Standards of Medical Care in Diabetes 2011

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    POSITIONSTATEMENT

    StandardsofMedicalCareinDiabetes2011

    AMERICANDIABETESASSOCIATION

    CONTENTS

    I.CLASSIFICATIONANDDIAGNOSIS

    OFDIABETES,p.S12A.ClassificationofdiabetesB.DiagnosisofdiabetesC.

    Categoriesofincreasedriskfordiabetes(prediabetes)II.TESTINGFORDIABETESINASYMPTOMATIC

    PATIENTS,p.S13A.Testingfortype2diabetesand

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    riskoffuturediabetesinadultsB.Testingfortype2diabetesinchildrenC.Screeningfortype1diabetesIII.DETECTIONANDDIAGNOSIS

    OFGESTATIONALDIABETESMELLITUS,p.S15IV.PREVENTION/DELAYOFTYPE2DIABETES,p.

    S16V.DIABETESCARE,p.S16A.InitialevaluationB.ManagementC.Glycemic

    control1.Assessmentofglycemiccontrola.Glucosemonitoringb.

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    A1C2.GlycemicgoalsinadultsD.Pharmacologicandoverallapproachestotreatment1.Therapyfortype1diabetes2.Therapyfortype2

    diabetesE.Diabetesself-managementeducationF.MedicalnutritiontherapyG.PhysicalactivityH.

    PsychosocialassessmentandcareI.WhentreatmentgoalsarenotmetJ.Hypoglycemia

    K.IntercurrentillnessL.BariatricsurgeryM.ImmunizationVI.PREVENTION

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    ANDMANAGEMENTOFDIABETESCOMPLICATIONS,p.S27A.Cardiovasculardisease1.Hypertension/bloodpressurecontrol2.Dyslipidemia/lipidmanagement3.Antiplateletagents4.Smokingcessation5.

    CoronaryheartdiseasescreeningandtreatmentB.NephropathyscreeningandtreatmentC.Retinopathy

    screeningandtreatmentD.NeuropathyscreeningandtreatmentE.FootcareVII.DIABETES

    CAREINSPECIFICPOPULATIONS,p.S38A.Childrenandadolescents

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    1.Type1diabetesGlycemiccontrola.Screeningandmanagementofchroniccomplicationsinchildrenandadolescentswithtype1diabetesi.Nephropathyii.

    Hypertensioniii.Dyslipidemiaiv.Retinopathyv.Celiacdiseasevi.Hypothyroidismb.Self-managementc.

    Schoolanddaycared.Transitionfrompediatrictoadultcare2.Type

    2diabetes3.MonogenicdiabetessyndromesB.PreconceptioncareC.

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    OlderadultsD.CysticfibrosisrelateddiabetesVIII.DIABETESCAREINSPECIFICSETTINGS,p.S43A.Diabetescareinthehospital1.Glycemictargetsin

    hospitalizedpatients2.Anti-hyperglycemicagentsinhospitalizedpatients3.PreventinghypoglycemiaOriginallyapproved

    1988.Mostrecentreview/revisionOctober2010.

    DOI:10.2337/dc11-S011

    2011bytheAmericanDiabetesAssociation.Readersmayusethis

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    articleaslongastheworkisproperlycited,theuseiseducationalandnotforprofit,andtheworkisnotaltered.See

    http://creativecommons.org/licenses/by-nc-nd/3.0/fordetails.

    4.Diabetescareprovidersinthehospital

    5.Self-managementinthehospital6.Diabetesself-managementeducationinthehospital7.

    Medicalnutritiontherapyinthehospital8.Bedsidebloodglucose

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    monitoring9.DischargeplanningIX.STRATEGIESFORIMPROVINGDIABETESCARE,p.S46DDiabetesisachronicillnessthatrequirescontinuingmedicalcare

    andongoingpatientself-managementeducationandsupporttopreventacutecomplicationsandto

    reducetheriskoflong-termcomplications.Diabetescareiscomplexandrequiresthat

    manyissues,beyondglycemiccontrol,beaddressed.Alargebody

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    ofevidenceexiststhatsupportsarangeofinterventionstoimprovediabetesoutcomes.

    Thesestandardsofcareareintended

    to

    provideclinicians,patients,research

    ers,payors,andotherinterestedindivid

    ualswiththecomponentsofdiabetes

    care,generaltreatmentgoals,

    andtoolsto

    evaluatethequalityofcare.

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    Whileindi

    vidualpreferences,comorbidities,and

    otherpatientfactorsmayrequiremodifi

    cationofgoals,targetsthatare

    desirable

    formostpatientswithdiabetesarepro

    vided.

    Thesestandardsarenotintended

    toprecludeclinicaljudgmentormore

    ex

    tensiveevaluationandmanagementofthe

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    patientbyotherspecialistsasneeded.

    Formoredetailedinformationabout

    managementofdiabetes,refertorefer

    ences13.

    Therecommendationsincludedare

    screening,diagnostic,and

    therapeuticac

    tionsthatareknownorbelievedtofavor

    ablyaffecthealthoutcomesofpatients

    with

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    diabetes.Agradingsystem(Table1),

    developedbytheAmericanDiabetesAs

    sociation(ADA)andmodeledafterexist

    ingmethods,wasutilizedtoclarifyand

    codifytheevidencethat

    formsthebasis

    fortherecommendations.Thelevelofev

    idencethatsupportseachrecommenda

    care.diabetesjournals.orgDIABETES

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    CARE,VOLUME34,SUPPLEMENT1,JANUARY2011S11

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    StandardsofMedicalCare

    Table1ADAevidencegradingsystemforclinicalpracticerecommendations

    LevelofevidenceDescription

    AClearevidencefromwell-conducted,generalizable,randomizedcontrolledtrialsthatareadequatelypowered,

    including:Evidencefromawell-conductedmulticentertrialEvidencefromameta-analysis

    thatincorporatedqualityratingsintheanalysisCompellingnonexperimentalevidence,

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    i.e.,allornoneruledevelopedbyCenterforEvidenceBasedMedicineatOxfordSupportiveevidencefromwell-conductedrandomizedcontrolledtrialsthatareadequately

    powered,including:Evidencefromawell-conductedtrialatoneormoreinstitutions

    Evidencefromameta-analysisthatincorporatedqualityratingsintheanalysisB

    Supportiveevidencefromwell-conductedcohortstudiesEvidencefroma

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    well-conductedprospectivecohortstudyorregistryEvidencefromawell-conductedmeta-analysisofcohortstudiesSupportiveevidencefromawell-conductedcase-controlstudyCSupportive

    evidencefrompoorlycontrolledoruncontrolledstudiesEvidencefromrandomizedclinicaltrials

    withoneormoremajororthreeormoreminormethodologicalflawsthat

    couldinvalidatetheresultsEvidencefromobservationalstudieswith

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    highpotentialforbias(suchascaseserieswithcomparisontohistoricalcontrols)EvidencefromcaseseriesorcasereportsConflictingevidencewith

    theweightofevidencesupportingtherecommendationEExpertconsensusorclinicalexperience

    tionislistedaftereachrecommendationusingthelettersA,B,

    C,orE.

    Thesestandardsofcareare

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    revisedannuallybytheADAsmultidisciplinaryProfessionalPracticeCommittee,incorporatingnewevidence.MembersoftheProfessionalPracticeCommitteeandtheirdisclosedconflictsofinterest

    arelistedonpageS97.Subsequently,aswithallPositionStatements,thestandards

    ofcarearereviewedandapprovedbytheExecutiveCommitteeofADAsBoard

    ofDirectors.

    I.CLASSIFICATIONANDDIAGNOSISOFDIABETES

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    A.ClassificationofdiabetesTheclassificationofdiabetesincludesfourclinicalclasses:

    .Type1diabetes(resultsfrom-celldestruction,usuallyleading

    toabsoluteinsulindeficiency).Type2diabetes(resultsfromaprogressiveinsulin

    secretorydefectonthebackgroundofinsulinresistance).Otherspecifictypesof

    diabetesduetoothercauses,e.g.,geneticdefectsin-cell

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    function,geneticdefectsininsulinaction,diseasesoftheexocrinepancreas(suchascysticfibrosis),anddrug-orchemical-induced(suchasinthetreatment

    ofHIV/AIDSorafterorgantransplantation)

    .Gestationaldiabetesmellitus(GDM)

    (diabetesdiagnosedduringpregnancythatisnotclearlyovertdiabetes)Somepatientscannot

    beclearlyclassifiedashavingtype1ortype2

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    diabetes.Clinicalpresentationanddiseaseprogressionvaryconsiderablyinbothtypesofdiabetes.Occasionally,patientswhootherwisehavetype2diabetesmaypresentwith

    ketoacidosis.Similarly,patientswithtype1diabetesmayhavealateonsetand

    slow(butrelentless)progressionofdiseasedespitehavingfeaturesofautoimmunedisease.Such

    difficultiesindiagnosismayoccurinchildren,adolescents,andadults.

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    Thetruediagnosismaybecomemoreobviousovertime.

    B.DiagnosisofdiabetesFordecades,thediagnosisofdiabeteswasbasedon

    plasmaglucosecriteria,eitherthefastingplasmaglucose(FPG)orthe

    2-hvalueinthe75-goralglucosetolerancetest(OGTT)(4).

    In2009,anInternationalExpertCommitteethatincludedrepresentativesof

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    theADA,theInternationalDiabetesFederation(IDF),andtheEuropeanAssociationfortheStudyofDiabetes(EASD)recommendedtheuseoftheA1Ctest

    todiagnosediabetes,withathresholdof6.5%(5),andADAadoptedthis

    criterionin2010(4).Thediagnostictestshouldbeperformedusingamethod

    thatiscertifiedbytheNationalGlycohemoglobinStandardizationProgram(NGSP)

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    andstandardizedortraceabletotheDiabetesControlandComplicationsTrial(DCCT)referenceassay.Point-of-careA1Cassaysarenotsufficientlyaccurateatthistime

    tousefordiagnosticpurposes.

    Epidemiologicdatasetsshowasimilarrelationship

    betweenA1Candriskofretinopathyashasbeenshownforthecorresponding

    FPGand2-hplasmaglucosethresholds.TheA1Chasseveral

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    advantagestotheFPGandOGTT,includinggreaterconvenience,sincefastingisnotrequired;evidencetosuggestgreaterpre-analyticalstability;andlessday-to-day

    perturbationsduringperiodsofstressandillness.Theseadvantagesmustbebalancedby

    greatercost,thelimitedavailabilityofA1Ctestingincertainregionsofthe

    developingworld,andtheincompletecorrelationbetweenA1Candaverage

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    glucoseincertainindividuals.Inaddition,A1Clevelscanvarywithpatientsethnicity(6)aswellaswithcertainanemiasandhemoglobinopathies.Forpatients

    withanabnormalhemoglobinbutnormalredcellturnover,suchassicklecell

    trait,anA1Cassaywithoutinterferencefromabnormalhemoglobinsshouldbeused(an

    updatedlistisavailableatwww.ngsp.org/interf.asp).Forconditionswith

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    abnormalredcellturnover,suchaspregnancy,recentbloodlossortransfusion,orsomeanemias,thediagnosisofdiabetesmustemployglucosecriteriaexclusively.

    Theestablishedglucosecriteriaforthediagnosisofdiabetes(FPGand

    2-hPG)remainvalidaswell(Table2).Justasthereisless

    than100%concordancebetweentheFPGand2-hPGtests,

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    thereisnotperfectconcordancebetweenA1Candeitherglucose-basedtest.AnalysesofNationalHealthandNutritionExaminationSurvey(NHANES)dataindicatethat,assuming

    universalscreeningoftheundiagnosed,theA1Ccutpointof6.5%identifiesone-third

    fewercasesofundiagnoseddiabetesthanafastingglucosecutpointof126

    mg/dl(7.0mmol/l)(7).

    S12DIABETESCARE,VOLUME

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    34,SUPPLEMENT1,JANUARY2011care.diabetesjournals.org

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    PositionStatement

    Table2Criteriaforthediagnosisofdiabetes

    A1C6.5%.Thetestshouldbeperformedinalaboratory

    usingamethodthatisNGSPcertifiedandstandardizedtotheDCCTassay.*

    or

    FPG126mg/dl(7.0mmol/l).Fastingisdefinedasno

    caloricintakeforatleast8h.*or

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    2-hplasmaglucose200mg/dl(11.1mmol/l)duringanOGTT.ThetestshouldbeperformedasdescribedbytheWorldHealthOrganization,usinga

    glucoseloadcontainingtheequivalentof75ganhydrousglucosedissolvedinwater.*

    or

    Inapatientwithclassicsymptomsofhyperglycemiaorhyperglycemic

    crisis,arandomplasmaglucose200mg/dl(11.1mmol/l)

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    *Intheabsenceofunequivocalhyperglycemia,resultshouldbeconfirmedbyrepeattesting.

    However,inpractice,alargeportionofthe

    diabeticpopulationremainsunawareoftheircondition.Thus,thelowersensitivityofA1C

    atthedesignatedcutpointmaywellbeoffsetbythetestsgreater

    practicality,andwiderapplicationofamoreconvenienttest(A1C)

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    mayactuallyincreasethenumberofdiagnosesmade.

    Aswithmostdiagnostictests,atestresultdiagnosticofdiabetesshouldberepeated

    toruleoutlaboratoryerror,unlessthediagnosisisclearonclinicalgrounds,

    suchasapatientwithahyperglycemiccrisisorclassicsymptomsofhyperglycemia

    andarandomplasmaglucose200mg/dl.Itispreferable

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    thatthesametestberepeatedforconfirmation,sincetherewillbeagreaterlikelihoodofconcurrenceinthiscase.Forexample,ifthe

    A1Cis7.0%andarepeatresultis6.8%,thediagnosisofdiabetes

    isconfirmed.However,iftwodifferenttests(suchasA1CandFPG)are

    bothabovethediagnosticthresholds,thediagnosisofdiabetesis

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    alsoconfirmed.

    Ontheotherhand,iftwodifferenttestsareavailableinanindividualandtheresultsarediscordant,thetest

    whoseresultisabovethediagnosticcutpointshouldberepeated,andthe

    diagnosisismadeonthebasisoftheconfirmedtest.Thatis,if

    apatientmeetsthediabetescriterionoftheA1C(two

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    results6.5%)butnottheFPG(126mg/dlor7.0mmol/l),orviceversa,thatpersonshouldbeconsideredtohavediabetes.

    Sincethereispreanalyticandanalytic

    variabilityofallthetests,

    itisalsopossiblethatwhenatestwhoseresultwasabovethe

    diagnosticthresholdisrepeated,thesecondvaluewillbebelow

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    thediagnosticcutpoint.ThisisleastlikelyforA1C,somewhatmorelikelyforFPG,andmostlikelyforthe2-hPG.Barringa

    laboratoryerror,suchpatientsarelikelytohavetestresultsnearthemargins

    ofthethresholdforadiagnosis.Thehealthcareprofessionalmightopttofollow

    thepatientcloselyandrepeatthetestingin36

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    months.

    ThecurrentdiagnosticcriteriafordiabetesaresummarizedinTable2.

    C.Categoriesofincreasedriskfordiabetes(prediabetes)

    In1997and2003,TheExpertCommitteeonDiagnosisandClassificationofDiabetes

    Mellitus(8,9)recognizedanintermediategroupofindividualswhoseglucoselevels,althoughnot

    meetingcriteriafordiabetes,areneverthelesstoohightobe

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    considerednormal.Thesepersonsweredefinedashavingimpairedfastingglucose(IFG)(FPGlevels100125mg/dl

    [5.66.9mmol/l])orimpairedglucosetolerance

    (IGT)(2-hPGvaluesintheOGTTof140199mg/dl[7.811.0

    mmol/l]).ItshouldbenotedthattheWorldHealthOrganization(WHO)anda

    numberofotherdiabetesorganizationsdefinethecutoffforIFG

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    at110mg/dl(6.1mmol/l).IndividualswithIFGand/orIGThavebeenreferredtoashavingprediabetes,indicatingtherelativelyhighriskforthe

    futuredevelopmentofdiabetes.IFGandIGTshouldnotbeviewedasclinical

    entitiesintheirownrightbutratherriskfactorsfordiabetesaswell

    ascardiovasculardisease(CVD).IFGandIGTareassociatedwith

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    obesity(especiallyabdominalorvisceralobesity),dyslipidemiawithhightriglyceridesand/orlowHDLcholesterol,andhypertension.

    Asisthecasewiththe

    glucosemeasures,severalprospectivestudiesthatusedA1Ctopredicttheprogressionto

    diabetesdemonstratedastrong,continuousassociationbetweenA1Candsubsequentdiabetes.Ina

    systematicreviewof44,203individualsfrom16cohortstudieswith

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    afollow-upintervalaveraging5.6years(range2.812years),thosewithanA1Cbetween5.5and6.0%hadasubstantiallyincreasedriskofdiabetes

    with5-yearincidencesrangingfrom925%.AnA1Crangeof6.06.5%had

    a5-yearriskofdevelopingdiabetesbetween2550%andrelativerisk20

    timeshigher

    Table3Categoriesofincreasedriskfor

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    diabetes(prediabetes)*

    FPG100125mg/dl(5.66.9mmol/l):IFGor2-hplasmaglucoseinthe75-gOGTT140199mg/dl(7.811.0mmol/l):IGT

    orA1C5.76.4%

    *Forallthreetests,riskiscontinuous,extending

    belowthelowerlimitoftherangeandbecomingdisproportionatelygreaterathigher

    endsoftherange.

    comparedwithanA1C

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    of5.0%(10).Inacommunity-basedstudyofblackandwhiteadultswithoutdiabetes,baselineA1Cwasastrongerpredictorofsubsequentdiabetesand

    cardiovasculareventsthanfastingglucose(11).OtheranalysessuggestthatanA1Cof

    5.7%isassociatedwithdiabetesrisksimilartothatofthehigh-riskparticipants

    intheDiabetesPreventionProgram(DPP).

    Hence,it

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    isreasonabletoconsideranA1Crangeof5.76.4%asidentifyingindividualswithhighriskforfuturediabetes,astatethatmaybereferred

    toasprediabetes(4).Asisthecaseforindividualsfoundtohave

    IFGandIGT,individualswithanA1Cof5.76.4%shouldbeinformedof

    theirincreasedriskfordiabetesaswellasCVDand

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    counseledabouteffectivestrategiestolowertheirrisks(see

    IV.PREVENTION/DELAYOFTYPE2DIABETES).Aswithglucosemeasurements,thecontinuumof

    riskiscurvilinearasA1Crises,theriskofdiabetesrisesdisproportionately(10).Accordingly,

    interventionsshouldbemostintensiveandfollow-upparticularlyvigilantforthosewithA1Cs

    above6.0%,whoshouldbeconsideredtobeatvery

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    highrisk.Table3summarizesthecategoriesofincreasedriskfordiabetes.

    II.TESTINGFORDIABETESINASYMPTOMATICPATIENTSRecommendations

    .Testingtodetecttype2diabetesandassessriskforfuturediabetes

    inasymptomaticpeopleshouldbeconsideredinadultsofanyagewhoare

    overweightorobese(BMI25kg/m2)andwhohaveone

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    ormoreadditionalriskfactorsfordiabetes(Table4).Inthosewithouttheseriskfactors,testingshouldbeginatage45years.(B).

    Iftestsarenormal,repeattestingcarriedoutatleastat3-yearintervals

    isreasonable.(E)care.diabetesjournals.orgDIABETESCARE,VOLUME34,SUPPLEMENT1,JANUARY2011S13

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    StandardsofMedicalCare

    Table4Criteriafortestingfordiabetesinasymptomaticadultindividuals

    1.Testingshouldbeconsidered

    inalladultswhoareoverweight(BMI25kg/m2*)andhaveadditionalrisk

    factors:physicalinactivityfirst-degreerelativewithdiabeteshigh-riskrace/ethnicity(e.g.,

    AfricanAmerican,Latino,NativeAmerican,AsianAmerican,PacificIslander)

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    womenwhodeliveredababyweighing9lborwerediagnosedwithGDMhypertension(140/90mmHgorontherapyforhypertension)HDL

    cholesterollevel35mg/dl(0.90mmol/l)and/oratriglyceridelevel250mg/dl(2.82

    mmol/l)womenwithpolycysticovariansyndrome(PCOS)A1C5.7%,IGT,or

    IFGonprevioustestingotherclinicalconditionsassociatedwith

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    insulinresistance(e.g.,severeobesity,acanthosisnigricans)

    historyofCVD2.Intheabsenceoftheabovecriteria,testingfordiabetes

    shouldbeginatage45years.3.Ifresultsarenormal,testingshould

    berepeatedatleastat3-yearintervals,withconsiderationofmorefrequenttesting

    dependingoninitialresultsandriskstatus.*At-riskBMImay

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    belowerinsomeethnicgroups.

    .Totestfordiabetesortoassessriskoffuturediabetes,A1C,FPG,or2-h

    75-gOGTTisappropriate.(B).Inthoseidentifiedwithincreasedriskfor

    futurediabetes,identifyand,ifappropriate,treatotherCVDriskfactors.(B)For

    manyillnesses,thereisamajordistinctionbetweenscreeningand

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    diagnostictesting.However,fordiabetes,thesametestswouldbeusedforscreeningasfordiagnosis.Diabetesmaybeidentifiedanywherealongaspectrum

    ofclinicalscenariosrangingfromaseeminglylow-riskindividualwhohappensto

    haveglucosetesting,toahigher-riskindividualwhomtheprovidertestsbecauseof

    highsuspicionofdiabetes,tothesymptomaticpatient.Thediscussion

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    hereinisprimarilyframedastestingfordiabetesinthosewithoutsymptoms.Testingfordiabeteswillalsodetectindividualsatincreasedfutureriskfor

    diabetes,hereinreferredtoashavingprediabetes.

    A.Testingfortype

    2diabetesandriskoffuturediabetesinadultsType2diabetesis

    frequentlynotdiagnoseduntilcomplicationsappear,andapproximatelyone-fourthof

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    allpeoplewithdiabetesintheU.S.maybeundiagnosed.Theeffectivenessofearlyidentificationofprediabetesanddiabetesthroughmasstestingofasymptomatic

    individualshasnotbeenprovendefinitively,andrigoroustrialstoprovidesuchproof

    areunlikelytooccur.However,mathematicalmodelingstudiessuggestthatscreeningindependentof

    riskfactorsbeginningatage30or45yearsis

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    highlycost-effective($11,000perquality-adjustedlife-yeargained)(12).Prediabetesanddiabetesmeetestablishedcriteriaforconditionsinwhichearlydetectionisappropriate.Both

    conditionsarecommonandincreasinginprevalenceandimposesignificantpublichealthburdens.

    Thereisalongpresymptomaticphasebeforethediagnosisoftype2diabetes

    isusuallymade.Relativelysimpletestsareavailabletodetect

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    preclinicaldisease.Additionally,thedurationofglycemicburdenisastrongpredictorofadverseoutcomes,andeffectiveinterventionsexisttopreventprogressionofprediabetes

    todiabetes(seeIV.PREVENTION/DELAYOFTYPE2DIABETES)andtoreducerisk

    ofcomplicationsofdiabetes(seeVI.PREVENTIONANDMANAGEMENTOFDIABETESCOMPLICATIONS).

    Recommendationsfortestingfordiabetesinasymptomatic,undiagnosedadults

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    arelistedinTable4.TestingshouldbeconsideredinadultsofanyagewithBMI25kg/m2andoneormoreofthe

    knownriskfactorsfordiabetes.Becauseageisamajorriskfactorfor

    diabetes,testingofthosewithoutotherriskfactorsshouldbeginnolaterthan

    age45years.

    EitherA1C,FPG,orthe

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    2-hOGTTisappropriatefortesting.The2-hOGTTidentifiespeoplewitheitherIFGorIGTandthusmorepeopleatincreasedriskfor

    thedevelopmentofdiabetesandCVD.Itshouldbenotedthatthetwo

    testsdonotnecessarilydetectthesameindividuals.Theefficacyofinterventionsfor

    primarypreventionoftype2diabetes(1319)haveprimarilybeen

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    demonstratedamongindividualswithIGT,notforindividualswithIFG(whodonotalsohaveIGT)orforindividualswithspecificA1Clevels.

    Theappropriateintervalbetweentestsisnotknown(20).Therationalefor

    the3-yearintervalisthatfalsenegativeswillberepeatedbeforesubstantialtime

    elapses,andthereislittlelikelihoodthatanindividualwill

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    developsignificant

    complicationsofdiabeteswithin3yearsofanegativetestresult.Inthemodelingstudy,repeatscreeningevery3or

    5yearswascost-effective(12).

    Becauseoftheneedforfollow-up

    anddiscussionofabnormalresults,testingshouldbecarriedoutwithinthehealth

    caresetting.Communityscreeningoutsideahealthcaresettingis

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    notrecommendedbecausepeoplewithpositivetestsmaynotseek,orhaveaccessto,appropriatefollow-uptestingandcare.Conversely,theremaybefailure

    toensureappropriaterepeattestingforindividualswhotestnegative.Communityscreeningmay

    alsobepoorlytargeted,i.e.,itmayfailtoreachthegroupsmost

    atriskandinappropriatelytestthoseatlowrisk(the

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    worriedwell)oreventhosealreadydiagnosed.

    B.Testingfortype2diabetesinchildrenTheincidenceoftype2diabetesin

    adolescentshasincreaseddramaticallyinthelastdecade,especiallyinminoritypopulations(21),

    althoughthediseaseremainsrareinthegeneralpediatricpopulation(22).Consistentwith

    recommendationsforadults,childrenandyouthatincreasedriskfor

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    thepresenceorthedevelopmentoftype2diabetesshouldbetestedwithinthehealthcaresetting.TherecommendationsoftheADAConsensusStatement

    onType2DiabetesinChildrenandYouth(23),withsomemodifications,are

    summarizedinTable5.

    C.Screeningfortype1diabetesGenerally,

    peoplewithtype1diabetespresentwithacutesymptomsof

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    diabetesandmarkedlyelevatedbloodglucoselevels,andmostcasesarediagnosedsoonaftertheonsetofhyperglycemia.However,evidencefromtype1prevention

    studiessuggeststhatmeasurementofisletautoantibodiesidentifiesindividualswhoareatrisk

    fordevelopingtype1diabetes.Suchtestingmaybeappropriateinhigh-risk

    individuals,suchasthosewithpriortransienthyperglycemiaorthose

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    whohaverelativeswithtype1diabetes,inthecontextofclinicalresearchstudies(see,forexample,http://www2.diabetestrialnet.org).Widespreadclinicaltestingofasymptomaticlow-risk

    individualscannotcurrentlyberecommended,asitwouldidentifyveryfewindividualsin

    thegeneralpopulationwhoareatrisk.Individualswhoscreenpositiveshouldbe

    counseledabouttheirriskofdevelopingdiabetes.Clinicalstudiesare

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    beingconductedto

    S14DIABETESCARE,VOLUME34,SUPPLEMENT1,JANUARY2011care.diabetesjournals.org

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    PositionStatement

    Table5Testingfortype2diabetesinasymptomaticchildren

    Criteria

    Overweight(BMI85thpercentile

    forageandsex,weightforheight85thpercentile,orweight120%of

    idealforheight)Plusanytwoofthefollowingriskfactors:

    Familyhistoryoftype2diabetesinfirst-or

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    second-degreerelativeRace/ethnicity(NativeAmerican,AfricanAmerican,Latino,AsianAmerican,PacificIslander)Signsofinsulinresistanceorconditionsassociatedwithinsulinresistance

    (acanthosisnigricans,hypertension,dyslipidemia,PCOS,orsmall-forgestational-agebirthweight)Maternalhistory

    ofdiabetesorGDMduringthechildsgestationAgeofinitiation:age10

    yearsoratonsetofpuberty,ifpubertyoccursat

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    ayoungerage

    Frequency:every3years

    testvariousmethodsofpreventingtype1diabetes,orreversingearlytype1

    diabetes,inthosewithevidenceofautoimmunity.

    III.DETECTIONANDDIAGNOSIS

    OFGESTATIONALDIABETESMELLITUSRecommendations

    .Screenforundiagnosedtype2

    diabetesatthefirstprenatalvisitinthosewithrisk

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    factors,usingstandarddiagnosticcriteria.(B).Inpregnantwomennotknowntohavediabetes,screenforGDMat2428weeksofgestation,

    usinga75-g2-hOGTTandthediagnosticcutpointsinTable6.

    (B).ScreenwomenwithGDMforpersistentdiabetes612weekspostpartum.(E)

    .WomenwithahistoryofGDMshouldhavelifelong

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    screeningforthedevelopmentofdiabetesorprediabetesatleastevery3years.(E)Formanyyears,GDMwasdefinedasanydegreeof

    glucoseintolerancewithonsetorfirstrecognitionduringpregnancy(8),whetherornot

    theconditionpersistedafterpregnancy,andnotexcludingthepossibilitythatunrecognizedglucose

    intolerancemayhaveantedatedorbegunconcomitantlywiththepregnancy.

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    Thisdefinitionfacilitatedauniformstrategy

    fordetectionandclassificationofGDM,butitslimitationswererecognizedformanyyears.Asthe

    ongoingepidemicofobesityanddiabeteshasledtomoretype2diabetes

    inwomenofchildbearingage,thenumberofpregnantwomenwithundiagnosedtype

    2diabeteshasincreased(24).Becauseofthis,itis

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    reasonabletoscreenwomenwithriskfactorsfortype2diabetes(Table4)fordiabetesattheirinitialprenatalvisit,usingstandarddiagnosticcriteria

    (Table2).Womenwithdiabetesfoundatthisvisitshouldreceiveadiagnosis

    ofovert,notgestational,diabetes.

    GDMcarriesrisksforthemother

    andneonate.TheHyperglycemiaandAdversePregnancyOutcomes(HAPO)study

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    (25),alarge-scale(25,000pregnantwomen)multinationalepidemiologicstudy,demonstratedthatriskofadversematernal,fetal,andneonataloutcomescontinuouslyincreasedasafunction

    ofmaternalglycemiaat2428weeks,evenwithinrangespreviouslyconsiderednormalfor

    pregnancy.Formostcomplications,therewasnothresholdforrisk.Theseresultshave

    ledtocarefulreconsiderationofthediagnosticcriteriaforGDM.

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    Afterdeliberationsin20082009,theInternationalAssociationofDiabetesandPregnancyStudyGroups(IADPSG),aninternationalconsensusgroupwithrepresentativesfrommultipleobstetricaland

    diabetesorganizations,includingADA,developedrevisedrecommendationsfordiagnosingGDM.Thegrouprecommended

    thatallwomennotknowntohavediabetesundergoa75-gOGTTat

    2428weeksofgestation.Additionally,thegroupdevelopeddiagnosticcut

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    pointsforthefasting,1-h,and2-hplasmaglucosemeasurementsthatconveyedanoddsratioforadverseoutcomesofatleast1.75comparedwith

    themeanglucoselevelsintheHAPOstudy.Currentscreeninganddiagnosticstrategies,

    basedontheIADPSGstatement(26),areoutlinedinTable6.

    ThesenewcriteriawillsignificantlyincreasetheprevalenceofGDM,

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    primarilybecauseonlyoneabnormalvalue,nottwo,issufficienttomakethediagnosis.TheADArecognizestheanticipatedsignificantincreaseintheincidence

    ofGDMtobediagnosedbythesecriteriaandissensitivetoconcerns

    aboutthemedicalizationofpregnanciespreviouslycategorizedasnormal.Thesediagnosticcriteriachanges

    arebeingmadeinthecontextofworrisomeworldwideincreases

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    inobesityanddiabetesrates,withtheintentof

    Table6ScreeningforanddiagnosisofGDM

    Performa75-gOGTT,

    withplasmaglucosemeasurementfastingandat1and2h,at2428

    weeksofgestationinwomennotpreviouslydiagnosedwithovertdiabetes.

    TheOGTTshouldbeperformedinthemorningafteran

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    overnightfastofatleast8h.

    ThediagnosisofGDMismadewhenanyofthefollowingplasmaglucosevaluesare

    exceeded:

    Fasting92mg/dl(5.1mmol/l)1h180mg/dl

    (10.0mmol/l)2h153mg/dl(8.5mmol/l)optimizinggestationaloutcomesforwomen

    andtheirbabies.

    Admittedly,therearefewdata

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    fromrandomizedclinicaltrialsregardingtherapeuticinterventionsinwomenwhowillnowbediagnosedwithGDMbasedononlyonebloodglucosevalueabove

    thespecifiedcutpoints(incontrasttotheoldercriteriathatstipulatedat

    leasttwoabnormalvalues.)Expectedbenefitstotheirpregnanciesandoffspringisinferred

    frominterventiontrialsthatfocusedonwomenwithmoremild

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    hyperglycemiathanidentifiedusingolderGDMdiagnosticcriteriaandthatfoundmodestbenefits(27,28).Thefrequencyoftheirfollow-upandbloodglucosemonitoringis

    notyetclear,butlikelytobelessintensivethanwomendiagnosedby

    theoldercriteria.Additionalwell-designedclinicalstudiesareneededtodeterminetheoptimal

    intensityofmonitoringandtreatmentofwomenwithGDMdiagnosed

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    bythenewcriteria(thatwouldnothavemetthepriordefinitionofGDM).Itisimportanttonotethat8090%ofwomenin

    bothofthemildGDMstudies(whoseglucosevaluesoverlappedwiththethresholds

    recommendedherein)couldbemanagedwithlifestyletherapyalone.

    Becausesome

    casesofGDMmayrepresentpreexistingundiagnosedtype2diabetes,

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    womenwithahistoryofGDMshouldbescreenedfordiabetes612weekspostpartum,usingnonpregnantOGTTcriteria.Womenwithahistoryof

    GDMhaveagreatlyincreasedsubsequentriskfordiabetes(29)andshouldbe

    followedupwithsubsequentscreeningforthedevelopmentofdiabetesorprediabetes,as

    outlinedinII.TESTINGFORDIABETESINASYMPTOMATICPATIENTS.

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    care.diabetesjournals.orgDIABETESCARE,VOLUME34,SUPPLEMENT1,JANUARY2011S15

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    StandardsofMedicalCareTable7Therapiesproveneffectiveindiabetespreventiontrials

    Incidencein3-YearMeancontrolRelativerisknumberage

    DurationInterventionsubjectsreduction(%)neededtoStudy(ref.)nPopulation(years)(years)

    (dailydose)(%/year)(95%CI)treat.

    LifestyleFinnishDPS(14)522

    IGT,BMI25kg/m2553.2I-D&E658(3070)

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    8.5DPP(13)2,161*IGT,BMI24kg/m2,513I-D&E10.458(4866)6.9

    FPG5.3mmol/lDaQing(15)259*

    IGT(randomizedgroups)456G-D&E14.538(1456)7.9ToranomonStudy458

    IGT(men),BMI.24554I-D&E2.467(P.0.043)20.6

    (35)kg/m2IndianDPP(19)269*IGT46

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    2.5I-D&E2329(2137)6.4MedicationsDPP(13)2,155*IGT,BMI24kg/m2,512.8Metformin(1,70010.431(1743)13.9FPG5.3

    mmol/lmg)IndianDPP(19)269*IGT462.5Metformin(500mg)23

    26(1935)6.9STOP-NIDDM(17)1,419IGT,FPG5.6mmol/l543.2Acarbose

    (300mg)12.425(1037)9.6XENDOS(36)3,277BMI

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    30kg/m2434Orlistat(360mg)2.437(1454)45.5DREAM(18)5,269IGTorIFG553.0Rosiglitazone(8mg)9.160

    (5465)6.9VoglibosePh-31,780IGT563.0(1-yearVogliobose(0.2mg)12.0

    40(1857)21(1-year

    (37)Rx)Rx)Modifiedandreprintedwith

    permission(38).Percentagepoints:Numberneededtotreattoprevent

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    1caseofdiabetes,standardizedfora3-yearperiodtoimprovecomparisonsacrossstudies.*Numberofparticipantsintheindicatedcomparisons,notnecessarilyin

    entirestudy.Calculatedfrominformationinthearticle.DPP,DiabetesPreventionProgram;DPS,

    DiabetesPreventionStudy;DREAM,DiabetesReductionAssessmentwithRamiprilandRosiglitazoneMedication;STOP-NIDDM,

    StudytoPreventNon-InsulinDependentDiabetes;XENDOS,Xenicalinthe

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    preventionofDiabetesinObeseSubjects.I,individual;G,group;D&E,dietandexercise.

    IV.PREVENTION/DELAYOFTYPE2DIABETESRecommendations

    .PatientswithIGT(A),IFG(E),oranA1Cof5.7

    6.4%(E)shouldbereferredtoaneffectiveongoingsupportprogramtargetingweight

    lossof7%ofbodyweightandincreasingphysicalactivity

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    toatleast150min/weekofmoderateactivitysuchaswalking..Follow-upcounselingappearstobeimportantforsuccess.(B).Basedon

    potentialcostsavingsofdiabetesprevention,suchprogramsshouldbecoveredbythird-party

    payors.(E).Metformintherapyforpreventionoftype2diabetesmaybe

    consideredinthoseatthehighestriskfordevelopingdiabetes,

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    suchasthosewithmultipleriskfactors,especiallyiftheydemonstrateprogressionofhyperglycemia(e.g.,A1C6%)despitelifestyleinterventions.(B).Monitoringfor

    thedevelopmentofdiabetesinthosewithprediabetesshouldbeperformedeveryyear.

    (E)Randomizedcontrolledtrialshaveshownthatindividualsathighriskfordeveloping

    diabetes(thosewithIFG,IGT,orboth)canbegiven

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    interventionsthatsignificantlydecreasetherateofonsetofdi

    abetes(1319).Theseinterventionsincludeintensivelifestylemodificationprogramsthathavebeen

    showntobeveryeffective(58%reductionafter3years)anduseof

    thepharmacologicagentsmetformin,-glucosidaseinhibitors,orlistat,andthiazolidinediones(TZDs),eachofwhich

    hasbeenshowntodecreaseincidentdiabetestovariousdegrees.

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    AsummaryofmajordiabetespreventiontrialsisshowninTable7.

    Follow-upofallthreelargestudiesoflifestyleinterventionhas

    shownsustainedreductionintherateofconversiontotype2diabetes,with

    43%reductionat20yearsintheDaQingstudy(30),43%reduction

    at7yearsintheFinnishDiabetesPreventionStudy(DPS)

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    (31)and34%reductionat10yearsintheU.S.DiabetesPreventionProgramOutcomesStudy(DPPOS)(32).Acost-effectivenessanalysissuggestedthatlifestyleinterventions

    asdeliveredintheDPParecost-effective(33).GroupdeliveryoftheDPP

    interventionincommunitysettingshasthepotentialtobesignificantlylessexpensivewhile

    stillachievingsimilarweightloss(34).

    Basedon

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    theresultsofclinicaltrialsandtheknownrisksofprogressionofprediabetestodiabetes,personswithanA1Cof5.76.4%,IGT,orIFG

    shouldbecounseledonlifestylechangeswithgoalssimilartothoseofthe

    DPP(7%weight

    lossandmoderatephysicalactivityofatleast

    150min/week).Regardingthemoredifficultissueofdrugtherapy

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    fordiabetesprevention,aconsensuspanelfeltthatmetforminshouldbetheonlydrugconsidered(39).Forotherdrugs,theissuesofcost,side

    effects,andlackofpersistenceofeffectinsomestudiesledthepanel

    tonotrecommendtheirusefordiabetesprevention.Metformin,whichwassignificantlyless

    effectivethanlifestyleintheDPPandDPPOS,reasonablymay

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    berecommendedforvery-high-riskindividuals(thosewithriskfactorsfordiabetesand/orthosewithmoresevereorprogressivehyperglycemia).Ofnote,intheDPP

    metforminwasmosteffectivecomparedtolifestyleinthosewithBMIofat

    least35kg/m2andwasnotsignificantlybetterthanplacebointhoseover

    age60years.

    V.DIABETESCAREA.Initial

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    evaluationAcompletemedicalevaluationshouldbeperformedtoclassifythediabetes,detectthepresenceofdiabetescomplications,reviewprevioustreatmentandglycemiccontrol

    inpatientswithestablisheddiabetes,assistinformulatingamanagementplan,andprovide

    abasisforcontinuingcare.Laboratorytestsappropriatetotheevaluationofeach

    patientsmedicalcon

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    SUPPLEMENT1,JANUARY2011care.diabetesjournals.org

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    PositionStatement

    ditionshouldbeperformed.Afocusonthecomponentsofcomprehensivecare(Table8)willassistthehealthcare

    teamtoensureoptimalmanagementofthepatientwithdiabetes.

    B.

    ManagementPeoplewithdiabetesshouldreceivemedicalcarefromaphysician-coordinatedteam.Such

    teamsmayinclude,butarenotlimitedto,physicians,nurse

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    practitioners,physiciansassistants,nurses,dietitians,pharmacists,andmentalhealthprofessionalswithexpertiseandaspecialinterestindiabetes.Itisessentialinthiscollaborative

    andintegratedteamapproachthatindividualswithdiabetesassumeanactiverolein

    theircare.

    Themanagementplanshouldbeformulatedasacollaborative

    therapeuticallianceamongthepatientandfamily,thephysician,and

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    othermembersofthehealthcareteam.Avarietyofstrategiesandtechniquesshouldbeusedtoprovideadequateeducationanddevelopmentofproblem-solving

    skillsinthevariousaspectsofdiabetesmanagement.Implementationofthemanagementplan

    requiresthateachaspectisunderstoodandagreedtobythepatientand

    thecareprovidersandthatthegoalsandtreatmentplan

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    arereasonable.Anyplanshouldrecognizediabetesself-managementeducation(DSME)andongoingdiabetessupportasanintegralcomponentofcare.Indevelopingthe

    plan,considerationshouldbegiventothepatientsage,schoolorworkschedule

    andconditions,physicalactivity,eatingpatterns,socialsituationandculturalfactors,andpresence

    ofcomplicationsofdiabetesorothermedicalconditions.

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    C.Glycemiccontrol1.AssessmentofglycemiccontrolTwoprimarytechniquesareavailableforhealthprovidersandpatientstoassesstheeffectivenessofthe

    managementplanonglycemiccontrol:patientself-monitoringofbloodglucose(SMBG)orinterstitial

    glucose,andA1C.

    a.GlucosemonitoringRecommendations

    .SMBG

    shouldbecarriedoutthreeormoretimesdailyfor

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    patientsusingmultipleinsulininjectionsorinsulinpumptherapy.(A)Table8Componentsofthecomprehensivediabetesevaluation

    Medicalhistory

    Ageandcharacteristicsofonsetofdiabetes(e.g.,DKA,asymptomaticlaboratoryfinding)

    Eatingpatterns,physicalactivityhabits,nutritionalstatus,andweighthistory;growthanddevelopment

    inchildrenandadolescentsDiabeteseducationhistoryReview

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    ofprevioustreatmentregimensandresponsetotherapy(A1Crecords)Currenttreatmentofdiabetes,includingmedications,mealplan,physicalactivitypatterns,andresults

    ofglucosemonitoringandpatientsuseofdataDKAfrequency,severity,and

    causeHypoglycemicepisodesHypoglycemiaawarenessAnyseverehypoglycemia:frequencyand

    causeHistoryofdiabetes-relatedcomplicationsMicrovascular:retinopathy,nephropathy,

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    neuropathy(sensory,includinghistoryoffootlesions;autonomic,includingsexualdysfunctionandgastroparesis)Macrovascular:CHD,cerebrovasculardisease,PADOther:psychosocialproblems*,dental

    disease*PhysicalexaminationHeight,weight,BMIBloodpressuredetermination,includingorthostatic

    measurementswhenindicatedFundoscopicexamination*ThyroidpalpationSkinexamination(for

    acanthosisnigricansandinsulininjectionsites)Comprehensivefootexamination:

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    InspectionPalpationofdorsalispedisandposteriortibialpulsesPresence/absenceofpatellarandAchillesreflexesDeterminationofproprioception,vibration,and

    monofilamentsensationLaboratoryevaluationA1C,ifresultsnotavailablewithinpast23

    monthsIfnotperformed/availablewithinpastyear:Fastinglipidprofile,including

    total,LDLandHDLcholesterolandtriglyceridesLiverfunction

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    testsTestforurinealbuminexcretionwithspoturinealbumin-to-creatinineratioSerumcreatinineandcalculatedGFRThyroid-stimulatinghormoneintype1

    diabetes,dyslipidemia,orwomenoverage50yearsReferrals

    Annual

    dilatedeyeexamFamilyplanningforwomenofreproductiveageRegistered

    dietitianforMNTDSMEDentalexaminationMental

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    healthprofessional,ifneeded*Seeappropriatereferralsforthesecategories.

    .Forpatientsusingless-frequentinsulininjections,noninsulintherapies,ormedicalnutrition

    therapy(MNT)alone,SMBGmaybeusefulasaguidetothesuccess

    oftherapy.(E).Toachievepostprandialglucosetargets,postprandialSMBGmaybe

    appropriate.(E).WhenprescribingSMBG,ensurethatpatientsreceive

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    initialinstructionin,androutinefollow-upevaluationof,SMBGtechniqueandtheirabilitytousedatatoadjusttherapy.(E).Continuousglucosemonitoring

    (CGM)inconjunctionwithintensiveinsulinregimenscanbeausefultoolto

    lowerA1Cinselectedadults(age25years)withtype1diabetes.(A)

    .AlthoughtheevidenceforA1Cloweringisless

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    stronginchildren,teens,andyoungeradults,CGMmaybehelpfulinthesegroups.Successcorrelateswithadherencetoongoinguseofthedevice.

    (C).CGMmaybeasupplementaltooltoSMBGinthosewith

    hypoglycemiaunawarenessand/orfrequenthypoglycemicepisodes.(E)care.diabetesjournals.orgDIABETESCARE,VOLUME34,SUPPLEMENT

    1,JANUARY2011S17

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    StandardsofMedicalCare

    Majorclinicaltrialsofinsulin-treatedpatientsthatdemonstratedthebenefitsofintensiveglycemiccontrolondiabetescomplications

    haveincludedSMBGaspartofmultifactorialinterventions,suggestingthatSMBGisa

    componentofeffectivetherapy.SMBGallowspatientstoevaluatetheirindividualresponseto

    therapyandassesswhetherglycemictargetsarebeingachieved.Results

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    ofSMBGcanbeusefulinpreventinghypoglycemiaandadjustingmedications(particularlyprandialinsulindoses),MNT,andphysicalactivity.

    Thefrequencyand

    timingofSMBGshouldbedictatedbytheparticularneedsandgoalsof

    thepatient.SMBGisespeciallyimportantforpatientstreatedwithinsulintomonitor

    forandpreventasymptomatichypoglycemiaandhyperglycemia.Formostpatients

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    withtype1diabetesandpregnantwomentakinginsulin,SMBGisrecommendedthreeormoretimesdaily.Forthesepopulations,significantlymorefrequenttesting

    mayberequiredtoreachA1Ctargetssafelywithouthypoglycemia.Theoptimalfrequency

    andtimingofSMBGforpatientswithtype2diabetesonnoninsulintherapy

    isunclear.Ameta-analysisofSMBGinnoninsulin-treatedpatients

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    withtype2diabetesconcludedthatsomeregimenofSMBGwasassociatedwithareductioninA1Cof0.4%.However,manyofthestudies

    inthisanalysisalsoincludedpatienteducationwithdietandexercisecounselingand,

    insomecases,pharmacologicintervention,makingitdifficulttoassessthecontributionof

    SMBGalonetoimprovedcontrol(40).Severalrecenttrialshave

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    calledintoquestiontheclinicalutilityandcost-effectivenessofroutineSMBGinnoninsulin-treatedpatients(4143).

    BecausetheaccuracyofSMBGisinstrument

    anduserdependent(44),itisimportanttoevaluateeachpatientsmonitoringtechnique,

    bothinitiallyandatregularintervalsthereafter.Inaddition,optimaluseofSMBG

    requiresproperinterpretationofthedata.Patientsshouldbetaught

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    howtousethedatatoadjustfoodintake,exercise,orpharmacologicaltherapytoachievespecificglycemicgoals,andtheseskillsshouldbereevaluated

    periodically.

    CGMthroughthemeasurementofinterstitialglucose(whichcorrelateswell

    withplasmaglucose)isavailable.ThesesensorsrequirecalibrationwithSMBG,andthe

    latterarestillrecommendedformakingacutetreatmentdecisions.CGM

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    devicesalsohavealarmsforhypo-and

    hyperglycemicexcursions.Smallstudiesinselectedpatientswithtype1diabeteshavesuggestedthatCGMuse

    reducesthetimespentinhypo-andhyperglycemicrangesandmaymodestlyimproveglycemic

    control.Alarger26-weekrandomizedtrialof322type1patientsshowedthat

    adultsage25yearsandolderusingintensiveinsulintherapy

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    andCGMexperienceda0.5%reductioninA1C(from

    7.6%to7.1%)comparedtousualintensiveinsulintherapywithSMBG(45).Sensor

    useinchildren,teens,andadultsuptoage24yearsdidnot

    resultinsignificantA1Clowering,andtherewasnosignificantdifferenceinhypoglycemia

    inanygroup.Importantly,thegreatestpredictorofA1C-loweringin

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    thisstudyforallage-groupswasfrequencyofsensoruse,whichwaslowerinyoungerage-groups.Inasmallerrandomizedcontrolledtrialof

    129adultsandchildrenwithbaselineA1C7.0%,outcomescombiningA1Candhypoglycemia

    favoredthegrouputilizingCGM,suggestingthatCGMisalsobeneficialforindividuals

    withtype1diabeteswhohavealreadyachievedexcellentcontrol

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    withA1C7.0(46).AlthoughCGMisanevolvingtechnology,emergingdatasuggestthat,inappropriatelyselectedpatientswhoaremotivatedtowearit

    mostofthetime,itmayofferbenefit.CGMmaybeparticularlyuseful

    inthosewithhypoglycemiaunawarenessand/orfrequentepisodesofhypoglycemia,andstudiesin

    thisareaareongoing.b.A1CRecommendations

    .

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    PerformtheA1Ctestatleasttwotimesayearinpatientswhoaremeetingtreatmentgoals(andwhohavestableglycemiccontrol).(E)

    .PerformtheA1Ctestquarterlyinpatientswhosetherapyhaschangedor

    whoarenotmeetingglycemicgoals.(E).Useofpoint-of-caretestingfor

    A1Callowsfortimelydecisionsontherapychanges,whenneeded.

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    (E)BecauseA1Cisthoughttoreflectaverageglycemiaoverseveralmonths(44),andhasstrongpredictivevaluefordiabetescomplications(47,48),A1Ctesting

    shouldbeperformedroutinelyinallpatientswithdiabetes,atinitialassessmentand

    thenaspartofcontinuingcare.Measurementapproximatelyevery3monthsdetermineswhether

    apatientsglycemictargetshavebeenreachedandmaintained.For

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    anyindividualpatient,thefre-

    Table9CorrelationofA1Cwithaverageglucose

    MeanplasmaglucoseA1C(%)mg/dlmmol/l6126

    7.071548.6818310.2921211.81024013.4

    1126914.91229816.5

    Theseestimatesarebasedon

    ADAGdataof2,700glucosemeasurementsover3monthsper

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    A1Cmeasurementin507adultswithtype1,type2,andnodiabetes.ThecorrelationbetweenA1Candaverageglucosewas0.92(51).A

    calculatorforconvertingA1Cresultsintoestimatedaverageglucose(eAG),ineithermg/dl

    ormmol/l,isavailableathttp://professional.diabetes.org/eAG.

    quencyofA1Ctesting

    shouldbedependentontheclinicalsituation,thetreatmentregimen

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    used,andthejudgmentoftheclinician.Somepatientswithstableglycemiawellwithintargetmaydowellwithtestingonlytwiceperyear,

    whileunstableorhighlyintensivelymanagedpatients(e.g.,pregnanttype1women)may

    betestedmorefrequentlythanevery3months.TheavailabilityoftheA1C

    resultatthetimethatthepatientisseen(point-of-care

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    testing)hasbeenreportedtoresultinincreasedintensificationoftherapyandimprovementinglycemiccontrol(49,50).

    TheA1Ctestissubject

    tocertainlimitations.Conditionsthataffecterythrocyteturnover(hemolysis,bloodloss)andhemoglobin

    variantsmustbeconsidered,particularlywhentheA1Cresultdoesnotcorrelatewith

    thepatientsclinicalsituation(44).Inaddition,A1Cdoesnot

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    provideameasureofglycemicvariabilityorhypoglycemia.Forpatientspronetoglycemicvariability(especiallytype1patients,ortype2patientswithsevere

    insulindeficiency),glycemiccontrolisbestjudgedbythecombinationofresultsof

    SMBGtestingandtheA1C.TheA1Cmayalsoserveasacheck

    ontheaccuracyofthepatientsmeter(orthepatients

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    reportedSMBGresults)andtheadequacyoftheSMBGtestingschedule.

    Table9containsthecorrelationbetweenA1Clevelsandmeanplasma

    glucoselevelsbasedondatafromtheinternationalA1C-DerivedAverageGlucose(ADAG)trial

    utilizingfrequentSMBGandCGMin507adults(83%Caucasian)withtype1,

    type2,andnodiabe

    S18DIABETESCARE,

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    VOLUME34,SUPPLEMENT1,JANUARY2011care.diabetesjournals.org

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    PositionStatement

    tes(51).TheAmericanDiabetesAssociationandAmericanAssociationofClinicalChemistshavedeterminedthatthecorrelation(r.

    0.92)isstrongenoughtojustifyreportingbothanA1Cresultandan

    estimatedaverageglucose(eAG)resultwhenaclinicianorderstheA1Ctest.The

    tableinpreviousversionsoftheStandardsofMedicalCare

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    inDiabetesdescribingthecorrelationbetweenA1Candmeanglucosewasderivedfromrelativelysparsedata(one7-pointprofileover1dayperA1C

    reading)intheprimarilyCaucasiantype1diabeticparticipantsintheDCCT(52).

    Cliniciansshouldnotethatthenumbersinthetablearenowdifferent,as

    theyarebasedon

    2,800readingsperA1C

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    intheADAGtrial.IntheADAGtrial,therewerenosignificantdifferencesamongracialandethnicgroupsintheregressionlinesbetweenA1C

    andmeanglucose,althoughtherewasatrendtowardadifferencebetweenAfrican/African

    AmericanparticipantsandCaucasianonesthatmighthavebeensignificanthadmoreAfrican/African

    Americanparticipantsbeenstudied.ArecentstudycomparingA1Cwith

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    CGMdatain48type1diabeticchildrenfoundahighlystatisticallysignificantcorrelationbetweenA1Candmeanbloodglucose,althoughthecorrelation(r

    .0.7)wassignificantlylowerthanintheADAGtrial(53).Whetherthere

    aresignificantdifferencesinhowA1Crelatestoaverageglucoseinchildrenor

    inAfricanAmericanpatientsisanareaforfurtherstudy.

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    Forthetimebeing,thequestionhasnotledtodifferentrecommendationsabouttestingA1Cortodifferentinterpretationsoftheclinicalmeaningof

    givenlevelsofA1Cinthosepopulations.

    Forpatientsinwhom

    A1C/eAGandmeasuredbloodglucoseappeardiscrepant,cliniciansshouldconsiderthepossibilitiesof

    hemoglobinopathyoralteredredcellturnover,andtheoptionsof

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    morefrequentand/ordifferenttimingofSMBGoruseofCGM.Othermeasuresofchronicglycemiasuchasfructosamineareavailable,buttheirlinkage

    toaverageglucoseandtheirprognosticsignificancearenotasclearasis

    thecaseforA1C.

    2.GlycemicgoalsinadultsRecommendations

    .LoweringA1Ctobeloworaround7%has

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    beenshowntoreducemicrovascularandneuropathiccomplicationsofdiabetesand,ifimplementedsoonafterthediagnosisofdiabetes,isassociatedwithlong-termreduction

    inmacrovasculardisease.Therefore,areasonableA1Cgoalformanynonpregnantadultsis

    7%.(B)

    .Becauseadditionalanalysesfromseveralrandomizedtrialssuggest

    asmallbutincrementalbenefitinmicrovascularoutcomeswithA1C

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    valuesclosertonormal,providersmightreasonablysuggestmorestringentA1Cgoalsforselectedindividualpatients,ifthiscanbeachievedwithoutsignificanthypoglycemia

    orotheradverseeffectsoftreatment.Suchpatientsmightincludethosewithshort

    durationofdiabetes,longlifeexpectancy,andnosignificantCVD.(B).Conversely,

    lessstringentA1Cgoalsmaybeappropriateforpatientswith

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    ahistoryofseverehypoglycemia,limitedlifeexpectancy,advancedmicrovascularormacrovascularcomplications,extensivecomorbidconditions,andthosewithlongstandingdiabetesinwhomthe

    generalgoalisdifficulttoattaindespiteDSME,appropriateglucosemonitoring,andeffective

    dosesofmultipleglucose-loweringagentsincludinginsulin.(C)Glycemiccontrolisfundamentalto

    themanagementofdiabetes.TheDCCT(47)(inpatientswith

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    type1diabetes),theKumamotostudy(54),andtheUKProspectiveDiabetesStudy(UKPDS)(55,56)(bothinpatientswithtype2diabetes)wereprospective,

    randomized,controlledtrialsofintensiveversusstandardglycemiccontrolinpatientswithrelatively

    recentlydiagnoseddiabetes.Thesetrialsshoweddefinitivelythatimprovedglycemiccontrolisassociated

    withsignificantlydecreasedratesofmicrovascular(retinopathyandnephropathy)and

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    neuropathiccomplications.FollowupoftheDCCTcohortsintheEpidemiologyofDiabetesInterventionsandComplications(EDIC)study(57,58)andoftheUKPDScohort

    (59)hasshownpersistenceofthesemicrovascularbenefitsinpreviouslyintensivelytreatedsubjects,

    eventhoughtheirglycemiccontrolhasbeenequivalenttothatofpreviousstandard

    armsubjectsduringfollow-up.

    Subsequenttrialsinpatients

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    withmorelong-standingtype2diabetes,designedprimarilytolookattheroleofintensiveglycemiccontroloncardiovascularoutcomesalsoconfirmedabenefit,

    althoughmoremodest,ononsetorprogressionofmicrovascularcomplications.

    The

    VeteransAffairsDiabetesTrial(VADT)showedsignificantreductionsinalbuminuriawithintensive(achieved

    medianA1C6.9%)comparedtostandardglycemiccontrol,butno

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    differenceinretinopathyandneuropathy(60,61).TheActioninDiabetesandVascularDisease:PreteraxandDiamicronModifiedReleaseControlledEvaluation(ADVANCE)studyofintensive

    versusstandardglycemiccontrolintype2diabetesfoundastatisticallysignificantreduction

    inalbuminuriawithanA1Ctargetof6.5%(achievedmedianA1C6.3%)compared

    tostandardtherapyachievingamedianA1Cof7.0%(62).

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    RecentanalysesfromtheActiontoControlCardiovascularRiskinDiabetes(ACCORD)trialhaveshownlowerratesofmeasuresofmicrovascularcomplicationsinthe

    intensiveglycemiccontrolarmcomparedwiththestandardarm(63,64).

    Epidemiological

    analysesoftheDCCTandUKPDS(47,48)demonstrateacurvilinearrelationshipbetweenA1C

    andmicrovascularcomplications.Suchanalysessuggestthat,onapopulation

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    level,thegreatestnumberofcomplicationswillbeavertedbytakingpatientsfromverypoorcontroltofairorgoodcontrol.Theseanalysesalso

    suggestthatfurtherloweringofA1Cfrom7to6%isassociatedwith

    furtherreductionintheriskofmicrovascularcomplications,albeittheabsoluteriskreductions

    becomemuchsmaller.Giventhesubstantiallyincreasedriskofhypoglycemia

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    (particularlyinthosewithtype1diabetes,butalsointherecenttype2trials),theconcerningmortalityfindingsintheACCORDtrial(65),

    andtherelativelymuchgreatereffortrequiredtoachievenear-normoglycemia,therisksof

    lowertargetsmayoutweighthepotentialbenefitsonmicrovascularcomplicationsonapopulation

    level.However,selectedindividualpatients,especiallythosewithlittlecomorbidity

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    andlonglifeexpectancy(whomayreapthebenefitsoffurtherloweringofglycemiabelow7%)may,atpatientandproviderjudgment,adoptglycemic

    targetsasclosetonormalaspossibleaslongassignificanthypoglycemiadoes

    notbecomeabarrier.

    Whereasmanyepidemiologicstudiesandmeta-analyses(66,67)

    haveclearlyshownadirectrelationshipbetweenA1CandCVD,

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    thepotentialofintensiveglycemiccontroltoreduceCVDhasbeenlessclearlydefined.IntheDCCT,therewasatrendtowardlowerrisk

    ofCVDeventswithintensivecontrol.However,9-yearpost-DCCTfollow-upofthecohort

    has

    care.diabetesjournals.orgDIABETESCARE,VOLUME34,SUPPLEMENT1,JANUARY2011S19

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    StandardsofMedicalCare

    shownthatparticipantspreviouslyrandomizedtotheintensivearmhada42%reduction(P.0.02)in

    CVDoutcomesanda57%reduction(P.0.02)intheriskof

    nonfatalmyocardialinfarction(MI),stroke,orCVDdeathcomparedwiththosepreviouslyin

    thestandardarm(68).Thebenefitofintensiveglycemiccontrol

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    inthistype1cohorthasrecentlybeenshowntopersistforseveraldecades(69).

    TheUKPDStrialoftype2diabetes

    observeda16%reductionincardiovascularcomplications(combinedfatalornonfatalMIand

    suddendeath)intheintensiveglycemiccontrolarm,althoughthisdifferencewasnot

    statisticallysignificant(P.0.052),andtherewasnosuggestion

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    ofbenefitonotherCVDoutcomessuchasstroke.However,10yearsoffollow-upoftheUKPDScohortdemonstrated,forparticipantsoriginallyrandomized

    tointensiveglycemiccontrolcomparedwiththoserandomizedtoconventionalglycemiccontrol,long-term

    reductionsinMI(15%withsulfonylureaorinsulinasinitialpharmacotherapy,33%with

    metforminasinitialpharmacotherapy,bothstatisticallysignificant)andinall-cause

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    mortality(13and27%,respectively,bothstatisticallysignificant)(59).

    Resultsofthreelargetrials(ACCORD,ADVANCE,andVADT)suggestednosignificantreduction

    inCVDoutcomeswithintensiveglycemiccontrolinthesepopulations,whohadmore

    advanceddiabetesthanUKPDSparticipants.Detailsofthesethreestudiesarereviewedextensively

    inarecentADApositionstatement(70).

    The

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    glycemiccontrolarmofACCORDwashaltedearlyduetothefindingofanincreasedrateofmortalityintheintensivearmcomparedwith

    thestandardarm(1.41%vs.1.14%peryear;HR

    1.22[95%

    CI1.01to1.46]);withasimilarincreaseincardiovasculardeaths.Theprimary

    outcomeofACCORD(MI,stroke,orcardiovasculardeath)waslower

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    intheintensiveglycemiccontrolgroup,duetoareductioninnonfatalMI,butthisreductionwasnotstatisticallysignificantwhenthestudywas

    terminated(65).Thepotentialcauseofexcessdeathsintheintensivegroupof

    theACCORDhasbeendifficulttopinpoint.Exploratoryanalysesofthemortalityfindings

    ofACCORD(evaluatingvariablesincludingweightgain,useofany

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    specificdrugordrugcombination,andhypoglycemia)werereportedlyunabletoidentifyaclear

    explanationfortheexcessmortalityintheintensive

    arm.TheACCORDinvestigatorssubsequentlypublishedadditionalanalysesshowingnoincreaseinmortality

    intheintensivearmparticipantswhoachievedA1Clevels7%orinthose

    wholoweredtheirA1Cquicklyaftertrialenrollment.Infact,

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    theconversewasobservedthoseathighestriskformortalitywereparticipantsintheintensivearmwiththehighestA1Clevels(71).

    TheprimaryoutcomeofADVANCEwasacombinationofmicrovascularevents(nephropathyand

    retinopathy)andmajoradversecardiovascularevents(MI,stroke,andcardiovasculardeath).Intensiveglycemic

    controlsignificantlyreducedtheprimaryendpoint,althoughthiswas

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    duetoasignificantreductioninthemicrovascularoutcome,primarilydevelopmentofmacroalbuminuria,withnosignificantreductioninthemacrovascularoutcome.Therewasno

    differenceinoverallorcardiovascularmortalitybetweentheintensivecomparedwiththestandard

    glycemiccontrolarms(62).

    TheVADTrandomizedparticipantswithtype2

    diabetesuncontrolledoninsulinormaximaldoseoralagents(median

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    entryA1C9.4%)toastrategyofintensiveglycemiccontrol(goalA1C

    6.0%)orstandardglycemiccontrol,withaplannedA1Cseparation

    ofatleast1.5%.TheprimaryoutcomeoftheVADTwasacomposite

    ofCVDevents.Thecumulativeprimaryoutcomewasnonsignificantlylowerintheintensive

    arm(60).UnliketheUKPDS,whichwascarriedoutin

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    patientswithnewlydiagnoseddiabetes,allthreeoftherecenttype2cardiovasculartrialswereconductedinparticipantswithestablisheddiabetes(meanduration811

    years)andeitherknownCVDormultipleriskfactors,suggestingthepresenceof

    establishedatherosclerosis.Subsetanalysesofthethreetrialssuggestedasignificantbenefitof

    intensiveglycemiccontrolonCVDinparticipantswithshorterduration

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    ofdiabetes,lowerA1Catentry,and/ororabsenceofknownCVD.TheDCCT-EDICstudyandthelong-termfollow-upoftheUKPDScohortboth

    suggestthatintensiveglycemiccontrolinitiatedsoonafterdiagnosisofdiabetesinpatients

    withalowerlevelofCVDriskmayimpartlong-termprotectionfromCVD

    events.Asisthecasewithmicrovascularcomplications,itmay

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    bethatglycemiccontrolplaysagreaterrolebeforemacrovasculardiseaseiswelldevelopedandminimalornorolewhenitisadvanced.Consistent

    withthis

    concept,datafromanancillarystudyoftheVADT

    demonstratedthatintensiveglycemiccontrolwasquiteeffectiveinreducingCVDeventsin

    individualswithlessatherosclerosisatbaseline(assessedbycoronarycalcium)

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    butnotinpersonswithmoreextensivebaselineatherosclerosis(72).

    Theevidenceforacardiovascularbenefitofintensiveglycemiccontrolprimarilyrests

    onlong-termfollow-upofstudycohortstreatedearlyinthecourseoftype

    1andtype2diabetesandsubsetanalysesofACCORD,ADVANCE,andVADT.

    Arecentgroup-levelmetaanalysisofthelatterthreetrialssuggests

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    thatglucoseloweringhasamodest(9%)butstatisticallysignificantreductioninmajorCVDoutcomes,primarilynonfatalMI,withnosignificanteffectonmortality.

    AprespecifiedsubgroupanalysissuggestedthatmajorCVDoutcomereductionoccurredinpatients

    withoutknownCVDatbaseline(HR0.84[95%CI0.740.94])(73).

    Conversely,themortalityfindingsinACCORDandsubgroupanalysesof

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    VADTsuggestthatthepotentialrisksofveryintensiveglycemiccontrolmayoutweighitsbenefitsinsomepatients,suchasthosewithverylong

    durationofdiabetes,knownhistoryofseverehypoglycemia,advancedatherosclerosis,andadvancedage/frailty.

    Certainly,providersshouldbevigilantinpreventingseverehypoglycemiainpatientswithadvanced

    diseaseandshouldnotaggressivelyattempttoachievenear-normalA1C

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    levelsinpatientsinwhomsuchatargetcannotbereasonablyeasilyandsafelyachieved.

    Recommendedglycemicgoalsformanynonpregnantadults

    areshowninTable10.TherecommendationsarebasedonthoseforA1C

    values,withlistedbloodglucoselevelsthatappeartocorrelatewithachievementof

    anA1Cof7%.Less-stringenttreatmentgoalsmaybeappropriate

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    foradultswithlimitedlifeexpectanciesoradvancedvasculardisease.GlycemicgoalsforchildrenareprovidedinVII.A.1.a.Glycemiccontrol.Severeorfrequenthypoglycemia

    isanabsoluteindicationforthemodificationoftreatmentregimens,includingsettinghigher

    glycemicgoals.

    Theissueofpre-versuspostprandialSMBGtargetsiscomplex

    (74).Elevatedpostchallenge(2-hOGTT)glucosevalueshavebeenassociated

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    withincreasedcardiovascularriskindependentofFPGinsomeepidemiologicalstudies.Indiabeticsubjects,somesurrogatemeasuresofvas

    S20DIABETESCARE,

    VOLUME34,SUPPLEMENT1,JANUARY2011care.diabetesjournals.org

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    PositionStatementTable10Summaryofglycemicrecommendationsformanynonpregnantadultswithtype1diabetesconsistsofthefollowingdiabetescomponents:1)use

    ofmultipledosein

    A1CPreprandialcapillaryplasmaglucosePeakpostprandial

    capillaryplasmaglucose

    Goalsshouldbeindividualizedbasedon*:

    durationofdiabetesage/lifeexpectancycomorbidconditions

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    knownCVDoradvancedmicrovascularcomplicationshypoglycemiaunawarenessindividualpatientconsiderationsMoreorlessstringentglycemicgoalsmaybeappropriatefor

    individualpatients.PostprandialglucosemaybetargetedifA1Cgoalsarenot

    metdespitereachingpreprandialglucosegoals.7.0%*70130mg/dl*(3.97.2mmol/l)180mg/dl*

    (10.0mmol/l)

    Postprandialglucosemeasurementsshouldbemade

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    12hafterthebeginningofthemeal,generallypeak

    levelsinpatientswithdiabetes.

    cularpathology,suchasendothelial

    dysfunction,arenegativelyaffectedbypostprandialhyperglycemia(75).Itisclearthatpostprandial

    hyperglycemia,likepreprandialhyperglycemia,contributestoelevatedA1Clevels,withitsrelativecontribution

    beinghigheratA1Clevelsthatarecloserto7%.

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    However,outcomestudieshaveclearlyshownA1Ctobetheprimarypredictorofcomplications,andlandmarkglycemiccontroltrialssuchastheDCCTand

    UKPDSreliedoverwhelminglyonpreprandialSMBG.Additionally,arandomizedcontrolledtrialinpatients

    withknownCVDfoundnoCVDbenefitofinsulinregimenstargetingpostprandialglucose

    comparedwithtargetingpreprandialglucose(76).Areasonablerecommendationfor

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    postprandialtestingandtargetsisthatforindividualswhohavepremealglucosevalueswithintargetbuthaveA1Cvaluesabovetarget,monitoringpostprandialplasma

    glucose(PPG)12hafterthestartofthemealandtreatmentaimed

    atreducingPPGvaluesto180mg/dlmayhelplowerA1C.

    AsregardsgoalsforglycemiccontrolforwomenwithGDM,

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    recommendationsfromtheFifthInternationalWorkshop-ConferenceonGestationalDiabetes(77)weretotargetmaternalcapillaryglucoseconcentrationsof:

    Preprandial95

    mg/dl(5.3mmol/l)andeither1-hpostmeal140mg/dl(7.8mmol/l)or

    2-hpostmeal120mg/dl(6.7mmol/l)Forwomenwithpreexisting

    type1ortype2diabeteswhobecomepregnant,a

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    recentconsensusstatement(78)recommendedthefollowingasoptimalglycemicgoals,iftheycanbeachievedwithoutexcessivehypoglycemia:

    .premeal,bedtime,

    andovernightglucose6099mg/dl(3.35.4mmol/l).peakpostprandialglucose100129

    mg/dl(5.47.1mmol/l).A1C6.0%D.Pharmacologicandoverallapproachestotreatment1.

    Therapyfortype1diabetesTheDCCTclearlyshowedthat

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    intensiveinsulintherapy(threeormoreinjectionsperdayofinsulin,orcontinuoussubcutaneousinsulininfusion(CSII)(insulinpumptherapy)wasakeypart

    ofimprovedglycemiaandbetteroutcomes(47,68).Atthetimeofthestudy,

    therapywascarriedoutwithshort-andintermediate-actinghumaninsulins.Despitebettermicrovascular

    outcomes,intensiveinsulintherapywasassociatedwithahighrate

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    inseverehypoglycemia(62episodesper100patient-yearsoftherapy).SincethetimeoftheDCCT,anumberofrapid-actingandlong-actinginsulin

    analogshavebeendeveloped.Theseanalogsareassociatedwithlesshypoglycemiawithequal

    A1C-loweringintype1diabetes(79,80).

    Therefore,recommendedtherapyfor

    sulininjections(threetofourinjectionsperdayof

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    basalandprandialinsulin)orCSIItherapy;2)matchingofprandialinsulintocarbohydrateintake,premealbloodglucose,andanticipatedactivity;and3)for

    manypatients(especiallyifhypoglycemiaisaproblem),useofinsulinanalogs.There

    areexcellentreviewsavailablethatguidetheinitiationandmanagementofinsulintherapy

    toachievedesiredglycemicgoals(3,79,81).

    Becauseof

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    theincreasedfrequencyofotherautoimmunediseasesintype1diabetes,screeningforthyroiddysfunction,vitaminB12deficiency,orceliacdiseaseshouldbeconsidered

    basedonsignsandsymptoms.Periodicscreeninginabsenceofsymptomshasbeen

    recommended,buttheeffectivenessandoptimalfrequencyareunclear.

    2.Therapy

    fortype2diabetesTheADAandtheEASDpublished

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    anexpertconsensusstatementontheapproachtomanagementofhyperglycemiainindividualswithtype2diabetes(82).Highlightsofthisapproachare:intervention

    atthetimeofdiagnosiswithmetforminincombinationwithlifestylechanges(MNT

    andexercise)andcontinuingtimelyaugmentationoftherapywithadditionalagents(includingearly

    initiationofinsulintherapy)asameansofachievingand

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    maintainingrecommendedlevelsofglycemiccontrol(i.e.,A1C7%formostpatients).AsA1Ctargetsarenotachieved,treatmentintensificationisbasedonthe

    additionofanotheragentfromadifferentclass.Theoverallobjectiveisto

    achieveandmaintainglycemiccontrolandtochangeinterventionswhentherapeuticgoalsare

    notbeingmet.

    Thealgorithmtookintoaccount

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    theevidenceforA1C-loweringoftheindividualinterventions,theiradditiveeffects,andtheirexpense.Theprecisedrugsusedandtheirexactsequencemaynot

    beasimportantasachievingandmaintainingglycemictargetssafely.Medicationsnotincluded

    intheconsensusalgorithm,owingtolessglucose-loweringeffectiveness,limitedclinicaldata,and/or

    relativeexpense,stillmaybeappropriatechoicesinindividualpatients

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    toachieveglycemicgoals.Initiationofinsulinattimeofdiagnosisisrecommendedforindividualspresentingwithweightlossorotherseverehyperglycemicsymptoms

    orsigns.

    care.diabetesjournals.orgDIABETESCARE,VOLUME34,SUPPLEMENT1,JANUARY2011

    S21

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    StandardsofMedicalCare

    E.Diabetesself-managementeducationRecommendations

    .Peoplewithdiabetesshouldreceivediabetesself-managementeducation(DSME)

    accordingtonationalstandardswhentheirdiabetesisdiagnosedandasneededthereafter.

    (B).Effectiveself-managementandqualityoflifearethekeyoutcomesof

    DSMEandshouldbemeasuredandmonitoredaspartof

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    care.(C).DSMEshouldaddresspsychosocialissues,sinceemotionalwell-beingisassociatedwithpositivediabetesoutcomes.(C).BecauseDSMEcanresultin

    cost-savingsandimprovedoutcomes(B),DSMEshouldbeadequatelyreimbursedbythird-party

    payors.(E)DSMEisanessentialelementofdiabetescare(8388),andnational

    standardsforDSME(89)arebasedonevidenceforits

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    benefits.Educationhelpspeoplewithdiabetesinitiateeffectiveself-managementandcopewithdiabeteswhentheyarefirstdiagnosed.OngoingDSMEandsupportalsohelp

    peoplewithdiabetesmaintaineffectiveself-managementthroughoutalifetimeofdiabetesasthey

    facenewchallengesandtreatmentadvancesbecomeavailable.DSMEhelpspatientsoptimizemetabolic

    control,preventandmanagecomplications,andmaximizequalityoflife

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    inacost-effectivemanner(90).

    DSMEistheongoingprocessoffacilitatingtheknowledge,skill,andabilitynecessaryfordiabetesself-care.This

    processincorporatestheneeds,goals,andlifeexperiencesofthepersonwithdiabetes.

    TheoverallobjectivesofDSMEaretosupportinformeddecision-making,self-carebehaviors,problem-solving,

    andactivecollaborationwiththehealthcareteamtoimprove

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    clinicaloutcomes,healthstatus,andqualityoflifeinacost-effectivemanner(89).

    CurrentbestpracticeofDSMEisaskills-basedapproach

    thatfocusesonhelpingthosewithdiabetestomakeinformedself-managementchoices.DSME

    haschangedfromadidacticapproachfocusingonprovidinginformationtomoretheoretically

    basedempowermentmodelsthatfocusonhelpingthosewithdiabetes

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    makeinformedself-managementdecisions.Careofdiabeteshasshiftedtoanapproachthatismorepatientcenteredandplacesthepersonwithdiabetesand

    hisorherfamilyatthecenterofthecare

    model

    workingincollaborationwithhealthcareprofessionals.Patient-centeredcareisrespectfulof

    andresponsivetoindividualpatientpreferences,needs,andvaluesand

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    ensuresthatpatientvaluesguidealldecisionmaking(91).

    EvidenceforthebenefitsofDSME

    Multiplestudieshavefoundthat

    DSMEisassociatedwithimproveddiabetesknowledgeandimprovedself-carebehavior(83),improved

    clinicaloutcomessuchaslowerA1C(84,85,87,88,92),lowerself-reportedweight(83),improvedquality

    oflife(86,93),healthycoping(94),andlowercosts(95).

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    BetteroutcomeswerereportedforDSMEinterventionsthatwerelongerandincludedfollow-upsupport(83,9699),thatwereculturally(100,101)andageappropriate(102,103)and

    tailoredtoindividualneedsandpreferences,andthataddressedpsychosocialissuesandincorporated

    behavioralstrategies(83,87,104106).Bothindividualandgroupapproacheshavebeenfoundeffective(107110).

    Thereisgrowingevidencefortheroleofcommunityhealth

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    workersandpeer(111,112)andlayleaders(113)indeliveringDSMEandsupportinadditiontothecoreteam(114).

    Diabeteseducation

    isassociatedwithincreaseduseofprimaryandpreventiveservicesandloweruse

    ofacute,inpatienthospitalservices(95).Patientswhoparticipateindiabeteseducationare

    morelikelytofollowbestpracticetreatmentrecommendations,particularlyamong

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    theMedicarepopulation,andhavelowerMedicareandcommercialclaimcosts(115).

    NationalstandardsforDSME

    NationalstandardsforDSME

    aredesignedtodefinequalityDSMEandtoassistdiabeteseducatorsina

    varietyofsettingstoprovideevidence-basededucation(89).Thestandards,mostrecentlyrevised

    in2007,arereviewedandupdatedevery5yearsby

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    ataskforcerepresentingkeyorganizationsinvolvedinthefieldofdiabeteseducationandcare.

    ReimbursementforDSME

    DSME,when

    providedbyaprogramthatmeetsthenationalstandardsforDSMEandis

    recognizedbytheADAorotherapprovalbodies,isreimbursedaspartofthe

    MedicareprogramasoverseenbytheCentersforMedicareand

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    MedicaidServices(CMS)(www.cms.hhs.gov/DiabetesSelfManagement).DSMEisalsocoveredbyagrowingnumberofotherhealthinsuranceplans.

    F.Medicalnutritiontherapy

    Generalrecommendations

    .Individualswhohaveprediabetesordiabetesshouldreceive

    individualizedmedicalnutritiontherapy(MNT)asneededtoachievetreatmentgoals,preferablyprovided

    byaregistereddietitianfamiliarwiththecomponentsofdiabetes

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    MNT.(A).BecauseMNTcanresultincost-savingsandimprovedoutcomes(B),MNTshouldbeadequatelycoveredbyinsuranceandotherpayors.(E)

    Energybalance,overweight,andobesity

    .Inoverweightandobeseinsulin-

    resistantindividuals,modestweightlosshasbeenshowntoreduceinsulinresistance.Thus,

    weightlossisrecommendedforalloverweightorobeseindividuals

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    whohaveorareatriskfordiabetes.(A).Forweightloss,eitherlow-carbohydrate,low-fatcalorie-restricted,orMediterraneandietsmaybeeffectivein

    theshort-term(upto2years).(A).Forpatientsonlow-carbohydrate

    diets,monitorlipidprofiles,renalfunction,andproteinintake(inthosewithnephropathy),

    andadjusthypoglycemictherapyasneeded.(E).Physicalactivity

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    andbehaviormodificationareimportantcomponentsofweightlossprogramsandaremosthelpfulinmaintenanceofweightloss.(B)Recommendationsforprimaryprevention

    ofdiabetes

    .Amongindividualsathighriskfordevelopingtype

    2diabetes,structuredprogramsthatemphasizelifestylechangesthatincludemoderateweightloss

    (7%bodyweight)andregularphysicalactivity(150min/week),with

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    dietarystrategiesincludingreducedcaloriesandreducedintakeofdietaryfat,canreducetheriskfordevelopingdiabetesandarethereforerecommended.(A).

    Individualsathighriskfortype2diabetesshouldbeencouragedtoachieve

    theU.S.DepartmentofAgriculture(USDA)recommendationfordietaryfiber(14gfiber/1,000

    kcal)andfoodscontainingwholegrains(one-halfofgrainintake).

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    (B)S22DIABETESCARE,VOLUME34,SUPPLEMENT1,JANUARY2011care.diabetesjournals.org

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    PositionStatement

    Recommendationsformanagementofdiabetes

    Macronutrientsindiabetesmanagement

    .Thebestmixofcarbohydrate,

    protein,andfatmaybeadjustedtomeetthemetabolicgoalsandindividual

    preferencesofthepersonwithdiabetes.(E).Monitoringcarbohydrate,whetherbycarbohydrate

    counting,choices,orexperience-basedestimation,remainsakeystrategy

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    inachievingglycemiccontrol.(A).Forindividualswithdiabetes,theuseoftheglycemicindexandglycemicloadmayprovideamodestadditional

    benefitforglycemiccontroloverthatobservedwhentotalcarbohydrateisconsideredalone.

    (B).Saturatedfatintakeshouldbe7%oftotalcalories.(A).

    ReducingintakeoftransfatlowersLDLcholesterolandincreases

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    HDLcholesterol(A),thereforeintakeoftransfatshouldbeminimized.(E)Othernutritionrecommendations

    .Ifadultswithdiabeteschooseto

    usealcohol,dailyintakeshouldbelimitedtoamoderateamount(onedrink

    perdayorlessforadultwomenandtwodrinksperdayor

    lessforadultmen).(E).Routinesupplementationwithantioxidants,

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    suchasvitaminsEandCandcarotene,isnotadvisedbecauseoflackofevidenceofefficacyandconcernrelatedtolong-termsafety.

    (A).Individualizedmealplanningshouldincludeoptimizationoffoodchoicestomeet

    recommendeddietaryallowance(RDA)/dietaryreferenceintake(DRI)forallmicronutrients.(E)MNTis

    anintegralcomponentofdiabetesprevention,management,andself-management

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    education.Inadditiontoitsroleinpreventingandcontrollingdiabetes,ADArecognizestheimportanceofnutritionasanessentialcomponentofanoverall

    healthylifestyle.Afullreviewoftheevidenceregardingnutritioninpreventingand

    controllingdiabetesanditscomplicationsandadditionalnutrition-relatedrecommendationscanbefound

    intheADApositionstatement,NutritionRecommendationsandInterventionsfor

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    Diabetes,publishedin2007andupdatedfor2008(116).Achievingnutrition-relatedgoalsrequiresacoordinatedteameffortthatincludestheactivein

    volvementofthepersonwithprediabetesordiabetes.Becauseofthecomplexity

    ofnutritionissues,itisrecommendedthataregistereddietitianwhoisknowledgeable

    andskilledinimplementingnutritiontherapyintodiabetesmanagementand

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    educationbetheteammemberwhoprovidesMNT.

    Clinicaltrials/outcomestudiesofMNThavereporteddecreasesinA1Cat36monthsranging

    from0.25%to2.9%withhigherreductionsseenintype2diabetesof

    shorterduration.MultiplestudieshavedemonstratedsustainedimprovementsinA1Cat12months

    andlongerwhenanRegisteredDietitianprovidedfollow-upvisitsranging

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    frommonthlytothreesessionsperyear(117124).StudiesinnondiabeticpeoplesuggestthatMNTreducesLDLcholesterolby1525mg/dlupto

    16%(125)andsupportaroleforlifestylemodificationintreatinghypertension(125,126).

    Becauseoftheeffectsofobesityoninsulinresistance,weightloss

    isanimportanttherapeuticobjectiveforoverweightorobeseindividuals

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    withprediabeteso