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StandardsofMedicalCareinDiabetes—2009
A
MERICAN
D
IABETES
A
SSOCIATION
D
iabetes is a chronic illness that re-quires continuing medical careand patient self-management ed-ucation to prevent acute complicationsand to reduce the risk of long-termcomplications. Diabetes care is complexand requires that many issues, beyondglycemic control, be addressed. A largebody of evidence exists that supports arange of interventions to improve dia-betes outcomes.These standards of care are in-tended to provide clinicians, patients,researchers, payors, and other inter-ested individuals with the componentsof diabetes care, treatment goals, andtools to evaluate the quality of care. While individual preferences, comor-bidities, and other patient factors mayrequire modification of goals, targetsthat are desirable for most patients withdiabetes are provided. These standardsare not intended to preclude more ex-tensive evaluation and management of the patient by other specialists asneeded. For more detailed information,refer to references 1–3.The recommendations included arescreening, diagnostic, and therapeuticactions that are known or believed tofavorably affect health outcomes of pa-tients with diabetes. A grading system(Table 1), developed by the AmericanDiabetes Association (ADA) and mod-eled after existing methods, was utilizedto clarify and codify the evidence thatforms the basis for the recommenda-tions. The level of evidence that sup-ports each recommendation is listedafter each recommendation using theletters A, B, C, or E.
I. CLASSIFICATION ANDDIAGNOSIS
 A. Classification
In 1997, ADA issued new diagnostic andclassification criteria (4); in 2003, modi-ficationsweremaderegardingthediagno-sis of impaired fasting glucose (5). Theclassification of diabetes includes fourclinical classes:
●
type 1 diabetes (results from
-cell de-struction, usually leading to absoluteinsulin deficiency)
●
type 2 diabetes (results from a progres-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 AIDS or after organ trans-plantation)
●
gestational diabetes mellitus (GDM)(diabetes diagnosed during pregnancy)Somepatientscannotbeclearlyclassifiedastype1ortype2diabetes.Clinicalpresenta-tionanddiseaseprogressionvaryconsider-ablyinbothtypesofdiabetes.Occasionally,patientswhootherwisehavetype2diabetesmay present with ketoacidosis. Similarly,patients with type 1 may have a late onsetandslow(butrelentless)progressionofdis-easedespitehavingfeaturesofautoimmunedisease. Such difficulties in diagnosis mayoccur in children, adolescents, and adults.Thetruediagnosismaybecomemoreobvi-ous over time.
B. Diagnosis of diabetes
CurrentcriteriaforthediagnosisofdiabetesinnonpregnantadultsareshowninTable2.Threewaystodiagnosediabetesarerecom-mended at the time of this statement, andeach must be confirmed on a subsequentday unless unequivocal symptoms of hy-perglycemiaarepresent.Althoughthe75-goral glucose tolerance test (OGTT) is moresensitive and modestly more specific thanthe fasting plasma glucose (FPG) to diag-nosediabetes,itispoorlyreproducibleanddifficult to perform in practice. Because of ease of use, acceptability to patients, andlower cost, the FPG has been the preferreddiagnostictest.ThoughFPGislesssensitivethantheOGTT,thevastmajorityofpeoplewhodonotmeetdiagnosticcriteriafordia-betesbyFPGbutwouldbyOGTTwillhavean A1C value well under 7.0% (6).Though the OGTT is not recom-mended for routine clinical use, it may beusefulforfurtherevaluationofpatientsinwhom diabetes is still strongly suspectedbut who have normal FPG or IFG (seeSection I.C).The use of the A1C for the diagnosisof diabetes has previously not been rec-ommended due to lack of global stan-dardization and uncertainty aboutdiagnostic thresholds. However, with aworld-wide move toward a standardizedassay and with increasing observationalevidence about the prognostic signifi-cance of A1C, an Expert Committee onthe Diagnosis of Diabetes was convenedin2008.ThisjointcommitteeofADA,theEuropeanAssociationfortheStudyofDi-abetes, and the International DiabetesFederationwilllikelyrecommendthatthe A1C become the preferred diagnostic testfordiabetes.Diagnosticcut-pointsarebe-ingdiscussedatthetimeofpublicationof this statement. Updated recommenda-tions will be published in
Diabetes Care
and will be available at diabetes.org.
C. Diagnosis of pre-diabetes
Hyperglycemia not sufficient to meet thediagnostic criteria for diabetes is catego-
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
The recommendations in this article are based on the evidence reviewed in the following publication:Standards of Care for Diabetes (Technical Review).
Diabetes Care
17:1514–1522, 1994.Originally approved 1988. Most recent review/revision October 2008.DOI: 10.2337/dc09-S013© 2009 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.
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rized as either impaired fasting glucose(IFG) or impaired glucose tolerance(IGT), depending on whether it is identi-fied through the FPG or the OGTT:
●
IFG
FPG 100 mg/dl (5.6 mmol/l) to125 mg/dl (6.9 mmol/l)
●
IGT
2-h plasma glucose 140 mg/dl(7.8 mmol/l) to 199 mg/dl (11.0mmol/l)IFG and IGT have been officially termed“pre-diabetes.” Both categories of pre-diabetesareriskfactorsforfuturediabetesand for cardiovascular disease (CVD) (7).
II. TESTING FOR PRE-DIABETES AND DIABETESIN ASYMPTOMATICPATIENTS
Recommendations
●
Testing to detect pre-diabetes and type2 diabetes in asymptomatic peopleshould be considered in adults of anyage who are overweight or obese (BMI
25kg/m
2
)andwhohaveoneormoreadditional risk factors for diabetes (Ta-ble 3). In those without these risk fac-tors, testing should begin at age 45years. (B)
●
Iftestsarenormal,repeattestingshouldbe carried out at least at 3-year inter-vals. (E)
●
To test for pre-diabetes or diabetes, anFPG test or 2-h OGTT (75-g glucoseload) or both are appropriate. (B)
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An OGTT may be considered in pa-tients with IFG to better define the riskof diabetes. (E)
●
In those identified with pre-diabetes,identify and, if appropriate, treat otherCVD risk factors. (B)For many illnesses, there is a major dis-tinction between screening and diagnos-tic testing. However, for diabetes, thesame tests would be used for “screening”as for diagnosis. Type 2 diabetes has along asymptomatic phase and significantclinical risk markers. Diabetes may beidentified anywhere along a spectrum of clinical scenarios ranging from a seem-ingly low-risk individual who happens tohave glucose testing, to a higher-risk in-dividualwhomtheprovidertestsbecauseofhighsuspicionofdiabetes,tothesymp-tomatic patient. The discussion herein isprimarily framed as testing for diabetes inthose without symptoms. Testing for dia-beteswillalsodetectindividualswithpre-diabetes.
 A. Testing for pre-diabetes and type2 diabetes in adults
Type 2 diabetes is frequently not diag-nosed until complications appear, andapproximately one-third of all peoplewith diabetes may be undiagnosed. Al-though the effectiveness of early identifi-cation of pre-diabetes and diabetesthrough mass testing of asymptomatic in-dividualshasnotbeendefinitivelyproven(and rigorous trials to provide such proof are unlikely to occur), pre-diabetes anddiabetes meet established criteria for con-ditions in which early detection is appro-priate. Both conditions are common,increasing in prevalence, and impose sig-nificant public health burdens. There is alongpresymptomaticphasebeforethedi-agnosisoftype2diabetesisusuallymade.Relatively simple tests are available to de-tect preclinical disease (8). Additionally,the duration of glycemic burden is astrong predictor of adverse outcomes,and effective interventions exist to pre-ventprogressionofpre-diabetestodiabe-tes (see Section IV) and to reduce risk of complications of diabetes (see Section VI).Recommendations for testing for pre-
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 the Centre 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, including:
●
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
Table 2—
Criteria for the diagnosis of diabetes
1. FPG
126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for atleast 8 h.*OR2. Symptoms of hyperglycemia and a casual (random) plasma glucose
200mg/dl (11.1 mmol/l). Casual (random) is defined as any time of day withoutregard to time since last meal. The classic symptoms of hyperglycemiainclude polyuria, polydipsia, and unexplained weight loss.OR3. 2-h plasma glucose
200 mg/dl (11.1 mmol/l) during an OGTT. The testshould be performed as described by the World Health Organization usinga glucose load containing the equivalent of 75-g anhydrous glucosedissolved in water.*
*In the absence of unequivocal hyperglycemia, these criteria should be confirmed by repeat testing on adifferent day (5).
Standards of Medical Care
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diabetes and diabetes in asymptomatic,undiagnosed adults are listed in Table 3.Testing should be considered in adults of any age with BMI
25 kg/m
2
and one ormoreriskfactorsfordiabetes.Becauseageis a major risk factor for diabetes, testingof those without other risk factors shouldbegin no later than age 45 years.EitherFPGtestingorthe2-hOGTTisappropriate for testing. The 2-h OGTTidentifies people with either IFG or IGT,and thus, more pre-diabetic people at in-creased risk for the development of dia-betes and CVD. It should be noted thatthe two tests do not necessarily detect thesame pre-diabetic individuals (9). The ef-ficacy of interventions for primary pre-vention of type 2 diabetes (10–16) hasprimarily been demonstrated among in-dividuals with IGT, not individuals withIFG(whodonotalsohaveIGT).Asnotedin the diagnosis section (Section I.B), theFPG test is more convenient, more repro-ducible, less costly, and easier to admin-ister than the 2-h OGTT (4,5). An OGTTmay be useful in patients with IFG to bet-ter define the risk of diabetes.The appropriate interval betweentests is not known (17). The rationale forthe 3-year interval is that false-negativeswill be repeated before substantial timeelapses, and there is little likelihood thatan individual will develop significantcomplications of diabetes within 3 yearsof a negative test result.Becauseoftheneedforfollow-upanddiscussion of abnormal results, testingshould be carried out within the healthcare setting. Community screening out-side a health care setting is not recom-mended because people with positivetests may not seek, or have access to, ap-propriate follow-up testing and care.Conversely,theremaybefailuretoensureappropriate repeat testing for individualswho test negative. Community screeningmay also be poorly targeted, i.e., it mayfail to reach the groups most at risk andinappropriately test those at low risk (theworried well) or even those already diag-nosed (18,19).
B. Testing for type 2 diabetes inchildren
The incidence of type 2 diabetes in ado-lescents has increased dramatically in thelast decade, especially in minority popu-lations(20),althoughthediseaseremainsrare in the general adolescent population(21). Consistent with recommendationsfor adults, children and youth at in-creased risk for the presence or the devel-opment of type 2 diabetes should betested within the health care setting (22).The recommendations of the ADA con-sensus statement on type 2 diabetes inchildren and youth, with some modifica-tions, are summarized in Table 4.
C. Screening for type 1 diabetes
Generally, people with type 1 diabetespresent with acute symptoms of diabetesand markedly elevated blood glucose lev-els, and most cases are diagnosed soonafter the onset of hyperglycemia. How-ever, evidence from type 1 preventionstudiessuggeststhatmeasurementofisletautoantibodies identifies individuals whoare at risk for developing type 1 diabetes.Such testing may be appropriate in high-risk individuals, such as those with priortransient hyperglycemia or those who haverelativeswithtype1diabetes,inthecontextof clinical research studies (see, for exam-ple, http://www2.diabetestrialnet.org). Widespread clinical testing of asymptom-atic low-risk individuals cannot currentlybe recommended, as it would identify veryfew individuals in the general populationwhoareatrisk.Individualswhoscreenpos-itiveshouldbecounseledabouttheirriskof developingdiabetes.Clinicalstudiesarebe-ing conducted to test various methods of preventing type 1 diabetes, or reversingearlytype1diabetes,inthosewithevidenceof autoimmunity.
III. DETECTION ANDDIAGNOSIS OF GDM
Recommendations
●
Screen for GDM using risk factor anal-ysis and, if appropriate, use of anOGTT. (C)
●
Women with GDM should be screenedfor diabetes 6–12 weeks postpartumand should be followed up with subse-quentscreeningforthedevelopmentof diabetes or pre-diabetes. (E)GDM is defined as any degree of glucoseintolerance with onset or first recognitionduring pregnancy (4). Although mostcases resolve with delivery, the definitionapplies whether or not the condition per-sistsafterpregnancyanddoesnotexcludethe possibility that unrecognized glucoseintolerance may have antedated or begunconcomitantly with the pregnancy. Ap-
Table 3—
Criteria for testing for pre-diabetes and diabetes in asymptomatic adult individuals
1. Testing should be considered in all adults who are overweight (BMI
25 kg/m
2
*) andhave additional risk factors:
●
physical inactivity
●
first-degree relative with diabetes
●
members of a high-risk ethnic population (e.g., African American, Latino, Native American, Asian American, Pacific Islander)
●
women who delivered a baby weighing
9 lb or were diagnosed with GDM
●
hypertension (
140/90 mmHg or on therapy for hypertension)
●
HDL cholesterol level
35 mg/dl (0.90 mmol/l) and/or a triglyceride level
250mg/dl (2.82 mmol/l)
●
women with polycystic ovarian syndrome (PCOS)
●
IGT or IFG on previous testing
●
other clinical conditions associated with insulin resistance (e.g., severe obesity,acanthosis nigricans)
●
history of CVD2. In the absence of the above criteria, testing for pre-diabetes and diabetes should beginat age 45 years3. If results are normal, testing should be repeated at least at 3-year intervals, withconsideration of more frequent testing depending on initial results and risk status.
*At-risk BMI may be lower in some ethnic groups.
Table 4—
Testing for type 2 diabetes inasymptomatic children
Criteria:
●
Overweight (BMI
85th percentile forage and sex, weight for height
85thpercentile, or weight
120% of ideal forheight)Plus any two of the following risk factors:
●
Family history of type 2 diabetes in first-or second-degree relative
●
Race/ethnicity (Native American, African American, Latino, Asian American, PacificIslander)
●
Signs of insulin resistance or conditionsassociated with insulin resistance(acanthosis nigricans, hypertension,dyslipidemia, PCOS, or small-for-gestational-age birthweight)
●
Maternal history of diabetes or GDMduring the child’s gestation Age of initiation: age 10 years or at onset of puberty, if puberty occurs at a youngerageFrequency: every 3 yearsTest: FPG preferred
Position Statement
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