Standards of Medical Care in Diabetes 2011
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Transcript of 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
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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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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,
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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.
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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