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Guideline ADA 2010 (management of diabetes)

Guideline ADA 2010 (management of diabetes)

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StandardsofMedicalCareinDiabetes2010
A
MERICAN
D
IABETES
A
SSOCIATION
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-tensiveevaluationandmanagementofthepatientbyotherspecialistsasneeded.Formoredetailedinformationaboutmanage-ment of diabetes, refer to references 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 used to clarify andcodify the evidence that forms the basisfortherecommendations.Thelevelofev-idence that supports each recommenda-tion is listed after each recommendationusing the letters A, B, C, or E.These standards of care are revisedannually by the ADA multidisciplinaryProfessional Practice Committee, andnew evidence is incorporated. Membersof the Professional Practice Committeeandtheirdisclosedconflictsofinterestarelisted in the Introduction. Subsequently,as with all position statements, the stan-dards of care are reviewed and approvedby the Executive Committee of ADA’sBoard of Directors.
I. CLASSIFICATION ANDDIAGNOSIS
 A. Classification
The classification of diabetes includesfour clinical 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 diabetes (such asin the treatment of AIDS or after organtransplantation)
gestational diabetes mellitus (GDM)(diabetes diagnosed during pregnancy)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 despite hav-ing features of autoimmune disease. Suchdifficultiesindiagnosismayoccurinchil-dren, adolescents, and adults. The truediagnosismaybecomemoreobviousovertime.
B. Diagnosis of diabetesRecommendations
For decades, the diagnosis of diabetes hasbeen based on plasma glucose (PG) crite-ria, either fasting PG (FPG) or 2-h 75-goralglucosetolerancetest(OGTT)values.In 1997, the first Expert Committee onthe DiagnosisandClassificationofDiabe-tes Mellitus revised the diagnostic criteriausing the observed association between
● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●
Originally approved 1988. Most recent review/revision October 2009.DOI: 10.2337/dc10-S011
Abbreviations:
ABI, ankle-brachial index; ACCORD, Action to Control Cardiovascular Risk in Diabetes; ADAG, A1C-Derived Average Glucose Trial; ADVANCE, Action in Diabetes and Vascular Disease: Pre-teraxandDiamicronModifiedReleaseControlledEvaluation;ACE,angiotensinconvertingenzyme;ARB,angiotensin receptor blocker; ACT-NOW, ACTos Now Study for the Prevention of Diabetes; BMI, bodymass index; CBG, capillary blood glucose; CFRD, cystic fibrosis–related diabetes; CGM, continuousglucose monitoring; CHD, coronary heart disease; CHF, congestive heart failure; CCM, chronic caremodel;CKD,chronickidneydisease;CMS,CentersforMedicareandMedicaidServices;CSII,continuoussubcutaneous insulin infusion; CVD, cardiovascular disease; DASH, Dietary Approaches to Stop Hyper-tension; DCCT, Diabetes Control and Complications Trial; DKA, diabetic ketoacidosis; DMMP, diabetesmedical management plan; DPN, distal symmetric polyneuropathy; DPP, Diabetes Prevention Program;DPS, Diabetes Prevention Study; DREAM, Diabetes Reduction Assessment with Ramipril and Rosiglita-zone Medication; DRS, Diabetic Retinopathy Study; DSME, diabetes self-management education; DSMT,diabetesself-managementtraining;eAG,estimatedaverageglucose;eGFR,estimatedglomerularfiltrationrate; ECG, electrocardiogram; EDIC, Epidemiology of Diabetes Interventions and Complications; ERP,education recognition program; ESRD, end-stage renal disease; ETDRS, Early Treatment Diabetic Reti-nopathy Study; FDA, Food and Drug Administration; FPG, fasting plasma glucose; GDM, gestationaldiabetes mellitus; GFR, glomerular filtration rate; HAPO, Hyperglycemia and Adverse Pregnancy Out-comes; ICU, intensive care unit; IFG, impaired fasting glucose; IGT, impaired glucose tolerance; Look AHEAD, Action for Health in Diabetes; MDRD, Modification of Diet in Renal Disease; MNT, medicalnutritiontherapy;NDEP,NationalDiabetesEducationProgram;NGSP,NationalGlycohemoglobinStan-dardization Program; NPDR, nonproliferative diabetic retinopathy; OGTT, oral glucose tolerance test;PAD,peripheralarterialdisease;PCOS,polycysticovariansyndrome;PDR,proliferativediabeticretinop-athy; PPG, postprandial plasma glucose; RAS, renin-angiotensin system; SMBG, self-monitoring of bloodglucose; STOP-NIDDM, Study to Prevent Non-Insulin Dependent Diabetes; SSI, sliding scale insulin;TZD,thiazolidinedione;UKPDS,U.K.ProspectiveDiabetesStudy;VADT,VeteransAffairsDiabetesTrial;XENDOS, XENical in the prevention of Diabetes in Obese Subjects.© 2010 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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glucose levels and presence of retinopa-thy as the key factor with which to iden-tify threshold FPG and 2-h PG levels. Thecommittee examined data from threecross-sectionalepidemiologicstudiesthatassessedretinopathywithfundusphotog-raphy or direct ophthalmoscopy andmeasured glycemia as FPG, 2-h PG, andHbA
1c
(A1C). The studies demonstratedglycemiclevelsbelowwhichtherewaslit-tle prevalent retinopathy and abovewhich the prevalence of retinopathy in-creased in an apparently linear fashion.The deciles of FPG, 2-h PG, and A1C atwhichretinopathybegantoincreasewerethe same for each measure within eachpopulation. The analyses helped to in-form a then-new diagnostic cut point of 
126 mg/dl (7.0 mmol/l) for FPG andconfirmed the long-standing diagnostic2-h PG value of 
200 mg/dl (11.1mmol/l) (4). ADA has not previously recom-mended the use of A1C for diagnosingdiabetes, in part due to lack of standard-ization of the assay. However, A1C assaysarenowhighlystandardized,andtheirre-sults can be uniformly applied both tem-porally and across populations. In arecentreport(5),afteranextensivereviewof both established and emerging epide-miological evidence, an international ex-pert committee recommended the use of the A1C test to diagnose diabetes with athresholdof 
6.5%,andADAaffirmsthisdecision (6). The diagnostic test shouldbe performed using a method certified bythe National Glycohemoglobin Standard-ization Program (NGSP) and standard-ized or traceable to the Diabetes Controland Complications Trial (DCCT) refer-ence assay. Point-of-care A1C assays arenotsufficientlyaccurateatthistimetousefor diagnostic purposes.Epidemiologic datasets show a rela-tionship between A1C and the risk of ret-inopathy similar to that which has beenshownforcorrespondingFPGand2-hPGthresholds. The A1C has several advan-tagestotheFPG,includinggreaterconve-nience, since fasting is not required;evidence to suggest greater preanalyticalstability; and less day-to-day perturba-tions during periods of stress and illness.These advantages must be balanced bygreater cost, limited availability of A1Ctesting in certain regions of the develop-ingworld,andincompletecorrelationbe-tween A1C and average glucose in certainindividuals. In addition, the A1C can bemisleading in patients with certain formsof anemia and hemoglobinopathies. Forpatients with a hemoglobinopathy butnormal red cell turnover, such as sicklecell trait, an A1C assay without interfer-ence from abnormal hemoglobins shouldbeused(anupdatedlistofA1Cassaysandwhether abnormal hemoglobins impactthem is available at www.ngsp.org/prog/ index3.html). For conditions with abnor-malredcellturnover,suchaspregnancyoranemias from hemolysis and iron defi-ciency, the diagnosis of diabetes must useglucose criteria exclusively.The established glucose criteria forthe diagnosis of diabetes (FPG and 2-hPG)remainvalid.Patientswithseverehy-perglycemia such as those who presentwith severe classic hyperglycemic symp-tomsorhyperglycemiccrisiscancontinueto be diagnosed when a random (or ca-sual) PG of 
200 mg/dl (11.1 mmol/l) isfound. It is likely that in such cases thehealth care professional would also con-duct an A1C test as part of the initial as-sessment of the severity of the diabetesand that it would be above the diagnosticcut point. However, in rapidly evolvingdiabetes such as the development of type1 in some children, the A1C may not besignificantly elevated despite frankdiabetes. Just as there is
100% concordancebetween the FPG and 2-h PG tests, thereis not 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 
6.5%identifiesone-thirdfewercasesofundiag-nosed diabetes than a fasting glucose cutpoint of 
126 mg/dl (7.0 mmol/l) (E.Gregg, personal communication). How-ever, in practice, a large portion of thediabetic population remains unaware of their condition. Thus, the lower sensitiv-ityofA1Catthedesignatedcutpointmaywell be offset by the test’s greater practi-cality, and wider application of a moreconvenient test (A1C) may actually in-crease 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,suchasapatientwithclassicsymptomsof hyperglycemia or hyperglycemic crisis. Itispreferablethatthesametestberepeatedfor confirmation, since there will be agreater likelihood of concurrence in thiscase. For example, if the A1C is 7.0% anda repeat result is 6.8%, the diagnosis of diabetes is confirmed. However, there arescenariosinwhichresultsoftwodifferenttests (e.g., FPG and A1C) are available forthe same patient. In this situation, if thetwo different tests are both above the di-
Table 1 —
 ADA evidence grading system for clinical practice recommendations
Level of evidence Description A Clear evidence from well-conducted, generalizable, randomized controlled trials thatare adequately powered, including:
Evidence from a well-conducted multicenter trial
Evidence from a meta-analysis that incorporated quality ratings in the analysisCompelling nonexperimental evidence, i.e.,
all or none
rule developed by Centerfor Evidence Based Medicine at OxfordSupportive evidence from well-conducted randomized controlled trials that areadequately powered, including:
Evidence from a well-conducted trial at one or more institutions
Evidence from a meta-analysis that incorporated quality ratings in the analysisB 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 or three ormore minor methodological flaws that could invalidate the results
Evidence from observational studies with high potential for bias (such as caseseries with comparison to historical controls)
Evidence from case series or case reportsConflicting evidence with the weight of evidence supporting the recommendationE Expert consensus or clinical experience
Standards of Medical Care
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agnostic threshold, the diagnosis of dia-betes is 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
6.5%)butnottheFPG(
126mg/dlor7.0mmol/l),or vice versa, that person should be con-sidered to have diabetes. Admittedly, inmost circumstance the “nondiabetic” testis likely to be in a range very close to thethreshold that defines 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
In1997and2003,TheExpertCommitteeon the Diagnosis and Classification of Di-abetes Mellitus (4,7) recognized an inter-mediate group of individuals whoseglucose levels, although not meeting cri-teria for diabetes, are nevertheless toohightobeconsiderednormal.Thisgroupwas defined as having impaired fastingglucose (IFG) (FPG levels of 100 mg/dl[5.6 mmol/l] to 125 mg/dl [6.9 mmol/l])or impaired glucose tolerance (IGT) (2-hOGTT values of 140 mg/dl [7.8 mmol/l]to 199 mg/dl [11.0 mmol/l]).IndividualswithIFGand/orIGThavebeen referred to as having pre-diabetes,indicating the relatively high risk for thefuture 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 areassociated with obesity (especiallyabdominal or visceral obesity), dyslipide-mia with high triglycerides and/or lowHDL cholesterol, and hypertension.Structuredlifestyleintervention,aimedatincreasing physical activity and produc-ing 5–10% loss of body weight, and cer-tain pharmacological agents have beendemonstrated to prevent or delay the de-velopment of diabetes in people with IGT(see Table 7). It should be noted that the2003 ADA Expert Committee report re-duced the lower FPG cut point to defineIFG from 110 mg/dl (6.1 mmol/l) to 100mg/dl (5.6 mmol/l), in part to make theprevalence of IFG more similar to that of IGT. However, the World Health Organi-zation (WHO) and many other diabetesorganizations did not adopt this change. As the A1C becomes increasinglyused to diagnose diabetes in individualswithriskfactors,itwillalsoidentifythoseat high risk for developing diabetes in thefuture. As was the case with the glucosemeasures, defining a lower limit of an in-termediate category of A1C is somewhatarbitrary, since risk of diabetes with anymeasureorsurrogateofglycemiaisacon-tinuum extending well into the normalranges.Tomaximizeequityandefficiencyof preventive interventions, such an A1Ccutpoint,shouldbalancethecostsoffalsenegatives(failingtoidentifythosewhoaregoing to develop diabetes) against thecosts of false positives (falsely identifyingandthenspendinginterventionresourceson those who were not going to developdiabetes anyway).Linear regression analyses of nation-ally representative U.S. data (NHANES2005–2006) indicate that among thenondiabetic adult population, an FPG of 110 mg/dl corresponds to an A1C of 5.6%, while an FPG of 100 mg/dl corre-sponds to an A1C of 5.4%. Receiver op-erating curve analyses of these dataindicate that an A1C value of 5.7%, com-pared with other cut points, has the bestcombination of sensitivity (39%) andspecificity (91%) to identify cases of IFG(FPG
100 mg/dl [5.6 mmol/l]) (R.T. Ackerman, Personal Communication).Other analyses suggest that an A1C of 5.7% is associated with diabetes risk sim-ilar to that of the high-risk participants inthe Diabetes Prevention Program (DPP)(R.T. Ackerman, personal communica-tion). Hence, it is reasonable to consideran A1C range of 5.7–6.4% as identifyingindividuals with high risk for future dia-betes and to whom the term pre-diabetesmay be applied (6). As is the case for individuals found tohave IFG and IGT, individuals with an A1C of 5.7–6.4% should be informed of their increased risk for diabetes as wellas CVD and counseled about effectivestrategiestolowertheirrisks(seeIV.PRE- VENTION/DELAYOFTYPE2DIABETES). As with glucose measurements, the contin-uum of risk is curvilinear, so that as A1Crises, the risk of diabetes rises dispropor-tionately. Accordingly, interventionsshould be most intensive and follow-upshould be particularly vigilant for thosewith an A1C
6.0%, who should be con-sidered to be at very high risk. However, justasanindividualwithafastingglucoseof 98 mg/dl (5.4 mmol/l) may not be at negli-gible risk for diabetes, individuals with an A1C
5.7%maystillbeatrisk,dependingon the level of A1C and presence of otherrisk factors, such as obesity and familyhistory.
Table 2—
Criteria for the diagnosis of diabetes
1.
A1C
6.5%. The test should be performed in a laboratory using a methodthat is NGSP certified and standardized to the DCCT assay.*OR
2.
FPG
126 mg/dl (7.0 mmol/l). Fasting is defined as no caloric intake for atleast 8 h.*OR
3.
Two-hour plasma glucose
200 mg/dl (11.1 mmol/l) during an OGTT.The test should be performed as described by the World HealthOrganization, using a glucose load containing the equivalent of 75 ganhydrous glucose dissolved in water.*OR
4.
In a patient with classic symptoms of hyperglycemia or hyperglycemiccrisis, a random plasma glucose
200 mg/dl (11.1 mmol/l).
*In the absence of unequivocal hyperglycemia, criteria 1–3 should be confirmed by repeat testing.
Table 3—
Categories of increased risk fordiabetes*
FPG 100–125 mg/dl (5.6–6.9 mmol/l)
IFG
2-h PG on the 75-g OGTT 140–199 mg/dl(7.8–11.0 mmol/l)
IGT
 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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