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ADA 2011

ADA 2011

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StandardsofMedicalCareinDiabetes—2011
A
MERICAN
D
IABETES
A
SSOCIATION
CONTENTS
I. CLASSIFICATION AND DIAGNOSISOF DIABETES, p. S12 A. Classification of diabetesB. Diagnosis of diabetesC. Categories of increased risk for di-abetes (prediabetes)II. TESTING FOR DIABETES IN ASYMP-TOMATIC PATIENTS, p. S13 A. Testingfortype2diabetesandriskof future diabetes in adultsB. Testing for type 2 diabetes in chil-drenC. Screening for type 1 diabetesIII. DETECTION AND DIAGNOSIS OFGESTATIONAL DIABETES MELLI-TUS, p. S15IV. PREVENTION/DELAY OF TYPE 2DIABETES, p. S16 V. DIABETES CARE, p. S16 A. Initial evaluationB. ManagementC. Glycemic control1. Assessment of glycemic controla. Glucose monitoringb. A1C2. Glycemic goals in adultsD. Pharmacologic and overall ap-proaches to treatment1. Therapy for type 1 diabetes2. Therapy for type 2 diabetesE. Diabetes self-management educa-tionF. Medical nutrition therapyG. Physical activityH. Psychosocial assessment and careI. When treatment goals are not met J. HypoglycemiaK. Intercurrent illnessL. Bariatric surgeryM. Immunization VI. PREVENTIONANDMANAGEMENTOF DIABETES COMPLICATIONS, p.S27 A. Cardiovascular disease1. Hypertension/blood pressurecontrol2. Dyslipidemia/lipid management3. Antiplatelet agents4. Smoking cessation5. Coronary heart disease screen-ing and treatmentB. Nephropathy screening and treat-mentC. Retinopathy screening and treat-mentD. Neuropathy screening and treat-mentE. Foot care VII. DIABETESCAREINSPECIFICPOP-ULATIONS, p. S38 A. Children and adolescents1. Type 1 diabetesGlycemic controla. Screeningandmanagementof chroniccomplicationsinchil-dren and adolescents withtype 1 diabetesi. Nephropathyii. Hypertensioniii. Dyslipidemiaiv. Retinopathyv. Celiac diseasevi. Hypothyroidismb. Self-managementc. School and day cared. Transition from pediatric toadult care2. Type 2 diabetes3. Monogenic diabetes syndromesB. Preconception careC. Older adultsD. Cystic fibrosis–related diabetes VIII. DIABETES CARE IN SPECIFICSETTINGS, p. S43 A. Diabetes care in the hospital1. Glycemic targets in hospitalizedpatients2. Anti-hyperglycemic agents inhospitalized patients3. Preventing hypoglycemia4. Diabetes care providers in thehospital5. Self-managementinthehospital6. Diabetes self-management edu-cation in the hospital7. Medical nutrition therapy in thehospital8. Bedside blood glucose monitor-ing9. Discharge planningIX. STRATEGIES FOR IMPROVING DI- ABETES CARE, p. S46
D
iabetes is a chronic illness that re-quires continuing medical care andongoing patient self-managementeducation and support to prevent acutecomplications and to reduce the risk of long-term complications. Diabetes care iscomplex and requires that many issues,beyondglycemiccontrol,beaddressed.Alarge body of evidence exists that sup-ports a range of interventions to improvediabetes outcomes.These standards of care are intendedto provide clinicians, patients, research-ers, payors, and other interested individ-uals with the components of diabetescare, general treatment goals, and tools toevaluate the quality of care. While indi-vidual preferences, comorbidities, andother patient factors may require modifi-cation of goals, targets that are desirablefor most patients with diabetes are pro-vided. These standards are not intendedtoprecludeclinicaljudgmentormoreex-tensiveevaluationandmanagementofthepatient by other specialists as needed.For more detailed information aboutmanagement of diabetes, refer to refer-ences 1–3.The recommendations included arescreening,diagnostic,andtherapeuticac-tions that are known or believed to favor-ably affect health outcomes of patientswithdiabetes.Agradingsystem(Table1),developed by the American Diabetes As-sociation (ADA) and modeled after exist-ing methods, was utilized to clarify andcodify the evidence that forms the basisfortherecommendations.Thelevelofev-idence that supports each recommenda-
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Originally approved 1988. Most recent review/revision October 2010.DOI: 10.2337/dc11-S011© 2011 by the American Diabetes Association. Readers may use this article as long as the work is properlycited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.
P O S I T I O N S T A T E M E N T
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tion is listed after each recommendationusing the letters A, B, C, or E.These standards of care are revisedannually by the ADA’s multidisciplinaryProfessional Practice Committee, incor-porating new evidence. Members of theProfessionalPracticeCommitteeandtheirdisclosedconflictsofinterestarelistedonpage S97. Subsequently, as with all Posi-tion Statements, the standards of care arereviewed and approved by the ExecutiveCommittee of ADA’s Board of Directors.
I. CLASSIFICATION ANDDIAGNOSIS OF DIABETES
 A. Classification of diabetes
The classification of diabetes includesfour clinical classes:
Type 1 diabetes (results from
-cell de-struction, usually leading to absoluteinsulin deficiency)
Type2diabetes(resultsfromaprogres-sive insulin secretory defect on thebackground of insulin resistance)
Other specific types of diabetes due toother causes, e.g., genetic defects in
-cell function, genetic defects in insu-lin action, diseases of the exocrine pan-creas(suchascysticfibrosis),anddrug-or chemical-induced (such as in thetreatment of HIV/AIDS or after organtransplantation)
Gestational diabetes mellitus (GDM)(diabetes diagnosed during pregnancythat is not clearly overt diabetes)Some patients cannot be clearly classifiedas having type 1 or type 2 diabetes. Clin-ical presentation and disease progressionvary considerably in both types of diabe-tes. Occasionally, patients who otherwisehavetype2diabetesmaypresentwithke-toacidosis. Similarly, patients with type 1diabetes may have a late onset and slow(but relentless) progression of disease de-spite having features of autoimmune dis-ease. Such difficulties in diagnosis mayoccur in children, adolescents, andadults. The true diagnosis may becomemore obvious over time.
B. Diagnosis of diabetes
Fordecades,thediagnosisofdiabeteswasbased on plasma glucose criteria, eitherthe fasting plasma glucose (FPG) or the2-h value in the 75-g oral glucose toler-ance test (OGTT) (4).In 2009, an International ExpertCommittee that included representativesof the ADA, the International DiabetesFederation (IDF), and the European As-sociation for the Study of Diabetes(EASD)recommendedtheuseoftheA1Ctesttodiagnosediabetes,withathresholdof 
Ն
6.5% (5), and ADA adopted this cri-terion in 2010 (4). The diagnostic testshould be performed using a method thatis certified by the National Glycohemo-globin Standardization Program (NGSP)and standardized or traceable to the Dia-betes Control and Complications Trial(DCCT) reference assay. Point-of-care A1Cassaysarenotsufficientlyaccurateatthis time to use for diagnostic purposes.Epidemiologic datasets show a simi-lar relationship between A1C and risk of retinopathy as has been shown for thecorresponding FPG and 2-h plasma glu-cose thresholds. The A1C has several ad-vantagestotheFPGandOGTT,includinggreater convenience, since fasting is notrequired; evidence to suggest greater pre-analytical stability; and less day-to-dayperturbationsduringperiodsofstressandillness. These advantages must be bal-anced by greater cost, the limited avail-ability of A1C testing in certain regions of thedevelopingworld,andtheincompletecorrelationbetweenA1Candaverageglu-cose in certain individuals. In addition, A1C levels can vary with patients’ ethnic-ity (6) as well as with certain anemias andhemoglobinopathies.Forpatientswithanabnormalhemoglobinbutnormalredcellturnover, such as sickle cell trait, an A1Cassaywithoutinterferencefromabnormalhemoglobins should be used (an updatedlist is available at www.ngsp.org/interf.asp). For conditions with abnormal redcell turnover, such as pregnancy, recentblood loss or transfusion, or some ane-mias, the diagnosis of diabetes must em-ploy glucose criteria exclusively.The established glucose criteria forthe diagnosis of diabetes (FPG and 2-hPG) remain valid as well (Table 2). Just asthere is less than 100% concordance be-tween the FPG and 2-h PG tests, there isnot perfect concordance between A1Cand either glucose-based test. Analyses of National Health and Nutrition Examina-tionSurvey(NHANES)dataindicatethat,assuminguniversalscreeningoftheundi-agnosed, the A1C cut point of 
Ն
6.5%identifiesone-thirdfewercasesofundiag-nosed diabetes than a fasting glucose cutpoint of 
Ն
126 mg/dl (7.0 mmol/l) (7).
Table 1—
 ADA evidence grading system for clinical practice recommendations
Level of evidence Description A Clear evidence from well-conducted, generalizable, randomized controlledtrials that are adequately powered, including:
Evidence from a well-conducted multicenter trial
Evidence from a meta-analysis that incorporated quality ratings in theanalysisCompelling nonexperimental evidence, i.e., “all or none” rule developedby Center for Evidence Based Medicine at OxfordSupportive evidence from well-conducted randomized controlled trialsthat are adequately powered, including:
Evidence from a well-conducted trial at one or more institutions
Evidence from a meta-analysis that incorporated quality ratings in theanalysisB Supportive evidence from well-conducted cohort studies
Evidence from a well-conducted prospective cohort study or registry
Evidence from a well-conducted meta-analysis of cohort studiesSupportive evidence from a well-conducted case-control studyC Supportive evidence from poorly controlled or uncontrolled studies
Evidence from randomized clinical trials with one or more major orthree or more minor methodological flaws that could invalidate theresults
Evidence from observational studies with high potential for bias (suchas case series with comparison to historical controls)
Evidence from case series or case reportsConflicting evidence with the weight of evidence supporting therecommendationE Expert consensus or clinical experience
Standards of Medical Care
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However, in practice, a large portion of the diabetic population remains unawareof their condition. Thus, the lower sensi-tivity of A1C at the designated cut pointmay well be offset by the test’s greaterpracticality, and wider application of amore convenient test (A1C) may actuallyincrease the number of diagnoses made. As with most diagnostic tests, a testresult diagnostic of diabetes should be re-peatedtoruleoutlaboratoryerror,unlessthe diagnosis is clear on clinical grounds,such as a patient with a hyperglycemiccrisis or classic symptoms of hyperglyce-mia and a random plasma glucose
Ն
200mg/dl.Itispreferablethatthesametestberepeatedforconfirmation,sincetherewillbe a greater likelihood of concurrence inthis case. For example, if the A1C is 7.0%and a repeat result is 6.8%, the diagnosisof diabetes is confirmed. However, if twodifferent tests (such as A1C and FPG) areboth above the diagnostic thresholds, thediagnosis of diabetes is also confirmed.On the other hand, if two differenttestsareavailableinanindividualandtheresults are discordant, the test whose re-sult is above the diagnostic cut pointshould be repeated, and the diagnosis ismade on the basis of the confirmed test.That is, if a patient meets the diabetes cri-terionoftheA1C(tworesults
Ն
6.5%)butnottheFPG(
Ͻ
126mg/dlor7.0mmol/l),or vice versa, that person should be con-sidered to have diabetes.Sincethereispreanalyticandanalyticvariabilityofallthetests,itisalsopossiblethat when a test whose result was abovethe diagnostic threshold is repeated, thesecond value will be below the diagnosticcut point. This is least likely for A1C,somewhat more likely for FPG, and mostlikely for the 2-h PG. Barring a laboratoryerror, such patients are likely to have testresults near the margins of the thresholdfor a diagnosis. The healthcare profes-sional might opt to follow the patientclosely and repeat the testing in 3–6months.The current diagnostic criteria for di-abetes are summarized in Table 2.
C. Categories of increased risk fordiabetes (prediabetes)
In1997and2003,TheExpertCommitteeon Diagnosis and Classification of Diabe-tes Mellitus (8,9) recognized an interme-diate group of individuals whose glucoselevels, although not meeting criteria fordiabetes, are nevertheless too high to beconsidered normal. These persons weredefined as having impaired fasting glu-cose (IFG) (FPG levels 100–125 mg/dl[5.6–6.9 mmol/l]) or impaired glucosetolerance (IGT) (2-h PG values in theOGTT of 140–199 mg/dl [7.8–11.0mmol/l]). It should be noted that the WorldHealthOrganization(WHO)andanumber of other diabetes organizationsdefinethecutoffforIFGat110mg/dl(6.1mmol/l).IndividualswithIFGand/orIGThavebeenreferredtoashavingprediabetes,in-dicating the relatively high risk for the fu-ture development of diabetes. IFG andIGT should not be viewed as clinical en-tities in their own right but rather riskfactors for diabetes as well as cardiovas-cular disease (CVD). IFG and IGT are as-sociated with obesity (especiallyabdominal or visceral obesity), dyslipide-mia with high triglycerides and/or lowHDL cholesterol, and hypertension. As is the case with the glucose mea-sures, several prospective studies thatused A1C to predict the progression todiabetes demonstrated a strong, continu-ous association between A1C and subse-quent diabetes. In a systematic review of 44,203 individuals from 16 cohort stud-ieswithafollow-upintervalaveraging5.6years (range 2.8–12 years), those with an A1C between 5.5 and 6.0% had a sub-stantially increased risk of diabetes with5-year incidences ranging from 9–25%. An A1C range of 6.06.5% had a 5-yearrisk of developing diabetes between 25–50% and relative risk 20 times highercompared with an A1C of 5.0% (10). In acommunity-based study of black andwhite adults without diabetes, baseline A1C was a stronger predictor of subse-quent diabetes and cardiovascular eventsthan fasting glucose (11). Other analysessuggest that an A1C of 5.7% is associatedwith diabetes risk similar to that of thehigh-riskparticipantsintheDiabetesPre-vention Program (DPP).Hence, it is reasonable to consider an A1C range of 5.7–6.4% as identifying in-dividuals with high risk for future diabe-tes, a state that may be referred to asprediabetes (4). As is the case for individ-uals found to have IFG and IGT, individ-uals with an A1C of 5.7–6.4% should beinformedoftheirincreasedriskfordiabe-tes as well as CVD and counseled abouteffectivestrategiestolowertheirrisks(see
IV
.
PREVENTION
 / 
DELAY OF TYPE
2
DIABETES
). Aswith glucose measurements, the contin-uum of risk is curvilinear—as A1C rises,the risk of diabetes rises disproportion-ately (10). Accordingly, interventionsshould be most intensive and follow-upparticularly vigilant for those with A1Csabove6.0%,whoshouldbeconsideredtobe at very high risk.Table 3 summarizes the categories of increased risk for diabetes.
II. TESTING FOR DIABETESIN ASYMPTOMATICPATIENTS
Recommendations
Testing to detect type 2 diabetes andassessriskforfuturediabetesinasymp-tomaticpeopleshouldbeconsideredinadultsofanyagewhoareoverweightorobese (BMI
Ն
25 kg/m
2
) and who haveone or more additional risk factors fordiabetes (Table 4). In those withoutthese risk factors, testing should beginat age 45 years. (B)
If tests are normal, repeat testing car-ried out at least at 3-year intervals isreasonable. (E)
Table 2—
Criteria for the diagnosis of diabetes
 A1C
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6.5%. The test should be performedin a laboratory using a method that isNGSP certified and standardized to theDCCT assay.*orFPG
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126 mg/dl (7.0 mmol/l). Fasting isdefined as no caloric intake for at least8 h.*or2-h plasma glucose
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200 mg/dl (11.1mmol/l) during an OGTT. The test shouldbe performed as described by the WorldHealth Organization, using a glucose loadcontaining the equivalent of 75 ganhydrous glucose dissolved in water.*orIn a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, arandom plasma glucose
Ն
200 mg/dl (11.1mmol/l)
*In the absence of unequivocal hyperglycemia, re-sult should be confirmed by repeat testing.
Table 3—
Categories of increased risk for di-abetes (prediabetes)*
FPG 100–125 mg/dl (5.6–6.9 mmol/l): IFGor2-h plasma glucose in the 75-g OGTT 140–199 mg/dl (7.8–11.0 mmol/l): IGTor A1C 5.7–6.4%
*For all three tests, risk is continuous, extendingbelow the lower limit of the range and becomingdisproportionately greater at higher ends of therange.
Position Statement
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