat and calories, led to weight loss averaging status of the patient (e.g., lipid prole, renal people with diabetes initiate effective self-
7% at 6 months and maintenance of function) and/or food preferences. A management and cope with diabetes when
5% weight loss at 3 years, associated variety of dietary meal patterns are likely they are rst diagnosed. Ongoing DSME
with a 58% reduction in incidence of effective in managing diabetes including and diabetes self-management support
type 2 diabetes (20). A RCT looking at Mediterranean-style, plant-based (vegan or (DSMS) also help people with diabetes
high-risk individuals in Spain showed the vegetarian), low-fat and lower-carbohydrate maintain effective self-management
Mediterranean dietary pattern reduced the eating patterns (113,126128). throughout a lifetime of diabetes as they
incidence of diabetes in the absence of It should be noted that the RDA for face new challenges and as treatment ad-
weight loss by 52% compared with the digestible carbohydrate is 130 g/day and vances become available. DSME helps pa-
low-fat diet control group (118). is based on providing adequate glucose as tients optimize metabolic control, prevent
Although our society abounds with the required fuel for the central nervous and manage complications, and maximize
examples of high-calorie nutrient-poor system without reliance on glucose pro- quality of life in a cost-effective manner
foods, large increases in the consumption duction from ingested protein or fat. (138).

S24 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

DSME and DSMS are the on-going recommendations, particularly among adults over age 18 years perform 150 min
processes of facilitating the knowledge, the Medicare population, and have lower per week of moderate-intensity or 75 min
skill, and ability necessary for diabetes Medicare and commercial claim costs per week of vigorous aerobic physical activ-
self-care. This process incorporates the (166,167). ity or an equivalent combination of the two.
needs, goals, and life experiences of the National standards for DSME. The In addition, the guidelines suggest that
person with diabetes. The overall objec- national standards for DSME are designed adults also perform muscle-strengthening
tives of DSME and DSMS are to support to dene quality DSME and to assist activities that involve all major muscle
informed decision-making, self-care be- diabetes educators in a variety of settings groups 2 or more days per week. The guide-
haviors, problem-solving, and active col- to provide evidence-based education lines suggest that adults over age 65 years,
laboration with the health care team to (137). The standards, currently being up- or those with disabilities, follow the adult
improve clinical outcomes, health status, dated, are reviewed and updated every guidelines if possible or (if this is not pos-
and quality of life in a cost-effective man- 5 years by a task force representing key sible) be as physically active as they are able.
ner (137). organizations involved in the eld of di- Studies included in a meta-analysis of the
Current best practice for DSME is a abetes education and care. effects of exercise interventions on glycemic
skills-based approach that focuses on Reimbursement for DSME. DSME, control (168) had a mean number of ses-
helping those with diabetes make in- when provided by a program that meets sions per week of 3.4, with a mean duration
formed self-management choices. DSME national standards for DSME and is recog- of 49 min per session. The DPP lifestyle in-
has changed from a didactic approach nized by ADA or other approval bodies, is tervention, which included 150 min per
focusing on providing information to reimbursed as part of the Medicare program week of moderate-intensity exercise, had a
more theoretically based empowerment as overseen by the Centers for Medicare and benecial effect on glycemia in those with
models that focus on helping those with Medicaid Services (CMS) (www.cms.gov). prediabetes. Therefore, it seems reasonable
diabetes make informed self-management DSME is also covered by most health insur- to recommend that people with diabetes try
decisions. Care of diabetes has shifted to an ance plans. to follow the physical activity guidelines for
approach that is more patient centered and the general population.
places the person with diabetes and his or G. Physical activity Progressive resistance exercise im-
her family at the center of the care model Recommendations proves insulin sensitivity in older men
working in collaboration with health care c People with diabetes should be advised with type 2 diabetes to the same or even a
professionals. Patient-centered care is re- to perform at least 150 min/week of greater extent as aerobic exercise (172).
spectful of and responsive to individual moderate-intensity aerobic physical Clinical trials have provided strong evi-
patient preferences, needs, and values and activity (5070% of maximum heart dence for the A1C lowering value of resis-
ensures that patients values guide all deci- rate), spread over at least 3 days per tance training in older adults with type 2
sion making (139). week with no more than 2 consecutive diabetes (173,174), and for an additive
Evidence for the benets of DSME. Mul- days without exercise. (A) benet of combined aerobic and resistance
tiple studies have found that DSME is c In the absence of contraindications, exercise in adults with type 2 diabetes
associated with improved diabetes knowl- people with type 2 diabetes should be (175,176). In the absence of contraindica-
edge and self-care behavior (131), improved encouraged to perform resistance train- tions, patients with type 2 diabetes should
clinical outcomes such as lower A1C ing at least twice per week. (A) be encouraged to do at least two weekly
(132,133,135,136,140,141), lower self- sessions of resistance exercise (exercise
reported weight (131), improved quality Exercise is an important part of the with free weights or weight machines),
of life (134,141,142), healthy coping diabetes management plan. Regular exer- with each session consisting of at least
(143), and lower costs (144). Better out- cise has been shown to improve blood one set of ve or more different resistance
comes were reported for DSME inter- glucose control, reduce cardiovascular risk exercises involving the large muscle groups
ventions that were longer and included factors, contribute to weight loss, and (170).
follow-up support (DSMS) (131,145149) improve well-being. Furthermore, regular Evaluation of the diabetic patient before
(150), that were culturally (151,152) and exercise may prevent type 2 diabetes in recommending an exercise program.
age appropriate (153,154), that were tai- high-risk individuals (2022). Structured Prior guidelines suggested that before
lored to individual needs and prefer- exercise interventions of at least 8-week recommending a program of physical
ences, and that addressed psychosocial duration have been shown to lower A1C activity, the provider should assess pa-
issues and incorporated behavioral strat- by an average of 0.66% in people with tients with multiple cardiovascular risk
egies (131,135,155157). Both individual type 2 diabetes, even with no signicant factors for coronary artery disease (CAD).
and group approaches have been found change in BMI (168). Higher levels of ex- As discussed more fully in section VI.A.5.
effective (158161). There is growing evi- ercise intensity are associated with CHD Screening and Treatment, the area of
dence for the role of community health greater improvements in A1C and in t- screening asymptomatic diabetic patients
workers and peer (162,163) and lay leaders ness (169). A joint position statement by for CAD remains unclear, and a recent ADA
(164) in delivering DSME and support in ADA and the American College of Sports consensus statement on this issue con-
addition to the core team (165). Medicine summarizes the evidence for ben- cluded that routine screening is not rec-
Diabetes education is associated with ets of exercise in people with type 2 diabe- ommended (177). Providers should use
increased use of primary and preventive tes (170). clinical judgment in this area. Certainly,
services and lower use of acute, inpatient Frequency and type of exercise. high-risk patients should be encouraged
hospital services (144). Patients who par- The U.S. Department of Health and Hu- to start with short periods of low-inten-
ticipate in diabetes education are more man Services Physical Activity Guide- sity exercise and increase the intensity
likely to follow best practice treatment lines for Americans (171) suggests that and duration slowly.

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Position Statement

Providers should assess patients for Autonomic neuropathy. health, and no intervention characteris-
conditions that might contraindicate certain Autonomic neuropathy can increase the tics predicted benet on both outcomes,
types of exercise or predispose to injury, risk of exercise-induced injury or ad- was shown (189).
such as uncontrolled hypertension, se- verse event through decreased cardiac Key opportunities for screening of
vere autonomic neuropathy, severe pe- responsiveness to exercise, postural hy- psychosocial status occur at diagnosis,
ripheral neuropathy or history of foot potension, impaired thermoregulation, during regularly scheduled management
lesions, and unstable proliferative reti- impaired night vision due to impaired visits, during hospitalizations, at discovery
nopathy. The patients age and previous papillary reaction, and unpredictable car- of complications, or when problems with
physical activity level should be consid- bohydrate delivery from gastroparesis pre- glucose control, quality of life, or adherence
ered. disposing to hypoglycemia (181). are identied. Patients are likely to exhibit
Exercise in the presence of nonoptimal Autonomic neuropathy is also strongly as- psychological vulnerability at diagnosis
glycemic control hyperglycemia. When sociated with CVD in people with diabetes and when their medical status changes,
people with type 1 diabetes are deprived (182,183). People with diabetic auto- e.g., the end of the honeymoon period,
of insulin for 1248 h and are ketotic, nomic neuropathy should undergo car- when the need for intensied treatment is
exercise can worsen hyperglycemia and diac investigation before beginning evident, and when complications are dis-
ketosis (178); therefore, vigorous activity physical activity that is more intense covered (187).
should be avoided in the presence of ke- than that to which they are accustomed. Issues known to impact self-management
tosis. However, it is not necessary to Albuminuria and nephropathy. and health outcomes include but are not
postpone exercise based simply on hy- Physical activity can acutely increase uri- limited to attitudes about the illness,
perglycemia, provided the patient feels nary protein excretion. However, there is expectations for medical management
well and urine and/or blood ketones are no evidence that vigorous exercise increa- and outcomes, affect/mood, general and
negative. ses the rate of progression of diabetic diabetes-related quality of life, diabetes-
Hypoglycemia. In individuals taking in- kidney disease, and there is likely no need related distress (190,191), resources (-
sulin and/or insulin secretagogues, phys- for any specic exercise restrictions for nancial, social, and emotional) (192), and
ical activity can cause hypoglycemia if people with diabetic kidney disease psychiatric history (193195). Screening
medication dose or carbohydrate con- (184). tools are available for a number of these
sumption is not altered. For individuals areas (156). Indications for referral to a
on these therapies, added carbohydrate H. Psychosocial assessment and care mental health specialist familiar with diabe-
should be ingested if preexercise glucose Recommendations tes management may include gross non-
c It is reasonable to include assessment of compliance with medical regimen (by self
levels are ,100 mg/dL (5.6 mmol/L).
Hypoglycemia is rare in diabetic individ- the patients psychological and social or others) (195), depression with the pos-
uals who are not treated with insulin or situation as an ongoing part of the sibility of self-harm, debilitating anxiety
insulin secretagogues, and no preventive medical management of diabetes. (E) (alone or with depression), indications of
c Psychosocial screening and follow-up an eating disorder (196), or cognitive func-
measures for hypoglycemia are usually
advised in these cases. may include, but is not limited to, atti- tioning that signicantly impairs judgment.
tudes about the illness, expectations for It is preferable to incorporate psychological
Exercise in the presence of specic medical management and outcomes, assessment and treatment into routine care
long-term complications of diabetes affect/mood, general and diabetes- rather than waiting for identication of a
retinopathy. In the presence of prolifer- related quality of life, resources (nancial, specic problem or deterioration in psy-
ative diabetic retinopathy (PDR) or severe social, and emotional), and psychiatric chological status (156). Although the cli-
nonproliferative diabetic retinopathy history. (E) nician may not feel qualied to treat
(NPDR), vigorous aerobic or resistance c Consider screening for psychosocial psychological problems, utilizing the
exercise may be contraindicated because problems such as depression and patient-provider relationship as a foun-
of the risk of triggering vitreous hemor- diabetes-related distress, anxiety, eat- dation for further treatment can increase
rhage or retinal detachment (179). ing disorders, and cognitive impairment the likelihood that the patient will accept
Peripheral neuropathy. Decreased pain when self-management is poor. (C) referral for other services. It is important
sensation in the extremities results in to establish that emotional well-being is
increased risk of skin breakdown and Psychological and social problems part of diabetes management.
infection and of Charcot joint destruction. can impair the individuals (185188) or
Prior recommendations have advised non familys ability to carry out diabetes care I. When treatment goals are not met
weight-bearing exercise for patients with tasks and therefore compromise health For a variety of reasons, some people with
severe peripheral neuropathy. However, status. There are opportunities for the cli- diabetes and their health care providers
studies have shown that moderate-intensity nician to assess psychosocial status in a do not achieve the desired goals of treat-
walking may not lead to increased risk of timely and efcient manner so that re- ment (Table 9). Rethinking the treatment
foot ulcers or reulceration in those with ferral for appropriate services can be regimen may require assessment of barriers
peripheral neuropathy (180). All indi- accomplished. A systematic review and including income, health literacy, diabetes
viduals with peripheral neuropathy meta-analysis showed that psychosocial distress, depression, and competing de-
should wear proper footwear and exam- interventions modestly but signicantly mands, including those related to family
ine their feet daily to detect lesions early. improved A1C (standardized mean responsibilities and dynamics. Other strat-
Anyone with a foot injury or open sore difference 20.29%) and mental health egies may include culturally appropriate
should be restricted to nonweight- outcomes. However, a limited association and enhanced DSME, co-management
bearing activities. between the effects on A1C and mental with a diabetes team, referral to a medical

S26 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

social worker for assistance with insurance c Glucagon should be prescribed for all taken to ensure that unexpired glucagon
coverage, or change in pharmacological individuals at signicant risk of severe kits are available.
therapy. Initiation of or increase in SMBG, hypoglycemia, and caregivers or family Prevention of hypoglycemia is a crit-
utilization of continuous glucose monitor- members of these individuals instructed ical component of diabetes management.
ing, frequent contact with the patient, or in its administration. Glucagon admin- Patients should understand situations
referral to a mental health professional or istration is not limited to health care that increase their risk of hypoglycemia,
physician with special expertise in diabetes professionals. (E) such as when fasting for tests or proce-
may be useful. Providing patients with an c Individuals with hypoglycemia un- dures, during or after intense exercise, and
algorithm for self-titration of insulin doses awareness or one or more episodes of during sleep; and that increase the risk of
based on SMBG results may be helpful for severe hypoglycemia should be advised harm to self or others from hypoglycemia,
type 2 patients who take insulin (197). to raise their glycemic targets to strictly such as with driving. Teaching people with
avoid further hypoglycemia for at least diabetes to balance insulin use, carbohy-
several weeks, to partially reverse hypo- drate intake, and exercise is a necessary but
J. Intercurrent illness glycemia unawareness and reduce risk of not always sufcient strategy for preven-
The stress of illness, trauma, and/or surgery future episodes. (B) tion. In type 1 diabetes and severely
frequently aggravates glycemic control and
insulin-decient type 2 diabetes, the syn-
may precipitate diabetic ketoacidosis Hypoglycemia is the leading limiting drome of hypoglycemia unawareness, or
(DKA) or nonketotic hyperosmolar stated factor in the glycemic management of type hypoglycemia-associated autonomic fail-
life-threatening conditions that require 1 and insulin-treated type 2 diabetes (199). ure, can severely compromise stringent
immediate medical care to prevent com- Mild hypoglycemia may be inconvenient or diabetes control and quality of life. The
plications and death. Any condition lead- frightening to patients with diabetes, and decient counter-regulatory hormone re-
ing to deterioration in glycemic control more severe hypoglycemia can cause acute lease and autonomic responses in this
necessitates more frequent monitoring harm to the person with diabetes or others, syndrome are both risk factors for, and
of blood glucose and (in ketosis-prone if it causes falls, motor vehicle accidents, or caused by, hypoglycemia. A corollary to
patients) urine or blood ketones. Marked other injury. A large cohort study suggested this vicious cycle is that several weeks of
hyperglycemia requires temporary ad- that among older adults with type 2 avoidance of hypoglycemia has been
justment of the treatment program and, diabetes, a history of severe hypoglyce- demonstrated to improve counterregula-
if accompanied by ketosis, vomiting, or mia was associated with greater risk of tion and awareness to some extent in
alteration in level of consciousness, im- dementia (200). Conversely, evidence many patients (202). Hence, patients with
mediate interaction with the diabetes from the DCCT/EDIC study, which in- one or more episodes of severe hypoglyce-
care team. The patient treated with non- volved younger type 1 patients, suggested mia may benet from at least short-term re-
insulin therapies or MNT alone may tem- no association of frequency of severe hypo- laxation of glycemic targets.
porarily require insulin. Adequate uid glycemia with cognitive decline (201).
and caloric intake must be assured. In- Treatment of hypoglycemia (plasma glucose L. Bariatric surgery
fection or dehydration are more likely to ,70 mg/dL) requires ingestion of glucose- Recommendations
necessitate hospitalization of the person or carbohydrate-containing foods. The c Bariatric surgery may be considered for
with diabetes than the person without acute glycemic response correlates better adults with BMI .35 kg/m2 and type 2
diabetes. with the glucose content than with the car- diabetes, especially if the diabetes or
The hospitalized patient should be bohydrate content of the food. Although associated comorbidities are difcult to
treated by a physician with expertise in pure glucose is the preferred treatment, control with lifestyle and pharmaco-
the management of diabetes. For further any form of carbohydrate that contains glu- logic therapy. (B)
information on management of patients cose will raise blood glucose. Added fat may c Patients with type 2 diabetes who have
with hyperglycemia in the hospital, see retard and then prolong the acute glycemic undergone bariatric surgery need life-
section IX.A. Diabetes Care in the Hospital. response. Ongoing activity of insulin or in- long lifestyle support and medical moni-
For further information on management of sulin secretagogues may lead to recurrence toring. (B)
DKA or nonketotic hyperosmolar state, of hypoglycemia unless further food is in- c Although small trials have shown gly-
refer to the ADA consensus statement on gested after recovery. cemic benet of bariatric surgery in
hyperglycemic crises (198). Severe hypoglycemia (where the in- patients with type 2 diabetes and BMI
dividual requires the assistance of another of 3035 kg/m2, there is currently in-
K. Hypoglycemia person and cannot be treated with oral sufcient evidence to generally rec-
Recommendations carbohydrate due to confusion or un- ommend surgery in patients with BMI
c Glucose (1520 g) is the preferred consciousness) should be treated using ,35 kg/m2 outside of a research pro-
treatment for the conscious individual emergency glucagon kits, which require a tocol. (E)
with hypoglycemia, although any form prescription. Those in close contact with, c The long-term benets, cost-effectiveness,
of carbohydrate that contains glucose or having custodial care of, people with and risks of bariatric surgery in indi-
may be used. If SMBG 15 min after hypoglycemia-prone diabetes (family viduals with type 2 diabetes should be
treatment shows continued hypoglyce- members, roommates, school personnel, studied in well-designed controlled
mia, the treatment should be repeated. child care providers, correctional institu- trials with optimal medical and lifestyle
Once SMBG glucose returns to normal, tion staff, or coworkers), should be instruc- therapy as the comparator. (E)
the individual should consume a meal or ted in use of such kits. An individual does
snack to prevent recurrence of hypo- not need to be a health care professional to Gastric reduction surgery, either gas-
glycemia. (E) safely administer glucagon. Care should be tric banding or procedures that involve

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S27


Position Statement

bypassing, transposing, or resecting sec- (207). Recent retrospective analyses and specically in people with diabetes, obser-
tions of the small intestine, when part of a modeling studies suggest that these proce- vational studies of patients with a variety of
comprehensive team approach, can be an dures may be cost-effective, when one con- chronic illnesses, including diabetes, show
effective weight loss treatment for severe siders reduction in subsequent health care that these conditions are associated with an
obesity, and national guidelines support costs (208210). increase in hospitalizations for inuenza
its consideration for people with type 2 Some caution about the benets of and its complications. People with diabetes
diabetes who have BMI .35 kg/m2. Bariat- bariatric surgery might come from recent may be at increased risk of the bacteremic
ric surgery has been shown to lead to near- studies. A propensity scoreadjusted form of pneumococcal infection and
or complete normalization of glycemia in analyses of older severely obese patients have been reported to have a high risk
;5595% of patients with type 2 diabetes, with high baseline mortality in Veterans of nosocomial bacteremia, which has a
depending on the surgical procedure. A Affairs Medical Centers found that the use mortality rate as high as 50% (213).
meta-analysis of studies of bariatric surgery of bariatric surgery was not associated Safe and effective vaccines are avail-
involving 3,188 patients with diabetes re- with decreased mortality compared with able that can greatly reduce the risk of
ported that 78% had remission of diabe- usual care during a mean 6.7 years of serious complications from these diseases
tes (normalization of blood glucose levels follow-up (211). A study that followed pa- (214,215). In a case-control series, inu-
in the absence of medications), and that tients who had undergone laparoscopic enza vaccine was shown to reduce diabe-
the remission rates were sustained in adjustable gastric banding (LAGB) for 12 tes-related hospital admission by as much
studies that had follow-up exceeding 2 years found that 60% were satised with as 79% during u epidemics (214). There
years (203). Remission rates tend to be the procedure. Nearly one of three pa- is sufcient evidence to support that peo-
lower with procedures that only constrict tients experienced band erosion, and al- ple with diabetes have appropriate sero-
the stomach and higher with those that most half had required removal of their logic and clinical responses to these
bypass portions of the small intestine. bands. The authors conclusion was that, vaccinations. The Centers for Disease
Additionally, there is a suggestion that in- LAGB appears to result in relatively poor Control and Prevention (CDC) Advisory
testinal bypass procedures may have gly- long-term outcomes (212). Studies of the Committee on Immunization Practices
cemic effects that are independent of their mechanisms of glycemic improvement recommends inuenza and pneumococcal
effects on weight, perhaps involving the and long-term benets and risks of bariat- vaccines for all individuals with diabetes
incretin axis. ric surgery in individuals with type 2 di- (http://www.cdc.gov/vaccines/recs/).
One RCT compared adjustable gastric abetes, especially those who are not At the time these standards went to
banding to best available medical and severely obese, will require well-designed press, the CDC was considering recom-
lifestyle therapy in subjects with type 2 clinical trials, with optimal medical and mendations to immunize all or some adults
diabetes diagnosed less than 2 years be- lifestyle therapy of diabetes and cardiovas- with diabetes for hepatitis B. ADA awaits
fore randomization and with BMI 3040 cular risk factors as the comparator. the nal recommendations and will sup-
kg/m2 (204). In this trial, 73% of surgi- port them when they are released in 2012.
cally treated patients achieved remis- M. Immunization
sion of their diabetes, compared with Recommendations VI. PREVENTION AND
13% of those treated medically. The latter c Annually provide an inuenza vaccine MANAGEMENT OF DIABETES
group lost only 1.7% of body weight, sug- to all diabetic patients $6 months of COMPLICATIONS
gesting that their therapy was not opti- age. (C)
mal. Overall the trial had 60 subjects, c Administer pneumococcal polysaccha- A. CVD
and only 13 had a BMI ,35 kg/m2, mak- ride vaccine to all diabetic patients $2 CVD is the major cause of morbidity and
ing it difcult to generalize these results years of age. A one-time revaccination is mortality for individuals with diabetes
widely to diabetic patients who are less recommended for individuals .64 years and the largest contributor to the direct
severely obese or with longer duration of age previously immunized when and indirect costs of diabetes. The com-
of diabetes. In a more recent study involv- they were ,65 years of age if the vac- mon conditions coexisting with type 2
ing 110 patients with type 2 diabetes cine was administered .5 years ago. diabetes (e.g., hypertension and dyslipi-
and a mean BMI of 47 kg/m2, Roux-en-Y Other indications for repeat vaccina- demia) are clear risk factors for CVD, and
gastric bypass resulted in a mean loss of tion include nephrotic syndrome, diabetes itself confers independent risk.
excess weight of 63% at 1 year and 84% at chronic renal disease, and other immu- Numerous studies have shown the ef-
2 years (205). nocompromised states, such as after cacy of controlling individual cardiovas-
Bariatric surgery is costly in the short transplantation. (C) cular risk factors in preventing or slowing
term and has some risks. Rates of mor- c Administer hepatitis B vaccination to CVD in people with diabetes. Large ben-
bidity and mortality directly related to the adults with diabetes as per Centers for ets are seen when multiple risk factors
surgery have been reduced considerably Disease Control and Prevention (CDC) are addressed globally (216,217). There is
in recent years, with 30-day mortality rates recommendations. (C) evidence that measures of 10-year coro-
now 0.28%, similar to those of laparo- nary heart disease (CHD) risk among U.S.
scopic cholecystectomy (206). Longer- Inuenza and pneumonia are com- adults with diabetes have improved sig-
term concerns include vitamin and mineral mon, preventable infectious diseases asso- nicantly over the past decade (218).
deciencies, osteoporosis, and rare but of- ciated with high mortality and morbidity in 1. Hypertension/blood pressure control
ten severe hypoglycemia from insulin hy- the elderly and in people with chronic Recommendations
persecretion. Cohort studies attempting to diseases. Though there are limited studies Screening and diagnosis
match subjects suggest that the procedure reporting the morbidity and mortality of c Blood pressure should be measured
may reduce longer-term mortality rates inuenza and pneumococcal pneumonia at every routine diabetes visit. Patients

S28 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

found to have systolic blood pressure type of diabetes, age, obesity, and ethnic- stroke, and CVD death; the hazard ratio
(SBP) $ 130mmHg or diastolic blood ity. Hypertension is a major risk factor for for the primary end point in the intensive
pressure (DBP) $80 mmHg should both CVD and microvascular complica- group was 0.88 (95% CI 0.731.06; P 5
have blood pressure conrmed on a tions. In type 1 diabetes, hypertension is 0.20). Of the prespecied secondary end
separate day. Repeat SBP $130 mmHg or often the result of underlying nephropathy, points, only stroke and nonfatal stroke
DBP $80 mmHg conrms a diagnosis of while in type 2 diabetes it usually coexists were statistically signicantly reduced by
hypertension. (C) with other cardiometabolic risk factors. intensive blood pressure treatment, with
Screening and diagnosis. Measurement hazard ratios of 0.59 (95% CI 0.390.89,
Goals
of blood pressure in the ofce should be P 5 0.01) and 0.63 (95% CI 0.410.96,
c A goal SBP ,130 mmHg is appropriate done by a trained individual and follow the P 5 0.03), respectively. If this nding is
for most patients with diabetes. (C) guidelines established for nondiabetic real, the number needed to treat to prevent
c Based on patient characteristics and individuals: measurement in the seated one stroke over the course of 5 years with
response to therapy, higher or lower position, with feet on the oor and arm intensive blood pressure management is 89.
SBP targets may be appropriate. (B) supported at heart level, after 5 min of rest. In predened subgroup analyses,
c Patients with diabetes should be treated Cuff size should be appropriate for the there was a suggestion of heterogeneity
to a DBP ,80 mmHg. (B) upper arm circumference. Elevated values (P 5 0.08) based on whether participants
Treatment should be conrmed on a separate day. were randomized to standard or intensive
c Patients with a SBP of 130139 mmHg Because of the clear synergistic risks of glycemia intervention. In those random-
or a DBP of 8089 mmHg may be given hypertension and diabetes, the diagnostic ized to standard glycemic control, the
lifestyle therapy alone for a maximum cutoff for a diagnosis of hypertension is event rate for the primary end point was
of 3 months and then, if targets are not lower in people with diabetes (blood 1.89 per year in the intensive blood pres-
achieved, be treated with addition of pressure $130/80 mmHg) than those sure arm and 2.47 in the standard blood
pharmacological agents. (E) without diabetes (blood pressure $140/ pressure arm, while the respective rates in
c Patients with more severe hypertension 90 mmHg) (219). the intensive glycemia arm were 1.85 and
(SBP $140 or DBP $90 mmHg) at Home blood pressure self-monitoring 1.73. If this observation is true, it suggests
diagnosis or follow-up should receive and 24-h ambulatory blood pressure that intensive management to a SBP target
pharmacologic therapy in addition to monitoring may provide additional evi- of ,120 mmHg may be of benet in those
lifestyle therapy. (A) dence of white coat and masked hyper- who are not targeting an A1C of ,6% and/
c Lifestyle therapy for hypertension con- tension and other discrepancies between or that the benet of intensive blood pres-
sists of weight loss, if overweight; Dietary ofce and true blood pressure, and stud- sure management is diminished by more
Approaches to Stop Hypertension ies in nondiabetic populations found that intensive glycemia management targeting
(DASH)-style dietary pattern, including home measurements may better correlate an A1C of ,6%.
reducing sodium and increasing potas- with CVD risk than ofce measurements Other recent randomized trial data
sium intake; moderation of alcohol in- (220,221). However, the preponderance include those of the ADVANCE trial in
take; and increased physical activity. (B) of the clear evidence of benets of treat- which treatment with an ACE inhibitor
c Pharmacologic therapy for patients with ment of hypertension in people with dia- and a thiazide-type diuretic reduced
diabetes and hypertension should be betes is based on ofce measurements. the rate of death but not the composite
with a regimen that includes either an Treatment goals. Epidemiologic analy- macrovascular outcome. However, the
ACE inhibitor or an ARB. If one class is ses show that blood pressure .115/75 ADVANCE trial had no specied targets
not tolerated, the other should be sub- mmHg is associated with increased car- for the randomized comparison, and the
stituted. (C) diovascular event rates and mortality in mean SBP in the intensive group (135
c Multiple drug therapy (two or more individuals with diabetes (219,222,223). mmHg) was not as low as the mean SBP in
agents at maximal doses) is generally Randomized clinical trials have demon- the ACCORD standard-therapy group
required to achieve blood pressure strated the benet (reduction of CHD (228). A post hoc analysis of blood pressure
targets. (B) events, stroke, and nephropathy) of control in 6,400 patients with diabetes and
c Administer one or more antihyperten- lowering blood pressure to ,140 mmHg CAD enrolled in the International Verapa-
sive medications at bedtime. (A) systolic and ,80 mmHg diastolic in indi- mil/Trandolapril Study (INVEST) demon-
c If ACE inhibitors, ARBs, or diuretics are viduals with diabetes (219,224226). The strated that tight control (,130 mmHg)
used, kidney function and serum po- ACCORD trial examined whether blood was not associated with improved cardio-
tassium levels should be monitored. (E) pressure lowering to systolic blood pressure vascular outcomes compared with usual
c In pregnant patients with diabetes and (SBP) ,120 mmHg provides greater car- care (130140 mmHg) (229).
chronic hypertension, blood pressure diovascular protection than an SBP of It is possible that lowering SBP from
target goals of 110129/6579 mmHg 130140 mmHg in patients with type 2 di- the low-130s to ,120 mmHg does not
are suggested in the interest of long-term abetes at high risk for CVD (227). The further reduce coronary events or death,
maternal health and minimizing im- blood pressure achieved in the intensive and that most of the benet from lowering
paired fetal growth. ACE inhibitors and group was 119/64 mmHg and in the stan- blood pressure is achieved by targeting a
ARBs are contraindicated during preg- dard group was 133/70 mmHg; the differ- goal ,140 mmHg. However, this has not
nancy. (E) ence achieved was attained with an average been formally assessed. Only the ACCORD
of 3.4 medications per participant in the blood pressure trial has formally examined
Hypertension is a common comor- intensive group and 2.1 in the standard treatment targets signicantly ,130
bidity of diabetes, affecting the majority of therapy group. The primary outcome mmHg in diabetes. The absence of signi-
patients, with prevalence depending on was a composite of nonfatal MI, nonfatal cant harms, the trends toward benet in

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S29


Position Statement

stroke, and the potential heterogeneity therapy of hypertension. In a nonhyper- to optimal doses of at least 3 antihyperten-
with respect to intensive glycemia manage- tension trial of high-risk individuals, sive agents of different classications, one
ment suggests that previously recommen- including a large subset with diabetes, of which should be a diuretic, clinicians
ded targets are reasonable pending further an ACE inhibitor reduced CVD outcomes should consider an evaluation for sec-
analyses and results. SBP targets more or (236). In patients with congestive heart ondary forms of hypertension. Growing
less stringent than ,130 mmHg may be failure (CHF), including diabetic sub- evidence suggests that there is an associ-
appropriate for individual patients, based groups, ARBs have been shown to reduce ation between increase in sleep-time
on response to therapy, medication toler- major CVD outcomes (237240), and in blood pressure and incidence of CVD
ance, and individual characteristics, keeping type 2 patients with signicant nephropa- events. A recent RCT of 448 participants
in mind that most analyses have suggested thy, ARBs were superior to calcium channel with type 2 diabetes and hypertension
that outcomes are worse if the SBP is .140 blockers for reducing heart failure (241). demonstrated reduced cardiovascular
mmHg. Though evidence for distinct advantages events and mortality with median follow-
Treatment strategies. Although there of RAS inhibitors on CVD outcomes in di- up of 5.4 years if at least one antihyperten-
are no well-controlled studies of diet abetes remains conicting (224,235), the sive medication was given at bedtime (243).
and exercise in the treatment of hyperten- high CVD risks associated with diabetes, During pregnancy in diabetic women
sion in individuals with diabetes, the Di- and the high prevalence of undiagnosed with chronic hypertension, target blood
etary Approaches to Stop Hypertension CVD, may still favor recommendations pressure goals of SBP 110129 mmHg
(DASH) study in nondiabetic individuals for their use as rst-line hypertension ther- and DBP 6579 mmHg are reasonable,
has shown antihypertensive effects similar apy in people with diabetes (219). as they contribute to long-term maternal
to pharmacologic monotherapy. Lifestyle Recently, the blood pressure arm of health. Lower blood pressure levels may
therapy consists of reducing sodium intake the ADVANCE trial demonstrated that be associated with impaired fetal growth.
(to ,1,500 mg per day) and excess body routine administration of a xed combi- During pregnancy, treatment with ACE
weight; increasing consumption of fruits, nation of the ACE inhibitor perindopril inhibitors and ARBs is contraindicated,
vegetables (810 servings per day), and and the diuretic indapamide signicantly since they can cause fetal damage. Antihy-
low-fat dairy products (23 servings per reduced combined microvascular and pertensive drugs known to be effective and
day); avoiding excessive alcohol consump- macrovascular outcomes, as well as CVD safe in pregnancy include methyldopa, la-
tion (no more than two servings per day in and total mortality. The improved out- betalol, diltiazem, clonidine, and prazosin.
men and no more than one serving per comes could also have been due to lower Chronic diuretic use during pregnancy has
day in women) (230); and increasing ac- achieved blood pressure in the perindopril- been associated with restricted maternal
tivity levels (219). These nonpharmaco- indapamide arm (228). In addition the plasma volume, which might reduce utero-
logical strategies may also positively affect ACCOMPLISH trial showed a decrease placental perfusion (244).
glycemia and lipid control. Their effects on in morbidity and mortality in those re- 2. Dyslipidemia/lipid management
cardiovascular events have not been estab- ceiving benazapril and amlodipine versus Recommendations
lished. An initial trial of nonpharmacologic benazapril and hydrochlorothiazide. The
Screening
therapy may be reasonable in diabetic indi- compelling benets of RAS inhibitors in
viduals with mild hypertension (SBP 130 diabetic patients with albuminuria or renal c In most adult patients, measure fasting
139 mmHg or DBP 8089 mmHg). If the insufciency provide additional rationale lipid prole at least annually. In adults
blood pressure is $140 mmHg systolic for use of these agents (see section VI.B. with low-risk lipid values (LDL choles-
and/or $90 mmHg diastolic at the time Nephropathy Screening and Treatment). terol ,100 mg/dL, HDL cholesterol .50
of diagnosis, pharmacologic therapy If needed to achieve blood pressure targets, mg/dL, and triglycerides ,150 mg/dL),
should be initiated along with nonpharma- amlodipine, HCTZ, or chlorthalidone can lipid assessments may be repeated every
cologic therapy (219). be added. If estimated glomerular ltration 2 years. (E)
Lowering of blood pressure with reg- rate (GFR) is ,30 ml/min/m2, a loop di- Treatment recommendations and goals
imens based on a variety of antihyperten- uretic, rather than HCTZ or chlorthatli- c Lifestyle modication focusing on the
sive drugs, including ACE inhibitors, done should be prescribed. Titration of reduction of saturated fat, trans fat, and
ARBs, b-blockers, diuretics, and calcium and/or addition of further blood pressure cholesterol intake; increase of n-3 fatty
channel blockers, has been shown to be medications should be made in timely fash- acids, viscous ber and plant stanols/
effective in reducing cardiovascular events. ion to overcome clinical inertia in achieving sterols; weight loss (if indicated); and
Several studies suggested that ACE inhibi- blood pressure targets. increased physical activity should be
tors may be superior to dihydropyridine Evidence is emerging that health in- recommended to improve the lipid
calcium channel blockers in reducing car- formation technology can be used safely and prole in patients with diabetes. (A)
diovascular events (231233). However, a effectively as a tool to enable attainment of c Statin therapy should be added to life-
variety of other studies have shown no spe- blood pressure goals. Using a telemonitor- style therapy, regardless of baseline
cic advantage to ACE inhibitors as initial ing intervention to direct titrations of anti- lipid levels, for diabetic patients:
treatment of hypertension in the general hypertensive medications between medical
hypertensive population, but rather an ofce visits has been demonstrated to have a with overt CVD. (A)
advantage on cardiovascular outcomes profound impact on SBP control (242). without CVD who are over the age of 40
of initial therapy with low-dose thiazide An important caveat is that most years and who have one or more other
diuretics (219,234,235). patients with hypertension require mul- CVD risk factors. (A)
In people with diabetes, inhibitors of tidrug therapy to reach treatment goals, c For patients at lower risk than those
the renin-angiotensin system (RAS) may especially diabetic patients whose targets are above (e.g., those without overt CVD
have unique advantages for initial or early lower (219). If blood pressure is refractory

S30 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

and under the age of 40 years), statin However, the evidence base for drugs that not denitive, consideration should be
therapy should be considered in addi- target these lipid fractions is signicantly given to lipid-lowering goals in type 1 di-
tion to lifestyle therapy if LDL choles- less robust than that for statin therapy abetic patients similar to those in type 2
terol remains .100 mg/dL or in those (253). Nicotinic acid has been shown to diabetic patients, particularly if they have
with multiple CVD risk factors. (E) reduce CVD outcomes (254), although other cardiovascular risk factors.
c In individuals without overt CVD, the the study was done in a nondiabetic co-
primary goal is an LDL cholesterol ,100 hort. Gembrozil has been shown to de- Alternative LDL cholesterol goals. Vir-
mg/dL (2.6 mmol/L). (A) crease rates of CVD events in subjects tually all trials of statins and CVD out-
c In individuals with overt CVD, a lower without diabetes (255,256) and in the di- comes tested specic doses of statins
LDL cholesterol goal of ,70 mg/dL abetic subgroup of one of the larger trials against placebo, other doses of statin, or
(1.8 mmol/L), using a high dose of a (255). However, in a large trial specic to other statins, rather than aiming for specic
statin, is an option. (B) diabetic patients, fenobrate failed to re- LDL cholesterol goals (259). Placebo-
c If drug-treated patients do not reach duce overall cardiovascular outcomes controlled trials generally achieved LDL
the above targets on maximal tolerated (257). cholesterol reductions of 3040% from
statin therapy, a reduction in LDL baseline. Hence, LDL cholesterol lower-
cholesterol of ;3040% from baseline Dyslipidemia treatment and target ing of this magnitude is an acceptable
is an alternative therapeutic goal. (A) lipid levels. For most patients with di- outcome for patients who cannot reach
c Triglycerides levels ,150 mg/dL (1.7 abetes, the rst priority of dyslipidemia LDL cholesterol goals due to severe base-
mmol/L) and HDL cholesterol .40 therapy (unless severe hypertriglyceride- line elevations in LDL cholesterol and/or
mg/dL (1.0 mmol/L) in men and .50 mia is the immediate issue) is to lower intolerance of maximal, or any, statin
mg/dL (1.3 mmol/L) in women, are de- LDL cholesterol to a target goal of ,100 doses. Additionally for those with baseline
sirable. However, LDL cholesterol mg/dL (2.60 mmol/L) (258). Lifestyle in- LDL cholesterol minimally .100 mg/dL,
targeted statin therapy remains the tervention, including MNT, increased prescribing statin therapy to lower LDL
preferred strategy. (C) physical activity, weight loss, and smok- cholesterol ;3040% from baseline is
c If targets are not reached on maximally ing cessation, may allow some patients to probably more effective than prescrib-
tolerated doses of statins, combination reach lipid goals. Nutrition intervention ing just enough to get LDL cholesterol
therapy using statins and other lipid- should be tailored according to each pa- slightly ,100 mg/dL.
lowering agents may be considered to tients age, type of diabetes, pharmacolog- Recent clinical trials in high-risk pa-
achieve lipid targets but has not been ical treatment, lipid levels, and other tients, such as those with acute coronary
evaluated in outcome studies for either medical conditions and should focus on syndromes or previous cardiovascular
CVD outcomes or safety. (E) the reduction of saturated fat, cholesterol, events (260262), have demonstrated
c Statin therapy is contraindicated in preg- and trans unsaturated fat intake and increa- that more aggressive therapy with high
nancy. (B) ses in n-3 fatty acids, viscous ber (such as doses of statins to achieve an LDL cho-
in oats, legumes, citrus), and plant stanols/ lesterol of ,70 mg/dL led to a signicant
Evidence for benets of lipid-lowering sterols. Glycemic control can also bene- reduction in further events. Therefore, a
therapy. Patients with type 2 diabetes have cially modify plasma lipid levels, particularly reduction in LDL cholesterol to a goal of
an increased prevalence of lipid abnormal- in patients with very high triglycerides and ,70 mg/dL is an option in very-high-
ities, contributing to their high risk of poor glycemic control. risk diabetic patients with overt CVD
CVD. For the past decade or more, In those with clinical CVD or who are (263).
multiple clinical trials demonstrated sig- over 40 years of age with other CVD risk In individual patients, LDL choles-
nicant effects of pharmacologic (primarily factors, pharmacological treatment terol lowering with statins is highly vari-
statin) therapy on CVD outcomes in sub- should be added to lifestyle therapy able and this variable response is poorly
jects with CHD and for primary CVD pre- regardless of baseline lipid levels. Statins understood (264). Reduction of CVD
vention (245). Subanalyses of diabetic are the drugs of choice for lowering LDL events with statins correlates very closely
subgroups of larger trials (246250) and tri- cholesterol. with LDL cholesterol lowering (245).
als specically in subjects with diabetes In patients other than those described When maximally tolerated doses of sta-
(251,252) showed signicant primary and above, statin treatment should be consid- tins fail to signicantly lower LDL choles-
secondary prevention of CVD events 1/2 ered if there is an inadequate LDL choles- terol (,30% reduction from patients
CHD deaths in diabetic populations. Similar terol response to lifestyle modications baseline), the primary aim of combination
to ndings in nondiabetic subjects, reduc- and improved glucose control, or if the therapy should be to achieve additional
tion in hard CVD outcomes (CHD death patient has increased cardiovascular risk LDL cholesterol lowering. Niacin, feno-
and nonfatal MI) can be more clearly seen (e.g., multiple cardiovascular risk factors brate, ezetimibe, and bile acid sequestrants
in diabetic subjects with high baseline or long duration of diabetes). Very little all offer additional LDL cholesterol lower-
CVD risk (known CVD and/or very high clinical trial evidence exists for type 2 ing. The evidence that combination therapy
LDL cholesterol levels), but overall the patients under the age of 40 years or for for LDL cholesterol lowering provides a sig-
benets of statin therapy in people with type 1 patients of any age. In the Heart nicant increment in CVD risk reduction
diabetes at moderate or high risk for CVD Protection Study (lower age limit: 40 years), over statin therapy alone is still elusive.
are convincing. the subgroup of ;600 patients with type 1 Some experts recommend a greater focus
Low levels of HDL cholesterol, often diabetes had a reduction in risk propor- on nonHDL cholesterol and apolipopro-
associated with elevated triglyceride levels, tionately similar to that of patients with tein B (apoB) in patients who are likely to
are the most prevalent pattern of dyslipi- type 2 diabetes, although not statistically have small LDL particles, such as people
demia in persons with type 2 diabetes. signicant (247). Although the data are with diabetes (265).

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S31


Position Statement

Treatment of other lipoprotein fractions 3. Antiplatelet agents Table 11dSummary of recommendations


or targets. Severe hypertriglyceridemia Recommendations for glycemic, blood pressure, and lipid
may warrant immediate therapy of this c Consider aspirin therapy (75162 control for most adults with diabetes
abnormality with lifestyle and usually mg/day) as a primary prevention strategy A1C ,7.0%*
pharmacologic therapy (bric acid deriv- in those with type 1 or type 2 diabetes at Blood pressure ,130/80 mmHg
ative, niacin, or sh oil) to reduce the risk increased cardiovascular risk (10-year Lipids
of acute pancreatitis. In the absence of risk .10%). This includes most men .50 LDL cholesterol ,100 mg/dL
severe hypertriglyceridemia, therapy years of age or women .60 years of age (,2.6 mmol/L)
targeting HDL cholesterol or triglycerides who have at least one additional major
*More or less stringent glycemic goals may be ap-
has intuitive appeal but lacks the evidence risk factor (family history of CVD, hy- propriate for individual patients. Goals should be
base of statin therapy. If the HDL choles- pertension, smoking, dyslipidemia, or individualized based on duration of diabetes, age/life
terol is ,40 mg/dL and the LDL cholesterol albuminuria). (C) expectancy, comorbid conditions, known CVD or
100129 mg/dL, gembrozil or niacin c Aspirin should not be recommended advanced microvascular complications, hypoglycemia
unawareness, individual and patient considerations.
might be used, especially if a patient is for CVD prevention for adults with Based on patient characteristics and response to
intolerant to statins. Niacin is the most diabetes at low CVD risk (10-year therapy, higher or lower SBP targets may be appro-
effective drug for raising HDL choles- CVD risk ,5%, such as in men ,50 priate. In individuals with overt CVD, a lower LDL
terol. It can signicantly increase blood years and women ,60 years with no cholesterol goal of ,70 mg/dL (1.8 mmol/L), using
glucose at high doses, but recent studies major additional CVD risk factors), a high dose of a statin, is an option.
demonstrate that at modest doses (750 since the potential adverse effects
2,000 mg/day), signicant improvements from bleeding likely offset the potential little effect on CHD death (RR 0.95, 95% CI
in LDL cholesterol, HDL cholesterol, and benets. (C) 0.781.15) or total stroke. There was some
triglyceride levels are accompanied by c In patients in these age-groups with evidence of a difference in aspirin effect by
only modest changes in glucose that are multiple other risk factors (e.g., 10-year gender. Aspirin signicantly reduced CHD
generally amenable to adjustment of dia- risk 510%), clinical judgment is re- events in men but not in women. Con-
betes therapy (266,267). quired. (E) versely, aspirin had no effect on stroke in
Combination therapy. Combination c Use aspirin therapy (75162 mg/day) men but signicantly reduced stroke in
therapy, with a statin and a brate or as a secondary prevention strategy in women. Notably, differences between
statin and niacin, may be efcacious for those with diabetes with a history of sexes in aspirins effects have not been ob-
treatment for all three lipid fractions, but CVD. (A) served in studies of secondary prevention
this combination is associated with an c For patients with CVD and documented (271). In the six trials examined by the
increased risk for abnormal transaminase aspirin allergy, clopidogrel (75 mg/day) ATT collaborators, the effects of aspirin
levels, myositis, or rhabdomyolysis. The should be used. (B) on major vascular events were similar for
risk of rhabdomyolysis is higher with c Combination therapy with ASA (75162 patients with or without diabetes (RR
higher doses of statins and with renal mg/day) and clopidogrel (75 mg/day) is 0.88, 95% CI 0.671.15, and 0.87, 0.79
insufciency and seems to be lower when reasonable for up to a year after an acute 0.96), respectively. The condence interval
statins are combined with fenobrate coronary syndrome. (B) was wider for those with diabetes because
than gembrozil (268). In the recent of their smaller number.
ACCORD study, the combination of fe- Aspirin has been shown to be effective Based on the currently available evi-
nobrate and simvastatin did not reduce in reducing cardiovascular morbidity and dence, aspirin appears to have a modest
the rate of fatal cardiovascular events, mortality in high-risk patients with pre- effect on ischemic vascular events, with
nonfatal MI, or nonfatal stroke, as com- vious MI or stroke (secondary prevention). the absolute decrease in events depending
pared with simvastatin alone, in patients Its net benet in primary prevention on the underlying CVD risk. The main
with type 2 diabetes who were at high risk among patients with no previous cardio- adverse effects appear to be an increased
for CVD. However, prespecied sub- vascular events is more controversial, both risk of gastrointestinal bleeding. The ex-
group analyses suggested heterogeneity for patients with and without a history of cess risk may be as high as 15 per 1,000
in treatment effects according to sex, diabetes (271). Two recent RCTs of aspirin per year in real-world settings. In adults
with a benet of combination therapy specically in patients with diabetes failed with CVD risk .1% per year, the number
for men and possible harm for women, to show a signicant reduction in CVD end of CVD events prevented will be similar to
and a possible benet for patients with points, raising further questions about the or greater than the number of episodes of
both triglyceride level $204 mg/dL and efcacy of aspirin for primary prevention in bleeding induced, although these compli-
HDL cholesterol level #34 mg/dL (269). people with diabetes (272,273). cations do not have equal effects on long-
The AIM-HIGH trial randomized over The Antithrombotic Trialist (ATT) col- term health (274).
3,000 patients (about one-third with di- laborators recently published an individual In 2010, a position statement of the
abetes) to statin therapy plus or minus patient-level meta-analysis of the six large ADA, AHA, and the American College of
addition of extended release niacin. The trials of aspirin for primary prevention in Cardiology Foundation (ACCF) updated
trial was halted early due to no difference the general population. These trials collec- prior joint recommendations for primary
in the primary CVD outcome and a pos- tively enrolled over 95,000 participants, prevention (275). Low-dose (75162
sible increase in ischemic stroke in those including almost 4,000 with diabetes. mg/day) aspirin use for primary preven-
on combination therapy (270). Table 11 Overall, they found that aspirin reduced tion is reasonable for adults with diabetes
summarizes common treatment goals the risk of vascular events by 12% (relative and no previous history of vascular disease
for A1C, blood pressure, and LDL cho- risk [RR] 0.88, 95% CI 0.820.94). The who are at increased CVD risk (10-year risk
lesterol. largest reduction was for nonfatal MI with of CVD events .10%) and who are not at

S32 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

increased risk for bleeding. This generally provides convincing documentation of the subsequent follow-up has intuitive appeal.
includes most men over age 50 years and causal link between cigarette smoking and However, recent studies concluded that us-
women over age 60 years who also have health risks. Much of the work document- ing this approach fails to identify which
one or more of the following major risk ing the impact of smoking on health does patients with type 2 diabetes will have si-
factors: smoking, hypertension, dyslipide- not separately discuss results on subsets of lent ischemia on screening tests (182,280).
mia,) family history of premature CVD, or individuals with diabetes, but suggests that Candidates for cardiac testing include
albuminuria. the identied risks are at least equivalent those with 1) typical or atypical cardiac
However, aspirin is no longer recom- to those found in the general population. symptoms and 2) an abnormal resting
mended for those at low CVD risk (women Other studies of individuals with diabetes ECG. The screening of asymptomatic pa-
under age 60 years and men under age 50 consistently demonstrate that smokers tients remains controversial. Intensive med-
years with no major CVD risk factors; 10- have a heightened risk of CVD and pre- ical therapy, which would be indicated
year CVD risk ,5%), as the low benet is mature death and increased rate of mi- anyway for diabetic patients at high risk for
likely to be outweighed by the risks of sig- crovascular complications of diabetes. CVD, seems to provide equal outcomes to
nicant bleeding. Clinical judgment should Smoking may have a role in the develop- invasive revascularization, which raises
be used for those at intermediate risk ment of type 2 diabetes. questions of how screening results would
(younger patients with one or risk factors, The routine and thorough assessment change management. (281,282). There is
or older patients with no risk factors; those of tobacco use is important as a means of also some evidence that silent myocardial
with 10-year CVD risk of 510%) until fur- preventing smoking or encouraging cessa- ischemia may reverse over time, adding to
ther research is available. Use of aspirin in tion. A number of large randomized clinical the controversy concerning aggressive
patients under the age of 21 years is contra- trials have demonstrated the efcacy and screening strategies (283). Finally, a recent
indicated due to the associated risk of cost-effectiveness of brief counseling in randomized observational trial demon-
Reyes syndrome. smoking cessation, including the use of strated no clinical benet to routine screen-
Average daily dosages used in most quit lines, in the reduction of tobacco use. ing of asymptomatic patients with type 2
clinical trials involving patients with di- For the patient motivated to quit, the addi- diabetes and normal ECGs (284). Despite
abetes ranged from 50 to 650 mg but were tion of pharmacological therapy to counsel- abnormal myocardial perfusion imaging in
mostly in the range of 100 to 325 mg/day. ing is more effective than either treatment more than one in ve patients, cardiac out-
There is little evidence to support any alone. Special considerations should in- comes were essentially equal (and very low)
specic dose, but using the lowest possi- clude assessment of the level of nicotine in screened versus unscreened patients. Ac-
ble dosage may help reduce side-effects dependence, which is associated with dif- cordingly, the overall effectiveness, especially
(276). Although platelets from patients culty in quitting and relapse (279). the cost-effectiveness, of such an indiscrim-
with diabetes have altered function, it is inate screening strategy is now questioned.
unclear what, if any, impact that nding 5. CHD screening and treatment Newer noninvasive CAD screening
has on the required dose of aspirin for car- Recommendations methods, such as computed tomography
Screening
dioprotective effects in the patient with di- (CT) and CT angiography have gained in
c In asymptomatic patients, routine
abetes. There are many alternate pathways popularity. These tests infer the presence
screening for CAD is not recommended,
for platelet activation that are independent of coronary atherosclerosis by measuring
as it does not improve outcomes as long
of thromboxane A2 and thus not sensitive the amount of calcium in coronary arteries
as CVD risk factors are treated. (A)
to the effects of aspirin (277). Therefore, and, in some circumstances, by direct
while aspirin resistance appears higher Treatment visualization of luminal stenoses. Although
in the diabetic patients when measured c In patients with known CVD, consider asymptomatic diabetic patients found to
by a variety of ex vivo and in vitro methods ACE inhibitor therapy (C) and use aspirin have a higher coronary disease burden have
(platelet aggrenometry, measurement of and statin therapy (A) (if not contra- more future cardiac events (285287), the
thromboxane B2), these observations alone indicated) to reduce the risk of cardio- role of these tests beyond risk stratication
are insufcient to empirically recommend vascular events. In patients with a prior is not clear. Their routine use leads to radi-
higher doses of aspirin be used in the di- MI, b-blockers should be continued for ation exposure and may result in unneces-
abetic patient at this time. at least 2 years after the event. (B) sary invasive testing such as coronary
Clopidogrel has been demonstrated c Longer-term use of b-blockers in the angiography and revascularization proce-
to reduce CVD events in diabetic individ- absence of hypertension is reasonable if dures. The ultimate balance of benet,
uals (278). It is recommended as adjunc- well tolerated, but data are lacking. (E) cost, and risks of such an approach in
tive therapy in the rst year after an acute c Avoid TZD treatment in patients with asymptomatic patients remains controver-
coronary syndrome or as alternative ther- symptomatic heart failure. (C) sial, particularly in the modern setting of
apy in aspirin-intolerant patients. c Metformin may be used in patients with aggressive CVD risk factor control.
stable CHF if renal function is normal. In all patients with diabetes, cardio-
4. Smoking cessation It should be avoided in unstable or hos- vascular risk factors should be assessed at
Recommendations pitalized patients with CHF. (C) least annually. These risk factors include
c Advise all patients not to smoke. (A) dyslipidemia, hypertension, smoking, a
c Include smoking cessation counseling Screening for CAD is reviewed in a positive family history of premature coro-
and other forms of treatment as a rou- recently updated consensus statement nary disease, and the presence of micro- or
tine component of diabetes care. (B) (177). To identify the presence of CAD in macroalbuminuria. Abnormal risk factors
diabetic patients without clear or suggestive should be treated as described elsewhere in
A large body of evidence from epide- symptoms, a risk factorbased approach to these guidelines. Patients at increased CHD
miological, case-control, and cohort studies the initial diagnostic evaluation and risk should receive aspirin and a statin, and

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S33


Position Statement

ACE inhibitor or ARB therapy if hyperten- kidney disease, difcult management of rise in potassium compared with ACE
sive, unless there are contraindications to a issues, or advanced kidney disease. (B) inhibitors in people with nephropathy
particular drug class. While clear benet (306,307). Combinations of drugs that
exists for ACE inhibitor and ARB therapy in Diabetic nephropathy occurs in 20 block the rennin-angiotensin-aldosterone
patients with nephropathy or hyperten- 40% of patients with diabetes and is the system (e.g., an ACE inhibitor plus an
sion, the benets in patients with CVD in single leading cause of end-stage renal ARB, a mineralocorticoid antagonist, or a
the absence of these conditions is less clear, disease (ESRD). Persistent albuminuria direct renin inhibitor) have been shown to
especially when LDL cholesterol is con- in the range of 30299 mg/24 h (micro- provide additional lowering of albuminuria
comitantly controlled (288,289). albuminuria) has been shown to be the (308311). However, the long-term effects
earliest stage of diabetic nephropathy in of such combinations on renal or cardiovas-
B. Nephropathy screening and type 1 diabetes and a marker for develop- cular outcomes have not yet been evaluated
treatment ment of nephropathy in type 2 diabetes. in clinical trials and they are associated with
Recommendations Microalbuminuria is also a well-established increased risk for hyperkalemia.
General recommendations marker of increased CVD risk (290,291). Other drugs, such as diuretics, cal-
c To reduce the risk or slow the pro- Patients with microalbuminuria who cium channel blockers, and b-blockers,
gression of nephropathy, optimize glu- progress to macroalbuminuria ($300 should be used as additional therapy to
cose control. (A) mg/24 h) are likely to progress to ESRD further lower blood pressure in patients
c To reduce the risk or slow the pro- (292,293). However, a number of interven- already treated with ACE inhibitors or
gression of nephropathy, optimize blood tions have been demonstrated to reduce ARBs (241), or as alternate therapy in
pressure control. (A) the risk and slow the progression of renal the rare individual unable to tolerate
Screening disease. ACE inhibitors or ARBs.
c Perform an annual test to assess urine Intensive diabetes management with Studies in patients with varying stages
albumin excretion in type 1 diabetic the goal of achieving near-normoglycemia of nephropathy have shown that protein
patients with diabetes duration of $5 has been shown in large prospective restriction of dietary protein helps slow
years and in all type 2 diabetic patients randomized studies to delay the onset the progression of albuminuria, GFR de-
starting at diagnosis. (B) of microalbuminuria and the progression of cline, and occurrence of ESRD (312
c Measure serum creatinine at least annu- micro- to macroalbuminuria in patients with 315). Dietary protein restriction should
ally in all adults with diabetes regardless type 1 (294,295) and type 2 (73,74,78,79) be considered particularly in patients
of the degree of urine albumin excretion. diabetes. The UKPDS provided strong evi- whose nephropathy seems to be progress-
The serum creatinine should be used to dence that control of blood pressure can re- ing despite optimal glucose and blood
estimate GFR and stage the level of chronic duce the development of nephropathy pressure control and use of ACE inhibitor
kidney disease (CKD), if present. (E) (224). In addition, large prospective ran- and/or ARBs (315).
Treatment domized studies in patients with type 1 Assessment of albuminuria status
c In the treatment of the nonpregnant diabetes have demonstrated that achieve- and renal function. Screening for
patient with micro- or macroalbuminuria, ment of lower levels of SBP (,140 mmHg) microalbuminuria can be performed by
either ACE inhibitors or ARBs should be resulting from treatment using ACE inhib- measurement of the albumin-to-creatinine
used. (A) itors provides a selective benet over other ratio in a random spot collection; 24-h or
c If one class is not tolerated, the other antihypertensive drug classes in delaying timed collections are more burdensome
should be substituted. (E) the progression from micro- to macroalbu- and add little to prediction or accuracy
c Reduction of protein intake to 0.81.0 minuria and can slow the decline in GFR in (316,317). Measurement of a spot urine
g z kg body wt21 z day21 in individuals patients with macroalbuminuria (296 for albumin only, whether by immuno-
with diabetes and the earlier stages of 298). In type 2 diabetes with hypertension assay or by using a dipstick test specic
CKD and to 0.8 g z kg body wt21 z day21 and normoalbuminuria, RAS inhibition for microalbumin, without simultaneously
in the later stages of CKD may improve has been demonstrated to delay onset measuring urine creatinine, is somewhat
measures of renal function (urine albu- of microalbuminuria in two studies less expensive but susceptible to false-
min excretion rate, GFR) and is recom- (299,300). In the latter study, there was negative and false-positive determinations
mended. (B) an unexpected higher rate of fatal cardio- as a result of variation in urine concentra-
c When ACE inhibitors, ARBs, or diuretics vascular events with olmesartan among pa- tion due to hydration and other factors.
are used, monitor serum creatinine and tients with preexisting CHD.
potassium levels for the development of ACE inhibitors have been shown to
increased creatinine and hyperkalemia. reduce major CVD outcomes (i.e., MI, stroke,
(E) death) in patients with diabetes (236), thus
c Continued monitoring of urine albu-
Table 12dDenitions of abnormalities in
further supporting the use of these agents
min excretion to assess both response albumin excretion
in patients with microalbuminuria, a CVD
to therapy and progression of disease is risk factor. ARBs do not prevent microalbu-
reasonable. (E) minuria in normotensive patients with type Spot collection (mg/mg
c When estimated GFR is ,60 ml z min/ 1 or type 2 diabetes (301,302); however, Category creatinine)
1.73 m2, evaluate and manage potential ARBs have been shown to reduce the rate of
complications of CKD. (E) Normal ,30
progression from micro- to macroalbumi-
c Consider referral to a physician expe-
Microalbuminuria 30299
nuria as well as ESRD in patients with type
rienced in the care of kidney disease Macro (clinical)-
2 diabetes (303305). Some evidence sug-
for uncertainty about the etiology of albuminuria $300
gests that ARBs have a smaller magnitude

S34 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Table 13dStages of CKD should not delay educating their patients


about the progressive nature of diabetic
GFR (ml/min per 1.73 m2 kidney disease; the renal preservation ben-
Stage Description body surface area) ets of aggressive treatment of blood pres-
sure, blood glucose, and hyperlipidemia;
1 Kidney damage* with normal or increased GFR $90 and the potential need for renal replace-
2 Kidney damage* with mildly decreased GFR 6089 ment therapy.
3 Moderately decreased GFR 3059
4 Severely decreased GFR 1529 C. Retinopathy screening and
5 Kidney failure ,15 or dialysis treatment
*Kidney damage dened as abnormalities on pathologic, urine, blood, or imaging tests. Adapted from ref. 317. Recommendations
General recommendations
Abnormalities of albumin excretion Complications of kidney disease cor-
are dened in Table 12. Because of vari- relate with level of kidney function. When c To reduce the risk or slow the progression
ability in urinary albumin excretion the eGFR is ,60 mL/min/1.73 m2, screen- of retinopathy, optimize glycemic con-
(UAE), two of three specimens collected ing for complications of CKD is indicated trol. (A)
within a 3- to 6-month period should be (Table 14). Early vaccination against hepa- c To reduce the risk or slow the pro-
abnormal before considering a patient to titis B is indicated in patients likely to prog- gression of retinopathy, optimize blood
have crossed one of these diagnostic ress to end-stage kidney disease. pressure control. (A)
thresholds. Exercise within 24 h, infec- Consider referral to a physician expe- Screening
tion, fever, CHF, marked hyperglycemia, rienced in the care of kidney disease when c Adults and children aged 10 years or
and marked hypertension may elevate there is uncertainty about the etiology of older with type 1 diabetes should have
UAE over baseline values. kidney disease (heavy proteinuria, active an initial dilated and comprehensive
Information on presence of abnormal urine sediment, absence of retinopathy, eye examination by an ophthalmologist
UAE in addition to level of GFR may be rapid decline in GFR, resistant hyperten- or optometrist within 5 years after the
used to stage CKD. The National Kidney sion). Other triggers for referral may include onset of diabetes. (B)
Foundation classication (Table 13) is difcult management issues (anemia, sec- c Patients with type 2 diabetes should
primarily based on GFR levels and there- ondary hyperparathyroidism, metabolic have an initial dilated and comprehen-
fore differs from other systems in which bone disease, or electrolyte disturbance), sive eye examination by an ophthalmol-
staging is based primarily on UAE (318). or advanced kidney disease. The threshold ogist or optometrist shortly after the
Studies have found decreased GFR in the for referral may vary depending on the diagnosis of diabetes. (B)
absence of increased UAE in a substantial frequency with which a provider encoun- c Subsequent examinations for type 1
percentage of adults with diabetes (319). ters diabetic patients with signicant and type 2 diabetic patients should be
Serum creatinine should therefore be mea- kidney disease. Consultation with a ne- repeated annually by an ophthalmolo-
sured at least annually in all adults with phrologist when Stage 4 CKD develops has gist or optometrist. Less-frequent exams
diabetes, regardless of the degree of UAE. been found to reduce cost, improve quality (every 23 years) may be considered
Serum creatinine should be used to of care, and keep people off dialysis longer following one or more normal eye ex-
estimate GFR and to stage the level of CKD, (322). However, nonrenal specialists ams. Examinations will be required
if present. Estimated GFR (eGFR) is com-
monly co-reported by laboratories, or can Table 14dManagement of CKD in diabetes
be estimated using formulae such as the
Modication of Diet in Renal Disease GFR Recommended
(MDRD) study equation (320). Recent re-
ports have indicated that the MDRD is All patients Yearly measurement of creatinine, UAE, potassium
more accurate for the diagnosis and strati- 45-60 Referral to nephrology if possibility for nondiabetic kidney disease exists
cation of CKD in patients with diabetes (duration type 1 diabetes ,10 years, heavy proteinuria, abnormal ndings
than the Cockcroft-Gault equation (321). on renal ultrasound, resistant hypertension, rapid fall in GFR, or active
GFR calculators are available at http:// urinary sediment on ultrasound)
www.nkdep.nih.gov. Consider need for dose adjustment of medications
The role of continued annual quanti- Monitor eGFR every 6 months
tative assessment of albumin excretion Monitor electrolytes, bicarbonate, hemoglobin, calcium, phosphorus,
after diagnosis of microalbuminuria and parathyroid hormone at least yearly
institution of ACE inhibitor or ARB ther- Assure vitamin D sufciency
apy and blood pressure control is unclear. Consider bone density testing
Continued surveillance can assess both Referral for dietary counseling
response to therapy and progression of 3044 Monitor eGFR every 3 months
disease. Some suggest that reducing ab- Monitor electrolytes, bicarbonate, calcium, phosphorus, parathyroid
normal albuminuria (.30 mg/g) to the nor- hormone, hemoglobin, albumin, weight every 36 months
mal or near-normal range may improve Consider need for dose adjustment of medications
renal and cardiovascular prognosis, but ,30 Referral to nephrologists
this approach has not been formally evalu- Adapted from National Kidney Foundation guidelines (available at http://www.kidney.org/professionals/
ated in prospective trials. KDOQI/guideline_diabetes/).

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S35


Position Statement

more frequently if retinopathy is pro- has been shown to decrease the progres- the time of diabetes diagnosis, should
gressing. (B) sion of retinopathy (224), although tight have an initial dilated and comprehensive
c High-quality fundus photographs can targets (systolic ,120 mmHg) do not im- eye examination soon after diagnosis.
detect most clinically signicant diabetic part additional benet (80). Several case Examinations should be performed by
retinopathy. Interpretation of the images series and a controlled prospective study an ophthalmologist or optometrist who is
should be performed by a trained eye suggest that pregnancy in type 1 diabetic pa- knowledgeable and experienced in diag-
care provider. While retinal photogra- tients may aggravate retinopathy (326,327); nosing the presence of diabetic retinopathy
phy may serve as a screening tool for laser photocoagulation surgery can mini- and is aware of its management. Subse-
retinopathy, it is not a substitute for a mize this risk (327). quent examinations for type 1 and type 2
comprehensive eye exam, which should One of the main motivations for diabetic patients are generally repeated
be performed at least initially and at in- screening for diabetic retinopathy is the annually. Less-frequent exams (every 23
tervals thereafter as recommended by an established efcacy of laser photocoagu- years) may be cost-effective after one or
eye care professional. (E) lation surgery in preventing visual loss. more normal eye exams, and in a popula-
c Women with preexisting diabetes who Two large trials, the Diabetic Retinopathy tion with well-controlled type 2 diabetes
are planning pregnancy or who have Study (DRS) in patients with PDR and the there was essentially no risk of development
become pregnant should have a com- Early Treatment Diabetic Retinopathy of signicant retinopathy with a 3-year in-
prehensive eye examination and be Study (ETDRS) in patients with macular terval after a normal examination (331).
counseled on the risk of development edema, provide the strongest support for Examinations will be required more fre-
and/or progression of diabetic retinopa- the therapeutic benets of photocoagu- quently if retinopathy is progressing (332).
thy. Eye examination should occur in lation surgery. The DRS (328) showed The use of retinal photography with
the rst trimester with close follow-up that panretinal photocoagulation surgery remote reading by experts has great po-
throughout pregnancy and for 1 year reduced the risk of severe vision loss from tential in areas where qualied eye care
postpartum. (B) PDR from 15.9% in untreated eyes to professionals are not available and may
6.4% in treated eyes, with greatest risk- also enhance efciency and reduce costs
Treatment to-benet ratio in those with baseline dis- when the expertise of ophthalmologists
c Promptly refer patients with any level ease (disc neovascularization or vitreous can be utilized for more complex exami-
of macular edema, severe NPDR, or any hemorrhage). nations and for therapy (333). In-person
PDR to an ophthalmologist who is The ETDRS (329) established the ben- exams are still necessary when the photos
knowledgeable and experienced in the et of focal laser photocoagulation surgery are unacceptable and for follow-up of de-
management and treatment of diabetic in eyes with macular edema, particularly tected abnormalities. Photos are not a
retinopathy. (A) those with clinically signicant macular substitute for a comprehensive eye exam,
c Laser photocoagulation therapy is in- edema, with reduction of doubling of the which should be performed at least initially
dicated to reduce the risk of vision loss visual angle (e.g., 20/50 to 20/100) from and at intervals thereafter as recommended
in patients with high-risk PDR, clini- 20% in untreated eyes to 8% in treated by an eye care professional. Results of eye
cally signicant macular edema, and in eyes. The ETDRS also veried the benets examinations should be documented and
cases of severe NPDR. (A) of panretinal photocoagulation for high- transmitted to the referring health care pro-
c The presence of retinopathy is not a risk PDR, and in older-onset patients with fessional.
contraindication to aspirin therapy for severe NPDR or less-than-high-risk PDR.
cardioprotection, as this therapy does Laser photocoagulation surgery in D. Neuropathy screening and
not increase the risk of retinal hem- both trials was benecial in reducing the treatment
orrhage. (A) risk of further visual loss, but generally Recommendations
not benecial in reversing already dimin- c All patients should be screened for distal
Diabetic retinopathy is a highly spe- ished acuity. Recombinant monoclonal symmetric polyneuropathy (DPN) start-
cic vascular complication of both type 1 antibody to vascular endothelial growth ing at diagnosis of type 2 diabetes and
and type 2 diabetes, with prevalence strongly factor is an emerging therapy that seems 5 years after the diagnosis of type 1 di-
related to the duration of diabetes. Diabetic to halt progression of macular edema and abetes and at least annually thereafter,
retinopathy is the most frequent cause of may in fact improve vision in some patients using simple clinical tests. (B)
new cases of blindness among adults aged (330). c Electrophysiological testing is rarely
2074 years. Glaucoma, cataracts, and other The preventive effects of therapy and needed, except in situations where the
disorders of the eye occur earlier and more the fact that patients with PDR or macular clinical features are atypical. (E)
frequently in people with diabetes. edema may be asymptomatic provide c Screening for signs and symptoms of
In addition to duration of diabetes, strong support for a screening program to cardiovascular autonomic neuropathy
other factors that increase the risk of, or detect diabetic retinopathy. As retinopa- should be instituted at diagnosis of type
are associated with, retinopathy include thy is estimated to take at least 5 years to 2 diabetes and 5 years after the diagnosis
chronic hyperglycemia (323), nephropa- develop after the onset of hyperglycemia, of type 1 diabetes. Special testing is rarely
thy (324), and hypertension (325). Inten- patients with type 1 diabetes should have needed and may not affect management
sive diabetes management with the goal of an initial dilated and comprehensive eye or outcomes. (E)
achieving near normoglycemia has been examination within 5 years after the onset c Medications for the relief of specic
shown in large prospective randomized of diabetes. Patients with type 2 diabetes, symptoms related to painful DPN and
studies to prevent and/or delay the onset who generally have had years of undiag- autonomic neuropathy are recommended,
and progression of diabetic retinopathy nosed diabetes and who have a signicant as they improve the quality of life of the
(61,73,74,80). Lowering blood pressure risk of prevalent diabetic retinopathy at patient. (E)

S36 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

The diabetic neuropathies are hetero- gastroparesis, erectile dysfunction, sudomo- Autonomic neuropathy
geneous with diverse clinical manifesta- tor dysfunction, impaired neurovascular Gastroparesis symptoms may improve
tions. They may be focal or diffuse. Most function, and potentially autonomic fail- with dietary changes and prokinetic agents
common among the neuropathies are ure in response to hypoglycemia. such as metoclopramide or erythromy-
chronic sensorimotor DPN and autonomic Cardiovascular autonomic neuropathy cin. Treatments for erectile dysfunction
neuropathy. Although DPN is a diagnosis (CAN), a CVD risk factor (93), is the most may include phosphodiesterase type 5
of exclusion, complex investigations to studied and clinically important form of inhibitors, intracorporeal or intraurethral
exclude other conditions are rarely needed. diabetic autonomic neuropathy. CAN may prostaglandins, vacuum devices, or penile
The early recognition and appropriate be indicated by resting tachycardia (.100 prostheses. Interventions for other mani-
management of neuropathy in the patient bpm) or orthostasis (a fall in SBP .20 festations of autonomic neuropathy are
with diabetes is important for a number of mmHg upon standing without an appro- described in an ADA statement on neu-
reasons: 1) nondiabetic neuropathies may priate heart rate response); it is also associ- ropathy (335). As with DPN treatments,
be present in patients with diabetes and ated with increased cardiac event rates. these interventions do not change the un-
may be treatable; 2) a number of treatment Although some societies have developed derlying pathology and natural history of
options exist for symptomatic diabetic neu- guidelines for screening for CAN, the the disease process, but may have a pos-
ropathy; 3) up to 50% of DPN may be benets of sophisticated testing beyond itive impact on the quality of life of the
asymptomatic and patients are at risk for risk stratication are not clear (339). patient.
insensate injury to their feet; 4) autonomic Gastrointestinal neuropathies (e.g.,
neuropathy and particularly cardiovascular esophageal enteropathy, gastroparesis, E. Foot care
autonomic neuropathy is associated with constipation, diarrhea, fecal incontinence) Recommendations
substantial morbidity and even mortality. are common, and any section of the gas- c For all patients with diabetes, perform
Specic treatment for the underlying nerve trointestinal tract may be affected. Gastro- an annual comprehensive foot exami-
damage is currently not available, other paresis should be suspected in individuals nation to identify risk factors predictive
than improved glycemic control, which with erratic glucose control or with upper of ulcers and amputations. The foot
may modestly slow progression (79) but gastrointestinal symptoms without other examination should include inspection,
not reverse neuronal loss. Effective symp- identied cause. Evaluation of solid-phase assessment of foot pulses, and testing for
tomatic treatments are available for some gastric emptying using double-isotope loss of protective sensation (10-g mono-
manifestations of DPN (334) and auto- scintigraphy may be done if symptoms lament plus testing any one of the fol-
nomic neuropathy. are suggestive, but test results often corre- lowing: vibration using 128-Hz tuning
late poorly with symptoms. Constipation is fork, pinprick sensation, ankle reexes,
Diagnosis of neuropathy the most common lower-gastrointestinal or vibration perception threshold). (B)
Distal symmetric polyneuropathy
symptom but can alternate with episodes of c Provide general foot self-care education

Patients with diabetes should be screened diarrhea. to all patients with diabetes. (B)
annually for DPN using tests such as Diabetic autonomic neuropathy is c A multidisciplinary approach is recom-

pinprick sensation, vibration perception also associated with genitourinary tract mended for individuals with foot ulcers
(using a 128-Hz tuning fork), 10-g mono- disturbances. In men, diabetic autonomic and high-risk feet, especially those with a
lament pressure sensation at the distal neuropathy may cause erectile dysfunc- history of prior ulcer or amputation. (B)
plantar aspect of both great toes and meta- tion and/or retrograde ejaculation. Eval- c Refer patients who smoke, have loss of

tarsal joints, and assessment of ankle re- uation of bladder dysfunction should be protective sensation and structural ab-
exes. Combinations of more than one test performed for individuals with diabetes normalities, or have history of prior
have .87% sensitivity in detecting DPN. who have recurrent urinary tract infections, lower-extremity complications to foot
Loss of 10-g monolament perception and pyelonephritis, incontinence, or a palpable care specialists for ongoing preventive
reduced vibration perception predict foot bladder. care and life-long surveillance. (C)
c Initial screening for peripheral arterial
ulcers (335). Importantly, in patients with Symptomatic treatments
neuropathy, particularly when severe, cau- disease (PAD) should include a his-
ses other than diabetes should always be
DPN tory for claudication and an assess-
The rst step in management of patients ment of the pedal pulses. Consider
considered, such as neurotoxic mediations,
with DPN should be to aim for stable and obtaining an ankle-brachial index (ABI),
heavy metal poisoning, alcohol abuse, vita-
optimal glycemic control. Although con- as many patients with PAD are asymp-
min B12 deciency (especially in those tak-
trolled trial evidence is lacking, several tomatic. (C)
ing metformin for prolonged periods
observational studies suggest that neuro- c Refer patients with signicant claudi-
(336), renal disease, chronic inammatory
pathic symptoms improve not only with cation or a positive ABI for further vas-
demyelinating neuropathy, inherited neu-
optimization of control, but also with cular assessment and consider exercise,
ropathies, and vasculitis (337).
the avoidance of extreme blood glucose medications, and surgical options. (C)
Diabetic autonomic neuropathy (338) uctuations. Patients with painful DPN
The symptoms and signs of autonomic may benet from pharmacological treat- Amputation and foot ulceration, con-
dysfunction should be elicited carefully ment of their symptoms; many agents have sequences of diabetic neuropathy and/or
during the history and physical examina- conrmed or probable efcacy conrmed PAD, are common and major causes of
tion. Major clinical manifestations of di- in systematic reviews of RCTs (334), with morbidity and disability in people with
abetic autonomic neuropathy include several U.S. Food and Drug Administra- diabetes. Early recognition and manage-
resting tachycardia, exercise intolerance, tion (FDA)-approved for the manage- ment of risk factors can prevent or delay
orthostatic hypotension, constipation, ment of painful DPN. adverse outcomes.

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S37


Position Statement

The risk of ulcers or amputations is and one other test. One or more abnormal prominent metatarsal heads, bunions) may
increased in people who have the follow- tests would suggest LOPS, while at least two need extra-wide or -depth shoes. People
ing risk factors: normal tests (and no abnormal test) would with extreme bony deformities (e.g., Char-
rule out LOPS. The last test listed, vibration cot foot) who cannot be accommodated
c Previous amputation assessment using a biothesiometer or sim- with commercial therapeutic footwear may
c Past foot ulcer history ilar instrument, is widely used in the U.S.; need custom-molded shoes.
c Peripheral neuropathy however, identication of the patient with Foot ulcers and wound care may re-
c Foot deformity LOPS can easily be carried out without this quire care by a podiatrist, orthopedic or
c Peripheral vascular disease or other expensive equipment. vascular surgeon, or rehabilitation specialist
c Visual impairment Initial screening for PAD should in- experienced in the management of individ-
c Diabetic nephropathy (especially patients clude a history for claudication and an uals with diabetes.
on dialysis) assessment of the pedal pulses. A diag-
c Poor glycemic control nostic ABI should be performed in any VII. ASSESSMENT OF COMMON
c Cigarette smoking patient with symptoms of PAD. Due to COMORBID CONDITIONS
the high estimated prevalence of PAD in
Many studies have been published patients with diabetes and the fact that Recommendations
proposing a range of tests that might usefully many patients with PAD are asymptom- c For patients with risk factors, signs or
identify patients at risk for foot ulceration, atic, an ADA consensus statement on PAD symptoms, consider assessment and
creating confusion among practitioners as to (341) suggested that a screening ABI be treatment for common diabetes-associated
which screening tests should be adopted in performed in patients over 50 years of age conditions (see Table 15). (B)
clinical practice. An ADA task force was and be considered in patients under 50
therefore assembled in 2008 to concisely years of age who have other PAD risk factors In addition to the commonly appre-
summarize recent literature in this area and (e.g., smoking, hypertension, hyperlipid- ciated comorbidities of obesity, hyperten-
then recommend what should be included emia, or duration of diabetes .10 years). sion, and dyslipidemia, diabetes is also
in the comprehensive foot exam for adult Refer patients with signicant symptoms associated with other diseases or conditions
patients with diabetes. Their recommenda- or a positive ABI for further vascular as- at rates higher than those of age-matched
tions are summarized below, but clinicians sessment and consider exercise, medica- people without diabetes. A few of the more
should refer to the task force report (340) for tions, and surgical options (341). common comorbidities are described
further details and practical descriptions of Patients with diabetes and high-risk herein, and listed in Table 15.
how to perform components of the compre- foot conditions should be educated re-
hensive foot examination. garding their risk factors and appropriate Hearing impairment
At least annually, all adults with di- management. Patients at risk should un- Hearing impairment, both high frequency
abetes should undergo a comprehensive derstand the implications of the loss of and low/mid frequency, is more common
foot examination to identify high risk con- protective sensation, the importance of foot in people with diabetes, perhaps due to
ditions. Clinicians should ask about history monitoring on a daily basis, the proper care neuropathy and/or vascular disease. In an
of previous foot ulceration or amputation, of the foot, including nail and skin care, NHANES analysis, hearing impairment
neuropathic or peripheral vascular symp- and the selection of appropriate footwear. was about twice as great in people with
toms, impaired vision, tobacco use, and Patients with loss of protective sensation diabetes than in those without diabetes,
foot care practices. A general inspection should be educated on ways to substitute after adjusting for age and other risk
of skin integrity and musculoskeletal other sensory modalities (hand palpation, factors for hearing impairment (342).
deformities should be done in a well-lit visual inspection) for surveillance of early Controlling for age, race, and other demo-
room. Vascular assessment would include foot problems. The patients understand- graphic factors, high-frequency loss in
inspection and assessment of pedal pulses. ing of these issues and their physical abil- those with diabetes was signicantly asso-
The neurologic exam recommended ity to conduct proper foot surveillance ciated with history of CHD and with pe-
is designed to identify loss of protective and care should be assessed. Patients ripheral neuropathy, while low/mid
sensation (LOPS) rather than early neu- with visual difculties, physical con- frequency loss was associated with low
ropathy. The clinical examination to identify straints preventing movement, or cogni- HDL cholesterol and with poor reported
LOPS is simple and requires no expensive tive problems that impair their ability to health status (343).
equipment. Five simple clinical tests (use assess the condition of the foot and to in-
of a 10-g monolament, vibration testing stitute appropriate responses will need
using a 128-Hz tuning fork, tests of pin- other people, such as family members, Table 15dCommon comorbidities for
prick sensation, ankle reex assessment, to assist in their care. which increased risk is associated with
and testing vibration perception threshold People with neuropathy or evidence diabetes
with a biothesiometer), each with evidence of increased plantar pressure (e.g., erythema,
Hearing impairment
from well-conducted prospective clinical warmth, callus, or measured pressure) may
Obstructive sleep apnea
cohort studies, are considered useful in the be adequately managed with well-tted
Fatty liver disease
diagnosis of LOPS in the diabetic foot. The walking shoes or athletic shoes that cushion
Low testosterone in men
task force agrees that any of the ve tests the feet and redistribute pressure. Callus
Periodontal disease
listed could be used by clinicians to identify can be debrided with a scalpel by a foot care
Certain cancers
LOPS, although ideally two of these should specialist or other health professional with
Fractures
be regularly performed during the screening experience and training in foot care. People
Cognitive impairment
examdnormally the 10-g monolament with bony deformities (e.g., hammertoes,

S38 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Obstructive sleep apnea included in the analysis (354). Several prospective study of a community-dwell-
Age-adjusted rates of obstructive sleep high-quality RCTs have not shown a sig- ing people over the age of 60 years, the
apnea, a risk factor for CVD, are signi- nicant effect (355). presence of diabetes at baseline signi-
cantly higher (4- to 10-fold) with obesity, cantly increased the age- and sex-adjusted
especially with central obesity, in men Cancer incidence of all-cause dementia, Alz-
and women (344). The prevalence in gen- Diabetes (possibly only type 2 diabetes) is heimer disease, and vascular dementia
eral populations with type 2 diabetes may associated with increased risk of cancers compared with rates in those with normal
be up to 23% (345) and in obese partic- of the liver, pancreas, endometrium, colon/ glucose tolerance (363). In a substudy of
ipants enrolled in the Look AHEAD trial rectum, breast, and bladder (356). The as- the ACCORD study, there were no differ-
exceeded 80% (346). Treatment of sleep sociation may result from shared risk fac- ences in cognitive outcomes between inten-
apnea signicantly improves quality of tors between type 2 diabetes and cancer sive and standard glycemic control,
life and blood pressure control. The evi- (obesity, age, physical inactivity) but may although there was signicantly less of a
dence for a treatment effect on glycemic also be due to hyperinsulinemia or hyper- decrement in total brain volume by MRI
control is mixed (347). glycemia (356a). Patients with diabetes in participants in the intensive arm (364).
should be encouraged to undergo recom- The effects of hyperglycemia and insulin
Fatty liver disease mended age- and sex-appropriate cancer on the brain are areas of intense research
Unexplained elevation of hepatic trans- screenings and to reduce their modiable interest.
aminase concentrations are signicantly cancer risk factors (obesity, smoking, phys-
associated with higher BMI, waist circum- ical inactivity). VIII. DIABETES CARE IN
ference, triglycerides, and fasting insulin SPECIFIC POPULATIONS
and with lower HDL cholesterol. Type 2 Fractures
diabetes and hypertension are indepen- Age-matched hip fracture risk is signi- A. Children and adolescents
dently associated with transaminase ele- cantly increased in both type 1 (summary 1. Type 1 diabetes
vations in women (348). In a prospective RR 6.3) and type 2 diabetes (summary Three-quarters of all cases of type 1 di-
analysis, diabetes was signicantly associ- RR 1.7) in both sexes (357). Type 1 di- abetes are diagnosed in individuals ,18
ated with incident nonalcoholic chronic abetes is associated with osteoporosis, but years of age. It is appropriate to consider
liver disease and with hepatocellular car- in type 2 diabetes an increased risk of hip the unique aspects of care and management
cinoma (349). Interventions that improve fracture is seen despite higher bone mineral of children and adolescents with type 1 di-
metabolic abnormalities in patients with density (BMD) (358). One study showed abetes. Children with diabetes differ from
diabetes (weight loss, glycemic control, that prevalent vertebral fractures were sig- adults in many respects, including changes
treatment with specic drugs for hyper- nicantly more common in men and in insulin sensitivity related to sexual ma-
glycemia or dyslipidemia) are also bene- women with type 2 diabetes, but were turity and physical growth, ability to pro-
cial for fatty liver disease (350). not associated with BMD (359). In three vide self-care, supervision in child care and
large observational studies of older adults, school, and unique neurologic vulnerabil-
Low testosterone in men femoral neck BMD T-score and the World ity to hypoglycemia and DKA. Attention to
Mean levels of testosterone are lower in men Health Organization Fracture Risk Algo- such issues as family dynamics, develop-
with diabetes compared with age-matched rithm (FRAX) score were associated mental stages, and physiological differen-
men without diabetes, but obesity is a major with hip and nonspine fracture, although ces related to sexual maturity are all
confounder (351). The issue of treatment in fracture risk was higher in diabetic partic- essential in developing and implementing
asymptomatic men is controversial. The ipants compared with participants without an optimal diabetes regimen. Although rec-
evidence for effects of testosterone re- diabetes for a given T-score and age or for a ommendations for children and adoles-
placement on outcomes is mixed, and re- given FRAX score risk (360). It is appropri- cents are less likely to be based on clinical
cent guidelines suggest that screening ate to assess fracture history and risk factors trial evidence, expert opinion and a review
and treatment of men without symptoms in older patients with diabetes and to rec- of available and relevant experimental data
is not recommended (352). ommend BMD testing if appropriate for the are summarized in the ADA statement on
patients age and sex. For at-risk patients, care of children and adolescents with type 1
Periodontal disease it is reasonable to consider standard pri- diabetes (365).
Periodontal disease is more severe, but mary or secondary prevention strategies Ideally, the care of a child or adoles-
not necessarily more prevalent, in pa- (reduce risk factors for falls, ensure ade- cent with type 1 diabetes should be provided
tients with diabetes than those without quate calcium and vitamin D intake, and by a multidisciplinary team of specialists
(353). Numerous studies have suggested avoid use of medications that lower BMD, trained in the care of children with pediat-
associations with poor glycemic control, such as glucocorticoids) and to consider ric diabetes. At the very least, education of
nephropathy, and CVD, but most studies pharmacotherapy for high-risk patients. the child and family should be provided by
are highly confounded. A comprehensive For patients with type 2 diabetes with health care providers trained and experi-
assessment, and treatment of identied fracture risk factors, avoidance of TZDs enced in childhood diabetes and sensitive
disease, is indicated in patients with dia- is warranted. to the challenges posed by diabetes in this
betes, but the evidence that periodontal age-group. At the time of initial diagnosis, it
disease treatment improves glycemic Cognitive impairment is essential that diabetes education be pro-
control is mixed. A meta-analysis re- Diabetes is associated with signicantly in- vided in a timely fashion, with the expec-
ported a signicant 0.47% improvement creased risk of cognitive decline, a greater tation that the balance between adult
in A1C, but noted multiple problems rate of cognitive decline, and increased risk supervision and self-care should be dened
with the quality of the published studies of dementia (361,362). In a 15-year by, and will evolve according to, physical,

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S39


Position Statement

psychological, and emotional maturity. glucose targets (369,370) in those fami- dietary intervention and exercise, aimed
MNT and psychological support should lies in which both parents and the child at weight control and increased physical
be provided at diagnosis, and regularly with diabetes participate jointly to per- activity, if appropriate. If target blood
thereafter, by individuals experienced with form the required diabetes-related tasks. pressure is not reached with 36 months
the nutritional and behavioral needs of the Furthermore, recent studies documenting of lifestyle intervention, pharmacologic
growing child and family. neurocognitive sequelae of hyperglycemia treatment should be considered. (E)
a. Glycemic control in children provide another compelling c Pharmacologic treatment of hyperten-
Recommendations motivation for achieving glycemic targets sion (systolic or diastolic blood pressure
c Consider age when setting glycemic
(371,372). consistently above the 95th percentile
goals in children and adolescents with In selecting glycemic goals, the benets for age, sex, and height or consistently
type 1 diabetes. (E) on long-term health outcomes of achieving a .130/80 mmHg, if 95% exceeds that
lower A1C should be balanced against the value) should be considered as soon as
While current standards for diabetes risks of hypoglycemia and the developmen- the diagnosis is conrmed. (E)
management reect the need to maintain tal burdens of intensive regimens in children c ACE inhibitors should be considered
glucose control as near to normal as safely and youth. Age-specic glycemic and A1C for the initial treatment of hypertension,
possible, special consideration should be goals are presented in Table 16. following appropriate reproductive
given to the unique risks of hypoglycemia b. Screening and management of counseling due to its potential terato-
in young children. Glycemic goals may chronic complications in children and genic effects. (E)
adolescents with type 1 diabetes c The goal of treatment is a blood pres-
need to be modied to take into account
the fact that most children ,6 or 7 years of
i. Nephropathy sure consistently ,130/80 mmHg or
Recommendations below the 90th percentile for age, sex,
age have a form of hypoglycemic unaware- c Annual screening for microalbuminuria,
ness, including immaturity of and a rela- and height, whichever is lower. (E)
with a random spot urine sample for al-
tive inability to recognize and respond to
bumin-to-creatinine ratio (ACR), should It is important that blood pressure
hypoglycemic symptoms, placing them at
be considered once the child is 10 years of measurements are determined correctly,
greater risk for severe hypoglycemia and
age and has had diabetes for 5 years. (B) using the appropriate size cuff, and with
its sequelae. In addition, and unlike the
c Treatment with an ACE inhibitor, ti- the child seated and relaxed. Hypertension
case in adults, young children below the
trated to normalization of albumin ex- should be conrmed on at least 3 separate
age of 5 years may be at risk for permanent
cretion, should be considered when days. Normal blood pressure levels for age,
cognitive impairment after episodes of severe
elevated ACR is subsequently conrmed sex, and height and appropriate methods
hypoglycemia (366368). Furthermore,
on two additional specimens from dif- for determinations are available online at
ndings from the DCCT demonstrated that ferent days. (E)
near-normalization of blood glucose levels www.nhlbi.nih.gov/health/prof/heart/hbp/
was more difcult to achieve in adolescents ii. Hypertension hbp_ped.pdf.
than adults. Nevertheless, the increased fre- Recommendations iii. Dyslipidemia
quency of use of basal-bolus regimens and c Initial treatment of high-normal blood Recommendations
insulin pumps in youth from infancy pressure (systolic or diastolic blood pres- Screening
through adolescence has been associated sure consistently above the 90th per- c If there is a family history of hypercho-
with more children reaching ADA blood centile for age, sex, and height) includes lesterolemia or a cardiovascular event
Table 16dPlasma blood glucose and A1C goals for type 1 diabetes by age-group

Plasma blood glucose goal range (mg/dL)


Values by age (years) Before meals Bedtime/overnight A1C Rationale
Toddlers and 100180 110200 ,8.5% c Vulnerability to hypoglycemia
preschoolers (06) 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 (612) 90180 100180 ,8% c Vulnerability of hypoglycemia
c A lower goal (,7.5%) is reasonable if it can be achieved
without excessive hypoglycemia
Adolescents and young 90130 90150 ,7.5% c A lower goal (,7.0%) is reasonable if it can be achieved
adults (1319) without excessive hypoglycemia
Key concepts in setting glycemic goals:
c Goals should be individualized and lower goals may be reasonable based on benet-risk assessment.

c Blood glucose goals should be modied 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.

S40 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

before age 55 years, or if family history is with type 1 diabetes prior to this age. For diarrhea, weight loss or poor weight gain,
unknown, then consider obtaining a postpubertal girls, issues of pregnancy pre- growth failure, abdominal pain, chronic fa-
fasting lipid prole on children .2 years vention are paramount, since statins are cat- tigue, malnutrition due to malabsorption,
of age soon after diagnosis (after glucose egory X in pregnancy. For more information, and other gastrointestinal problems, and
control has been established). If family see section VIII.B. Preconception care. unexplained hypoglycemia or erratic blood
history is not of concern, then consider glucose concentrations.
iv. Retinopathy
the rst lipid screening at puberty ($10 Screening for celiac disease includes
Recommendations
years of age). For children diagnosed measuring serum levels of tissue transglu-
c The rst ophthalmologic examination
with diabetes at or after puberty, con- should be obtained once the child is taminase or anti-endomysial antibodies,
sider obtaining a fasting lipid prole then small bowel biopsy in antibody-
$10 years of age and has had diabetes
soon after diagnosis (after glucose con- positive children. One small study that
for 35 years. (B)
trol has been established). (E) c After the initial examination, annual
included children with and without type
c For both age-groups, if lipids are ab- 1 diabetes suggested that antibody-positive
routine follow-up is generally recom-
normal, annual monitoring is reason- but biopsy-negative children were similar
mended. Less-frequent examinations
able. If LDL cholesterol values are within clinically to those who were biopsy posi-
may be acceptable on the advice of an
the accepted risk levels (,100 mg/dL tive, and that biopsy-negative children had
eye care professional. (E)
[2.6 mmol/L]), a lipid prole repeated benets from a gluten-free diet but worsen-
every 5 years is reasonable. (E) ing on a usual diet (387). Because this study
Although retinopathy (like albuminuria)
Treatment was small, and because children with type 1
most commonly occurs after the onset of
c Initial therapy may consist of optimi- diabetes already need to follow a careful
puberty and after 510 years of diabetes du-
zation of glucose control and MNT diet, it is difcult to advocate for not con-
ration (384), it has been reported in prepu-
using a Step 2 American Heart Associ- bertal children and with diabetes duration rming the diagnosis by biopsy before
ation diet aimed at a decrease in the recommending a gluten-free diet, especially
of only 12 years. Referrals should be made
amount of saturated fat in the diet. (E) in asymptomatic children. In symptomatic
to eye care professionals with expertise in
c After the age of 10, the addition of a statin children with type 1 diabetes and celiac dis-
diabetic retinopathy, an understanding of
in patients who, after MNT and lifestyle ease, gluten-free diets reduce symptoms
the risk for retinopathy in the pediatric
changes, have LDL cholesterol .160 and rates of hypoglycemia (388).
population, and experience in counseling
mg/dL (4.1 mmol/L), or LDL cholesterol vi. Hypothyroidism
the pediatric patient and family on the im-
.130 mg/dL (3.4 mmol/L) and one or Recommendations
portance of early prevention/intervention.
more CVD risk factors, is reasonable. (E) c Consider screening children with type
c The goal of therapy is an LDL cholesterol v. Celiac disease 1 diabetes for thyroid peroxidase and
value ,100 mg/dL (2.6 mmol/L). (E) Recommendations thyroglobulin antibodies soon after
c Consider screening children with type 1
diagnosis. (E)
People diagnosed with type 1 diabetes diabetes for celiac disease by measuring c Measuring TSH concentrations soon after
in childhood have a high risk of early tissue transglutaminase or anti-endomysial diagnosis of type 1 diabetes, after metabolic
subclinical (373375) and clinical (376) antibodies, with documentation of nor- control has been established, is reasonable.
CVD. Although intervention data are lack- mal total serum IgA levels, soon after the If normal, consider rechecking every 12
ing, the American Heart Association (AHA) diagnosis of diabetes. (E) years, especially if the patient develops
categorizes children with type 1 diabetes in c Testing should be considered in chil-
symptoms of thyroid dysfunction, thyro-
the highest tier for cardiovascular risk and dren with growth failure, failure to gain megaly, or an abnormal growth rate. (E)
recommends both lifestyle and pharmaco- weight, weight loss, diarrhea, atulence,
logic treatment for those with elevated LDL abdominal pain, or signs of malabsorp- Autoimmune thyroid disease is the
cholesterol levels (377,378). Initial therapy tion, or in children with frequent un- most common autoimmune disorder as-
should be with a Step 2 AHA diet, which explained hypoglycemia or deterioration sociated with diabetes, occurring in 17
restricts saturated fat to 7% of total calories in glycemic control. (E) 30% of patients with type 1 diabetes
and restricts dietary cholesterol to 200 mg c Consider referral to a gastroenterolo-
(389). About one-quarter of type 1 chil-
per day. Data from randomized clinical tri- gist for evaluation with endoscopy and dren have thyroid autoantibodies at the
als in children as young as 7 months of age biopsy for conrmation of celiac disease time of diagnosis of their diabetes (390),
indicate that this diet is safe and does not in asymptomatic children with positive and the presence of thyroid autoantibodies is
interfere with normal growth and devel- antibodies. (E) predictive of thyroid dysfunction, generally
opment (379,380). c Children with biopsy-conrmed celiac
hypothyroidism but less commonly hyper-
Neither long-term safety nor cardio- disease should be placed on a gluten- thyroidism (391). Subclinical hypothyroid-
vascular outcome efcacy of statin therapy free diet and have consultation with a ism may be associated with increased risk of
has been established for children. How- dietitian experienced in managing both symptomatic hypoglycemia (392) and with
ever, recent studies have shown short-term diabetes and celiac disease. (B) reduced linear growth (393). Hyperthyroid-
safety equivalent to that seen in adults, and ism alters glucose metabolism, potentially re-
efcacy in lowering LDL cholesterol levels, Celiac disease is an immune-mediated sulting in deterioration of metabolic control.
improving endothelial function, and caus- disorder that occurs with increased fre-
ing regression of carotid intimal thickening quency in patients with type 1 diabetes c. Self-management
(381383). No statin is approved for use un- (116% of individuals compared with 0.3 No matter how sound the medical regi-
der the age of 10 years, and statin treatment 1% in the general population) (385,386). men, it can only be as good as the ability of
should generally not be used in children Symptoms of celiac disease include the family and/or individual to implement

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S41


Position Statement

it. Family involvement in diabetes remains ongoing attention be given to comprehen- correctly diagnose one of the monogenic
an important component of optimal di- sive and coordinated planning for seamless forms of diabetes, as these children may
abetes management throughout childhood transition of all youth from pediatric to be incorrectly diagnosed with type 1 or
and into adolescence. Health care providers adult health care (396,397). A comprehen- type 2 diabetes, leading to nonoptimal
who care for children and adolescents, sive discussion regarding the challenges treatment regimens and delays in diagnos-
therefore, must be capable of evaluating faced during this period, including specic ing other family members.
the behavioral, emotional, and psychosocial recommendations is found in the ADA po- The diagnosis of monogenic diabetes
factors that interfere with implementation sition statement Diabetes Care for Emerg- should be considered in the following
and then must work with the individual ing Adults: Recommendations for the settings: diabetes diagnosed within the
and family to resolve problems that occur Transition from Pediatric to Adult Diabetes rst 6 months of life; in children with strong
and/or to modify goals as appropriate. Care Systems (397). family history of diabetes but without typical
The National Diabetes Education Pro- features of type 2 diabetes (nonobese, low-
d. School and day care gram (NDEP) has materials available to risk ethnic group); in children with mild
Since a sizable portion of a childs day is facilitate the transition process (http:// fasting hyperglycemia (100150 mg/dL
spent in school, close communication ndep.nih.gov/transitions/). [5.58.5 mmol]), especially if young and
with and cooperation of school or day nonobese; and in children with diabetes
care personnel is essential for optimal di- 2. Type 2 diabetes
The incidence of type 2 diabetes in ado- but with negative autoantibodies without
abetes management, safety, and maximal signs of obesity or insulin resistance. A re-
academic opportunities. See the ADA posi- lescents is increasing, especially in ethnic
minority populations (28). Distinction cent international consensus document dis-
tion statement on diabetes care in the cusses further in detail the diagnosis and
school and day care setting (394) for fur- between type 1 and type 2 diabetes in chil-
dren can be difcult, since the prevalence management of children with monogenic
ther discussion. forms of diabetes (401).
of overweight in children continues to rise
e. Transition from pediatric to adult and since autoantigens and ketosis may be
care present in a substantial number of patients B. Preconception care
Recommendations with features of type 2 diabetes (including Recommendations
c As teens transition into emerging adult- c A1C levels should be as close to normal
obesity and acanthosis nigricans). Such a
hood, health care providers and families distinction at the time of diagnosis is critical as possible (,7%) in an individual pa-
must recognize their many vulnerabilities since treatment regimens, educational ap- tient before conception is attempted. (B)
(B) and prepare the developing teen, be- proaches, and dietary counsel will differ c Starting at puberty, preconception coun-
ginning in early to mid adolescence and at markedly between the two diagnoses. seling should be incorporated in the rou-
least 1 year prior to the transition. (E) Type 2 diabetes has a signicant in- tine diabetes clinic visit for all women of
c Both pediatricians and adult health care childbearing potential. (C)
cidence of comorbidities already pres-
providers should assist in providing ent at the time of diagnosis (400). It is c Women with diabetes who are contem-
support and links to resources for the recommended that blood pressure mea- plating pregnancy should be evaluated
teen and emerging adult. (B) surement, a fasting lipid prole, microalbu- and, if indicated, treated for diabetic
minuria assessment, and dilated eye retinopathy, nephropathy, neuropathy,
Care and close supervision of diabetes examination be performed at the time of and CVD. (B)
management is increasingly shifted from diagnosis. Thereafter, screening guide- c Medications used by such women should
parents and other older adults through- lines and treatment recommendations be evaluated prior to conception, since
out childhood and adolescence; however, for hypertension, dyslipidemia, microal- drugs commonly used to treat diabetes
the shift from pediatric to adult health care buminuria and retinopathy in youth with and its complications may be contra-
providers often occurs very abruptly as the type 2 diabetes are similar to those for indicated or not recommended in preg-
older teen enters the next developmental youth with type 1. Additional problems nancy, including statins, ACE inhibitors,
stage, referred to as emerging adulthood that may need to be addressed include ARBs, and most noninsulin therapies. (E)
(395, 397), a critical period for young peo- polycystic ovarian disease and the vari- c Since many pregnancies are unplanned,
ple who have diabetes. During this period ous comorbidities associated with pedi- consider the potential risks and benets
of major life transitions, youth begin to atric obesity such as sleep apnea, hepatic of medications that are contraindicated
move out of their parents home and must steatosis, orthopedic complications, and in pregnancy in all women of child-
become more fully responsible for their di- psychosocial concerns. An ADA consensus bearing potential, and counsel women
abetes care including the many aspects of statement on this subject (30) provides using such medications accordingly. (E)
self management, making medical appoint- guidance on the prevention, screening,
ments, and nancing health care once they and treatment of type 2 diabetes and its Major congenital malformations re-
are no longer covered under their parents comorbidities in young people. main the leading cause of mortality and
health insurance (396,397). In addition to serious morbidity in infants of mothers
lapses in health care, this is also a period of 3. Monogenic diabetes syndromes with type 1 and type 2 diabetes. Observa-
deterioration in glycemic control, increased Monogenic forms of diabetes (neonatal tional studies indicate that the risk of mal-
occurrence of acute complications, psy- diabetes or maturity-onset diabetes of formations increases continuously with
chosocial and emotional behavioral issues, youth) represent a small fraction of chil- increasing maternal glycemia during the
and emergence of chronic complications dren with diabetes (,5%), but the ready rst 68 weeks of gestation, as dened
(396399). availability of commercial genetic testing is by rst-trimester A1C concentrations. There
Though scientic evidence continues now enabling a true genetic diagnosis with is no threshold for A1C values below
to be limited, it is clear that early and increasing frequency. It is important to which risk disappears entirely. However,

S42 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

malformation rates above the 12% back- 2) achieve the lowest A1C test results pos- therapy may benet those with life ex-
ground rate of nondiabetic pregnancies sible without excessive hypoglycemia, pectancy at least equal to the time frame
appear to be limited to pregnancies in 3) assure effective contraception until stable of primary or secondary prevention
which rst-trimester A1C concentrations and acceptable glycemia is achieved, and 4) trials. (E)
are .1% above the normal range for a identify, evaluate, and treat long-term dia- c Screening for diabetes complications
nondiabetic pregnant woman. betes complications such as retinopathy, should be individualized in older adults,
Preconception care of diabetes appears nephropathy, neuropathy, hypertension, but particular attention should be paid
to reduce the risk of congenital malforma- and CHD (94). to complications that would lead to
tions. Five nonrandomized studies com- Among the drugs commonly used in functional impairment. (E)
pared rates of major malformations in the treatment of patients with diabetes, a
infants between women who participated number may be relatively or absolutely Diabetes is an important health con-
in preconception diabetes care programs contraindicated during pregnancy. Sta- dition for the aging population; at least
and women who initiated intensive di- tins are category X (contraindicated for 20% of patients over the age of 65 years
abetes management after they were already use in pregnancy) and should be discon- have diabetes, and this number can be
pregnant. The preconception care programs tinued before conception, as should ACE expected to grow rapidly in the coming
were multidisciplinary and designed to inhibitors (402). ARBs are category C decades. Older individuals with diabetes
train patients in diabetes self-management (risk cannot be ruled out) in the rst tri- have higher rates of premature death, func-
with diet, intensied insulin therapy, and mester, but category D (positive evidence tional disability, and coexisting illnesses
SMBG. Goals were set to achieve normal of risk) in later pregnancy, and should such as hypertension, CHD, and stroke
blood glucose concentrations, and .80% generally be discontinued before preg- than those without diabetes. Older adults
of subjects achieved normal A1C concen- nancy. Since many pregnancies are un- with diabetes are also at greater risk than
trations before they became pregnant. In planned, health care professionals caring other older adults for several common
all ve studies, the incidence of major for any woman of childbearing potential geriatric syndromes, such as polyphar-
congenital malformations in women who should consider the potential risks and macy, depression, cognitive impairment,
participated in preconception care (range benets of medications that are contrain- urinary incontinence, injurious falls, and
1.01.7% of infants) was much lower dicated in pregnancy. Women using med- persistent pain.
than the incidence in women who did not ications such as statins or ACE inhibitors The American Geriatric Societys
participate (range 1.410.9% of infants) need ongoing family planning counsel- guidelines for improving the care of the
(94). One limitation of these studies is ing. Among the oral antidiabetic agents, older person with diabetes (404) have
that participation in preconception care metformin and acarbose are classied as inuenced the following discussion and
was self-selected rather than randomized. category B (no evidence of risk in hu- recommendations. The care of older adults
Thus, it is impossible to be certain that mans) and all others as category C. Poten- with diabetes is complicated by their clini-
the lower malformation rates resulted tial risks and benets of oral antidiabetic cal and functional heterogeneity. Some
fully from improved diabetes care. None- agents in the preconception period must older individuals developed diabetes years
theless, the evidence supports the concept be carefully weighed, recognizing that earlier and may have signicant complica-
that malformations can be reduced or pre- data are insufcient to establish the safety tions; others who are newly diagnosed may
vented by careful management of diabetes of these agents in pregnancy. have had years of undiagnosed diabetes
before pregnancy. For further discussion of preconcep- with resultant complications or may have
Planned pregnancies greatly facilitate tion care, see the ADA consensus statement few complications from the disease. Some
preconception diabetes care. Unfortu- on preexisting diabetes and pregnancy (94) older adults with diabetes are frail and have
nately, nearly two-thirds of pregnancies and also the position statement (403) on other underlying chronic conditions, sub-
in women with diabetes are unplanned, this subject. stantial diabetes-related comorbidity, or
leading to a persistent excess of malfor- limited physical or cognitive functioning.
mations in infants of diabetic mothers. To C. Older adults Other older individuals with diabetes
minimize the occurrence of these devas- Recommendations have little comorbidity and are active. Life
tating malformations, standard care for all c Older adults who are functional, cog- expectancies are highly variable for this
women with diabetes who have child- nitively intact, and have signicant life population, but often longer than clinicians
bearing potential, beginning at the onset expectancy should receive diabetes care realize. Providers caring for older adults
of puberty or at diagnosis, should include using goals developed for younger with diabetes must take this heterogeneity
1) education about the risk of malforma- adults. (E) into consideration when setting and prior-
tions associated with unplanned pregnan- c Glycemic goals for older adults not itizing treatment goals.
cies and poor metabolic control; and 2) use meeting the above criteria may be re- There are few long-term studies in
of effective contraception at all times, un- laxed using individual criteria, but hy- older adults demonstrating the benets of
less the patient has good metabolic control perglycemia leading to symptoms or risk intensive glycemic, blood pressure, and
and is actively trying to conceive. of acute hyperglycemic complications lipid control. Patients who can be expected
Women contemplating pregnancy should be avoided in all patients. (E) to live long enough to reap the benets of
need to be seen frequently by a multidis- c Other cardiovascular risk factors should long-term intensive diabetes management
ciplinary team experienced in the man- be treated in older adults with con- and who are active, have good cognitive
agement of diabetes before and during sideration of the time frame of benet function, and are willing should be pro-
pregnancy. The goals of preconception and the individual patient. Treatment vided with the needed education and skills
care are to 1) involve and empower the pa- of hypertension is indicated in virtually to do so and be treated using the goals for
tient in the management of her diabetes, all older adults, and lipid and aspirin younger adults with diabetes.

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S43


Position Statement

For patients with advanced diabetes patients with cystic brosis who do not mmol/L) is recommended for the ma-
complications, life-limiting comorbid ill- have CFRD (B). Use of A1C as a screening jority of critically ill patients. (A)
ness, or substantial cognitive or functional test for CFRD is not recommended. (B) More stringent goals, such as 110140
impairment, it is reasonable to set less in- c During a period of stable health the mg/dL (6.17.8 mmol/L) may be appro-
tensive glycemic target goals. These patients diagnosis of CFRD can be made in cystic priate for selected patients, as long as this
are less likely to benet from reducing the brosis patients according to usual di- can be achieved without signicant hy-
risk of microvascular complications and agnostic criteria. (E) poglycemia. (C)
more likely to suffer serious adverse effects c Patients with CFRD should be treated Critically ill patients require an in-
from hypoglycemia. However, patients with insulin to attain individualized travenous insulin protocol that has
with poorly controlled diabetes may be glycemic goals. (A) demonstrated efcacy and safety in
subject to acute complications of diabe- c Annual monitoring for complications achieving the desired glucose range
tes, including dehydration, poor wound of diabetes is recommended, beginning without increasing risk for severe hy-
healing, and hyperglycemic hyperosmo- 5 years after the diagnosis of CFRD. (E) poglycemia. (E)
lar coma. Glycemic goals at a minimum Noncritically ill patients: There is no
should avoid these consequences. CFRD is the most common comorbid- clear evidence for specic blood glucose
Although control of hyperglycemia ity in persons with cystic brosis, occurring goals. If treated with insulin, premeal
may be important in older individuals in about 20% of adolescents and 4050% blood glucose targets generally ,140
with diabetes, greater reductions in mor- of adults. The additional diagnosis of dia- mg/dL (7.8 mmol/L) with random
bidity and mortality may result from con- betes in this population is associated with blood glucose ,180 mg/dL (10.0
trol of other cardiovascular risk factors worse nutritional status, more severe in- mmol/L) are reasonable, provided these
rather than from tight glycemic control ammatory lung disease, and greater mor- targets can be safely achieved. More
alone. There is strong evidence from tality from respiratory failure. Insulin stringent targets may be appropriate in
clinical trials of the value of treating hyper- insufciency related to partial brotic de- stable patients with previous tight glyce-
tension in the elderly (405,406). There is struction of the islet mass is the primary mic control. Less stringent targets may be
less evidence for lipid-lowering and aspirin defect in CFRD. Genetically determined appropriate in those with severe co-
therapy, although the benets of these in- function of the remaining b-cells and insu- morbidities. (E)
terventions for primary and secondary pre- lin resistance associated with infection and
vention are likely to apply to older adults inammation may also play a role. Encour- c Scheduled subcutaneous insulin with
whose life expectancies equal or exceed the aging new data suggest that early detection basal, nutritional, and correction com-
time frames seen in clinical trials. and aggressive insulin therapy have nar- ponents is the preferred method for
Special care is required in prescribing rowed the gap in mortality between cystic achieving and maintaining glucose con-
and monitoring pharmacologic therapy in brosis patients with and without diabetes, trol in noncritically ill patients.
older adults. Metformin is often contra- and have eliminated the difference in mor- c Glucose monitoring should be initiated
indicated because of renal insufciency or tality between the sexes (407). in any patient not known to be diabetic
signicant heart failure. TZDs can cause Recommendations for the clinical who receives therapy associated with
uid retention, which may exacerbate or management of CFRD can be found in a high-risk for hyperglycemia, including
lead to heart failure. They are contraindi- recent ADA position statement on this high-dose glucocorticoid therapy, ini-
cated in patients with CHF (New York topic (408). tiation of enteral or parenteral nutrition,
Heart Association Class III and IV), and if or other medications such as octreotide
used at all should be used very cautiously or immunosuppressive medications. (B)
in those with, or at risk for, milder degrees IX. DIABETES CARE IN If hyperglycemia is documented and
of CHF. Sulfonylureas, other insulin secre- SPECIFIC SETTINGS persistent, consider treating such pa-
tagogues, and insulin can cause hypogly- tients to the same glycemic goals as pa-
cemia. Insulin use requires that patients or A. Diabetes care in the hospital tients with known diabetes. (E)
caregivers have good visual and motor Recommendations c A hypoglycemia management protocol
skills and cognitive ability. Drugs should c All patients with diabetes admitted to should be adopted and implemented
be started at the lowest dose and titrated up the hospital should have their diabetes by each hospital or hospital system. A
gradually until targets are reached or side clearly identied in the medical record. plan for preventing and treating hypo-
effects develop. (E) glycemia should be established for each
Screening for diabetes complications c All patients with diabetes should have patient. Episodes of hypoglycemia in
in older adults also should be individual- an order for blood glucose monitoring, the hospital should be documented in
ized. Particular attention should be paid with results available to all members of the medial record and tracked. (E)
to complications that can develop over short the health care team. (E) c Consider obtaining an A1C on patients
periods of time and/or that would signi- c Goals for blood glucose levels: with diabetes admitted to the hospital if
cantly impair functional status, such as visual the result of testing in the previous 23
and lower extremity complications. Critically ill patients: Insulin therapy months is not available. (E)
should be initiated for treatment of persis- c Patients with hyperglycemia in the hos-
D. Cystic brosisrelated diabetes tent hyperglycemia starting at a threshold of pital who do not have a prior diagnosis
(CFRD) no greater than 180 mg/dL (10 mmol/L). of diabetes should have appropriate
Recommendations Once insulin therapy is started, a glu- plans for follow-up testing and care
c Annual screening for CFRD with OGTT cose range of 140180 mg/dL (7.8 to 10 documented at discharge. (E)
should begin by age 10 years in all

S44 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Hyperglycemia in the hospital can both surgical and medical patients, as was in hospitalized patients has been dened by
represent previously known diabetes, mortality from cardiovascular causes. Se- many as ,40 mg/dL (2.2 mmol/L), al-
previously undiagnosed diabetes, or vere hypoglycemia was also more common though this is lower than the ;50 mg/dL
hospital-related hyperglycemia (fasting in the intensively treated group (6.8% vs. (2.8 mmol/L) level at which cognitive im-
blood glucose $126 mg/dL or random 0.5%; P , 0.001). The precise reason for pairment begins in normal individuals
blood glucose $200 mg/dL occurring the increased mortality in the tightly con- (420). As with hyperglycemia, hypoglyce-
during the hospitalization that reverts trolled group is unknown. The results of mia among inpatients is also associated
to normal after hospital discharge). Hyper- this study lie in stark contrast to a famous with adverse short- and long-term out-
glycemia in the hospital is extensively re- 2001 single-center study which reported a comes. Early recognition and treatment of
viewed in an ADA technical review (409). 42% relative reduction in ICU mortality in mild-to-moderate hypoglycemia (4069
An updated consensus statement by the critically ill surgical patients treated to a tar- mg/dL (2.23.8 mmol/L) can prevent dete-
American Association of Clinical Endocri- get blood glucose of 80110 mg/dL (411). rioration to a more severe episode with po-
nologists (AACE) and ADA (410) forms the Importantly, the control group in NICE- tential adverse sequelae (410).
basis for the discussion and guidelines in SUGAR had reasonably good blood glu- Critically ill patients. Based on the
this section. cose management, maintained at a mean weight of the available evidence, for the
The management of hyperglycemia in glucose of 144 mg/dL, only 29 mg/dL majority of critically ill patients in the ICU
the hospital has often been considered above the intensively managed patients. setting, insulin infusion should be used
secondary in importance to the condition Accordingly, this studys ndings do not to control hyperglycemia, with a starting
that prompted admission (409). However, a disprove the notion that glycemic control threshold of no higher than 180 mg/dL
body of literature now supports targeted in the ICU is important. However they do (10.0 mmol/L). Once intravenous insu-
glucose control in the hospital setting for strongly suggest that it may not be neces- lin is started, the glucose level should be
potential improved clinical outcomes. Hy- sary to target blood glucose values ,140 maintained between 140 and 180 mg/dL
perglycemia in the hospital may result from mg/dL, and that a highly stringent target (7.810.0 mmol/L). Greater benet
stress, decompensation of type 1 or type 2 of ,110 mg/dL may actually be dangerous. maybe realized at the lower end of this
or other forms of diabetes, and/or may be In a recent meta-analysis of 26 trials range. Although strong evidence is lack-
iatrogenic due to withholding of antihyper- (N 5 13,567), which included the NICE- ing, somewhat lower glucose targets
glycemic medications or administration of SUGAR data, the pooled relative risk (RR) may be appropriate in selected patients.
hyperglycemia-provoking agents such as of death with intensive insulin therapy However, targets ,110 mg/dL (6.1
glucocorticoids or vasopressors. was 0.93 as compared with conventional mmol/L) are not recommended. Use of
There is substantial observational ev- therapy (95% CI 0.831.04) (418). Ap- insulin infusion protocols with demon-
idence linking hyperglycemia in hospital- proximately half of these trials reported strated safety and efcacy, resulting in
ized patients (with or without diabetes) to hypoglycemia, with a pooled RR of inten- low rates of hypoglycemia, are highly
poor outcomes. Cohort studies as well as sive therapy of 6.0 (95% CI 4.58.0). The recommended (410).
a few early RCTs suggested that intensive specic ICU setting inuenced the nd- Noncritically ill patients. With no pro-
treatment of hyperglycemia improved hos- ings, with patients in surgical ICUs ap- spective RCT data to inform specic
pital outcomes (409,411,412). In general, pearing to benet from intensive insulin glycemic targets in noncritically ill patients,
these studies were heterogeneous in terms therapy (RR 0.63, 95% CI 0.440.91), recommendations are based on clinical
of patient population, blood glucose targets while those in other medical and mixed experience and judgment. For the majority
and insulin protocols used, provision of critical care settings did not. It was con- of noncritically ill patients treated with
nutritional support, and the proportion of cluded that, overall, intensive insulin insulin, premeal glucose targets should
patients receiving insulin, which limits the therapy increased the risk of hypoglyce- generally be ,140 mg/dL (7.8 mmol/L)
ability to make meaningful comparisons mia but provided no overall benet on with random blood glucose ,180 mg/dL
among them. Recent trials in critically ill mortality in the critically ill, although a (10.0 mmol/L), as long as these targets
patients have failed to show a signicant possible mortality benet to patients ad- can be safely achieved. To avoid hypogly-
improvement in mortality with intensive mitted to the surgical ICU was suggested. cemia, consideration should be given to
glycemic control (413,414) or have even 1. Glycemic targets in hospitalized reassessing the insulin regimen if blood
shown increased mortality risk (415). patients glucose levels fall ,100 mg/dL (5.6 mmol/
Moreover, these recent RCTs have high- Denition of glucose abnormalities in L). Modication of the regimen is required
lighted the risk of severe hypoglycemia re- the hospital setting. Hyperglycemia in when blood glucose values are ,70 mg/dL
sulting from such efforts (413418). the hospital has been dened as any (3.9 mmol/L), unless the event is easily ex-
The largest study to date, NICE- blood glucose .140 mg/dL (7.8 mmol/ plained by other factors (such as a missed
SUGAR, a multicenter, multinational RCT, L). Levels that are signicantly and per- meal). There is some evidence that system-
compared the effect of intensive glycemic sistently above this may require treat- atic attention to hyperglycemia in the emer-
control (target 81108 mg/dL, mean blood ment in hospitalized patients. A1C gency room leads to better glycemic control
glucose attained 115 mg/dL) to standard values .6.5% suggest, in undiagnosed in the hospital for those subsequently admit-
glycemic control (target 144180 mg/dL, patients, that diabetes preceded hospital- ted (421).
mean blood glucose attained 144 mg/dL) ization (419). Hypoglycemia has been de- Occasional patients with a prior his-
on outcomes among 6,104 critically ill par- ned as any blood glucose ,70 mg/dL tory of successful tight glycemic control
ticipants, almost all of whom required me- (3.9 mmol/L). This is the standard deni- in the outpatient setting who are clini-
chanical ventilation (415). Ninety-day tion in outpatients and correlates with the cally stable may be maintained with a
mortality was signicantly higher in the in- initial threshold for the release of counter- glucose range below the above cut points.
tensive versus the conventional group in regulatory hormones. Severe hypoglycemia Conversely, higher glucose ranges may be

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S45


Position Statement

acceptable in terminally ill patients or in insufciency, unstable hemodynamic sta- consciousness, have reasonably stable
patients with severe comorbidities, as well tus, or need for an imaging study that daily insulin requirements, successfully
as in those in patient-care settings where requires a radio-contrast dye. conduct self-management of diabetes at
frequent glucose monitoring or close nurs- 3. Preventing hypoglycemia home, have physical skills needed to
ing supervision is not feasible. In the hospital, multiple risk factors for successfully self-administer insulin and
Clinical judgment, combined with hypoglycemia are present. Patients with or perform SMBG, have adequate oral in-
ongoing assessment of the patients clini- without diabetes may experience hypogly- take, are procient in carbohydrate
cal status, including changes in the trajec- cemia in the hospital in association with counting, use multiple daily insulin in-
tory of glucose measures, the severity of altered nutritional state, heart failure, renal jections or insulin pump therapy, and em-
illness, nutritional status, or concurrent use or liver disease, malignancy, infection, or ploy sick-day management. The patient
of medications that might affect glucose sepsis. Additional triggering events leading and physician, in consultation with nurs-
levels (e.g., steroids, octreotide), must be to iatrogenic hypoglycemia include sudden ing staff, must agree that patient self-
incorporated into the day-to-day decisions reduction of corticosteroid dose, altered management is appropriate under the
regarding insulin dosing (410). ability of the patient to report symptoms, conditions of hospitalization.
2. Antihyperglycemic agents in hospi- reduction of oral intake, emesis, new n.p.o. Patients who use CSII pump therapy
talized patients status, inappropriate timing of short- or in the outpatient setting can be candidates
In the hospital setting, insulin therapy is rapid-acting insulin in relation to meals, for diabetes self-management in the hos-
the preferred method of glycemic control reduction of rate of administration of in- pital, provided that they have the mental
in majority of clinical situations (410). In travenous dextrose, and unexpected inter- and physical capacity to do so (410). A
the ICU, intravenous infusion is the pre- ruption of enteral feedings or parenteral hospital policy and procedures delineat-
ferred route of insulin administration. nutrition. ing inpatient guidelines for CSII therapy
When the patient is transitioned off intra- Despite the preventable nature of are advisable, and availability of hospital
venous insulin to subcutaneous therapy, many inpatient episodes of hypoglyce- personnel with expertise in CSII therapy
precautions should be taken to prevent mia, institutions are more likely to have is essential. It is important that nursing
hyperglycemia escape (422,423). Outside nursing protocols for the treatment of personnel document basal rates and bolus
of critical care units, scheduled subcuta- hypoglycemia than for its prevention. doses taken on a regular basis (at least
neous insulin that delivers basal, nutri- Tracking such episodes and analyzing daily).
tional, and correction (supplemental) their causes are important quality im- 6. MNT in the hospital
components is preferred. Prolonged ther- provement activities (410). The goals of MNT are to optimize glyce-
apy with sliding scale insulin (SSI) as the 4. Diabetes care providers in the mic control, provide adequate calories to
sole regimen is ineffective in the majority hospital meet metabolic demands, and create a
of patients, increases risk of both hypo- Inpatient diabetes management may be discharge plan for follow-up care
glycemia and hyperglycemia, and has re- effectively championed and/or provided (409,429). ADA does not endorse any
cently been shown in a randomized trial by primary care physicians, endocrinolo- single meal plan or specied percentages
to be associated with adverse outcomes in gists, intensivists or hospitalists. Involve- of macronutrients, and the term ADA
general surgery patients with type 2 dia- ment of appropriately trained specialists diet should no longer be used. Current
betes (424). SSI is potentially dangerous or specialty teams may reduce length of nutrition recommendations advise indi-
in type 1 diabetes (410). The reader is re- stay, improve glycemic control, and im- vidualization based on treatment goals,
ferred to several recent publications and prove outcomes (410). In the care of di- physiologic parameters, and medication
reviews that describe currently available abetes, implementation of standardized usage. Consistent carbohydrate meal
insulin preparations and protocols and order sets for scheduled and correction- plans are preferred by many hospitals be-
provide guidance in use of insulin therapy dose insulin may reduce reliance on cause they facilitate matching the prandial
in specic clinical settings including par- sliding-scale management. As hospitals insulin dose to the amount of carbohy-
enteral nutrition (425) and enteral tube move to comply with meaningful use drate consumed (430). Because of the
feedings and with high-dose glucocorti- regulations for electronic health records, complexity of nutrition issues in the
coid therapy (410). as mandated by the Health Information hospital, a registered dietitian, knowl-
There are no data on the safety and Technology Act, efforts should be made edgeable and skilled in MNT, should
efcacy of oral agents and injectable non- to assure that all components of structured serve as an inpatient team member. The
insulin therapies such as GLP1 analogs insulin order sets are incorporated into dietitian is responsible for integrating in-
and pramlintide in the hospital. They are electronic insulin order sets (426,427). formation about the patients clinical con-
generally considered to have a limited role A team approach is needed to estab- dition, eating, and lifestyle habits and for
in the management of hyperglycemia in lish hospital pathways. To achieve glyce- establishing treatment goals in order to
conjunction with acute illness. Continu- mic targets associated with improved determine a realistic plan for nutrition
ation of these agents may be appropriate hospital outcomes, hospitals will need therapy (431,432).
in selected stable patients who are expec- multidisciplinary support to develop in-
ted to consume meals at regular intervals, sulin management protocols that effec- 7. Bedside blood glucose monitoring
and they may be initiated or resumed in tively and safely enable achievement of Point-of-care (POC) blood glucose mon-
anticipation of discharge once the patient glycemic targets (428). itoring performed at the bedside is used to
is clinically stable. Specic caution is re- 5. Self-management in the hospital guide insulin dosing. In the patient who is
quired with metformin due to the possi- Self-management of diabetes in the hos- receiving nutrition, the timing of glucose
bility that a contraindication may develop pital may be appropriate for competent monitoring should match carbohydrate
during the hospitalization, such as renal adult patients who have a stable level of exposure. In the patient who is not

S46 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

receiving nutrition, glucose monitoring is Inpatients may be discharged to var- enable safe care at home. Patients hospi-
performed every 4 to 6 h (433,434). More- ied settings, including home (with or talized because of a crisis related to diabe-
frequent blood glucose testing ranging without visiting nurse services), assisted tes management or poor care at home
from every 30 min to every 2 h is required living, rehabilitation, or skilled nursing need education to prevent subsequent ep-
for patients on intravenous insulin infu- facilities. The latter two sites are generally isodes of hospitalization. An assessment
sions. staffed by health professionals, so diabe- of the need for a home health referral or
Safety standards should be estab- tes discharge planning will be limited to referral to an outpatient diabetes educa-
lished for blood glucose monitoring pro- communication of medication and diet tion program should be part of discharge
hibiting sharing of ngerstick lancing orders. For the patient who is discharged planning for all patients.
devices, lancets, needles, and meters to to assisted living or to home, the optimal DSME cannot wait until discharge,
reduce the risk of transmission of blood program will need to consider the type especially in those new to insulin therapy
borne diseases. Shared lancing devices carry and severity of diabetes, the effects of the or in whom the diabetes regimen has been
essentially the same risk as is conferred from patients illness on blood glucose levels, substantially altered during the hospital-
sharing of syringes and needles (435). and the capacities and desires of the pa- ization.
Accuracy of blood glucose measure- tient. Smooth transition to outpatient It is recommended that the following
ments using POC meters has limitations care should be ensured. The Agency for areas of knowledge be reviewed and
that must be considered. Although the Healthcare Research and Quality recom- addressed prior to hospital discharge:
FDA allows a 1/2 20% error for blood mends that at a minimum, discharge
glucose meters, questions about the ap- plans include: c Identication of health care provider
propriateness of these criteria have been who will provide diabetes care after
raised (388). Glucose measures differ sig- c Medication reconciliation: The patients discharge
nicantly between plasma and whole medications must be cross-checked to c Level of understanding related to the
blood, terms that are often used inter- ensure that no chronic medications diagnosis of diabetes, SMBG, and ex-
changeably and can lead to misinterpreta- were stopped and to ensure the safety of planation of home blood glucose goals
tion. Most commercially available capillary new prescriptions. c Denition, recognition, treatment, and
blood glucose meters introduce a correc- c Whenever possible, prescriptions for prevention of hyperglycemia and hy-
tion factor of ;1.12 to report a plasma new or changed medication should be poglycemia
adjusted value (436). lled and reviewed with the patient and c Information on consistent eating pat-
Signicant discrepancies between family at or before discharge. terns
capillary, venous, and arterial plasma sam- c Structured discharge communication: c When and how to take blood glucose
ples have been observed in patients with Information on medication changes, lowering medications including insulin
low or high hemoglobin concentrations, pending tests and studies, and follow- administration (if going home on in-
hypoperfusion, and the presence of in- up needs must be accurately and sulin)
terfering substances, particularly maltose, promptly communicated to outpatient c Sick-day management
as contained in immunoglobulins (437). physicians. c Proper use and disposal of needles and
Analytical variability has been described c Discharge summaries should be trans- syringes
with several POC meters (438). Increas- mitted to the primary physician as soon
ingly newer generation POC blood glu- as possible after discharge. It is important that patients be pro-
cose meters correct for variation in c Appointment-keeping behavior is en- vided with appropriate durable medical
hematocrit and for interfering substances. hanced when the inpatient team sched- equipment, medication, supplies, and pre-
Any glucose result that does not correlate ules outpatient medical follow up prior scriptions at the time of discharge in order
with the patients status should be con- to discharge. Ideally the inpatient care to avoid a potentially dangerous hiatus in
rmed through conventional laboratory providers or case managers/discharge care. These supplies/prescriptions should
sampling of plasma glucose. The FDA planners will schedule follow-up visit include:
has become increasingly concerned about (s) with the appropriate professionals,
the use of POC blood glucose meters in including the primary care provider, c Insulin (vials or pens) if needed
the hospital and is presently reviewing endocrinologist, and diabetes educator c Syringes or pen needles (if needed)
matters related to their use. (99). c Oral medications (if needed)
8. Discharge planning and DSME c Blood glucose meter and strips
Transition from the acute care setting is a Teaching diabetes self-management c Lancets and lancing device
high risk time for all patients, not just to patients in hospitals is a challenging c Urine ketone strips (type 1)
those with diabetes or new hyperglyce- task. Patients are ill, under increased c Glucagon emergency kit (insulin-treated)
mia. Although there is an extensive liter- stress related to their hospitalization and c Medical alert application/charm
ature concerning safe transition within diagnosis, and in an environment not
and from the hospital, little of it is specic conducive to learning. Ideally, people More expanded diabetes education
to diabetes (439). It is important to re- with diabetes should be taught at a time can be arranged in the community. An
member that diabetes discharge planning and place conducive to learningdas an outpatient follow-up visit with the pri-
is not a separate entity, but is part of an outpatient in a recognized program of di- mary care provider, endocrinologist, or
overall discharge plan. As such, discharge abetes education. For the hospitalized pa- diabetes educator within 1 month of
planning begins at admission to the hos- tient, diabetes survival skills education discharge is advised for all patients having
pital and is updated as projected patient is generally a feasible approach to provide hyperglycemia in the hospital. Clear com-
needs change. sufcient information and training to munication with outpatient providers

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S47


Position Statement

either directly or via hospital discharge The ADA position statement on di- achieving recommended levels of A1C,
summaries facilitates safe transitions to abetes and driving (441) recommends blood pressure, and LDL cholesterol in
outpatient care. Providing information against blanket restrictions based on the the last 10 years, both in primary care
regarding the cause or the plan for de- diagnosis of diabetes and urges individual settings and in endocrinology practices.
termining the cause of hyperglycemia, assessment by a health care professional Mean A1C nationally has declined from
related complications and comorbidities, knowledgeable in diabetes if restrictions 7.82% in 19992000 to 7.18% in 2004
and recommended treatments can assist on licensure are being considered. Pa- based on NHANES data (443). This has
outpatient providers as they assume on- tients should be evaluated for decreased been accompanied by improvements in
going care. awareness of hypoglycemia, hypoglyce- lipids and blood pressure control and
mia episodes while driving, or severe hy- has led to substantial reductions in end-
B. Diabetes and employment poglycemia. Patients with retinopathy or stage microvascular complications in
Any person with diabetes, whether insulin- peripheral neuropathy require assessment those with diabetes. Nevertheless in
treated or noninsulin treated, should be to determine if those complications inter- some studies only 57.1% of adults with
eligible for any employment for which fere with operation of a motor vehicle. diagnosed diabetes achieved an A1C
he/she is otherwise qualied. Employ- Health care professionals should be cogni- ,7%, only 45.5% had a blood pressure
ment decisions should never be based on zant of the potential risk of driving with ,130/80 mmHg, and only 46.5% had a
generalizations or stereotypes regarding diabetes and counsel their patients about total cholesterol ,200 mg/dL, with only
the effects of diabetes. When questions detecting and avoiding hypoglycemia 12.2% of people with diabetes achieving
arise about the medical tness of a person while driving. all three treatment goals (444). Evidence
with diabetes for a particular job, a health also suggests that progress in risk factor
care professional with expertise in treat- D. Diabetes management in control may be slowing (445). Certain pa-
ing diabetes should perform an individ- correctional institutions tient groups, such as those with complex
ualized assessment. See the ADA position People with diabetes in correctional facil- comorbidities, nancial or other social
statement on diabetes and employment ities should receive care that meets na- hardships, and/or limited English pro-
(440). tional standards. Because it is estimated ciency (LEP), may present particular chal-
that nearly 80,000 inmates have diabetes, lenges to goal-based care (446,447).
C. Diabetes and driving correctional institutions should have Persistent variation in quality of diabetes
A large percentage of people with diabetes written policies and procedures for the care across providers and across practice
in the U.S. and elsewhere seek a license management of diabetes and for training settings even after adjusting for patient
to drive, either for personal or employ- of medical and correctional staff in di- factors indicates that there remains poten-
ment purposes. There has been consider- abetes care practices. See the ADA posi- tial for substantial further improvements
able debate whether, and the extent to tion statement on diabetes management in diabetes care.
which, diabetes may be a relevant factor in in correctional institutions (442) for fur- While numerous interventions to im-
determining the driver ability and eligi- ther discussion. prove adherence to the recommended
bility for a license. standards have been implemented, a ma-
People with diabetes are subject to a X. STRATEGIES FOR jor barrier to optimal care is a delivery
great variety of licensing requirements IMPROVING DIABETES CARE system that too often is fragmented, lacks
applied by both state and federal juris- clinical information capabilities, often
dictions, which may lead to loss of em- Recommendations duplicates services, and is poorly de-
ployment or signicant restrictions on a c Care should be aligned with compo- signed for the coordinated delivery of
persons license. Presence of a medical nents of the Chronic Care Model to en- chronic care. The Chronic Care Model
condition that can lead to signicantly sure productive interactions between a (CCM) has been shown in numerous
impaired consciousness or cognition prepared proactive practice team and an studies to be an effective framework for
may lead to drivers being evaluated for informed activated patient. (A) improving the quality of diabetes care
tness to drive. For diabetes, this typi- c When feasible, care systems should (448). The CCM includes six core ele-
cally arises when the person has had a support team-based care, community ments for the provision of optimal care
hypoglycemic episode behind the wheel, involvement, patient registries, and em- of patients with chronic disease: 1) deliv-
even if this did not lead to a motor vehicle bedded decision support tools to meet ery system design (moving from a reactive
accident. patient needs (B). to a proactive care delivery system where
Epidemiologic and simulator data c Treatment decisions should be timely planned visits are coordinated through a
suggest that people with insulin-treated and based on evidence-based guidelines team based approach), 2) self-management
diabetes have a small increase in risk of that are tailored to individual patient support, 3) decision support (basing
motor vehicle accidents, primarily due to preferences, prognoses, and comorbid- care on evidence-based, effective care
hypoglycemia and decreased awareness ities. (B) guidelines), 4) clinical information sys-
of hypoglycemia. This increase (RR 1.12 c A patient-centered communication style tems (using registries that can provide
1.19) is much smaller than the risks asso- should be employed that incorporates patient-specic and population-based
ciated with teenage male drivers (RR 42), patient preferences, assesses literacy and support to the care team), 5) community
driving at night (RR 142), driving on rural numeracy, and addresses cultural bar- resources and policies (identifying or de-
roads compared with urban roads (RR 9.2), riers to care. (B) veloping resources to support healthy
and obstructive sleep apnea (RR 2.4), all lifestyles), and 6) health systems (to
of which are accepted for unrestricted li- There has been steady improvement create a quality-oriented culture). Redef-
censure. in the proportion of diabetes patients inition of the roles of the clinic staff and

S48 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

promoting self-management on the part approach that includes clinical content 7. Ziemer DC, Kolm P, Weintraub WS,
of the patient are fundamental to the suc- and skills and behavioral strategies (goal- et al. Glucose-independent, black-white
cessful implementation of the CCM setting, problem solving) and addresses differences in hemoglobin A1c levels:
(449). Collaborative, multidisciplinary emotional concerns in each needed curric- a cross-sectional analysis of 2 studies.
Ann Intern Med 2010;152:770777
teams are best suited to provide such ulum content area.
8. Kumar PR, Bhansali A, Ravikiran M, et al.
care for people with chronic conditions Utility of glycated hemoglobin in di-
like diabetes and to facilitate patients per- Objective 3: Change the system agnosing type 2 diabetes mellitus: a
formance of appropriate self-management of care community-based study. J Clin Endo-
(148,150,450,451). The most successful practices have an crinol Metab 2010;95:28322835
NDEP maintains an online resource institutional priority for providing high 9. Selvin E, Steffes MW, Ballantyne CM,
(www.betterdiabetescare.nih.gov) to help quality of care (465). Changes that have Hoogeveen RC, Coresh J, Brancati FL.
health care professionals design and im- been shown to increase quality of diabetes Racial differences in glycemic markers:
plement more effective health care deliv- care include basing care on evidence- a cross-sectional analysis of community-
ery systems for those with diabetes. Three based data. Ann Intern Med 2011;154:
based guidelines (466), expanding the
303309
specic objectives, with references to lit- role of teams and staff (449,467), rede- 10. Nowicka P, Santoro N, Liu H, et al. Utility
erature that outline practical strategies to signing the processes of care (468,469), of hemoglobin A(1c) for diagnosing pre-
achieve each, are below. implementing electronic health record diabetes and diabetes in obese children
tools (470,471), activating and educating and adolescents. Diabetes Care 2011;34:
Objective 1: Optimize provider and patients (472,473), and identifying and/ 13061311
team behavior or developing and engaging community 11. Cowie CC, Rust KF, Byrd-Holt DD, et al.
The care team should prioritize timely resources and public policy that support Prevalence of diabetes and high risk for
and appropriate intensication of lifestyle healthy lifestyles (474). Recent initiatives diabetes using A1C criteria in the U.S.
and/or pharmaceutical therapy of patients such as the Patient Centered Medical population in 1988-2006. Diabetes Care
who have not achieved benecial levels of 2010;33:562568
Home show promise to improve outcomes
12. Expert Committee on the Diagnosis and
blood pressure, lipid, or glucose control through coordinated primary care and of- Classication of Diabetes Mellitus. Re-
(452). Strategies such as explicit goal set- fer new opportunities for team-based port of the Expert Committee on the
ting with patients (453); identifying and chronic disease care (475). Alterations in Diagnosis and Classication of Diabetes
addressing language, numeracy, or cul- reimbursement that reward the provision Mellitus. Diabetes Care 1997;20:11831197
tural barriers to care (454456); integrat- of appropriate and high quality care rather 13. Genuth S, Alberti KG, Bennett P, et al.;
ing evidence-based guidelines and clinical than visit-based billing (476), and that can Expert Committee on the Diagnosis and
information tools into the process of care accommodate the need to personalize care Classication of Diabetes Mellitus. Follow-
(457459); and incorporating care man- goals, may provide additional incentives to up report on the diagnosis of diabetes
agement teams including nurses, pharma- improve diabetes care (477). mellitus. Diabetes Care 2003;26:3160
cists, and other providers (460463) have 3167
It is clear that optimal diabetes man-
14. Zhang X, Gregg EW, Williamson DF,
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Position Statement

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Position Statement

N, Basora J, Estruch R, Covas MI, Corella individuals with type 2 diabetes. Di- children diagnosed with type 1 diabetes
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289. Yusuf S, Teo K, Anderson C, et al.; Tel- study. J Am Soc Nephrol 2006;17(Suppl 311. Parving HH, Persson F, Lewis JB, Lewis
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324. Estacio RO, McFarling E, Biggerstaff S, 336. Wile DJ, Toth C. Association of metfor- Prevention. Diabetes Res Clin Pract 2008;
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327. Diabetes Control and Complications Diabetic Neuropathy Study Group of the enterology 2002;123:17021704
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care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S59


Position Statement

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Position Statement

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Position Statement

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435. Klonoff DC, Perz JF. Assisted monitoring 450. Parchman ML, Zeber JE, Romero RR, of a nurse-directed diabetes disease
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436. DOrazio P, Burnett RW, Fogh-Andersen model in primary care settings: a STAR- abetes Care 2007;30:224227
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et al. Discharge planning from hospital Closing the loop: physician communication et al. Diabetes performance measures:

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Position Statement

current status and future directions. 470. Cebul RD, Love TE, Jain AK, Hebert CJ. 474. Pullen-Smith B, Carter-Edwards L, Leathers
Diabetes Care 2011;34:16511659 Electronic health records and quality of KH. Community health ambassadors:
467. Peikes D, Chen A, Schore J, Brown R. diabetes care. N Engl J Med 2011;365: a model for engaging community leaders
Effects of care coordination on hospi- 825833 to promote better health in North Caro-
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2009;301:603618 a pilot randomized trial. Diabetes Care centered medical home and diabetes.
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233241 in primary care. Jt Comm J Qual Patient Saf mative potential. N Engl J Med 2011;
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care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S63


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

Diagnosis and Classication of Diabetes


Mellitus
AMERICAN DIABETES ASSOCIATION therefore do not require insulin. Other
individuals who have some residual insu-
lin secretion but require exogenous insu-
lin for adequate glycemic control can
DEFINITION AND cardiovascular symptoms and sexual dys-
survive without it. Individuals with ex-
DESCRIPTION OF DIABETES function. Patients with diabetes have an
tensive b-cell destruction and therefore
MELLITUSdDiabetes is a group of increased incidence of atherosclerotic car-
no residual insulin secretion require in-
metabolic diseases characterized by hy- diovascular, peripheral arterial, and cere-
sulin for survival. The severity of the met-
perglycemia resulting from defects in in- brovascular disease. Hypertension and
abolic abnormality can progress, regress,
sulin secretion, insulin action, or both. abnormalities of lipoprotein metabolism
or stay the same. Thus, the degree of hy-
The chronic hyperglycemia of diabetes is are often found in people with diabetes.
perglycemia reects the severity of the
associated with long-term damage, dys- The vast majority of cases of diabetes
underlying metabolic process and its
function, and failure of different organs, fall into two broad etiopathogenetic cate-
treatment more than the nature of the
especially the eyes, kidneys, nerves, heart, gories (discussed in greater detail below).
process itself.
and blood vessels. In one category, type 1 diabetes, the cause
Several pathogenic processes are in- is an absolute deciency 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 identied by serological evidence of an
OF GLUCOSE
consequent insulin deciency 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 decient action of in- combination of resistance to insulin action
uals do not easily t into a single class. For
sulin on target tissues. Decient insulin and an inadequate compensatory insulin
example, a person with gestational di-
action results from inadequate insulin se- secretory response. In the latter category, a
abetes mellitus (GDM) may continue to
cretion and/or diminished tissue respon- degree of hyperglycemia sufcient to cause
be hyperglycemic after delivery and may
ses to insulin at one or more points in the pathologic and functional changes in var-
be determined to have, in fact, type 2
complex pathways of hormone action. ious target tissues, but without clinical
diabetes. Alternatively, a person who
Impairment of insulin secretion and de- symptoms, may be present for a long
acquires diabetes because of large doses
fects in insulin action frequently coexist in period of time before diabetes is detected.
of exogenous steroids may become nor-
the same patient, and it is often unclear During this asymptomatic period, it is
moglycemic once the glucocorticoids are
which abnormality, if either alone, is the possible to demonstrate an abnormality in
discontinued, but then may develop di-
primary cause of the hyperglycemia. carbohydrate metabolism by measurement
abetes 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. The degree of hyperglycemia (if any)
who develops diabetes years later. Because
Impairment of growth and susceptibility to may change over time, depending on the
thiazides in themselves seldom cause severe
certain infections may also accompany extent of the underlying disease process
hyperglycemia, such individuals probably
chronic hyperglycemia. Acute, life-threaten- (Fig. 1). A disease process may be present
have type 2 diabetes that is exacerbated by
ing consequences of uncontrolled diabetes but may not have progressed far enough
the drug. Thus, for the clinician and patient,
are hyperglycemia with ketoacidosis or the to cause hyperglycemia. The same disease
it is less important to label the particular
nonketotic hyperosmolar syndrome. process can cause impaired fasting glu-
type of diabetes than it is to understand the
Long-term complications of diabetes cose (IFG) and/or impaired glucose toler-
pathogenesis of the hyperglycemia and to
include retinopathy with potential loss ance (IGT) without fullling the criteria
treat it effectively.
of vision; nephropathy leading to renal for the diagnosis of diabetes. In some in-
failure; peripheral neuropathy with risk dividuals with diabetes, adequate glyce- Type 1 diabetes (b-cell destruction,
of foot ulcers, amputations, and Charcot mic control can be achieved with weight usually leading to absolute insulin
joints; and autonomic neuropathy caus- reduction, exercise, and/or oral glucose- deciency)
ing gastrointestinal, genitourinary, and lowering agents. These individuals 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
510% of those with diabetes, previously
Section on gestational diabetes diagnosis revised Fall 2010. encompassed by the terms insulin-
DOI: 10.2337/dc12-s064
2012 by the American Diabetes Association. Readers may use this article as long as the work is properly
dependent diabetes, type 1 diabetes, or
cited, the use is educational and not for prot, and the work is not altered. See http://creativecommons.org/ juvenile-onset diabetes, results from a cel-
licenses/by-nc-nd/3.0/ for details. lular-mediated autoimmune destruction

S64 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Figure 1dDisorders of glycemia: etiologic types and stages. *Even after presenting in ketoacidosis, these patients can briey 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.

of the b-cells of the pancreas. Markers of C-peptide. Immune-mediated diabetes Type 2 diabetes (ranging from
the immune destruction of the b-cell in- commonly occurs in childhood and ado- predominantly insulin resistance
clude islet cell autoantibodies, autoanti- lescence, but it can occur at any age, even with relative insulin deciency to
bodies to insulin, autoantibodies to GAD in the 8th and 9th decades of life. predominantly an insulin secretory
(GAD65), and autoantibodies to the ty- Autoimmune destruction of b-cells defect with insulin resistance)
rosine phosphatases IA-2 and IA-2b. has multiple genetic predispositions and This form of diabetes, which accounts for
One and usually more of these autoanti- is also related to environmental factors ;9095% of those with diabetes, previ-
bodies are present in 8590% of individ- that are still poorly dened. Although pa- ously referred to as noninsulin-depen-
uals when fasting hyperglycemia is tients are rarely obese when they present dent diabetes, type 2 diabetes, or adult-
initially detected. Also, the disease has with this type of diabetes, the presence of onset diabetes, encompasses individuals
strong HLA associations, with linkage to obesity is not incompatible with the diag- who have insulin resistance and usually
the DQA and DQB genes, and it is inu- nosis. These patients are also prone to have relative (rather than absolute) insu-
enced by the DRB genes. These HLA-DR/ other autoimmune disorders such as lin deciency At least initially, and often
DQ alleles can be either predisposing or Graves disease, Hashimotos thyroiditis, throughout their lifetime, these individu-
protective. Addisons disease, vitiligo, celiac sprue, als do not need insulin treatment to sur-
In this form of diabetes, the rate of autoimmune hepatitis, myasthenia gravis, vive. There are probably many different
b-cell destruction is quite variable, being and pernicious anemia. causes of this form of diabetes. Although
rapid in some individuals (mainly infants Idiopathic diabetes. Some forms of type the specic etiologies are not known, au-
and children) and slow in others (mainly 1 diabetes have no known etiologies. toimmune destruction of b-cells does not
adults). Some patients, particularly chil- Some of these patients have permanent occur, and patients do not have any of the
dren and adolescents, may present with insulinopenia and are prone to ketoaci- other causes of diabetes listed above or
ketoacidosis as the rst manifestation of dosis, but have no evidence of autoim- below.
the disease. Others have modest fasting munity. Although only a minority of Most patients with this form of di-
hyperglycemia that can rapidly change patients with type 1 diabetes fall into abetes are obese, and obesity itself causes
to severe hyperglycemia and/or ketoaci- this category, of those who do, most are of some degree of insulin resistance. Patients
dosis in the presence of infection or other African or Asian ancestry. Individuals who are not obese by traditional weight
stress. Still others, particularly adults, with this form of diabetes suffer from criteria may have an increased percentage
may retain residual b-cell function suf- episodic ketoacidosis and exhibit varying of body fat distributed predominantly in
cient to prevent ketoacidosis for many degrees of insulin deciency between the abdominal region. Ketoacidosis sel-
years; such individuals eventually be- episodes. This form of diabetes is strongly dom occurs spontaneously in this type of
come dependent on insulin for survival inherited, lacks immunological evidence diabetes; when seen, it usually arises in
and are at risk for ketoacidosis. At this for b-cell autoimmunity, and is not HLA association with the stress of another
latter stage of the disease, there is little associated. An absolute requirement for illness such as infection. This form of
or no insulin secretion, as manifested by insulin replacement therapy in affected diabetes frequently goes undiagnosed for
low or undetectable levels of plasma patients may come and go. many years because the hyperglycemia

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S65


Diagnosis and Classication

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

S66 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Table 1dEtiologic classication of diabetes mellitus have HLA and immune markers charac-
teristic of type 1 diabetes. In addition,
I. Type 1 diabetes (b-cell destruction, usually leading to absolute insulin deciency)
A. Immune mediated coxsackievirus B, cytomegalovirus, ade-
B. Idiopathic novirus, and mumps have been impli-
II. Type 2 diabetes (may range from predominantly insulin resistance with relative insulin deciency cated in inducing certain cases of the
to a predominantly secretory defect with insulin resistance) disease.
III. Other specic types
A. Genetic defects of b-cell function
Uncommon forms of immune-mediated
1. Chromosome 12, HNF-1a (MODY3) diabetes. In this category, there are two
2. Chromosome 7, glucokinase (MODY2) known conditions, and others are likely
3. Chromosome 20, HNF-4a (MODY1) to occur. The stiff-man syndrome is an
4. Chromosome 13, insulin promoter factor-1 (IPF-1; MODY4) autoimmune disorder of the central ner-
5. Chromosome 17, HNF-1b (MODY5)
6. Chromosome 2, NeuroD1 (MODY6) vous system characterized by stiffness of
7. Mitochondrial DNA the axial muscles with painful spasms.
8. Others Patients usually have high titers of the
B. Genetic defects in insulin action GAD autoantibodies, and approximately
1. Type A insulin resistance
2. Leprechaunism
one-third will develop diabetes.
3. Rabson-Mendenhall syndrome Anti-insulin receptor antibodies can
4. Lipoatrophic diabetes cause diabetes by binding to the insulin
5. Others receptor, thereby blocking the binding of
C. Diseases of the exocrine pancreas insulin to its receptor in target tissues.
1. Pancreatitis
2. Trauma/pancreatectomy However, in some cases, these antibodies
3. Neoplasia can act as an insulin agonist after binding
4. Cystic brosis to the receptor and can thereby cause
5. Hemochromatosis hypoglycemia. Anti-insulin receptor anti-
6. Fibrocalculous pancreatopathy
7. Others
bodies are occasionally found in patients
D. Endocrinopathies with systemic lupus erythematosus and
1. Acromegaly other autoimmune diseases. As in other
2. Cushings syndrome states of extreme insulin resistance, pa-
3. Glucagonoma tients with anti-insulin receptor antibod-
4. Pheochromocytoma
5. Hyperthyroidism ies often have acanthosis nigricans. In the
6. Somatostatinoma past, this syndrome was termed type B
7. Aldosteronoma insulin resistance.
8. Others Other genetic syndromes sometimes
E. Drug or chemical induced
1. Vacor
associated with diabetes. Many genetic
2. Pentamidine syndromes are accompanied by an in-
3. Nicotinic acid creased incidence of diabetes. These in-
4. Glucocorticoids clude the chromosomal abnormalities of
5. Thyroid hormone Down syndrome, Klinefelter syndrome,
6. Diazoxide
7. b-adrenergic agonists and Turner syndrome. Wolframs syn-
8. Thiazides drome is an autosomal recessive disorder
9. Dilantin characterized by insulin-decient diabe-
10. g-Interferon tes and the absence of b-cells at autopsy.
11. Others
F. Infections
Additional manifestations include diabetes
1. Congenital rubella insipidus, hypogonadism, optic atrophy,
2. Cytomegalovirus and neural deafness. Other syndromes are
3. Others listed in Table 1.
G. Uncommon forms of immune-mediated diabetes
1. Stiff-man syndrome
2. Anti-insulin receptor antibodies Gestational diabetes mellitus
3. Others For many years, GDM has been dened as
H. Other genetic syndromes sometimes associated with diabetes any degree of glucose intolerance with
1. Down syndrome onset or rst recognition during preg-
2. Klinefelter syndrome
3. Turner syndrome
nancy. Although most cases resolve with
4. Wolfram syndrome delivery, the denition applied whether
5. Friedreich ataxia or not the condition persisted after preg-
6. Huntington chorea nancy and did not exclude the possibility
7. Laurence-Moon-Biedl syndrome that unrecognized glucose intolerance
8. Myotonic dystrophy
9. Porphyria may have antedated or begun concomi-
10. Prader-Willi syndrome tantly with the pregnancy. This denition
11. Others facilitated a uniform strategy for detection
IV. Gestational diabetes mellitus and classication of GDM, but its limi-
Patients with any form of diabetes may require insulin treatment at some stage of their disease. Such use of tations were recognized for many years.
insulin does not, of itself, classify the patient. As the ongoing epidemic of obesity and

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Diagnosis and Classication

Table 2dCategories of increased risk for abdominal or visceral obesity), dyslipide- communication). Finally, evidence from
diabetes* mia with high triglycerides and/or low the Diabetes Prevention Program (DPP),
FPG 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9
HDL cholesterol, and hypertension. wherein the mean A1C was 5.9% (SD
mmol/l) [IFG]
Structured lifestyle intervention, aimed 0.5%), indicates that preventive interven-
2-h PG in the 75-g OGTT 140 mg/dl (7.8
at increasing physical activity and pro- tions are effective in groups of people with
mmol/l) to 199 mg/dl (11.0 mmol/l) [IGT]
ducing 510% loss of body weight, and A1C levels both below and above 5.9%
A1C 5.76.4%
certain pharmacological agents have been (9). For these reasons, the most appropri-
demonstrated to prevent or delay the de- ate A1C level above which to initiate pre-
*For all three tests, risk is continuous, extending
below the lower limit of the range and becoming velopment of diabetes in people with IGT; ventive interventions is likely to be
disproportionately greater at higher ends of the the potential impact of such interventions somewhere in the range of 5.56%.
range. to reduce mortality or the incidence of As was the case with FPG and 2-h PG,
cardiovascular disease has not been dem- dening a lower limit of an intermediate
onstrated to date. It should be noted that category of A1C is somewhat arbitrary,
diabetes has led to more type 2 diabetes in the 2003 ADA Expert Committee report as the risk of diabetes with any measure
women of childbearing age, the number of reduced the lower FPG cut point to dene or surrogate of glycemia is a continuum,
pregnant women with undiagnosed type 2 IFG from 110 mg/dl (6.1 mmol/l) to 100 extending well into the normal ranges. To
diabetes has increased. mg/dl (5.6 mmol/l), in part to ensure that maximize equity and efciency of pre-
After deliberations in 20082009, the prevalence of IFG was similar to that of ventive interventions, such an A1C cut
International Association of Diabetes and IGT. However, the World Health Organi- point should balance the costs of false
Pregnancy Study Groups (IADPSG), an zation (WHO) and many other diabetes negatives (failing to identify those who
international consensus group with rep- organizations did not adopt this change in are going to develop diabetes) against
resentatives from multiple obstetrical and the denition 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. Compared to the fasting glucose cut-
natal visit, using standard criteria (Table When recommending the use of the A1C point of 100 mg/dl (5.6 mmol/l), an A1C
3), receive a diagnosis of overt, not gesta- to diagnose diabetes in its 2009 report, cutpoint of 5.7% is less sensitive but more
tional, diabetes. Approximately 7% of all the International Expert Committee (3) specic and has a higher positive predic-
pregnancies (ranging from 1 to 14%, de- stressed the continuum of risk for diabe- tive value to identify people at risk for
pending on the population studied and tes with all glycemic measures and did not later development of diabetes. A large
the diagnostic tests employed) are com- formally identify an equivalent intermedi- prospective study found that a 5.7% cut-
plicated by GDM, resulting in more than ate category for A1C. The group did note point has a sensitivity of 66% and speci-
200,000 cases annually. that those with A1C levels above the lab- city of 88% for the identication of
oratory normal range but below the di- subsequent 6-year diabetes incidence
CATEGORIES OF INCREASED agnostic cut point for diabetes (6.0 to (10). Receiver operating curve analyses
RISK FOR DIABETESdIn 1997 and ,6.5%) are at very high risk of develop- of nationally representative U.S. data
2003, The Expert Committee on Diagno- ing diabetes. Indeed, incidence of diabe- (NHANES 1999-2006) indicate that an
sis and Classication of Diabetes Mellitus tes in people with A1C levels in this range A1C value of 5.7% has modest sensitivity
(1,2) recognized an intermediate group of is more than 10 times that of people with (39-45%) but high specicity (81-91%)
individuals whose glucose levels do not lower levels (47). However, the 6.0 to to identify cases of IFP (FPG .100 mg/
meet criteria for diabetes, yet are higher ,6.5% range fails to identify a substantial dl) (5.6 mmol/l) or IGT (2-h glucose .
than those considered normal. These peo- number of patients who have IFG and/or 140 mg/dl) (R.T. Ackerman, personal
ple were dened as having impaired fast- IGT. Prospective studies indicate that communication). Other analyses suggest
ing glucose (IFG) [fasting plasma glucose people within the A1C range of 5.5 that an A1C of 5.7% is associated with
(FPG) levels 100 mg/dl (5.6 mmol/l) to 6.0% have a 5-year cumulative incidence diabetes risk similar to the high-risk par-
125 mg/dl (6.9 mmol/l)], or impaired glu- of diabetes that ranges from 12 to 25% ticipants in the DPP (R.T. Ackerman, per-
cose tolerance (IGT) [2-h values in the (47), which is appreciably (three- to sonal communication). Hence, it is
oral glucose tolerance test (OGTT) of eightfold) higher than incidence in the reasonable to consider an A1C range of
140 mg/dl (7.8 mmol/l) to 199 mg/dl U.S. population as a whole (8). Analyses 5.7 to 6.4% as identifying individuals
(11.0 mmol/l)]. of nationally representative data from the with high risk for future diabetes and to
Individuals with IFG and/or IGT have National Health and Nutrition Examina- whom the term pre-diabetes may be ap-
been referred to as having pre-diabetes, tion Survey (NHANES) indicate that the plied if desired.
indicating the relatively high risk for the A1C value that most accurately identies Individuals with an A1C of 5.76.4%
future development of diabetes. IFG and people with IFG or IGT falls between 5.5 should be informed of their increased risk
IGT should not be viewed as clinical and 6.0%. In addition, linear regression for diabetes as well as cardiovascular dis-
entities in their own right but rather risk analyses of these data indicate that among ease and counseled about effective strate-
factors for diabetes as well as cardiovas- the nondiabetic adult population, an FPG gies, such as weight loss and physical
cular disease. They can be observed as of 110 mg/dl (6.1 mmol/l) corresponds activity, to lower their risks. As with glu-
intermediate stages in any of the disease to an A1C of 5.6%, while an FPG of 100 cose measurements, the continuum of risk
processes listed in Table 1. IFG and IGT mg/dl (5.6 mmol/l) corresponds to an is curvilinear, so that as A1C rises, the risk
are associated with obesity (especially A1C of 5.4% (R.T. Ackerman, personal of diabetes rises disproportionately.

S68 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

Accordingly, interventions should be Table 3dCriteria for the diagnosis of diabetes


most intensive and follow-up should be A1C $6.5%. The test should be performed in a laboratory using a method that is NGSP certied
particularly vigilant for those with A1C and standardized to the DCCT assay.*
levels above 6.0%, who should be consid- OR
ered to be at very high risk. However, just FPG $126 mg/dl (7.0 mmol/l). Fasting is dened as no caloric intake for at least 8 h.*
as an individual with a fasting glucose of OR
98 mg/dl (5.4 mmol/l) may not be at neg- 2-h plasma glucose $200 mg/dl (11.1 mmol/l) during an OGTT. The test should be performed as
ligible risk for diabetes, individuals with described by the World Health Organization, using a glucose load containing the equivalent of
A1C levels below 5.7% may still be at 75 g anhydrous glucose dissolved in water.*
risk, depending on level of A1C and pres- OR
ence of other risk factors, such as obesity In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma
and family history. glucose $200 mg/dl (11.1 mmol/l).
Table 2 summarizes the categories of
*In the absence of unequivocal hyperglycemia, criteria 13 should be conrmed by repeat testing.
increased risk for diabetes. Evaluation of
patients at risk should incorporate a
global risk factor assessment for both di- microvascular and, to a lesser extent, glucose in certain individuals. In addi-
abetes and cardiovascular disease. Screen- macrovascular complications and is tion, the A1C can be misleading in pa-
ing for and counseling about risk of widely used as the standard biomarker tients with certain forms of anemia and
diabetes should always be in the prag- for the adequacy of glycemic manage- hemoglobinopathies, which may also
matic context of the patients comorbidi- ment. Prior Expert Committees have not have unique ethnic or geographic distri-
ties, life expectancy, personal capacity to recommended use of the A1C for diag- butions. For patients with a hemoglobin-
engage in lifestyle change, and overall nosis of diabetes, in part due to lack of opathy but normal red cell turnover, such
health goals. standardization of the assay. However, as sickle cell trait, an A1C assay without
A1C assays are now highly standardized interference from abnormal hemoglobins
DIAGNOSTIC CRITERIA FOR so that their results can be uniformly should be used (an updated list is avail-
DIABETES MELLITUSdFor deca- applied both temporally and across pop- able at www.ngsp.org/prog/index3.
des, the diagnosis of diabetes has been ulations. In their recent report (3), an In- html). For conditions with abnormal red
based on glucose criteria, either the FPG ternational Expert Committee, after an cell turnover, such as anemias from he-
or the 75-g OGTT. In 1997, the rst extensive review of both established and molysis and iron deciency, the diagnosis
Expert Committee on the Diagnosis and emerging epidemiological evidence, rec- of diabetes must employ glucose criteria
Classication of Diabetes Mellitus revised ommended the use of the A1C test to di- exclusively.
the diagnostic criteria, using the observed agnose diabetes, with a threshold of The established glucose criteria for
association between FPG levels and pres- $6.5%, and ADA afrms this decision. the diagnosis of diabetes remain valid.
ence of retinopathy as the key factor with The diagnostic A1C cut point of 6.5% is These include the FPG and 2-h PG.
which to identify threshold glucose level. associated with an inection point for ret- Additionally, patients with severe hyper-
The Committee examined data from three inopathy prevalence, as are the diagnostic glycemia such as those who present with
cross-sectional epidemiologic studies that thresholds for FPG and 2-h PG (3). The severe classic hyperglycemic symptoms
assessed retinopathy with fundus pho- diagnostic test should be performed or hyperglycemic crisis can continue to be
tography or direct ophthalmoscopy and using a method that is certied by the Na- diagnosed when a random (or casual)
measured glycemia as FPG, 2-h PG, and tional Glycohemoglobin Standardization plasma glucose of $200 mg/dl (11.1
A1C. These studies demonstrated glyce- Program (NGSP) and standardized or mmol/l) is found. It is likely that in such
mic levels below which there was little traceable to the Diabetes Control and cases the health care professional would
prevalent retinopathy and above which Complications Trial reference assay. also measure an A1C test as part of the
the prevalence of retinopathy increased in Point-of-care A1C assays are not suf- initial assessment of the severity of the di-
an apparently linear fashion. The deciles ciently accurate at this time to use for di- abetes and that it would (in most cases) be
of the three measures at which retinopa- agnostic purposes. above the diagnostic cut point for diabe-
thy began to increase were the same for There is an inherent logic to using a tes. However, in rapidly evolving diabe-
each measure within each population. more chronic versus an acute marker of tes, such as the development of type 1
Moreover, the glycemic values above dysglycemia, particularly since the A1C is diabetes in some children, A1C may not
which retinopathy increased were similar already widely familiar to clinicians as a be signicantly elevated despite frank
among the populations. These analyses marker of glycemic control. Moreover, diabetes.
helped to inform a new diagnostic cut the A1C has several advantages to the Just as there is less than 100% con-
point of $126 mg/dl (7.0 mmol/l) for FPG, including greater convenience, cordance between the FPG and 2-h PG
FPG and conrmed the long-standing di- since fasting is not required, evidence to tests, there is not full concordance be-
agnostic 2-h PG value of $200 mg/dl suggest greater preanalytical stability, and tween A1C and either glucose-based
(11.1 mmol/l). less day-to-day perturbations during pe- test. Analyses of NHANES data indicate
A1C is a widely used marker of riods of stress and illness. These advan- that, assuming universal screening of the
chronic glycemia, reecting average tages, however, must be balanced by undiagnosed, the A1C cut point of
blood glucose levels over a 2- to 3-month greater cost, the limited availability of $6.5% identies one-third fewer cases
period of time. The test plays a critical role A1C testing in certain regions of the of undiagnosed diabetes than a fasting
in the management of the patient with developing world, and the incomplete glucose cut point of $126 mg/dl (7.0
diabetes, since it correlates well with both correlation between A1C and average mmol/l) (cdc website tbd). However, in

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S69


Diagnosis and Classication

practice, a large portion of the population that when a test whose result was above Table 4dScreening for and diagnosis of
with type 2 diabetes remains unaware of the diagnostic threshold is repeated, the GDM
their condition. Thus, it is conceivable second value will be below the diagnostic Perform a 75-g OGTT, with plasma glucose
that the lower sensitivity of A1C at the cut point. This is least likely for A1C, measurement fasting and at 1 and 2 h, at
designated cut point will be offset by the somewhat more likely for FPG, and most 24-28 of weeks gestation in women not
tests greater practicality, and that wider likely for the 2-h PG. Barring a laboratory previously diagnosed with overt diabetes.
application of a more convenient test error, such patients are likely to have test The OGTT should be performed in the
(A1C) may actually increase the number results near the margins of the threshold morning after an overnight fast of at least
of diagnoses made. for a diagnosis. The healthcare profes- 8 h.
Further research is needed to better sional might opt to follow the patient The diagnosis of GDM is made when any of the
characterize those patients whose glyce- closely and repeat the testing in 36 following plasma glucose values are
mic status might be categorized differ- months. exceeded
ently by two different tests (e.g., FPG and The decision about which test to use c Fasting: $92 mg/dl (5.1 mmol/l)
A1C), obtained in close temporal approx- to assess a specic patient for diabetes c 1 h: $180 mg/dl (10.0 mmol/l)
imation. Such discordance may arise from should be at the discretion of the health c 2 h: $153 mg/dl (8.5 mmol/l)
measurement variability, change over care professional, taking into account the
time, or because A1C, FPG, and post- availability and practicality of testing an
challenge glucose each measure different individual patient or groups of patients.
physiological processes. In the setting of Perhaps more important than which di- These new criteria will signicantly
an elevated A1C but nondiabetic FPG, agnostic test is used, is that the testing for increase the prevalence of GDM, primar-
the likelihood of greater postprandial glu- diabetes be performed when indicated. ily because only one abnormal value, not
cose levels or increased glycation rates There is discouraging evidence indicating two, is sufcient to make the diagnosis.
for a given degree of hyperglycemia may that many at-risk patients still do not re- The ADA recognizes the anticipated sig-
be present. In the opposite scenario (high ceive adequate testing and counseling for nicant increase in the incidence of GDM
FPG yet A1C below the diabetes cut this increasingly common disease, or for its to be diagnosed by these criteria and is
point), augmented hepatic glucose pro- frequently accompanying cardiovascular sensitive to concerns about the medical-
duction or reduced glycation rates may risk factors. The current diagnostic criteria ization of pregnancies previously catego-
be present. for diabetes are summarized in Table 3. rized as normal. These diagnostic criteria
As with most diagnostic tests, a test changes are being made in the context of
result diagnostic of diabetes should be Diagnosis of gestational diabetes worrisome worldwide increases in obe-
repeated to rule out laboratory error, GDM carries risks for the mother and sity and diabetes rates, with the intent of
unless the diagnosis is clear on clinical neonate. The Hyperglycemia and Adverse optimizing gestational outcomes for
grounds, such as a patient with classic Pregnancy Outcomes (HAPO) study women and their babies.
symptoms of hyperglycemia or hypergly- (11), a large-scale (;25,000 pregnant Admittedly, there are few data from
cemic crisis. It is preferable that the same women) multinational epidemiologic randomized clinical trials regarding ther-
test be repeated for conrmation, since study, demonstrated that risk of adverse apeutic interventions in women who will
there will be a greater likelihood of con- maternal, fetal, and neonatal outcomes now be diagnosed with GDM based on
currence in this case. For example, if the continuously increased as a function of only one blood glucose value above the
A1C is 7.0% and a repeat result is 6.8%, maternal glycemia at 24-28 weeks, even specied cutpoints (in contrast to the
the diagnosis of diabetes is conrmed. within ranges previously considered nor- older criteria that stipulated at least two
However, there are scenarios in which re- mal for pregnancy. For most complica- abnormal values). Expected benets to
sults of two different tests (e.g., FPG and tions, there was no threshold for risk. their pregnancies and offspring is inferred
A1C) are available for the same patient. In These results have led to careful reconsid- from intervention trials that focused on
this situation, if the two different tests are eration of the diagnostic criteria for GDM. women with more mild hyperglycemia
both above the diagnostic thresholds, the After deliberations in 2008-2009, the than identied using older GDM diag-
diagnosis of diabetes is conrmed. IADPSG, an international consensus nostic criteria and that found modest
On the other hand, when two differ- group with representatives from multiple benets (13,14). The frequency of their
ent tests are available in an individual and obstetrical and diabetes organizations, in- follow-up and blood glucose monitoring
the results are discordant, the test whose cluding ADA, developed revised recom- is not yet clear but likely to be less inten-
result is above the diagnostic cut point mendations for diagnosing GDM. The sive than women diagnosed by the older
should be repeated, and the diagnosis is group recommended that all women not criteria. Additional well-designed clinical
made on the basis of the conrmed test. known to have diabetes undergo a 75-g studies are needed to determine the op-
That is, if a patient meets the diabetes OGTT at 24-28 weeks of gestation. Addi- timal intensity of monitoring and treat-
criterion of the A1C (two results $6.5%) tionally, the group developed diagnostic ment of women with GDM diagnosed
but not the FPG (,126 mg/dl or 7.0 cutpoints for the fasting, 1-h, and 2-h by the new criteria (that would not
mmol/l), or vice versa, that person should plasma glucose measurements that con- have met the prior denition of GDM).
be considered to have diabetes. Admit- veyed an odds ratio for adverse outcomes It is important to note that 80-90% of
tedly, in most circumstance the nondia- of at least 1.75 compared with women women in both of the mild GDM studies
betic test is likely to be in a range very with mean glucose levels in the HAPO (whose glucose values overlapped with
close to the threshold that denes diabetes. study. Current screening and diagnostic the thresholds recommended herein)
Since there is preanalytic and analytic strategies, based on the IADPSG state- could be managed with lifestyle therapy
variability of all the tests, it is also possible ment (12), are outlined in Table 4. alone.

S70 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

6. Sato KK, Hayashi T, Harita N, Yoneda T, Resistance Syndrome (DESIR) Diabetes


References Nakamura Y, Endo G, Kambe H. Com- Care 2006;29:16191625.
1. Expert Committee on the Diagnosis and bined measurement of fasting plasma 11. Metzger BE, Lowe LP, Dyer AR, Trimble
Classication of Diabetes Mellitus. Report glucose and A1C is effective for the pre- ER, Chaovarindr U, Coustan DR, Hadden
of the Expert Committee on the Diagnosis DR, McCance DR, Hod M, McIntyre HD,
diction of type 2 diabetes: the Kansai
and Classication of Diabetes Mellitus.
Healthcare Study. Diabetes Care 2009;32: Oats JJ, Persson B, Rogers MS, Sacks DA.
Diabetes Care 1997;20:11831197
644646 Hyperglycemia and adverse pregnancy
2. Genuth S, Alberti KG, Bennett P, Buse J,
7. Shimazaki T, Kadowaki T, Ohyama Y, outcomes. N Engl J Med 2008;358:1991
Defronzo R, Kahn R, Kitzmiller J, Knowler
Ohe K, Kubota K. Hemoglobin A1c 2002
WC, Lebovitz H, Lernmark A, Nathan D,
(HbA1c) predicts future drug treatment 12. Metzger BE, Gabbe SG, Persson B,
Palmer J, Rizza R, Saudek C, Shaw J,
Steffes M, Stern M, Tuomilehto J, Zimmet for diabetes mellitus: a follow-up study Buchanan TA, Catalano PA, Damm P,
P, Expert Committee on the Diagnosis and using routine clinical data in a Japanese Dyer AR, Leiva A, Hod M, Kitzmiler JL,
Classication of Diabetes Mellitus2, the university hospital. Translational Re- Lowe LP, McIntyre HD, Oats JJ, Omori Y,
Expert Committee on the Diagnosis and search 2007;149:196204 Schmidt MI. International Association of
Classication of Diabetes Mellitus. Fol- 8. Geiss LS, Pan L, Cadwell B, Gregg EW, Diabetes and Pregnancy Study Groups
low-up report on the diagnosis of diabetes Benjamin SM, Engelgau MM. Changes in recommendations on the diagnosis and
mellitus. Diabetes Care 2003;26:3160 incidence of diabetes in U.S. adults, classication of hyperglycemia in preg-
3167 19972003. Am J Prev Med 2006;30: nancy. Diabetes Care 2010;33:676682
3. International Expert Committee. Inter- 371377 13. Landon MB, Spong CY, Thom E,
national Expert Committee report on the 9. Knowler WC, Barrett-Connor E, Fowler Carpenter MW, Ramin SM, Casey B,
role of the A1C assay in the diagnosis of SE, Hamman RF, Lachin JM, Walker EA, Wapner RJ, Varner MW, Rouse DJ, Thorp
diabetes. Diabetes Care 2009;32:1327 Nathan DM, Diabetes Prevention Program JM, Jr., Sciscione A, Catalano P, Harper M,
1334 Research Group. Reduction in the in- Saade G, Lain KY, Sorokin Y, Peaceman
4. Edelman D, Olsen MK, Dudley TK, Harris cidence of type 2 diabetes with lifestyle AM, Tolosa JE, Anderson GB. A multi-
AC, Oddone EZ. Utility of hemoglobin intervention or metformin. N Engl J Med center, randomized trial of treatment for
A1c in predicting diabetes risk. J Gen In- 2002;346:393403 mild gestational diabetes. N Engl J Med
tern Med 2004;19:11751180 10. Droumaguet C, Balkau B, Simon D, Caces 2009;361:13391348
5. Pradhan AD, Rifai N, Buring JE, Ridker E, Tichet J, Charles MA, Eschwege E, the 14. Crowther CA, Hiller JE, Moss JR, McPhee
PM. Hemoglobin A1c predicts diabetes DESIR Study Group. Use of HbA1c in AJ, Jeffries WS, Robinson JS. Effect of
but not cardiovascular disease in non- predicting progression to diabetes in treatment of gestational diabetes mellitus
diabetic women. Am J Med 2007;120: French men and women: data from an on pregnancy outcomes. N Engl J Med
720727 Epidemiological Study on the Insulin 2005;352:24772486

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S71


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

Diabetes Management at Camps for


Children With Diabetes
AMERICAN DIABETES ASSOCIATION schedule changes (such as for rainy
weather) can have a signicant impact
on the risk of hypoglycemia as insulin
dosing at the previous meal takes into ac-

S
ince Leonard F.C. Wendt, MD, with respect to the prevention and man- count the planned activities. If a low-,
opened the doors of the rst di- agement of hypoglycemia (5). moderate-, or high-level activity event is
abetes camp in Michigan in 1925, Each camper should have a standard- originally planned, a replacement activity
the concept of specialized residential and ized comprehensive health history form with an equivalent activity level should
day camps for children with diabetes has completed by his/her family and a health be substituted when possible.
become widespread throughout the U.S. evaluation form (6) completed by the di- To ensure safety and optimal diabetes
and many other parts of the world. In abetes care provider that details the camp- management, blood glucose testing ma-
2011, approximately 30,000 children at- ers past medical history, immunization terials and treatment supplies for hypo-
tended diabetes camps in North America record, and diabetes regimen. The home glycemia should be readily available to
and over 16,000 more campers partici- insulin regimen should be recorded for campers at all times. Multiple blood
pated in one of the 180 diabetes camps each camper, including type(s) of insulin glucose determinations should be made
throughout the rest of the world. used, number and timing of insulin injec- and recorded throughout each 24-h pe-
The mission of camps specialized for tions (if on shots), and insulin pump riod: before meals; at bedtime; before, af-
children and youth with diabetes is to basal, bolus, and correction dose settings ter, or during prolonged and strenuous
facilitate a traditional camping experience (if on an insulin pump). Records for in- activity; in the middle of the night, when
in a medically safe environment. An sulin dosages and blood glucose values indicated for prior hypoglycemia; after an
equally important goal is to enable chil- for the week immediately before camp insulin pump site change; and after extra
dren with diabetes to meet and share their should be provided as a baseline. Addi- doses of insulin. Use of a continuous
experiences with one another while they tional medical information, such as prior glucose monitoring system (CGMS) does
learn to be more responsible for their con- diabetes-related illnesses and hospitaliza- not preclude the need to test nger-stick
dition. For this to occur, a skilled medical tions, history of severe hypoglycemia, blood glucose.
and camping staff must be available to previous hemoglobin A1C levels, other Because exercise may still impact
ensure optimal safety and an integrated medications, signicant medical con- blood glucose 1218 h after completion,
camping/educational experience. ditions, and psychological issues also campers who have repeated lows during
The recommendations for diabetes should be available to camp personnel exercise may also need nocturnal testing.
management of children at a diabetes and reviewed with diligence by those re- Campers with a bedtime blood glucose
camp are not signicantly different from sponsible for the health and well-being of level ,100 mg/dL and campers on an in-
what has been outlined by the American the individual camper. sulin pump with a blood glucose .240
Diabetes Association (the Association) as During camp, a record of the campers mg/dL should have their blood glucose
the standards of care for people with type diabetes care progress should be docu- rechecked overnight. The intervention
1 diabetes (1) or for children with diabe- mented daily. All blood glucose values for campers with an overnight blood glu-
tes in the school or day care setting (2). In and insulin dosages should be recorded cose level ,100 mg/dL should be deter-
general, the diabetes camping experience in a format that allows for review and anal- mined based on their insulin regimen and
is short term and is most often associated ysis to determine whether alterations in risk for nocturnal hypoglycemia. Camp-
with increased physical activity and more the diabetes regimen are required during ers on insulin pumps with a blood glucose
controlled access to food relative to that the camp stay. A record of the degree of .240 mg/dL should follow an estab-
experienced at home. Thus, while away at activity and food intake may also be helpful lished pump protocol for ketone testing
camp, glycemic control goals are more re- in determining subsequent alterations in and changing of the insulin pump site.
lated to avoiding blood glucose extremes the diabetes regimen. It is imperative Campers should be encouraged to check
than optimizing overall glycemic control that the medical staff have advanced blood glucose levels at times other than
(3,4). The management protocol aims to bal- knowledge about the exercise schedule the routine times if they have symptoms
ance insulin dosage with activity level and and the meal plan at camp so that they of hypo-/hyperglycemia or if they have
food intake so that blood glucose levels can make appropriate insulin dosage ad- other physical complaints. These recom-
stay within a safe target range, especially justments. Inadvertent schedule delays or
mendations imply that there is adequate
stafng and that they have received training
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c in blood glucose monitoring procedures as
This updated position statement was peer reviewed by the Professional Practice Committee in September, well as the indications and treatment pro-
2011, and approved by the Executive Committee of the American Diabetes Association in November, 2011. tocols for hypo-/hyperglycemic events.
DOI: 10.2337/dc12-s072
2012 by the American Diabetes Association. Readers may use this article as long as the work is properly Every attempt should be made to
cited, the use is educational and not for prot, and the work is not altered. See http://creativecommons.org/ follow the home insulin regimen of each
licenses/by-nc-nd/3.0/ for details. camper as closely as possible. If a campers

S72 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

blood glucose record prior to camp indi- incidence of celiac disease in the diabetic on the surface of the meter (7). If blood
cates tight glucose control and a low ac- population. Snacks between meals may be glucose meters must be shared, the device
tivity level, it may be advisable to decrease appropriate to prevent hypoglycemia, es- must be cleaned and disinfected after every
the insulin dosage in anticipation of the pecially in the youngest campers who may use, per the manufacturer instructions, to
increased activity. Supervision of each not recognize their hypoglycemic symp- prevent potential cross contamination of
and every insulin administration is im- toms. These meals and snacks should be infectious agents. Glucose meters should
portant to ensure camper safety and com- balanced, and their composition (speci- be calibrated regularly using control solu-
pliance with the prescribed insulin dose. cally the carbohydrate content) should be tion to verify accuracy (frequency should
Hypoglycemia may occur at the begin- made known to campers and staff. Car- be per the manufacturer instructions).
ning of camp because of increased phys- bohydrate counting is optimally presented
ical activity, failure to have free access to in grams and should be as exact as possible MEDICAL STAFF
food, or other conditions such as a major (not rounded to the nearest complete COMPOSITION AND
change in altitude. Other alterations in in- serving or 15 g). The carbohydrate com- STAFF TRAININGdIt is imperative
sulin dosage may need to be made for ex- ponent of food should be taught to camp- that each camp have a medical director
treme physical activity, such as prolonged ers, according to their developmental who is a physician with expertise in man-
hikes or active water sports. level, to enable them to learn how to aging type 1 and type 2 diabetes. The
A rising percentage (and often a ma- balance food and activity. Supervision of medical director or his/her on-site licensed
jority) of children at camp manage their the food intake of children by counselors designee ultimately is responsible for the
diabetes with an insulin pump, with al- ensures that the campers are consuming daily review of blood glucose results, in-
most all of the remaining children on a adequate nutrition. sulin logs, and other prescribed medica-
subcutaneous basal/bolus insulin regimen. A formal relationship with a nearby tions of all campers and staff with diabetes
The camp medical director and other medical facility should be secured for each to make appropriate adjustments. The
appropriate camp staff should be familiar camp so that camp medical staff has the medical director or the on-site licensed
with the programming of insulin pumps, ability to refer to this facility for prompt designee also is responsible for providing
the replacement of insulin pump infusion treatment of medical emergencies. (The guidance in all medical emergencies and
sets, and insulin adjustments using a American Camp Association requires the should ensure that the medical program is
basal/bolus insulin regimen or an insulin notication of all emergency medical sup- integrated into the overall camping expe-
pump. The medical staff should ensure port systems local to the camp.) If the camp rience. One licensed physician must be on
that adequate backup pump supplies, in- is located in a remote area, an arrangement site at all times for resident camp programs
cluding extra batteries, reservoirs, and should be made with a medical helicopter and available on call at all times for a day
catheter sets, are available for the duration or xed-wing aircraft to provide rapid camp program.
of camp. transport if necessary. The medical staff can be comprised
If major alterations of a campers reg- Universal precautions including Oc- of licensed healthcare professionals and
imen appear to be indicated, such as add- cupational Safety & Health Association nonhealthcare professionals with an in-
ing an additional insulin injection(s) or (OSHA) regulations, Clinical Laboratory terest in diabetes. Physicians, medical
changing an insulin type, it is important Improvement Amendments (CLIA) residents, midlevel providers (physician
to discuss this with the camper and the standards, and state regulations must be assistants and advanced practice nurses),
family in addition to the childs local di- followed by all, with gloves worn for all diabetes educators, pharmacists, and
abetes care provider before the change is procedures that involve blood draws and nurses should also be encouraged to
made. A record of the blood glucose val- appropriate containers placed throughout participate. In addition, registered dieti-
ues, insulin doses, and other medical care the camp to dispose of sharps without tians with expertise in diabetes should
provided at camp, with an additional hazard. Retractable single-use lancets and have input into the design of the menu
copy for the family to share with their pri- glucose meters in which blood does not and the education program. It is benecial
mary diabetes team (if they choose), touch the machine itself are preferable to include some medical, nursing, phar-
should be available to (and discussed for group testing. No lancing device that macy, physician assistant, nurse practi-
with) the family at the end of camp. For can be reset and used again should be tioner, and dietetic students as volunteer
campers returning home by bus or car- available to campers. Retractable insulin counselors or junior medical staff to learn
pool, the record should be sent with the syringe/pen needles may be considered to about diabetes as well as the needs of
camper or mailed to his/her family. Pa- further reduce the risk of needle sticks children with a chronic disease.
rents and campers should be advised to among campers and staff. Insulin pens All camp staff, including medical,
return to their precamp regimen once are for single person use and should never nursing, nutrition, and other volunteer or
they are home, unless the alterations ap- be shared between two individuals. Care paid staff, should undergo background
pear to signicantly improve glycemic should also be taken to ensure that insulin checks to ensure the appropriateness of their
control. In this circumstance, the family pumps are individually labeled so that working with children. All staff should re-
should seek the guidance of its primary when they are disconnected (for swim- ceive training concerning routine diabetes
diabetes team. ming or bathing), the proper pump is re- management, issues related to lifestyle
Dietary planning at camp should be connected to the proper camper to prevent modication for type 2 diabetes, and the
overseen by a registered dietitian. Meals uid contamination and improper insulin treatment of diabetes-related emergen-
should be given at set times each day and administration. Whenever possible, blood cies (hypoglycemia or ketosis) before
should accommodate special dietary glucose meters should be assigned to an camp begins. Camp policies and job de-
needs, when needed, especially those re- individual person due to the risk of blood- scriptions for staff should be understood
lated to food allergies and the increasing borne pathogen contamination from blood and available in print before the start of

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S73


American Diabetes Association

camp. All camp staff should be familiar insulin should be given to reverse ketosis. Guide Modules (9) includes a variety of
with the signs and symptoms of hypo-/ A ow sheet should be produced to doc- resources including sample policies, job
hyperglycemia, indications for blood ument the progress of the treatment reg- descriptions, and medical forms.
glucose testing, and treatment of hypogly- imen. Referral to an appropriate medical
cemia, including the administration of facility is required if vomiting and ketosis DIABETES EDUCATION AND
glucagon to treat severe hypoglycemia do not resolve promptly. PSYCHOLOGICAL ISSUESdThe
(5,8). Competency testing of these skills camp setting is an ideal place for teaching
for staff medically responsible for the WRITTEN CAMP diabetes self-management skills. Educa-
campers is strongly suggested. All diabetes MANAGEMENT PLANdA written tion programs should be developmentally
supplies should be monitored and distrib- plan that includes camp policies and appropriate. Examples of educational top-
uted by responsible medical staff. medical management procedures must ics suitable for the camp setting include:
Reliable communication methods to be available at camp. It should be written
allow contact with on-site medical staff or reviewed by the camp medical director c Blood glucose monitoring
should exist in every activity area. Supplies in collaboration with others, such as the c Recognition and management of hypo-
for routine rst aid and for the treatment camp program director, members of the /hyperglycemia and ketosis
of intercurrent illnesses, such as allergies, camp oversight and/or policy commit- c Insulin types and administration tech-
asthma, sore throats, diarrhea/vomiting, tees, local pediatric endocrinologists and niques
and minor trauma, should be available. diabetes educators, etc. The plan must c Carbohydrate counting
All medical treatment should be recorded adhere to the American Diabetes Associ- c Insulin dosage adjustment based on nu-
in both the campers le and in the yearly ations standards of medical care and the trition and activity schedules
camp medical log. American Camp Association accredita- c Insulin pump trouble shooting and
tion standards. All medical staff should problem solving
TREATMENT OF DIABETES- review this management plan before c The importance of diabetes control
RELATED EMERGENCIES camp begins. c Healthy lifestyles issues, including in-
The written medical management plan tegration of healthy eating, physical ac-
Hypoglycemia should include information about: tivity, and relaxation
Glucagon or intravenous glucose solu- c Problem-solving skills for caring for
tions must be available for administration c General diabetes management diabetes at home versus camp
by trained camp personnel for treatment c Insulin injections/pump therapy c Life skills for independent living
of severe hypoglycemia. All possible c Blood glucose monitoring and ketone c Stress management and coping skills
measures should be taken to avert severe testing c Sexual health and preconception issues
hypoglycemia. These measures may in- c Nutrition, timing, and content of meals c Diabetes complications
clude nighttime blood glucose testing, and snacks c New therapies including technologies
decreasing insulin dosages for extreme c Routine and special activities
activity, and altering insulin regimens for c Hypoglycemia and treatment Medical personnel with the aid of
campers with prior severe hypoglycemia. c Hyperglycemia/ketosis and treatment on-site psychologists/social workers, if
Extra snacks should be provided to chil- c Medical forms available, should aim to improve the psy-
dren with blood glucose levels ,100 mg/dL c Assessment and treatment of intercur- chological well-being of campers. These
at bedtime. Additional snacks or modi- rent illness staff members should be willing to address
cations of insulin for children with blood c Pharmacy compendium specic and general psychosocial issues
glucose levels ,80 mg/dL should also be c Universal precautions and policies for and be able to offer suggestions for sub-
considered. needle sticks and handling of infectious sequent follow-up if indicated. Individu-
A set protocol for the treatment of waste alized attention may be needed for campers
mild-to-moderate hypoglycemia with c Psychological issues at camp with type 2 versus type 1 diabetes.
oral glucose at other times should be c Quality control of medical equipment
followed so that hypoglycemia is consis- according to OSHA and CLIA stand- RESEARCH AT CAMPdClinical re-
tently managed. Repeat blood glucose ards search is often performed and encouraged
testing should be performed within 15 c Incident/accident reporting at diabetes camps. However, if such proj-
20 min to ensure resolution of hypogly- c When to notify parents/guardians, pri- ects are to be done, they must not in-
cemia. mary care physician, and diabetes care terfere with the integrity of the camping
provider program. All research conducted in the
Ketosis c Policies for camp closure and returning camp setting should be minimally inva-
It may be possible to treat mild-to- home sive to the camping experience. All stud-
moderate diabetic ketosis at camp. Urine ies should be approved by an institutional
or blood should be measured for the In addition, camp policies should review board in good standing and by the
presence of ketones if a camper has per- cover emergency procedures (e.g., medi- camp medical and program director be-
sistent hyperglycemia (blood glucose cal and natural disasters), out-of-camp fore the camping session. Parents and
level .240 mg/dL [13.3 mmol/l]) or if a excursions, and the prevention of physi- campers must be provided the consent
camper has an intercurrent illness, re- cal, sexual, and psychological abuse. A form, a summary/synopsis of the research
gardless of blood glucose level. Oral or risk management plan should also be protocol, and the ability to contact the
intravenous hydration (if vomiting) developed and understood by all camp principal investigator before consenting to
should be administered, and adequate staff. The ADAs Camp Implementation enter the research study. Informed consent

S74 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

from parents or guardians and assent from an environment where the norm is to have treatment of diabetes on the development
the camper must be obtained, preferably diabetes. Providing high-standard diabe- and progression of long-term complica-
before arrival at camp. tes care is imperative to maximize the tions in insulin-dependent diabetes melli-
experience offered by camps specialized tus. N Engl J Med 1993;329:977986
OTHERdAt times, industries related to for children with diabetes. Using the 4. Diabetes Control and Complications Trial
diabetes may wish to have a presence at Research Group. Effect of intensive diabetes
active camping environment as a teaching
camp. Camp medical staff and adminis- treatment on the development and pro-
opportunity is an invaluable way for gression of long-term complications in ado-
trative personnel should develop policies children with diabetes to gain skills in
for visits from industries while camp is in lescents with insulin-dependent diabetes
managing their disease within the sup- mellitus: Diabetes Control and Complica-
session. Industry representatives seeking portive camp community. tions Trial. J Pediatr 1994;125:177188
to have a presence at camp should be 5. Cryer PE, Davis SN, Shamoon H. Hypo-
subject to the same background checks glycemia in diabetes. Diabetes Care 2003;
and standards outlined by the Association. AcknowledgmentsdThe original version of 26:19021912
Employees of industries should be en- this Position Statement was prepared by Fran- 6. American Academy of Pediatrics Commit-
couraged to participate at camp for their cine Kaufman, MD, Desmond Schatz, MD, and tee on School Health; American Academy
expertise, ability to educate others, and Janet Silverstein, MD, and approved in 1998. of Pediatrics Section on School Health.
added resources, while understanding The current revision was prepared by Lowell Health appraisal guidelines for day camps
that their role is to support the experience Schmeltz, MD, with contribution from Russ and resident camps. Pediatrics 2005;115:
of the campers rather than to solicit or Kolski, RN, Chair, and other members of the 17701773
ADA National Camp and Youth Subcommittee. 7. Centers for Disease Control. Infection pre-
promote their individual product.
vention during blood glucose monitor-
CONCLUSIONSdCamps for chil- ing and insulin administration [article
dren and youth focused on diabetes are References online]. Available from http://www.cdc.gov/
invaluable. Most camps have a high re- 1. American Diabetes Association: Standards injectionsafety/blood-glucose-monitoring.
of medical care in diabetesd2012 (Position html. Accessed 7 August 2011.
turn rate for campers, many of whom go
Statement). Diabetes Care 2012;35(Suppl. 8. American Diabetes Association. Medical
on to become counselors, medical pro- 1):S11S63 Management of Type 1 Diabetes. 4th ed.
fessionals, staff, and role models for 2. American Diabetes Association. Diabetes Alexandria, VA, American Diabetes Associ-
campers. Thus, it is reasonable to assume care in the school and day care setting. Di- ation, 2008
that they have beneted not only from the abetes Care 2012;35(Suppl. 1):S76S80 9. American Diabetes Association. Camp Im-
camp experience but also from the friend- 3. The Diabetes Control and Complications plementation Guide Modules. Alexandria,
ships that have developed from being in Trial Research Group. The effect of intensive VA, American Diabetes Association, 2005

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S75


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 emergencies (3,18,19,20,34,36). Knowl-
chronic diseases of childhood (1). activities (8,9). edgeable trained personnel are essential
There are ;215,000 individu- Despite these protections, children in if the student is to avoid the immediate
als ,20 years of age with diabetes in the school and day care setting still face health risks of low blood glucose and to
the U.S. (2). The majority of these young discrimination. For example, some day achieve the metabolic control required to
people attend school and/or some type care centers may refuse admission to decrease risks for later development of di-
of day care and need knowledgeable children with diabetes, and children in abetes complications (3,20). Studies have
staff to provide a safe school environ- the classroom may not be provided the shown that the majority of school person-
ment. Both parents and the health care assistance necessary to monitor blood nel have an inadequate understanding of
team should work together to provide glucose and administer insulin and may diabetes (21,22). Consequently, diabetes
school systems and day care providers be prohibited from eating needed snacks. education must be targeted toward day
with the information necessary to allow The American Diabetes Association works care providers, teachers, and other school
children with diabetes to participate to ensure the safe and fair treatment of personnel who interact with the child, in-
fully and safely in the school experience children with diabetes in the school and cluding school administrators, school
(3,4). day care setting (1015) (www.diabetes. nurses, coaches, health aides, bus drivers,
org/schooldiscrimination). secretaries, etc. (3,20). Current recom-
DIABETES AND mendations and up-to-date resources re-
THE LAWdFederal laws that protect Diabetes care in schools garding appropriate care for children with
children with diabetes include Section Appropriate diabetes care in the school diabetes in the school are universally avail-
504 of the Rehabilitation Act of 1973 and day care setting is necessary for the able to all school personnel (3,23).
(5), the Individuals with Disabilities Edu- childs immediate safety, long-term well The purpose of this position statement
cation Act (originally the Education for being, and optimal academic perfor- is to provide recommendations for the
All Handicapped Children Act of 1975) mance. The Diabetes Control and Com- management of children with diabetes in
(6), and the Americans with Disabilities plications Trial showed a signicant link the school and day care setting.
Act (7). Under these laws, diabetes has between blood glucose control and later
been considered to be a disability, and it development of diabetes complications,
is illegal for schools and/or day care cen- with improved glycemic control decreas-
ters to discriminate against children with ing the risk of these complications
disabilities. In addition, any school that (16,17). To achieve glycemic control, a GENERAL GUIDELINES FOR
receives federal funding or any facility child must check blood glucose fre- THE CARE OF THE CHILD IN
considered open to the public must rea- quently, monitor food intake, take medi- THE SCHOOL AND DAY CARE
sonably accommodate the special needs cations, and engage in regular physical SETTING
of children with diabetes. Indeed, federal activity. Insulin is usually taken in multi-
I. Diabetes medical management
law requires an individualized assessment ple daily injections or through an infusion
of any child with diabetes. The required pump. Crucial to achieving glycemic con- plan
An individualized Diabetes Medical Man-
accommodations should be documented trol is an understanding of the effects of
agement Plan (DMMP) should be devel-
in a written plan developed under the ap- physical activity, nutrition therapy, and
oped by the students personal diabetes
plicable federal law such as a Section 504 insulin on blood glucose levels.
health care team with input from the
Plan or Individualized Education Pro- To facilitate the appropriate care of
parent/guardian. Inherent in this process
gram (IEP). The needs of a student with the student with diabetes, the school
are delineated responsibilities assumed by
diabetes should be provided for within nurse as well as other school and day care
all parties, including the parent/guardian,
the childs usual school setting with as personnel must have an understanding of
the school personnel, and the student
little disruption to the schools and the diabetes and must be trained in its man-
(3,24,25). These responsibilities are out-
childs routine as possible and allowing agement and in the treatment of diabetes
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/dc12-s076
2012 by the American Diabetes Association. Readers may use this article as long as the work is properly specic needs of the child and provide
cited, the use is educational and not for prot, and the work is not altered. See http://creativecommons.org/ specic instructions for each of the fol-
licenses/by-nc-nd/3.0/ for details. lowing:

S76 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


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 specic 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-specic 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 students 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 students 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 students 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 students DMMP
8. Emergency evacuation/school lock- ing emergencies. as well as immediate accessibility to
down instructions. 6. Information about the students meal/ treatment for hyperglycemia including
snack schedule. The parent should insulin administration as set out by the
A sample DMMP (http://www.dia- work with the school during the students DMMP.
betes.org/uedocuments/DMMP-nalfor teacher preparation period before the 5. A location in the school that provides
matted.pdf) may be accessed online and beginning of the school year or before privacy during blood glucose moni-
customized for each individual student. the student returns to school after di- toring and insulin administration, if
For detailed information on the symptoms agnosis to coordinate this schedule desired by the student and family, or
and treatment of hypoglycemia and hy- with that of the other students as closely permission for the student to check
perglycemia, refer to Medical Management as possible. For young children, in- his or her blood glucose level and
of Type 1 Diabetes (26). A brief description structions should be given for when take appropriate action to treat hy-
of diabetes targeted to school and day care food is provided during school parties poglycemia in the classroom or any-
personnel is included in the APPENDIX; it and other activities. where the student is in conjunction
may be helpful to include this information 7. In most locations, and increasingly, a with a school activity, if indicated in
as an introduction to the DMMP. signed release of condentiality from the students 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 (3) 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 ofces. dents 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 students 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 students
and performing controlled testing of a student with diabetes, recogni- meal times or exercise routine and
per the manufacturers instructions) tion of hypoglycemia and hyper- will remind young children of snack
and must provide materials necessary glycemia, and who to contact for times.

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S77


American Diabetes Association

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
tasks and in the treatment of diabetes
Education Program, 2003. Available at http://www.ndep.nih.gov/Diabetes/pubs/
emergencies. This training should be pro-
Youth_SchoolGuide.pdf
vided by the school nurse or another
Diabetes Care Tasks at School: What Key Personnel Need to Know. Alexandria, VA, American
qualied health care professional with ex-
Diabetes Association, 2008. Available online at http://shopdiabetes.org/58-diabetes-care-
pertise in diabetes. Members of the stu-
tasks-at-school-what-key-personnel-need-to-know-2010-edition.aspx.
dents diabetes health care team should
Your School & Your Rights: Protecting Children with Diabetes Against Discrimination in Schools and
provide school personnel and parents/
Day Care Centers. Alexandria, VA, American Diabetes Association, 2005 (brochure). Available
guardians with educational materials
online at http://www.diabetes.org/assets/pdfs/schools/your-school-your-right-2010.pdf.*
from the American Diabetes Association
Children with Diabetes: Information for School and Child Care Providers. Alexandria, VA, American
and other sources targeted to school per-
Diabetes Association, 2004 (brochure). Available at http://shopdiabetes.org/42-children-with-
sonnel and/or parents. Table 1 includes a
diabetes-information-for-school-and-child-care-providers.aspx.*
listing of appropriate resources.
ADAs Safe at School campaign and information on how to keep children with diabetes safe at
school. Call 1-800-DIABETES and go to www.diabetes.org/living-with-diabetes/parents-and-
III. Expectations of the student in
kids/diabetes-care-at-school/safe-at-school
diabetes care
American Diabetes Association: Complete Guide to Diabetes. Alexandria, VA, American Diabetes
Children and youth should be allowed to
Association, 2005. Available at http://shopdiabetes.org/114-american-diabetes-association-
provide their own diabetes care at school
complete-guide.aspx.
to the extent that is appropriate based on
Raising a Child with Diabetes: A Guide for Parents. Alexandria, VA, American Diabetes Association,
the students development and his or her
2000. Available at http://shopdiabetes.org/137-ada-guide-to-raising-a-child-with-diabetes-
experience with diabetes. The extent of
2nd-edition.aspx.
the students ability to participate in di-
Clarke W: Advocating for the child with diabetes. Diabetes Spectrum 12:230236, 1999.
abetes care should be agreed upon by the
School Discrimination Resources. Alexandria, VA, American Diabetes Association, 2006. Available
school personnel, the parent/guardian,
at http://www.diabetes.org/living-with-diabetes/know-your-rights/discrimination/school-
and the health care team, as necessary.
discrimination/*
The ages at which children are able to
Every Day Wisdom: A Kit for Kids with Diabetes (and their parents). Alexandria, VA, American
perform self-care tasks are variable and
Diabetes Association, 2000. Available at http://www.diabetes.org/living-with-diabetes/
depend on the individual, and a childs
parents-and-kids/everyday-wisdom-kit.html
capabilities and willingness to provide
ADAs Planet D, on-line information for children and youth with diabetes. Accessible at http://
self-care should be respected (18).
www.diabetes.org/living-with-diabetes/parents-and-kids/planet-d/
1. Toddlers and preschool-aged children:
*Available in the American Diabetes Associations Education Discrimination Packet by calling 1-800-
DIABETES. unable to perform diabetes tasks in-
dependently and will need an adult to
provide all aspects of diabetes care.
8. Permission for self-sufcient 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 difculty in recognizing hypo-
supplies, medication, and snacks; to students 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 nger 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 schoolaged 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 specied 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 eld trips, par- to self-administer insulin with super-
students 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
doctors 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 uids (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 schoolaged
and/or glucagon storage, if neces- It is the schools responsibility to pro- children: usually able to provide self-
sary. vide appropriate training of an adequate care depending on the length of

S78 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


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 (3) 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 bodys 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- insufcient 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 bodys 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 sulin and must receive insulin through AcknowledgmentsdThe American Diabetes
range. Ultimately, each person with di- either injections or an insulin pump. In- Association thanks the members of the health
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 students 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 ously low. Type 2 diabetes, the most geanna Klingensmith, MD; Desmond Schatz,
of a students ability to provide self-care, common form of the disease, typically MD; Janet H. Silverstein, MD; and Linda M.
help will always be needed in the event aficting obese adults, has been shown to Siminerio, RN, PhD, CDE.
of a diabetes emergency. be increasing in youth. This may be due
to the increase in obesity and decrease in
MONITORING BLOOD physical activity in young people. Stu- References
GLUCOSE IN THE dents with type 2 diabetes may be able to 1. American Diabetes Association: American
CLASSROOMdIt is best for a stu- control their disease through diet and Diabetes Association Complete Guide to Di-
dent with diabetes to monitor blood glu- exercise alone or may require oral medi- abetes. 4th ed. Alexandria, VA, American
cose levels and respond to the results as Diabetes Association, 2008
cations and/or insulin injections. All
quickly and conveniently as possible. 2. Centers for Disease Control and Pre-
people with type 1 and type 2 diabetes vention: National Diabetes Fact Sheet: Na-
This is important to avoid medical prob- must carefully balance food, medica- tional Estimates and General Information
lems being worsened by a delay in tions, and activity level to keep blood on Diabetes and Prediabetes in the United
monitoring and treatment and to mini- glucose levels as close to normal as pos- States, 2011. Atlanta, GA, U.S. Depart-
mize educational problems caused by sible. ment of Health and Human Services,
missing instruction in the classroom. Low blood glucose (hypoglycemia) is Centers for Disease Control and Preven-
Accordingly, as stated earlier, a student the most common immediate health tion, 2011
should be permitted to monitor his or problem for students with diabetes. It 3. National Diabetes Education Program:
her blood glucose level and take appro- occurs when the body gets too much in- Helping the Student with Diabetes Succeed: A
priate action to treat hypoglycemia and Guide for School Personnel. Bethesda, MD,
sulin, too little food, a delayed meal, or
hyperglycemia in the classroom or any- National Institutes of Health (NIH publi-
more than the usual amount of exercise. cation no. 03-5127), 2003
where the student is in conjunction Symptoms of mild to moderate hypogly- 4. Nabors L, Troillett A, Nash T, Masiulis B:
with a school activity, if preferred by cemia include tremors, sweating, light- School nurse perceptions of barriers and
the student and indicated in the stu- headedness, irritability, confusion, and supports for children with diabetes. J Sch
dents DMMP (3,24). However, some drowsiness. In younger children other Health 75: 119124, 2005
students desire privacy for blood glu- symptoms may include inattention, falling 5. 504 of the Rehabilitation Act of 1973, 29
cose monitoring and other diabetes asleep at inappropriate times, unexplained U.S.C. 794, implementing regulations at
care tasks, and this preference should behavior, and temper tantrums. A student 35 CFR Part 104
also be accommodated. with this degree of hypoglycemia will 6. Individuals with Disabilities Education
In summary, with proper planning Act, 20 U.S.C. 1400 et seq., implementing
need to ingest carbohydrates promptly
and the education and training of school regulations at 34 CRF Part 300
and may require assistance. Severe hypo- 7. Title II of the Americans with Disabilities
personnel, children and youth with di- glycemia, which is rare, may lead to un- Act of 1990, 42 U.S.C. 12134 et seq., im-
abetes can fully participate in the school consciousness and convulsions and can be plementing regulations at 28 CFR Part 35
experience. To this end, the family, the life-threatening if not treated promptly 8. Rapp J: Students with diabetes in schools.
health care team, and the school should with glucagon as per the students DMMP In Inquiry & Analysis. Alexandria, VA,
work together to ensure a safe learning (18,24,29,30,31). National School Boards Association Council
environment. of School Attorneys, June 2005

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S79


American Diabetes Association

9. Arent S, Kaufman F: Federal laws and 19. Barrett JC, Goodwin DK, Kendrick O: Association, Children with Diabetes, Dis-
diabetes management at school. School Nursing, food service, and the child with ability Rights Education Defense Fund,
Nurse News, November 2004 diabetes. J Sch Nurs 18: 150156, 2002 Juvenile Diabetes Research Foundation,
10. Jesi Stuthard and ADA v. Kindercare 20. Jameson P: Developing diabetes training Lawson Wilkins Pediatric Endocrine So-
Learning Centers, Inc. Case no. C2-96- programs for school personnel. School ciety, Pediatric Endocrine Nursing Society,
0185 (USCD South Ohio 8/96) Nurse News, September 2004 Endocrine Society [article online]. Avail-
11. Calvin Davis and ADA v. LaPetite Academy, 21. Wysocki T, Meinhold P, Cox DJ, Clarke able from http://www.diabetes.org/advo-
Inc. Case no. CIV97-0083-PHX-SMM WL: Survey of diabetes professionals cacy-and-legalresources/discrimina-
(USCD Arizona 1997) regarding developmental charges in di- tion/safeatschoolprinciples.jsp
12. Agreement, Loudoun County Public abetes self-care. Diabetes Care 13: 6568, 29. Evert A: Managing hypoglycemia in the
Schools (VA) and the Ofce for Civil 1990 school setting. School Nurse News, No-
Rights, United States Department of Ed- 22. Lindsey R, Jarrett L, Hillman K: Elemen- vember 2005
ucation (Complaint nos. 11-99-1003, 11- tary schoolteachers understanding of di- 30. Bulsara MD, Holman CD, David EA, Jones
99-1064, 11-99-1069, 1999) abetes. Diabetes Educ 13: 312314, 1987 TW: The impact of a decade of changing
13. Henderson County (NC) Pub. Schls., Com- 23. American Diabetes Association: Diabetes treatment on rates of severe hypoglycemia
plaint no. 11-00-1008, 34 IDLER 43 Care Tasks at School: What Key Personnel in a population-based cohort of children
(OCR 2000) Need to Know. Alexandria, VA, American with type 1 diabetes. Diabetes Care 27:
14. Rapp J, Arent S, Dimmick B, Jackson C: Diabetes Association, 2008 (available on- 22932298, 2004
Legal Rights of Students with Diabetes. 2nd line at www.diabetes/schooltraining) 31. Nabors L, Lehmkuhl H, Christos N,
ed. Alexandria, VA, American Diabetes 24. Jameson P: Helping students with di- Andreone TF: Children with diabetes: per-
Association, October 2005, updated October abetes thrive in school. In On the Cut- ceptions of supports for self-management
2009. Available from http://www.diabetes. ting Edge, American Dietetic Associations at school. J Sch Health 73: 216221,
org/living-with-diabetes/know-your-rights/ Diabetes Care and Education Practice 2003
for-lawyers/education-materials-for-lawyers/ Group Newsletter. Summer 2006, p. 26 32. Kaufman FR: Diabetes mellitus. Pediatr
legal-rights-of-students-with-diabetes. 29 Rev 18: 383392, 1997
html 25. Owen S: Pediatric pumpsdbarriers and 33. Pediatric Endocrine Nursing Society:
15. Greene MA: Diabetes legal advocacy breakthroughs. Pediatric Pumps 32 (Suppl. Children With Diabetes at School. Septem-
comes of age. Diabetes Spectr 19: 171 1), January/February 2006 ber 2005. Available from the Pediatric
179, 2006 26. American Diabetes Association: Medical Endocrinology Nursing Society, 7794
16. Diabetes Control and Complications Trial Management of Type 1 Diabetes. 5th ed. Grow Dr., Pensacola, FL 32514
Research Group: Effect of intensive di- Alexandria, VA, American Diabetes Asso- 34. Committee on School Health, American
abetes treatment on the development and ciation, 2008 Academy of Pediatrics Policy Statement:
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insulin-dependent diabetes mellitus. N etary Needs in the School Nutrition Program: cation in school. Pediatrics 124: 1244
Engl J Med 329: 977986, 1993 Guidance for School Food Service Staff. 1251, 2009
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Research Group: Effect of intensive di- Agriculture Food and Nutrition Service, a Virginia experience. Diabetes Care 30:
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progression of long-term complications in 28. American Diabetes Association: Safe at 36. American Medical Association: Report 4
adolescents with insulin-dependent diabetes School Campaign Statement of Principles of the Council on Science and Public
mellitus. J Pediatr 125: 177188, 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
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28: 186212, 2005 betes Association, American Dietetic 18643.html.

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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 identied, 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
drivers 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 persons license, in- to signicantly impaired consciousness are
issues in light of current scientic and cluding restrictions on the type of vehicle evaluated for their tness 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 tness 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 dened as trade, states, such reporting by physicians is man-
that persons diabetes managementdwith trafc 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 sufcient two places in a state as part of trade, trafc 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 identies individual states. These rules vary widely, from the report.
general guidelines for assessing driver t- with each state taking its own approach to When licensing authorities learn
ness and determining appropriate licensing determining medical tness 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/dc12-s081
2012 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 prot, 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

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S81


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, Parkinsons society tolerates these conditions, it would
and range from a simple conrmation of disease, or alcohol and substance abuse, be unjustied to restrict the driving priv-
the persons 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 signicant 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 signicant 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 (1,3,1821).
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 dened se-
part of an ongoing tness 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-specic 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 certi- tiating those with a signicant risk from followed monthly for 12 months, 185 par-
cates to qualied 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 1219% 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. conrmed 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 signicant 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 societys tol- by multiple studies demonstrating that
neuropathy affecting the ability to feel foot erance of other and much higherrisk moderate hypoglycemia signicantly and
petals can each impact driving safety (4). conditions. For example, 16-year-old consistently impairs driving safety (2426)
However, the incidence of these conditions males have 42 times more collisions than and judgment (27,28) as to whether to con-
is not sufciently 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 signicant 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 (3235), there is only one re-
However, just as there are some pa- 11:00 A.M. (7). Drivers with attention decit/ port suggesting extreme hyperglycemia
tients with conditions that increase their hyperactivity disorder have a relative risk can impact driving safety (36). Thus,

S82 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


American Diabetes Association

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 justied. ing.com), a program funded by the ications 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 drivers gly-
with type 1 diabetes (3739). 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 nicantly elevated risk to safe driving and provide to the licensing agency a
while driving, hypoglycemia-related driv- must be identied 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 identication and evaluation pro- concerning the drivers 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 persons
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 difculties in avoiding diabetes-related problem for specic rec-
that those with a history of mishaps: 1) hypoglycemia or the presence of compli- ommendations.
drove signicantly worse during progres- cations. In addition, the logistics of regis- Physicians should be requested to
sive mild hypoglycemia (7050 mg/dL, tering and evaluating millions of people provide the following information: 1)
3.92.8 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 scal 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 identication to reports of diabetes- 2) whether there was an explanation for
strated greater difculties 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 nd 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 sufcient 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 (4245). 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

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S83


Position statement

investigate the reasons for the hypoglyce- Generally, severe hypoglycemia that glucose monitoring may also be benecial,
mia and to determine whether it is a occurs during sleep should not disqualify particularly when noting the direction of
function of the drivers 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 ed 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 reect deference to the pro- episodes of severe hypoglycemia, dened 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 agencys need operate a motor vehicle. at some point in the future, the drivers
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 drivers 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 signicantly 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 tness
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 drivers 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 tness.
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 drivers license re- from impaired driving, such laws have
As discussed above, a history of hy- instated following a sufcient 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 persons diabetes journey lasting more than 3060 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 drivers mental or physical
of an accidentdshould not itself pre- hypoglycemia while driving, there should condition impairs the patients ability to
determine a licensing decision. not be license restrictions. Continuous exercise safe control over a motor vehicle.

S84 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


American Diabetes Association

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- als 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 Anderson,
communication that ultimately promotes timing of blood glucose monitoring, MD; Shereen Arent, JD; Daniel J. Cox, PhD, ABPP;
safety, it is important that physicians be medication dosage changes, and estab- Brian M. Frier, BSc, MD, FRCPE, FRCPG; Michael
immunized from liability, both for mak- lishing more conservative glucose targets A. Greene, JD; John W. Grifn, Jr., JD; Gary
ing reports and not making reports. if there is a history of severe hypo- Gross, JD; Katie Hathaway, JD; Irl Hirsch, MD;
Daniel B. Kohrman, JD; David G. Marrero, PhD;
glycemia. Certain people who have a
Thomas J. Songer, PhD; and Alan L. Yatvin, JD.
Patient education and clinical history of severe hypoglycemia may be
interventions encouraged by their health care provider
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25. Quillian WC, Cox DJ, Gonder-Frederick type 1 and 2 diabetes (Abstract). Diabetes Type 1 diabetes. Diabet Med 2004;21:
LA, Driesen NR, Clarke WL. Reliability of 2011;60(Suppl. 1):A223 230237

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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 Intake screening
Patients with a diagnosis of diabetes
should have a complete medical history

A
t any given time, over 2 million peo- loss, renal failure, and amputation. Early and physical examination by a licensed
ple are incarcerated in prisons and identication and intervention for people health care provider with prescriptive au-
jails in the U.S (1). It is estimated with diabetes is also likely to reduce thority in a timely manner. If one is not
that nearly 80,000 of these inmates have short-term risks for acute complications re- available on site, one should be consulted
diabetes, a prevalence of 4.8% (2). In ad- quiring transfer out of the facility, thus im- by those performing reception screening.
dition, many more people pass through proving security. The purposes of this history and physical
the corrections system in a given year. In This document provides a general set examination are to determine the type of
1998 alone, over 11 million people were of guidelines for diabetes care in correc- diabetes, current therapy, alcohol use, and
released from prison to the community tional institutions. It is not designed to be a behavioral health issues, as well as to screen
(1). The current estimated prevalence of diabetes management manual. More de- for the presence of diabetes-related com-
diabetes in correctional institutions is tailed information on the management of plications. The evaluation should review
somewhat lower than the overall U.S. prev- diabetes and related disorders can be found the previous treatment and the past history
alence of diabetes, perhaps because the in- in the American Diabetes Association of both glycemic control and diabetes
carcerated population is younger than the (ADA) Clinical Practice Recommendations, complications. It is essential that medica-
general population. The prevalence of di- published each year in January as the rst tion and medical nutrition therapy (MNT)
abetes and its related comorbidities and supplement to Diabetes Care, as well as the be continued without interruption upon
complications, however, will continue to Standards of Medical Care in Diabetes (4) entry into the correctional system, as a
increase in the prison population as current contained therein. This discussion will fo- hiatus in either medication or appropriate
sentencing guidelines continue to increase cus on those areas where the care of people nutrition may lead to either severe hypo- or
the number of aging prisoners and the in- with diabetes in correctional facilities may hyperglycemia that can rapidly progress to
cidence of diabetes in young people con- differ, and specic recommendations are irreversible complications, even death.
tinues to increase. made at the end of each section.
People with diabetes in correctional Intake physical examination and
facilities should receive care that meets INTAKE MEDICAL laboratory
national standards. Correctional institu- ASSESSMENT All potential elements of the initial med-
tions have unique circumstances that ical evaluation are included in Table 5 of
need to be considered so that all standards Reception screening the ADAs Standards of Medical Care in
of care may be achieved (3). Correctional Reception screening should emphasize Diabetes, referred to hereafter as the
institutions should have written policies patient safety. In particular, rapid identi- Standards of Care (4). The essential
and procedures for the management of cation of all insulin-treated persons with components of the initial history and
diabetes and for training of medical and diabetes is essential in order to identify physical examination are detailed in Fig.
correctional staff in diabetes care practices. those at highest risk for hypo- and hyper- 1. Referrals should be made immediately
These policies must take into consideration glycemia and diabetic ketoacidosis if the patient with diabetes is pregnant.
issues such as security needs, transfer from (DKA). All insulin-treated patients should
one facility to another, and access to med- have a capillary blood glucose (CBG) Recommendations
ical personnel and equipment, so that all determination within 12 h of arrival. c Patients with a diagnosis of diabetes
appropriate levels of care are provided. Ide- Signs and symptoms of hypo- or hyper- should have a complete medical history
ally, these policies should encourage or at glycemia can often be confused with in- and undergo an intake physical exam-
least allow patients to self-manage their di- toxication or withdrawal from drugs or ination by a licensed health pro-
abetes. Ultimately, diabetes management is alcohol. Individuals with diabetes exhib- fessional in a timely manner. (E)
dependent upon having access to needed iting signs and symptoms consistent with c Insulin-treated patients should have a
medical personnel and equipment. Ongo- hypoglycemia, particularly altered mental CBG determination within 12 h of
ing diabetes therapy is important in order status, agitation, combativeness, and dia- arrival. (E)
to reduce the risk of later complications, phoresis, should have nger-stick blood c Medications and MNT should be con-
including cardiovascular events, visual glucose levels measured immediately. tinued without interruption upon entry
into the correctional environment. (E)
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
Originally approved 1989. Most recent revision, 2008.
Abbreviations: CBG, capillary blood glucose; DKA, diabetic ketoacidosis; GDM, gestational diabetes mellitus; SCREENING FOR DIABETESd
MNT, medical nutrition therapy. Consistent with the ADA Standards of
DOI: 10.2337/dc12-s087
2012 by the American Diabetes Association. Readers may use this article as long as the work is properly
Care, patients should be evaluated for
cited, the use is educational and not for prot, and the work is not altered. See http://creativecommons.org/ diabetes risk factors at the intake physical
licenses/by-nc-nd/3.0/ for details. and at appropriate times thereafter. Those

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S87


Correctional Institutions

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

who are at high risk should be considered elderly adults, and individuals with co- correctional institution. Common hous-
for blood glucose screening. If pregnant, a morbid conditions (4). This plan should ing not only can facilitate mealtimes and
risk assessment for gestational diabetes be documented in the patients record medication administration, but also po-
mellitus (GDM) should be undertaken at and communicated to all persons in- tentially provides an opportunity for di-
the rst 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

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Table 1dSummary of recommendations for priate staff should be trained to adminis- sponse protocol for recognition and treat-
glycemic, blood pressure, and lipid control ter glucagon. After such emergency care, ment of hypoglycemia. Every attempt
for most adults with diabetes patients should be referred for appropri- should be made to document CBG before
A1C ,7.0%*
ate medical care to minimize risk of future treatment. Patients must have immediate
decompensation. access to glucose tablets or other glucose-
Blood pressure ,130/80 mmHg Institutions should implement a pol- containing foods. Hypoglycemia can gen-
Lipids
icy requiring staff to notify a physician of erally be treated by the patient with oral
LDL cholesterol ,100 mg/dL all CBG results outside of a specied carbohydrates. If the patient cannot be
(,2.6 mmol/L) range, as determined by the treating relied on to keep hypoglycemia treatment
*More or less stringent glycemic goals may be ap- physician (e.g., ,50 or .350 mg/dl). on his/her person, staff members should
propriate for individual patients. Goals should be
individualized based on duration of diabetes, age/life have ready access to glucose tablets or
expectancy, comorbid conditions, known CVD or Hyperglycemia equivalent. In general, 1520 g oral glu-
advanced microvascular complications, hypoglycemia Severe hyperglycemia in a person with cose will be adequate to treat hypoglyce-
unawareness, individual and patient considerations. diabetes may be the result of intercurrent mic events. CBG and treatment should be
Based on patient characteristics and response to
therapy, higher or lower SBP targets may be appro-
illness, missed or inadequate medication, repeated at 15-min intervals until blood
priate. In individuals with overt CVD, a lower LDL or corticosteroid therapy. Correctional glucose levels return to normal (.70 mg/
cholesterol goal of ,70 mg/dL (1.8 mmol/L), using institutions should have systems in place dl).
a high dose of a statin, is an option. to identify and refer to medical staff all Staff should have glucagon for intra-
patients with consistently elevated blood muscular injection or glucose for intra-
diabetes control is the rst step in facili- glucose as well as intercurrent illness. venous infusion available to treat severe
tating self-management. This education The stress of illness in those with type hypoglycemia without requiring trans-
enables the patient to identify better food 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 46 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 uid 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 dened 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 dened 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 Po- or withdrawal. Individuals with diabetes tion, and immediately refer the patient
sition Statement Nutrition Principles exhibiting signs and symptoms consistent for appropriate medical care. (E)
and Recommendations in 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 specied
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)

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Correctional Institutions

MEDICATIONdFormularies should more injections a day) can be effective The following complications should
provide access to usual and customary means of implementing intensive diabetes be considered.
oral medications and insulins necessary to management with the goal of achieving
treat diabetes and related conditions. near-normal levels of blood glucose (9). c Foot care: Recommendations for foot
While not every brand name of insulin While the use of these modalities may be care for patients with diabetes and no
and oral medication needs to be available, difcult in correctional institutions, every history of an open foot lesion are de-
individual patient care requires access to effort should be made to continue multi- scribed in the ADA Standards of Care.
short-, medium-, and long-acting insulins ple daily insulin injection or continuous A comprehensive foot examination is
and the various classes of oral medica- subcutaneous insulin infusion in people recommended annually for all patients
tions (e.g., insulin secretagogues, bigua- who were using this therapy before incar- with diabetes to identify risk factors
nides, a-glucosidase inhibitors, and ceration or to institute these therapies as predictive of ulcers and amputations.
thiazolidinediones) necessary for current indicated in order to achieve blood glu- Persons with an insensate foot, an open
diabetes management. cose targets. foot lesion, or a history of such a lesion
Patients at all levels of custody should It is essential that transport of patients should be referred for evaluation by an
have access to medication at dosing fre- from jails or prisons to off-site appoint- appropriate licensed health professional
quencies that are consistent with their ments, such as medical visits or court (e.g., podiatrist or vascular surgeon).
treatment plan and medical direction. If appearances, does not cause signicant Special shoes should be provided as
feasible and consistent with security con- disruption in medication or meal timing. recommended by licensed health pro-
cerns, patients on multiple doses of short- Correctional institutions and police lock- fessionals to aid healing of foot lesions
acting oral medications should be placed ups should implement policies and pro- and to prevent development of new
in a keep on person program. In other cedures to diminish the risk of hypo- and lesions.
situations, patients should be permitted hyperglycemia by, for example, providing c Retinopathy: Annual retinal examina-
to self-inject insulin when consistent carry-along meals and medication for tions by a licensed eye care professional
with security needs. Medical department patients traveling to off-site appointments should be performed for all patients
nurses should determine whether patients or changing the insulin regimen for that with diabetes, as recommended in the
have the necessary skill and responsible be- day. The availability of prelled insulin ADA Standards of Care. Visual changes
havior to be allowed self-administration pens provides an alternative for off-site that cannot be accounted for by acute
and the degree of supervision necessary. insulin delivery. changes in glycemic control require
When needed, this skill should be a part prompt evaluation by an eye care pro-
of patient education. Reasonable syringe fessional.
control systems should be established. Recommendations c Nephropathy: An annual spot urine
In the past, the recommendation that c Formularies should provide access to test for determination of microalbumin-
regular insulin be injected 3045 min be- usual and customary oral medications to-creatinine ratio should be performed.
fore meals presented a signicant prob- and insulins to treat diabetes and re- The use of ACE inhibitors or angiotensin
lem when lock downs or other lated conditions. (E) receptor blockers is recommended for
disruptions to the normal schedule of c Patients should have access to medi- all patients with albuminuria. Blood
meals and medications occurred. The cation at dosing frequencies that are pressure should be controlled to ,130/
use of multiple-dose insulin regimens us- consistent with their treatment plan 80 mmHg.
ing rapid-acting analogs can decrease the and medical direction. (E) c Cardiac: People with type 2 diabetes
disruption caused by such changes in c Correctional institutions and police are at a particularly high risk of coro-
schedule. Correctional institutions lock-ups should implement policies nary artery disease. Cardiovascular
should have systems in place to ensure and procedures to diminish the risk of disease risk factor management is of
that rapid-acting insulin analogs and hypo- and hyperglycemia during off- demonstrated benet in reducing this
oral agents are given immediately before site travel (e.g., court appearances). (E) complication in patients with diabetes.
meals if this is part of the patients medical Blood pressure should be measured at
plan. It should be noted however that every routine diabetes visit. In adult
even modest delays in meal consumption ROUTINE SCREENING FOR AND patients, test for lipid disorders at least
with these agents can be associated with MANAGEMENT OF DIABETES annually and as needed to achieve goals
hypoglycemia. If consistent access to food COMPLICATIONSdAll patients with treatment. Use aspirin therapy
within 10 min cannot be ensured, rapid- with a diagnosis of diabetes should re- (75162 mg/day) in all adult patients
acting insulin analogs and oral agents are ceive routine screening for diabetes-related with diabetes and cardiovascular risk
approved for administration during or complications, as detailed in the ADA factors or known macrovascular dis-
immediately after meals. Should circum- Standards of Care (4). Interval chronic ease. Current national standards for
stances arise that delay patient access to disease clinics for persons with diabetes adults with diabetes call for treatment
regular meals following medication ad- provide an efcient mechanism to monitor of lipids to goals of LDL #100, HDL
ministration, policies and procedures patients for complications of diabetes. In .40, triglycerides ,150 mg/dl and
must be implemented to ensure the pa- this way, appropriate referrals to consul- blood pressure to a level of ,130/80
tient receives appropriate nutrition to tant specialists, such as optometrists/ mmHg.
prevent hypoglycemia. ophthalmologists, nephrologists, and
Both continuous subcutaneous insu- cardiologists, can be made on an as-needed MONITORING/TESTS OF
lin infusion and multiple daily insulin basis and interval laboratory testing can GLYCEMIAdMonitoring of CBG is a
injection therapy (consisting of three or be done. strategy that allows caregivers and people

S90 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


with diabetes to evaluate diabetes man- implemented to enable CBG monitoring c what diabetes is
agement regimens. The frequency of to occur at the frequency necessitated by c signs and symptoms of diabetes
monitoring will vary by patients glycemic the individual patients glycemic control c risk factors
control and diabetes regimens. Patients and diabetes regimen. (E) c signs and symptoms of, and emergency
with type 1 diabetes are at risk for hypo- c A1C should be checked every 36 response to, hypo- and hyperglycemia
glycemia and should have their CBG months. (E) c glucose monitoring
monitored three or more times daily. Pa- c medications
tients with type 2 diabetes on insulin need c exercise
to monitor at least once daily and more SELF-MANAGEMENT c nutrition issues including timing of
frequently based on their medical plan. EDUCATIONdSelf-management ed- meals and access to snacks
Patients treated with oral agents should ucation is the cornerstone of treatment
have CBG monitored with sufcient fre- for all people with diabetes. The health Recommendations
quency to facilitate the goals of glycemic staff must advocate for patients to partic- c Include diabetes in correctional staff
control, assuming that there is a program ipate in self-management as much as education programs. (E)
for medical review of these data on an possible. Individuals with diabetes who
ongoing basis to drive changes in medica- learn self-management skills and make ALCOHOL AND DRUGSdPatients
tions. Patients whose diabetes is poorly lifestyle changes can more effectively with diabetes who are withdrawing from
controlled or whose therapy is changing manage their diabetes and avoid or delay drugs and alcohol need special consider-
should have more frequent monitoring. complications associated with diabetes. ation. This issue particularly affects initial
Unexplained hyperglycemia in a patient In the development of a diabetes self- police custody and jails. At an intake
with type 1 diabetes may suggest impend- management education program in the facility, proper initial identication and
ing DKA, and monitoring of ketones correctional environment, the unique cir- assessment of these patients are critical.
should therefore be performed. cumstances of the patient should be The presence of diabetes may complicate
Glycated hemoglobin (A1C) is a mea- considered while still providing, to the detoxication. Patients in need of com-
sure of long-term (2- to 3-month) glyce- greatest extent possible, the elements plicated detoxication should be referred
mic control. Perform the A1C test at least of the National Standards for Diabetes to a facility equipped to deal with high-
two times a year in patients who are Self-Management Education (11). A risk detoxication. Patients with diabetes
meeting treatment goals (and who have staged approach may be used depend- should be educated in the risks involved
stable glycemic control) and quarterly in ing on the needs assessment and the with smoking. All inmates should be
patients whose therapy has changed or length of incarceration. Table 2 sets advised not to smoke. Assistance in
who are not meeting glycemic goals. out the major components of diabetes smoking cessation should be provided
Discrepancies between CBG monitor- self-management education. Survival as practical.
ing results and A1C may indicate a he- skills should be addressed as soon as
moglobinopathy, hemolysis, or need for possible; other aspects of education
evaluation of CBG monitoring technique may be provided as part of an ongoing TRANSFER AND
and equipment or initiation of more education program. DISCHARGEdPatients in jails may be
frequent CBG monitoring to identify Ideally, self-management education is housed for a short period of time before
when glycemic excursions are occurring coordinated by a certied diabetes edu- being transferred or released, and it is not
and which facet of the diabetes regimen is cator who works with the facility to de- unusual for patients in prison to be trans-
changing. velop polices, procedures, and protocols ferred within the system several times
In the correctional setting, policies to ensure that nationally recognized edu- during their incarceration. One of the many
and procedures need to be developed and cation guidelines are implemented. The challenges that health care providers face
implemented regarding CBG monitoring educator is also able to identify patients working in the correctional system is how
that address the following. who need diabetes self-management ed- to best collect and communicate important
ucation, including an assessment of the health care information in a timely manner
c infection control patients medical, social, and diabetes when a patient is in initial police custody, is
c education of staff and patients histories; diabetes knowledge, skills, and jailed short term, or is transferred from
c proper choice of meter behaviors; and readiness to change. facility to facility. The importance of this
c disposal of testing lancets communication becomes critical when the
c quality control programs patient has a chronic illness such as di-
c access to health services STAFF EDUCATIONdPolicies and abetes.
c size of the blood sample procedures should be implemented to Transferring a patient with diabetes
c patient performance skills ensure that the health care staff has from one correctional facility to another
c documentation and interpretation of adequate knowledge and skills to direct requires a coordinated effort. To facilitate a
test results the management and education of per- thorough review of medical information
c availability of test results for the health sons with diabetes. The health care staff and completion of a transfer summary, it is
care provider (10) needs to be involved in the development critical for custody personnel to provide
of the correctional ofcers training pro- medical staff with sufcient notice before
gram. The staff education program movement of the patient.
Recommendations should be at a lay level. Training should Before the transfer, the health care
c In the correctional setting, policies and be offered at least biannually, and the staff should review the patients medical
procedures need to be developed and curriculum should cover the following. record and complete a medical transfer

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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) dene 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
summary that includes the patients cur- care provider upon arrival at the receiving tracking requests.
rent health care issues. At a minimum, the institution. Facilities that use outside medical
summary should include the following. Planning for patients discharge from providers should implement policies
prisons should include instruction in the and procedures for ensuring that key
c the patients 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 patients 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 specied, 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, appli- CHILDREN AND ADOLESCENTS
to that appointment cation 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- patients knowledge of diabetes care problems in disease management, even
cility who can provide additional in- need to be identied and addressed. It is outside the setting of a correctional in-
formation, if needed helpful if the patient is given a directory or stitution. Children and adolescents with
list of community resources and if an diabetes should have initial and follow-up
The medical transfer summary, which appointment for follow-up care with a care with physicians who are experienced
acts as a quick medical reference for the community provider is made. A supply of in their care. Connement increases the
receiving facility, should be transferred medication adequate to last until the rst difculty in managing diabetes in chil-
along with the patient. To supplement the postrelease medical appointment should dren and adolescents, as it does in adults
ow of information and to increase the be provided to the patient upon release. with diabetes. Correctional authorities
probability that medications are correctly The patient should be provided with a also have different legal obligations for
identied at the receiving institution, written summary of his/her current heath children and adolescents.
sending institutions are encouraged to care issues, including medications and
provide each patient with a medication doses, recent A1C values, etc. Nutrition and activity
card to be carried by the patient that 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.

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Medical management and follow-up behavioral plans should be adjusted by 5. American Diabetes Association: Screening
Children and adolescents who are incar- health care professionals in collaboration for type 2 diabetes (Position Statement).
cerated for extended periods should have with the prison staff. It is critical for Diabetes Care 27 (Suppl. 1):S11S14,
follow-up visits at least every 3 months correctional institutions to identify par- 2004
6. Krauss RM, Eckel RH, Howard B, Appel
with individuals who are experienced in ticularly high-risk patients in need of
LJ, Daniels SR, Deckelbaum RJ, Erdman
the care of children and adolescents with more intensive evaluation and therapy, JW Jr, Kris-Etherton P, Goldberg IJ,
diabetes. Thyroid function tests and fast- including pregnant women, patients with Kotchen TA, Lichtenstein AH, Mitch WE,
ing lipid and microalbumin measure- advanced complications, a history of re- Mullis R, Robinson K, Wylie-Rosett J, St
ments should be performed according to peated severe hypoglycemia, or recurrent Jeor S, Suttie J, Tribble DL, Bazzarre TL:
recognized standards for children and DKA. American Heart Association Dietary
adolescents (12) in order to monitor for A comprehensive, multidisciplinary Guidelines: revision 2000: a statement for
autoimmune thyroid disease and compli- approach to the care of people with di- healthcare professionals from the Nutri-
cations and comorbidities of diabetes. abetes can be an effective mechanism to tion Committee of the American Heart
Children and adolescents with diabe- improve overall health and delay or pre- Association. Stroke 31:27512766, 2000
7. American Diabetes Association: Nutrition
tes exhibiting unusual behavior should vent the acute and chronic complications
recommendations and interventions for
have their CBG checked at that time. of this disease. diabetes (Position Statement). Diabetes
Because children and adolescents are Care 31 (Suppl. 1):S61S78, 2008
reported to have higher rates of nocturnal 8. American Diabetes Association: Hyper-
hypoglycemia (13), consideration should AcknowledgmentsdThe following members glycemic crisis in diabetes (Position
be given regarding the use of episodic of the American Diabetes Association/National Statement). Diabetes Care 27 (Suppl. 1):
overnight blood glucose monitoring in Commission on Correctional Health Care S94S102, 2004
these patients. In particular, this should Joint Working Group on Diabetes Guidelines 9. American Diabetes Association: Continu-
for Correctional Institutions contributed to ous subcutaneous insulin infusion (Posi-
be considered in children and adolescents
the revision of this document: Daniel L. tion Statement). Diabetes Care 27 (Suppl.
who have recently had their overnight in- Lorber, MD, FACP, CDE (chair); R. Scott 1):S110, 2004
sulin dose changed. Chavez, MPA, PA-C; Joanne Dorman, RN, 10. American Diabetes Association: Tests of
CDE, CCHP-A; Lynda K. Fisher, MD; glycemia in diabetes (Position Statement).
PREGNANCYdPregnancy in a Stephanie Guerken, RD, CDE; Linda B. Haas, Diabetes Care 27 (Suppl. 1):S91S93,
woman with diabetes is by denition a CDE, RN; Joan V. Hill, CDE, RD; David Ken- 2004
high-risk pregnancy. Every effort should dall, MD; Michael Puisis, DO; Kathy Salo- 11. American Diabetes Association: National
be made to ensure that treatment of the mone, CDE, MSW, APRN; Ronald M. standards for diabetes self-management
pregnant woman with diabetes meets Shansky, MD, MPH; and Barbara Wakeen, education (Standards and Review Criteria).
RD, LD. Diabetes Care 31 (Suppl. 1):S97S104, 2008
accepted standards (14,15). It should be
noted that glycemic standards are more 12. International Society for Pediatric and
stringent, the details of dietary manage- Adolescent Diabetes: Consensus Guidelines
References 2000: ISPAD Consensus Guidelines for the
ment are more complex and exacting, in- 1. National Commission on Correctional Management of Type 1 Diabetes Mellitus in
sulin is the only antidiabetic agent Health Care: The Health Status of Soon-to- Children and Adolescents. Zeist, Nether-
approved for use in pregnancy, and a Be Released Inmates: A Report to Congress. lands, Medical Forum International, 2000,
number of medications used in the man- Vol. 1. Chicago, NCCHC, 2002 p. 116, 118
agement of diabetic comorbidities are 2. Hornung CA, Greinger RB, Gadre S: A 13. Kaufman FR, Austin J, Neinstein A, Jeng L,
known to be teratogenic and must be dis- Projection Model of the Prevalence of Se- Halyorson M, Devoe DJ, Pitukcheewanont
continued in the setting of pregnancy. lected Chronic Diseases in the Inmate Pop- P: Nocturnal hypoglycemia detected with
ulation. Vol. 2. Chicago, NCCHC, 2002, the continuous glucose monitoring system
SUMMARY AND KEY p. 3956 in pediatric patients with type 1 diabetes.
POINTSdPeople with diabetes should 3. Puisis M: Challenges of improving quality J Pediatr 141:625630, 2002
in the correctional setting. In Clinical 14. American Diabetes Association: Gestational
receive care that meets national stand- Practice in Correctional Medicine. St. Louis, diabetes mellitus (Position Statement). Di-
ards. Being incarcerated does not change MO, Mosby-Yearbook, 1998, p. 1618 abetes Care 27 (Suppl. 1):S88S90, 2004
these standards. Patients must have access 4. American Diabetes Association: Standards 15. Jovanovic L (Ed.): Medical Management of
to medication and nutrition needed to of medical care in diabetesd2012 (Posi- Pregnancy Complicated by Diabetes. 4th ed.
manage their disease. In patients who do tion Statement). Diabetes Care 35 (Suppl. 1): Alexandria, VA, American Diabetes Asso-
not meet treatment targets, medical and S76S80 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 individuals 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. tness 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 noninsulin [treated], should be require employers to make decisions adverse employment decision, such as
eligible for any employment for which he/she
is otherwise qualied. 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 qualied 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 qualied 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 individuals 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 uals 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 employees treating physician
DIABETES FOR Therefore, persons with diabetes are and that of the employers 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 signicant 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 individuals 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 individuals 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/dc12-s094
2012 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 prot, 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.

S94 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


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 signicant Screening guidelines an objective way and based on the latest
risk of substantial harm) to health or A number of screening guidelines for scientic 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 Medicines 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 employees diabetes arises on the job Ofcers, the National Fire Protection people with diabetes to be a safety risk
and such problem could affect job perfor- Associations 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
employees tness to remain on the job of Transportations Federal Motor Car- provide information for evaluating an in-
and/or his or her ability to safely perform rier Safety Administrations 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 rst 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 scientic knowledge most types of employment (such as jobs
unless it is conducted by a health care about diabetes and its management. in an ofce, 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 sufcient and appropriate med- uated and updated to reect changes in the individuals 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 individuals diabetes and health care professionals with signicant individual must carry a rearm 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 ofce 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 individuals current capac- cic job and the individuals 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 dened 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 individuals hypoglycemia history may tness 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 individuals 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 sufcient and appropriate another person, is a medical emergency.

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S95


Diabetes and Employment

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 specic 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 specic 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 individuals 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 uctuate 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 reect the current state of di-
individual may in fact not be able to safely viduals 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 signicant 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-
persons 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 individuals 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 (eAG). Hemoglobin A1C (A1C) test re-
cades but does not normally lead to any changes to his or her diabetes treatment sults reect 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). An eAG is directly re-
velop over hours or days and do not occur dividuals over time lose the ability to lated to A1C and also provides an individ-
suddenly. Therefore, hyperglycemia does recognize the early warning signs of hypo- ual with an estimate of average blood
not pose an immediate risk of sudden in- glycemia. These individuals are at increased glucose over a period of time, but it uses
capacitation. While over years or decades, risk for a sudden episode of severe hypo- the same values and units that are ob-
high blood glucose may cause long-term glycemia. Some of these individuals may served when using a glucose meter or

S96 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Position Statement

recording a fasting glucose value on a lab are relevant in employment decisions care tasks that should be provided when-
report (5). A1C/eAG values provide only when they are established and ever feasible.
health care providers with important in- interfere with the performance of the Administering insulin. Employees may
formation about the effectiveness of an actual job being considered. (E) need short breaks during the workday to
individuals treatment regimen (4) but c Proper safety assessments should in- administer insulin when it is needed.
are often misused in assessing whether clude review of blood glucose test re- Insulin can be safely administered wher-
an individual can safely perform a job. sults, history of severe hypoglycemia, ever the employee happens to be. The
Because they identify only averages and presence of hypoglycemia unawareness, employee may also need a place to store
not whether the person had severe ex- and presence of diabetes-related com- insulin and other supplies if work con-
treme blood glucose readings, A1C/eAG plications and should not include urine ditions (such as extreme temperatures)
results are of no value in predicting short- glucose or AIC/eAG tests or be based prevent the supplies from being carried
term complications of diabetes and thus on a general assessment of level of con- on the person (10).
have no use in evaluating individuals in trol. (E) Food and drink. Employees may need
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 signicant 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 justied in employment evaluations exible 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 individuals 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 dened 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 difcult 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 qualied 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 modications 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 benet 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 benet
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 exibility 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

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S97


Diabetes and Employment

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- persons 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 specic job and the 4. American Diabetes Association: Standards
Recommendations individuals ability to perform that job, of medical care in diabetesd2012 (Posi-
with or without reasonable accommoda- tion Statement). Diabetes Care 2012;35
c Individuals with diabetes may need
tions, always need to be considered. (Suppl. 1): S76S80
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: 14731478, 2008
Assocation thanks the members of the volun-
and, when present, the complications teer writing group for this updated statement:
6. American Diabetes Association: Dening
of diabetes. All such accommodations and reporting hypoglycemia in diabetes,
John E. Anderson, MD; Michael A. Greene, JD; a report from the American Diabetes As-
must be tailored to the individual and John W. Grifn, Jr., JD; Daniel B. Kohrman, JD;
effective in helping the individual per- sociation Workgroup on Hypoglycemia.
Daniel Lorber, MD, FACP, CDE; Christopher D. Diabetes Care 28: 12451249, 2005
form his or her job. (E) Saudek, MD; Desmond Schatz, MD; and Linda 7. American Diabetes Association: Self-
Siminerio, RN, PhD, CDE. monitoring of blood glucose (Consensus
CONCLUSIONdIndividuals with di- Statement). Diabetes Care 17: 8186, 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): S91S93,
not every individual with diabetes will
vention: National Diabetes Fact Sheet: 2004
be qualied 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): S106S109, 2004

S98 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


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 ciations National Standards for Diabetes
diabetes to lead healthy, productive lives, control. Diabetes self-management edu- Self-Management Education. Further-
appropriate medical care based on current cation teaches individuals with diabetes more, third-party payers must also reim-
standards of practice, self-management to assess the interplay among medical burse for medications and supplies related
education, and medication and supplies nutrition therapy, physical activity, emo- to the daily care of diabetes. These same
must be available to everyone with diabe- tional/physical stress, and medications, standards should also apply to organiza-
tes. This paper is based on technical re- and then to respond appropriately and tions that purchase health care benets for
views titled Diabetes Self-Management continually to those factors to achieve and their members or employees, as well as
Education (3) and National Standards maintain optimal glucose control. managed care organizations that provide
for Diabetes Self-Management Education Today, self-management education is 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 laries, prior authorization, competitive
with diabetes is to optimize glycemic con- diabetes without systematic self-manage- bidding, and related provisions (hereafter
trol and minimize complications. The Di- ment education is regarded as inadequate. referred to as controls) can manage pro-
abetes Control and Complications Trial The National Standards for Diabetes Self- vider practices and costs to the potential
(DCCT) demonstrated that treatment that Management Education establish spe- benet of payors and patients. Social Se-
maintains blood glucose levels near nor- cic 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 signicant clinically meaningful
cular complications. The U.K. 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
benet 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 eld 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 paper 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 18:12041214, 1995; and National stand- risk of diabetes-related complications. Be-
ards for diabetes self-management education. Diabetes Care 33:S89S96, 2010. cause no single diabetes treatment regimen
Approved 1995. Revised 2008 is appropriate for all people with diabetes,
DOI: 10.2337/dc12-s099
2012 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 prot, 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.

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S99


Third-party reimbursement

However, the Association also recognizes ensure that patients with diabetes can
References
that there may be a number of medica- readily comply with therapy in the widely 1. Centers for Disease Control and Preven-
tions and/or supplies within any given variable circumstances encountered in tion. National estimates and general infor-
class. As such, any controls should ensure daily life. These protections should guar- mation on diabetes and prediabetes in the U.S.,
that all classes of antidiabetic agents with antee access to an acceptable range and 2011. Atlanta, GA, U.S. Department of Health
unique mechanisms of action are avail- all classes of antidiabetic medications, and Human Services, Centers for Disease
able to facilitate achieving glycemic goals equipment, and supplies. Furthermore, Control and Prevention, 2011
to reduce the risk of complications. Sim- fair and reasonable appeals processes 2. American Diabetes Association: Economic
ilar issues operate in the management of should ensure that diabetic patients and costs of diabetes in the U.S. in 2007. Di-
lipid disorders, hypertension, and other their medical care practitioners can obtain abetes Care 31: 596615, 2008
cardiovascular risk factors, as well as for medications, equipment, and supplies 3. Clement S: Diabetes self-management ed-
ucation (Technical Review). Diabetes Care
other diabetes complications. Further- that are not contained within existent 18: 12041214, 1995
more, any controls should ensure that controls. 4. Funnell MM, Haas LB: National standards
all classes of equipment and supplies Diabetes management needs individ- for diabetes self-management education
designed for use with such equipment are ualization in order for patients to reach programs (Technical Review). Diabetes
available to facilitate achieving glycemic glycemic targets. Because there is diver- Care 18: 100116, 1995
goals to reduce the risk of complications. sity in the manifestations of the disease 5. American Diabetes Association: Standards
It is important to note that medical ad- and in the impact of other medical con- of medical care in diabetesd2012 (Position
vances are rapidly changing the landscape ditions upon diabetes, it is common that Statement). Diabetes Care 2012;35(Suppl.
of diabetes medications and supplies. To practitioners will need to uniquely tailor 1):S11S63
ensure that patients with diabetes have treatment for their patients. To reach 6. American Diabetes Association: National
standards for diabetes self-management ed-
access to benecial updates in treatment diabetes treatment goals, practitioners ucation (Standards and Review Criteria).
modalities, systems of controls must em- should have access to all classes of anti- Diabetes Care 31 (Suppl. 1): S97S104, 2008
ploy efcient mechanisms through which diabetic medications, equipment, and 7. Herman WH, Dasbach DJ, Songer TJ,
to introduce and approve new products. supplies without undue controls. With- Thompson DE, Crofford OB: Assessing
Though it can seem appropriate for out appropriate safeguards, these con- the impact of intensive insulin therapy on
controls to restrict certain items in chronic trols could constitute an obstruction of the health care system. Diabetes Rev 2: 384
disease management, particularly with a effective care. 388, 1994
complex disorder such as diabetes, it The value of self-management edu- 8. Wagner EH, Sandu N, Newton KM,
should be recognized that adherence is a cation and provision of diabetes supplies McCullock DK, Ramsey SD, Grothaus LC:
major barrier to achieving targets. Any has been acknowledged by the passage Effects of improved glycemic control on
health care costs and utilization. JAMA 285:
controls should take into account the of the Balanced Budget Act of 1997 (9) 182189, 2001
huge mental and physical burden that in- and by stated medical policy on both di- 9. Balanced Budget Act of 1997. U.S. Govt.
tensive disease management exerts upon abetes education and medical nutrition Printing Ofce, 1997, p. 115116 (publ.
patients with diabetes. Protections should therapy. no. 869-033-00034-1)

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S T A N D A R D S A N D R E V I E W C R I T E R I A

National Standards for Diabetes


Self-Management Education
MARTHA M. FUNNELL, MS, RN, CDE1 MARK PEYROT, PHD8 1. Diabetes education is effective for im-
TAMMY L. BROWN, MPH, RD, BC-ADM, CDE2 JOHN D. PIETTE, PHD9,10 proving clinical outcomes and quality
BELINDA P. CHILDS, ARNP, MN, CDE, BC-ADM3 DIANE READER, RD, CDE11 of life, at least in the short-term (17).
LINDA B. HAAS, PHC, CDE, RN4 LINDA M. SIMINERIO, PHD, RN, CDE
12
2. DSME has evolved from primarily di-
GWEN M. HOSEY, MS, ARNP, CDE5 KATIE WEINGER, EDD, RN7
BRIAN JENSEN, RPH6 MICHAEL A. WEISS, JD13 dactic presentations to more theoreti-
MELINDA MARYNIUK, MED, RD, CDE7 cally based empowerment models
(3,8).
3. There is no one best education pro-
gram or approach; however, programs

D
iabetes self-management education their appropriateness, relevance, and sci- incorporating behavioral and psycho-
(DSME) is a critical element of care entic basis. The Standards were then social strategies demonstrate improved
for all people with diabetes and is reviewed and revised based on the available outcomes (911). Additional studies
necessary in order to improve patient evidence and expert consensus. The com- show that culturally and age-appropriate
outcomes. The National Standards for mittee convened on 31 March 2006 and 9 programs improve outcomes (1216)
DSME are designed to dene quality di- September 2006, and the Standards were and that group education is effective
abetes self-management education and to approved 25 March 2007. (4,6,7,17,18).
assist diabetes educators in a variety of 4. Ongoing support is critical to sustain
settings to provide evidence-based edu- DEFINITION AND progress made by participants during
cation. Because of the dynamic nature of OBJECTIVESdDiabetes self-manage- the DSME program (3,13,19,20).
health care and diabetes-related research, ment education (DSME) is the ongoing 5. Behavioral goal-setting is an effective
these Standards are reviewed and revised process of facilitating the knowledge, strategy to support self-management
approximately every 5 years by key or- skill, and ability necessary for diabetes behaviors (21).
ganizations and federal agencies within self-care. This process incorporates the
the diabetes education community. needs, goals, and life experiences of the STANDARDS
A Task Force was jointly convened by person with diabetes and is guided by
the American Association of Diabetes Edu- evidence-based standards. The overall Structure
cators and the American Diabetes Associa- objectives of DSME are to support informed Standard 1. The DSME entity will have
tion in the summer of 2006. Additional decision-making, self-care behaviors, documentation of its organizational struc-
organizations that were represented in- problem-solving and active collaboration ture, mission statement, and goals and will
cluded the American Dietetic Association, with the health care team and to improve recognize and support quality DSME as an
the Veterans Health Administration, the clinical outcomes, health status, and qual- integral component of diabetes care.
Centers for Disease Control and Prevention, ity of life. Documentation of the DSME organi-
the Indian Health Service, and the American zational structure, mission statement, and
Pharmaceutical Association. Members of GUIDING PRINCIPLESdBefore goals can lead to efcient and effective
the Task Force included a person with the review of the individual Standards, provision of services. In the business
diabetes; several health services researchers/ the Task Force identied overriding prin- literature, case studies and case report
behaviorists, registered nurses, and registered ciples based on existing evidence that investigations on successful management
dietitians; and a pharmacist. would be used to guide the review and strategies emphasize the importance of
The Task Force was charged with revision of the DSME Standards. These clear goals and objectives, dened rela-
reviewing the current DSME standards for are: tionships and roles, and managerial sup-
port (2225). While this concept is
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c relatively new in health care, business
The previous version of the National Standards for Diabetes Self-Management Education was originally and health policy experts and organiza-
published in Diabetes Care 23:682689, 2000. This version received nal approval in March 2007. tions have begun to emphasize written
From the 1Department of Medical Education, Diabetes Research and Training Center, University of Michigan,
Ann Arbor, Michigan; 2Indian Health Service, Albuquerque, New Mexico; 3MidAmerica Diabetes Asso- commitments, policies, support, and the
ciates, Wichita, Kansas; the 4 VA Puget Sound Health Care System, Seattle, Washington; the 5Division of importance of outcome variables in qual-
Diabetes Translation, National Center for Chronic Diseases Prevention and Health Promotion, Centers for ity improvement efforts (22,2637). The
Disease Control and Prevention, Atlanta, Georgia; 6Lakeshore Apothacare, Two Rivers, Wisconsin; the continuous quality improvement literature
7
Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts; 8Loyola College, Baltimore,
Maryland; the 9VA Ann Arbor Health Care System, Ann Arbor, Michigan; the 10Department of Internal
also stresses the importance of developing
Medicine, Diabetes Research and Training Center, University of Michigan, Ann Arbor, Michigan; the policies, procedures, and guidelines
11
International Diabetes Center, Minneapolis, Minnesota; the 12Diabetes Institute, University of Pittsburgh (22,26).
Medical Center, Pittsburgh, Pennsylvania; and 13Patient Centered Solutions, Pittsburgh, Pennsylvania. Documentation of the organizational
Corresponding author: Martha M. Funnell, mfunnell@umich.edu. structure, mission statement, and goals
DOI: 10.2337/dc12-s101
2012 by the American Diabetes Association. Readers may use this article as long as the work is properly can lead to efcient and effective pro-
cited, the use is educational and not for prot, and the work is not altered. See http://creativecommons.org/ vision of DSME. Documentation of an orga-
licenses/by-nc-nd/3.0/ for details. nizational structure that delineates channels

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S101


Standards and Review Criteria

of communication and represents institu- with diabetes do not receive any formal di- and the registered pharmacist as the key
tional commitment to the educational en- abetes education (56,57). Thus, identica- primary instructors for diabetes education
tity is critical for success (3842). tion of access issues is an essential part of and members of the multidisciplinary
According to the Joint Commission on Ac- the assessment process (58). Demographic team responsible for designing the curric-
creditation of Health Care Organizations variables, such as ethnic background, age, ulum and assisting in the delivery of
(JCAHO) (26), this type of documentation formal educational level, reading ability, DSME (17,77). In addition to registered
is equally important for small and large and barriers to participation in education, nurses, registered dietitians, and
health care organizations. Health care must also be considered to maximize the pharmacists, a number of studies reect
and business experts overwhelmingly effectiveness of DSME for the target popu- the ever-changing and evolving health
agree that documentation of the process lation (1319,4347,5961). care environment and include other
of providing services is a critical factor in Standard 4. A coordinator will be desig- health professionals (e.g., a physician,
clear communication and provides a solid nated to oversee the planning, implementation, behaviorist, exercise physiologist, oph-
basis from which to deliver quality diabetes and evaluation of diabetes self-management thalmologist, optometrist, podiatrist)
education (22,26,33,3537). In 2005, education. The coordinator will have aca- (48,8084) and, more recently, lay health
JACHO published the Joint Commission demic or experiential preparation in chronic and community workers (8591) and
International Standards for Disease or disease care and education and in program peers (92) to provide information, behav-
Condition-Specic Care, which outlines management. ioral support, and links with the health care
national standards and performance The role of the coordinator is essential system as part of DSME.
measurements for diabetes and addresses to ensure that quality diabetes education Expert consensus supports the need
diabetes self-management education as is delivered through a coordinated and for specialized diabetes and educational
one of seven critical elements (26). systematic process. As new and creative training beyond academic preparation for
Standard 2. The DSME entity shall appoint methods to deliver education are explored, the primary instructors on the diabetes
an advisory group to promote quality. This the coordinator plays a pivotal role in team (64,9397). Certication as a diabe-
group shall include representatives from the ensuring accountability and continuity of tes educator by the National Certication
health professions, people with diabetes, the the educational process (23,6062). The Board for Diabetes Educators (NCBDE) is
community, and other stakeholders. individual serving as the coordinator will one way a health professional can demon-
Established and new systems (e.g., be most effective if there is familiarity strate mastery of a specic body of knowl-
committees, governing bodies, advisory with the lifelong process of managing a edge, and this certication has become an
groups) provide a forum and a mecha- chronic disease (e.g., diabetes) and with accepted credential in the diabetes com-
nism for activities that serve to guide and program management. munity (98). An additional credential that
sustain the DSME entity (30,3941). indicates specialized training beyond basic
Broad participation of organization(s) Process preparation is board certication in ad-
and community stakeholders, including Standard 5. DSME will be provided by one vanced Diabetes Management (BC-ADM)
health professionals, people with diabe- or more instructors. The instructors will have offered by the American Nurses Creden-
tes, consumers, and other community recent educational and experiential prepa- tialing Center (ANCC), which is available
interest groups, at the earliest possible ration in education and diabetes manage- for masters prepared nurses, dietitians,
moment in the development, ongoing ment or will be a certied diabetes and pharmacists (48,84,99).
planning, and outcomes evaluation educator. The instructor(s) will obtain reg- DSME has been shown to be most
process (22,26,33,35,36,41) can in- ular continuing education in the eld of di- effective when delivered by a multidisci-
crease knowledge and skills about the abetes management and education. At least plinary team with a comprehensive plan
local community and enhance collabo- one of the instructors will be a registered of care (7,31,52,100102). Within the
rations and joint decision-making. The nurse, dietitian, or pharmacist. A mecha- multidisciplinary team, team members
result is a DSME program that is patient- nism must be in place to ensure that the par- work interdependently, consult with
centered, more responsive to consumer- ticipants needs are met if those needs are one another, and have shared objectives
identied needs and the needs to the outside the instructors scope of practice (7,103,104). The team should have a col-
community, more culturally relevant, and and expertise. lective combination of expertise in the
of greater personal interest to consumers Diabetes education has traditionally clinical care of diabetes, medical nutrition
(4350). been provided by nurses and dietitians. therapy, educational methodologies,
Standard 3. The DSME entity will deter- Nurses have been utilized most often as teaching strategies, and the psychosocial
mine the diabetes educational needs of the instructors in the delivery of formal DSME and behavioral aspects of diabetes self-
target population(s) and identify resources (2,3,5,6367). With the emergence of management. A referral mechanism
necessary to meet these needs. medical nutrition therapy (6670), regis- should be in place to ensure that the in-
Clarifying the target population and tered dietitians became an integral part of dividual with diabetes receives education
determining its self-management educa- the diabetes education team. In more re- from those with appropriate training and
tional needs serve to focus resources and cent years, the role of the diabetes educator credentials. It is essential in this collabo-
maximize health benets (5153). The as- has expanded to other disciplines, particu- rative and integrated team approach that
sessment process should identify the ed- larly pharmacists (7379). Reviews com- individuals with diabetes are viewed as
ucational needs of all individuals with paring the effectiveness of different leaders of their team and assume an active
diabetes, not just those who frequently disciplines for education report mixed re- role in designing their educational expe-
attend clinical appointments (51). DSME sults (3,5,6). Generally, the literature fa- rience (7,20,31,100102,104).
is a critical component of diabetes treatment vors current practice that utilizes the Standard 6. A written curriculum reect-
(2,54,55), yet the majority of individuals registered nurse, registered dietitian, ing current evidence and practice guidelines,

S102 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Standards and Review Criteria

with criteria for evaluating outcomes, will and patient-centered have been shown to calls), may augment face-to-face assess-
serve as the framework for the DSME entity. be effective (83,119,121,122,125127). ments (97,99).
Assessed needs of the individual with pre- These content areas are presented in While there is little direct evidence on
diabetes and diabetes will determine which behavioral terms and thereby exemplify the impact of documentation on patient
of the content areas listed below are to be the importance of action-oriented, behav- outcomes, it is required to receive pay-
provided: ioral goals and objectives (13,21,55,121 ment for services. In addition, documen-
123,128,129). Creative, patient-centered tation of patient encounters guides the
c Describing the diabetes disease process experience-based delivery methods are educational process, provides evidence of
and treatment options effective for supporting informed decision- communication among instructional
c Incorporating nutritional management making and behavior change and go be- staff, may prevent duplication of services,
into lifestyle yond the acquisition of knowledge. and provides information on adherence
c Incorporating physical activity into life- Standard 7. An individual assessment and to guidelines (37,64,100,131,153). Pro-
style education plan will be developed collabora- viding information to other members of
c Using medication(s) safely and for maxi- tively by the participant and instructor(s) to the patients health care team through
mum therapeutic effectiveness direct the selection of appropriate educa- documentation of educational objectives
c Monitoring blood glucose and other pa- tional interventions and self-management and personal behavioral goals increases
rameters and interpreting and using the support strategies. This assessment and edu- the likelihood that all of the members
results for self-management decision cation plan and the intervention and out- will address these issues with the patient
making comes will be documented in the education (37,98,153).
c Preventing, detecting, and treating acute record. The use of evidence-based performance
complications Multiple studies indicate the impor- and outcome measures has been adopted
c Preventing detecting, and treating chronic tance of individualizing education based by organizations and initiatives such as the
complications on the assessment (1,56,68,131135). Centers for Medicare and Medicaid Services
c Developing personal strategies to ad- The assessment includes information (CMS), the National Committee for Quality
dress psychosocial issues and con- about the individuals relevant medical Assurance (NCQA), the Diabetes Quality
cerns history, age, cultural inuences, health Improvement Project (DQIP), the Health
c Developing personal strategies to pro- beliefs and attitudes, diabetes knowledge, Plan Employer Data and Information Set
mote health and behavior change self-management skills and behaviors, (HEDIS), the Veterans Administration
readiness to learn, health literacy level, Health System, and JCAHO (26,154).
People with diabetes and their families physical limitations, family support, and Research suggests that the develop-
and caregivers have a great deal to learn in nancial status (1017,19,131,136 ment of standardized procedures for doc-
order to become effective self-managers of 138). The majority of these studies sup- umentation, training health professionals
their diabetes. A core group of topics are port the importance of attitudes and to document appropriately, and the use of
commonly part of the curriculum taught health beliefs in diabetes care outcomes structured standardized forms based on
in comprehensive programs that have (1,68,134,135,138,139). current practice guidelines can improve
demonstrated successful outcomes In addition, functional health literacy documentation and may ultimately im-
(1,2,3,6,105109). The curriculum, a co- (FHL) level can affect patients self- prove quality of care (100,153155).
ordinated set of courses and educational management, communication with clini- Standard 8. A personalized follow-up plan
experiences, includes learning outcomes cians, and diabetes outcomes (140,141). for ongoing self management support will be
and effective teaching strategies (110 Simple tools exist for measuring FHL as developed collaboratively by the participant
112). The curriculum is dynamic and part of an overall assessment process and instructor(s). The patients outcomes
needs to reect current evidence and (142144). and goals and the plan for ongoing self man-
practice guidelines (112117). Current Many people with diabetes experi- agement support will be communicated to
educational research reects the impor- ence problems due to medication costs, the referring provider.
tance of emphasizing practical, prob- and asking patients about their ability While DSME is necessary, it is not
lem-solving skills, collaborative care, to afford treatment is important (144). sufcient for patients to sustain a lifetime
psychosocial issues, behavior change, Comorbid chronic illness (e.g., depres- of diabetes self-care (55). Initial improve-
and strategies to sustain self-management sion and chronic pain) as well as more ments in metabolic and other outcomes
efforts (31,39,42,48,98,118122). general psychosocial problems can pose diminish after ;6 months (3). To sustain
The content areas delineated above signicant barriers to diabetes self- behavior at the level of self-management
provide instructors with an outline for management (104,146151); consider- needed to effectively manage diabetes,
developing this curriculum. It is impor- ing these issues in the assessment may most patients need ongoing diabetes
tant that the content be tailored to match lead to more effective planning (149 self-management support (DSMS).
each individuals needs and adapted as 151). DSMS is dened as activities to assist
necessary for age, type of diabetes (includ- Periodic reassessment determines at- the individual with diabetes to implement
ing pre-diabetes and pregnancy), cultural tainment of the educational objectives or and sustain the ongoing behaviors needed
inuences, health literacy, and other co- the need for additional and creative in- to manage their illness. The type of support
morbidities (123,124). The content areas terventions and future reassessment provided can include behavioral, educa-
are designed to be applicable in all settings (7,97,100,152). A variety of assessment tional, psychosocial, or clinical (13,121
and represent topics that can be developed modalities, including telephone follow- 123).
in basic, intermediate, and advanced levels. up and other information technologies A variety of strategies are available
Approaches to education that are interactive (e.g., Web-based, automated phone for providing DSMS both within and

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S103


Standards and Review Criteria

outside the DSME entity. Some patients The AADE Outcome Standards for Di- MD, CDE, of the American Diabetes Associa-
benet from working with a nurse case abetes Education specify self-management tion; Lori Porter, MBA, RD, CAE, of the
manager (7,20,98,157). Case manage- behavior as the key outcome (112,160). American Association of Diabetes Educators;
ment for DSMS can include reminders Knowledge is an outcome to the degree and Karmeen Kulkarni, MS, RD, BC-ADM,
Past President, Health Care and Education of
about needed follow-up care and tests, that it is actionable (i.e., knowledge that
the American Diabetes Association; Malinda
medication management, education, be- can be translated into self-management be- Peeples, MS, RN, CDE, Past President of the
havioral goal-setting, and psychosocial havior). In turn, effective self-management is American Association of Diabetes Educators;
support/ connection to community re- one (but not the only) contributor to longer- and Carole Mensing, RN, MA, CDE, for their
sources. term, higher-order outcomes such as clinical insights and helpful suggestions.
The effectiveness of providing DSMS status (e.g., control of glycemia, blood pres- We also gratefully acknowledge the work of
through disease-management programs, sure, and cholesterol), health status (e.g., the previous Task Force for the National
trained peers and health community avoidance of complications), and subjective Standards for DSME: Carole Mensing, RN,
workers, community-based programs, quality of life. Thus, patient self-manage- MA, CDE; Jackie Boucher, MS, RD, LD, CDE;
use of technology, ongoing education ment behaviors are at the core of the out- Marjorie Cypress, MS, C-ANP, CDE; Katie
Weinger, EdD, RN; Kathryn Mulcahy, MSN,
and support groups, and medical nutri- comes evaluation.
RN, CDE; Patricia Barta, RN, MPH, CDE;
tion therapy has also been established Standard 10. The DSME entity will mea- Gwen Hosey, MS, ARNP, CDE; Wendy Kopher,
(7,13,8992,101,121123,158159). sure the effectiveness of the education process RN, C, CDE, HTP; Andrea Lasichak, MS, RD,
While the primary responsibility for and determine opportunities for improvement CDE; Betty Lamb, RN, MSN; Mavourneen
diabetes education belongs to the DSME using a written continuous quality improve- Mangan, RN, MS, ANP, C, CDE; Jan Norman,
entity, patients benet by receiving re- ment plan that describes and documents a sys- RD, CDE; Jon Tanja, BS, MS, RPH; Linda Yauk,
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142. Nurss JR, Parker R, Williams M, Baker D: Joint Commission Journal on Quality and 164. Institute of Healthcare Improvement: Mea-
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tions to identify patients with inadequate training, equipment and supplies: past, 2006

S108 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Professional Practice Committee 2012
Conict of interest disclosures

Other research
Member Employment Research grant support
Roger Austin, MS, RPH, CDE Henry Ford Health System, Sterling None None
Heights, MI
Susan Braithwaite, MD Endocrine Consultants & Care S.C., None None
Evanston, IL
Martha Funnell, MSN, RN, CDE University of Michigan, NIDDK, NIH, Peers for Progress None
Ann Arbor, MI

Robert Gabbay, MD Pennsylvania State College of Medicine, NIDDK*, AHRQ* None


Hershey, PA
Richard Grant, MD, MPH Massachusetts General Hospital, None None
Boston, MA
Jane Kadohiro, DrPH, APRN, CDE The Queens Medical Center, None None
Honolulu, HI
James Lenhard, MD Christiana Care Health System Clinical pharmacology trials None
with Macrogenics, sano-aventis,
Lexicon, AstraZeneca*#
Daniel Lorber, MD Queens Diabetes and Endocrinology, Eli Lilly*, Johnson & Johnson*, None
Flushing, NY Novo Nordisk*
Michelle Magee, MD Medstar Diabetes Institute, sano-aventis*, Johnson & Johnson, None
Washington, DC Bayer, ESAI*, Boehringer Ingelheim*,
Microsoft, GE*, ADA*

Sunder Mudaliar, MD VA San Diego Healthcare System, sano-aventis*#, Amylin*#, None


San Diego, CA Daiichi-Sankyo*#, Astra-Zeneca*#

Patrick OConnor, MD, MPH HealthPartners Research Foundation, NHLBI/NIH*, NIDDK/NIH* Agency for None
Bloomington, MD Healthcare Research and Quality*,
National Institute of Mental
Health/NIH*

R. Harsha Rao, MD University of Pittsburg, Pittsburg, PA None None

Andrew Rhinehart, MD, CDE Johnston Memorial Diabetes Center, None None
Abingdon, VA

Stuart Weinzimer, MD Yale University, New Haven, CT None None

Carol Wysham, MD (Chair) Rockwood Clinic, Spokane, WA None None

Gretchen Youssef, MS, RD, CDE Medstar Diabetes Institute, None None
Washington, DC
Judy Fradkin, MD (Ex ofcio) NIDDK, Bethesda, MD None None
Stephanie Dunbar, RD, MPH (Staff) ADA, Alexandria, VA None None
Sue Kirkman, MD (Staff) ADA, Alexandria, VA None None

Updated as of 20 October 2011. *$$10,000. #money goes to employer. xPatent application led by VA Technology Transfer Program, DC01-#145823-v1-066072-
0050, System and Method for Automated Diabetes Control (Rao RH, Perreiah PL, Cunningham CA, Inventors). ADA, American Diabetes Association; AHRQ, Agency
for Healthcare Research and Quality; CME, continuing medical education; DSME, diabetes self-management education; ESAI, Endogenous Stem Cells Activators Inc.;
NDEP, National Diabetes Education Program; NHLBI, National Heart Lung and Blood Institute; NIDDK, National Institute of Diabetes and Digestive and Kidney
Diseases; NIH, National Institutes of Health; SHM, Society of Hospital Medicine.

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 S109


Professional Practice Committee

Speakers bureau/
Member honoraria Ownership interest Consultant/advisory board Other
R.A. None None Amylin Pharmaceuticals, Takeda None
Pharmaceuticals
S.B. None None None None

M.F. None None Eli Lilly, Halozyne Therapeutics, NDEP Chair*


Bristol-Myers Squibb/AstraZeneca
Diabetes, Hygeia Inc., Boehringer
Ingelheim, Johnson & Johnson,
Animas/LifeScan, Intuity Medical,
Bayer
R.G. None None Roche None

R.G. None None Joslin Diabetes Center None

J.K. Johnson & Johnson None None None


Diabetes Institute
J.L. AstraZeneca, Amylin, None sano-aventis Expert witness for
Merck, sano-aventis variety of legal rms

D.L. Novo Nordisk* Biodel* Novo Nordisk*, Merck* Biodel (Board of


Directors)*
M.M. sano-aventis*, Novo None sano-aventis*, SHM D.C. Department of
Nordisk# Health* (Community
Education), Medscape
(CME Program),
Novo Nordisk*
(Education Program)
S.M. American College of Physicians, None Daiichi-Sankyo None
Bristol-Myers Squibb/
AstraZeneca, Boehringer
Ingelheim,
P.O. Park Nicollett Medical Center#, Equity interest in SimCare None Patent pending on
ADA Postgraduate Course# Health to market decision software for clinical
support technology decision support
(company about to related to diabetes
be formed) care
R.R. None Co-inventor of GENIE. No None None
commercial agreements
or collaborationsx
A.R. Forest Laboratories*, Takeda, None sano-aventis, Valeritas National Standard
Abbott Laboratories, Eli Lilly, DSME Update
Novo Nordisk*, sano-aventis Workgroup
S.W. Eli Lilly None Animas/LifeScan, Becton-Dickinson, None
Medtronic, Novo Nordisk
C.W. Amylin Pharmaceuticals*, Eli Lilly*, None Amylin Pharmaceuticals*, None
Merck*, Novo Nordisk*, Boehringer Ingelheim, Eli Lilly*,
sano-aventis*, Boehringer Johnson & Johnson
Ingelhiem
G.Y. None None Novo Nordisk, Bayer Diagnostics None

J.F. None None None None


S.D. None None None None
S.K. None None None None

S110 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Systematic Reviews

A technical review is a balanced review mellitus: a systematic review. Diabetes Neuropathy


and analysis of the literature on a scien- Care 33:18721894, 2010 Vinik AI, Maser RE, Mitchell BD, Freeman
tic or medical topic related to diabetes. R: Diabetic autonomic neuropathy. Dia-
The technical review provides a scien- Exercise betes Care 26:15531579, 2003
tic rationale for a position statement and Sigal RJ, Kenny GP, Wasserman DH,
undergoes critical peer review before sub- Castaneda-Sceppa C: Physical activity/ Boulton AJ, Malik RA, Arezzo JC, Sosenko
mission to the Professional Practice Com- exercise and type 2 diabetes. Diabetes JM: Diabetic somatic neuropathies. Dia-
mittee for approval. Effective January Care 27:25182539, 2004 betes Care 27:14581486, 2004
2010, technical reports were replaced
Hospitals
with systematic reviews, for which a pri- Clement S, Braithwaite SS, Magee MF, Retinopathy
ori search and inclusion/exclusion criteria Fong DS, Aiello LP, Ferris FL III, Klein R:
Ahmann A, Smith EP, Schafer RG, Hirsh
are developed and published. Listed be-
IB: Management of diabetes and hyper- Diabetic retinopathy. Diabetes Care 27:
low are recent reviews. glycemia in hospitals. Diabetes Care 27: 25402553, 2004
553591, 2004
Cost-Effectiveness of Diabetes Inter- Tests of Glycemia
ventions Hypoglycemia Goldstein DE, Little RR, Lorenz RA,
Li R, Zhang P, Barker LE, Chowdhury Cryer PE, Davis SN, Shamoon H: Hypo- Malone JI, Nathan D, Peterson CM, Sacks
FM, Zhang X: Cost-effectiveness of inter- glycemia in diabetes. Diabetes Care 26: DB: Tests of glycemia in diabetes. Diabetes
ventions to prevent and control diabetes 19021912, 2003 Care 27:17611773, 2004

e110 DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 care.diabetesjournals.org


Consensus Reports

Effective January 2010, prior reports of the types listed below were renamed consensus reports.
EXPERT COMMITTEE REPORTS Diabetes Care 33:16741685, 2010
International Expert Committee Re- Lipoprotein Management in Patients
port on the Role of the A1C Assay in Medical Management of Hyperglyce- With Cardiometabolic Risk: Consen-
the Diagnosis of Diabetes mia in Type 2 Diabetes: A Consensus sus Statement From the American Di-
International Expert Committee Algorithm for the Initiation and Ad- abetes Association and the American
Diabetes Care 32:13271334, 2009 justment of Therapy: A Consensus College of Cardiology Foundation
Statement of the American Diabetes John D. Brunzell, Michael Davidson, Curt
Follow-Up Report on the Diagnosis of Association and the European Associa- D. Furberg, Ronald B. Goldberg, Barbara
Diabetes Mellitus tion for the Study of Diabetes V. Howard, James H. Stein, and Joseph L.
Expert Committee on the Diagnosis and David M. Nathan, John B. Buse, Mayer B. Witztum
Classication of Diabetes Davidson, Ele Ferrannini, Rury R. Hol- Diabetes Care 31:811822, 2008
Diabetes Care 26:31603167, 2003 man, Robert Sherwin, and Bernard Zin-
man Managing Preexisting Diabetes for
Pregnancy: Summary of Evidence and
WORKGROUP REPORTS Diabetes Care 32:193203, 2009 Consensus Recommendations for Care
The Charcot Foot in Diabetes John L. Kitzmiller, Jennifer M. Block,
Lee C. Rogers, Robert G. Frykberg, David American Association of Clinical Endo- Florence M. Brown, Patrick M. Catalano,
G. Armstrong, Andrew J.M. Boulton, crinologists and American Diabetes As- Deborah L. Conway, Donald R. Coustan,
Michael Edmonds, Georges Ha Van, sociation Consensus Statement on Erica P. Gunderson, William H. Herman,
Agnes Hartemann, Frances Game, William Inpatient Glycemic Control Lisa D. Hoffman, Maribeth Inturrisi, Lois
Jeffcoate,Alexandra Jirkovska, Edward Jude, Etie S. Moghissi, Mary T. Korytkowski, B. Jovanovic, Siri I. Kjos, Robert H. Knopp,
Stephan Morbach, William B. Morrison, Monica DiNardo, Daniel Einhorn, Ri- Martin N. Montoro, Edward S. Ogata,
Michael Pinzur, Dario Pitocco, Lee Sanders, chard Hellman, Irl B. Hirsch, Silvio E. Pathmaja Paramsothy, Diane M. Reader,
Dane K. Wukich, and Luigi Uccioli Inzucchi, Faramarz Ismail-Beigi, M. Sue Barak M. Rosenn, Alyce M. Thomas, and
Diabetes Care 34:21232129, 2011 Kirkman, and Guillermo E. Umpierrez M. Sue Kirkman
Diabetes Care 32:11191131, 2009 Diabetes Care 31:10601079, 2008
Comprehensive Foot Examination and
Risk Assessment: a Report of the Task
Hyperglycemic Crises in Adult Pa-
Force of the Foot Care Interest Group Inuence of Race, Ethnicity, and Culture
tients With Diabetes
of the American Diabetes Association, on Childhood Obesity: Implications for
Abbas E. Kitabchi, Guillermo E. Umpier-
With Endorsement by the American Prevention and Treatment: A Consensus
rez, John M. Miles, and Joseph N. Fisher
Association of Clinical Endocrinolo- Statement of Shaping Americas Health
Diabetes Care 32:13351343, 2009
gists and the Obesity Society
Andrew J.M. Boulton, David G. Armstrong, Sonia Caprio, Stephen R. Daniels, Adam
Stephen F. Albert, Robert G. Frykberg, How Do We Dene Cure of Diabetes? Drewnowski, Francine R. Kaufman, Law-
Richard Hellman, M. Sue Kirkman, John B. Buse, Sonia Caprio, William T. rence A. Palinkas, Arlan L. Rosenbloom,
Lawrence A. Lavery, Joseph W. LeMaster, Cefalu, Antonio Ceriello, Stefano Del and Jeffrey B. Schwimmer
Joseph L. Mills, Sr., Michael J. Mueller, Prato, Silvio E. Inzucchi, Sue McLaughlin, Diabetes Care 31:22112221, 2008
Peter Sheehan, and Dane K. Wukich Gordon L. Phillips II, R. Paul Robertson,
Diabetes Care 31:16791685, 2008 Francesco Rubino, Richard Kahn, and M. Screening for Coronary Artery Disease
Sue Kirkman. in Patients With Diabetes
American Diabetes Association State- Diabetes Care 32:21332135, 2009 Jeroen J. Bax, Lawrence H. Young, Robert
ment on Emergency and Disaster Pre- L. Frye, Robert O. Bonow, Helmut O.
paredness: a Report of the Disaster Management of Hyperglycemia in Type Steinberg, and Eugene J. Barrett
Response Task Force 2 Diabetes: A Consensus Algorithm Diabetes Care 30:27292736, 2007
Disaster Response Task Force for the Initiation and Adjustment of
Diabetes Care 30:23952398, 2007 Therapy: Update Regarding Thiazo- Consensus Statement on the World-
lidinediones: a Consensus Statement wide Standardization of the Hemoglo-
CONSENSUS REPORTS From the American Diabetes Associa- bin A1C Measurement: the American
Diabetes and Cancer tion and the European Association for Diabetes Association, European Asso-
Edward Giovannucci, David M. Harlan, the Study of Diabetes ciation for the Study of Diabetes,
Michael C. Archer, Richard M. Bergenstal, David M. Nathan, John B. Buse, Mayer B. International Federation of Clinical
Susan M. Gapstur, Laurel A. Habel, Mi- Davidson, Ele Ferrannini, Rury R. Holman, Chemistry and Laboratory Medicine,
chael Pollak, Judith G. Regensteiner, and Robert Sherwin, and Bernard Zinman and the International Diabetes Federa-
Douglas Yee Diabetes Care 31:173175, 2008 tion

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1 JANUARY 2012 e111


Consensus Committee Waist Circumference and Cardiometa- Impaired Fasting Glucose and Im-
Diabetes Care 30:23992400, 2007 bolic Risk: a Consensus Statement paired Glucose Tolerance: Implica-
From Shaping Americas Health: Asso- tions for Care
Use of Insulin Pump Therapy in the Pe- ciation for Weight Management and David M. Nathan, Mayer B. Davidson,
diatric Age-Group: Consensus State- Obesity Prevention; NAASO, The Obe- Ralph A. DeFronzo, Robert J. Heine,
ment From the European Society for sity Society; the American Society for Robert R. Henry, Richard Pratley, and
Paediatric Endocrinology, the Lawson Nutrition; and the American Diabetes Bernard Zinman
Wilkins Pediatric Endocrine Society, Association Diabetes Care 30:753759, 2007
and the International Society for Pedi- Samuel Klein, David B. Allison, Steven B.
atric and Adolescent Diabetes, En- Heymseld, David E. Kelley, Rudolph L.
dorsed by the American Diabetes Leibel, Cathy Nonas, and Richard Kahn
Association and the European Associa- Diabetes Care 30:16471652, 2007 Diabetic Ketoacidosis in Infants, Chil-
tion for the Study of Diabetes dren, and Adolescents: A Consensus
Moshe Phillip, Tadej Battelino, Henry Computer Modeling of Diabetes and Statement From the American Diabe-
Rodriguez, Thomas Danne, Francine Its Complications: a Report on the tes Association
Kaufman for the Consensus forum par- Fourth Mount Hood Challenge Meeting Joseph Wolfsdorf, Nicole Glaser, and
ticipants The Mount Hood 4 Modeling Group Mark A. Sperling
Diabetes Care 30:16531662, 2007 Diabetes Care 30:16381646, 2007 Diabetes Care 29:11501159, 2006

e112 DIABETES CARE, VOLUME 35, SUPPLEMENT 1 JANUARY 2012 care.diabetesjournals.org


Position Statements

A position statement is an ofcial point Association, a Scientic Statement Diabetes Care 32:187192, 2009
of view or belief of the ADA. Position of the American Heart Association,
statements are issued on scientic or and an Expert Consensus Document Nutrition Recommendations and
medical issues related to diabetes. They of the American College of Interventions for Diabetes: A Position
may be authored or unauthored and are Cardiology Foundation Statement of the American Diabetes
published in ADA journals and other Michael Pignone, Mark J. Alberts, John A. Association
scientic/medical publications as appro- Colwell, Mary Cushman, Silvio E. Inzuc- American Diabetes Association
priate. Position statements must be re- chi, Debabrata Mukherjee, Robert S. Diabetes Care 31 (Suppl. 1):S61S78, 2008
viewed and approved by the Professional Rosenson, Craig D. Williams, Peter W.
Practice Committee and, subsequently, Wilson, and M. Sue Kirkman Generic Drugs: A Position Statement
by the Executive Committee of the Board Diabetes Care 33:13951402, 2010 of the American Diabetes
of Directors. ADA position statements are Association
typically based on a technical review or Exercise and Type 2 Diabetes: The American Diabetes Association
other review of published literature. They American College of Sports Medicine Diabetes Care 30:173, 2007
are reviewed on an annual basis and upda- and the American Diabetes
ted as needed. In addition to those pub- Association: Joint Position Pancreas and Islet Transplantation
lished in this supplement, listed below are Statement in Type 1 Diabetes: A Position
recent position statements. Sheri R. Colberg, Ronald J. Sigal, Bo Fern- of the American
hall, Judith G. Regensteiner, Bryan J. Diabetes Association
Laboratory Analysis in the Diagnosis Blissmer, Richard R. Rubin, Lisa Chasan- American Diabetes Association
and Management of Diabetes Mellitus Taber, Ann L. Albright, and Barry Braun Diabetes Care 29:935, 2006
David B. Sacks, Mark Arnold, George L. Diabetes Care 33:e147e167, 2010
Bakris, David E. Bruns, Andrea Rita The Metabolic Syndrome: Time for a
Horvath,M. Sue Kirkman, Ake Lernmark, Clinical Care Guidelines for Cystic Critical Appraisal: Joint Statement
Boyd E. Metzger, and David M. Nathan FibrosisRelated Diabetes: A From the American Diabetes
Diabetes Care 34:14191423, 2011 Position Statement of the American Association and the European
Diabetes Association and a Clinical Association for the Study of
Practice Guideline of the Cystic Diabetes
Recommendations for Transition Fibrosis Foundation, Endorsed by Richard Kahn, John Buse, Ele Ferrannini,
From Pediatric to Adult Diabetes the Pediatric Endocrine Society and Michael Stern
Care Systems: Antoinette Moran, Carol Brunzell, Richard Diabetes Care 28:2289, 2005
A position statement of the American C. Cohen, Marcia Katz, Bruce C. Marshall,
Diabetes Association, with representation Gary Onady, Karen A. Robinson, Kathryn Diabetic Neuropathies: A Statement
by the American College of Osteopathic A. Sabadosa, Arlene Stecenko, and Bonnie by the American Diabetes
Family Physicians, the American Acad- Slovis, the CFRD Guidelines Committee Association
emy of Pediatrics, the American Associ- Diabetes Care 33:26972708, 2010 Andrew J.M. Boulton, Arthur I. Vinik, Jo-
ation of Clinical Endocrinologists, the seph C. Arezzo, Vera Bril, Eva L. Feldman,
American Osteopathic Association, the Intensive Glycemic Control and the Roy Freeman, Rayaz A. Malik, Raelene
Centers for Disease Control and Prevention, Prevention of Cardiovascular Events: E. Maser, Jay M. Sosenko, and Dan Ziegler
Children with Diabetes, The Endocrine So- Implications of the ACCORD, Diabetes Care 28:956, 2005
ciety, the International Society for Pediatric ADVANCE, and VA Diabetes Trials:
and Adolescent Diabetes, Juvenile Diabetes A Position Statement of the Care of Children and Adolescents
Research FoundationInternational, the American Diabetes Association and With Type 1 Diabetes: A Statement
National Diabetes Education Program, and a Scientic Statement of the of the American Diabetes
the Pediatric Endocrine Society (formerly American College of Cardiology Association
Lawson Wilkins Pediatric Endocrine Society) Foundation and the American Heart Janet Silverstein, Georgeanna Klingen-
Diabetes Care 34:24772485, 2011 Association smith, Kenneth Copeland, Leslie Plot-
Jay S. Skyler, Richard Bergenstal, Robert nick, Francine Kaufman, Lori Laffel, Larry
Aspirin for Primary Prevention of O. Bonow, John Buse, Prakash Deedwania, Deeb, Margaret Grey, Barbara Anderson,
Cardiovascular Events in People Edwin A.M. Gale, Barbara V. Howard, Lea Ann Holzmeister, and Nathaniel
With Diabetes: A Position Statement M. Sue Kirkman, Mikhail Kosiborod, Peter Clark
of the American Diabetes Reaven, and Robert S. Sherwin Diabetes Care 28:186, 2005

care.diabetesjournals.org DIABETES CARE, VOLUME 35, SUPPLEMENT 1, JANUARY 2012 e113

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