DIABETES PREVENTION PROGRAM
Transcript of DIABETES PREVENTION PROGRAM
The Cost of The Cost of Type 2 Diabetes Prevention Type 2 Diabetes Prevention
in the USAin the USA
Michael M. EngelgauMichael M. Engelgau
Division of Diabetes TranslationDivision of Diabetes Translation
CDCCDC
Symposium on Diabetes EconomicsSão Paulo, Brazil, 27 September 2004
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Never have doctors known so much about how to prevent and control this disease, yet the epidemic keeps on raging ….
Christine GormanTime 30 November 2003
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TIMETIME
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How can we stop (or slow down) the diabetes
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Rationale for Rationale for Primary PreventionPrimary Prevention
ScientificScientific
EconomicsEconomics
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Genetic predisposition
Preclinical state
Normal IGT
DisabilityDeath
Clinical disease
Type 2 DM
DisabilityDeath
Complications
Complications
Primary Secondary Tertiaryprevention prevention prevention
Stages in the Natural History of Type 2 diabetes
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What is theWhat is the ??
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Major StudiesMajor Studies Da Qing IGT and Diabetes StudyDa Qing IGT and Diabetes Study (China) (China)
Diabetes Prevention Study Diabetes Prevention Study (Finland) (Finland)
Diabetes Prevention Program Diabetes Prevention Program (USA)(USA)
STOP NIDDM STOP NIDDM (Europe, (Europe, Canada)Canada)
Troglitazone in the Prevention of Diabetes Troglitazone in the Prevention of Diabetes (TRIPOD) (TRIPOD) (USA)(USA)
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BenefitsBenefitsStudy Study Reduction in risk (%) Reduction in risk (%)
LifestyleLifestyle DrugDrug
Da QingDa Qing 31–46 31–46
DPSDPS 58 58
DPPDPP 58 58 31 31
Stop NIDDMStop NIDDM 25 25
TRIPODTRIPOD 55 55
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Primary prevention
works!!!!
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EconomicsEconomics
$$$$$$$$$$$$$$$$$$
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Medical Costs of DPP Interventions(per participant)
▲- Placebo
3-Yr. Cost
+2,701+2,463-
2,780 2,54279
LifestyleMetforminPlacebo
DPP Research Group, Diabetes Care 2003.
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Is it cost effective?Is it cost effective?
Societal judgement and is not absoluteSocietal judgement and is not absolute
Expert panels in developed countries Expert panels in developed countries suggest:suggest:
<$20,000/QALY<$20,000/QALY ready uptakeready uptake
$20-100,000/QALY$20-100,000/QALY considerconsider
>$100,000/QALY>$100,000/QALY less attractiveless attractive
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CE of Primary Prevention DPP* CE of Primary Prevention DPP* (USA)(USA) Within Group LS/Within Group LS/
DPP Generic Met DPP Generic Met
Cost/QALY Cost/QALY US$ US$ US$ US$
Lifestyle vs PlaceboLifestyle vs Placebo 51,600 27,10051,600 27,100
Metformin vs Placebo 99,200 35,000Metformin vs Placebo 99,200 35,000
*Societal perspectiveDPP Research Group, Diabetes Care 2003.
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Who should we target?Who should we target?High-Risk vs Entire PopulationHigh-Risk vs Entire Population
EpidemiologyEpidemiology
PreDM (IGT/IFG) have 10 fold higher risk than NGTPreDM (IGT/IFG) have 10 fold higher risk than NGT
Only 10% have IGT/IFG but yield 40-50% new DMOnly 10% have IGT/IFG but yield 40-50% new DM
PathophysiologyPathophysiology
Clinical trials in populations with preDMClinical trials in populations with preDM
Human behaviorHuman behavior
Health belief model – risk and benefitHealth belief model – risk and benefit
Narayan et al., BMJ 2002; 325:403.
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ParticipantsParticipants
EligibilityEligibility StudyStudy
criteriacriteria DaQing DPS DPP Stop TRIPOD DaQing DPS DPP Stop TRIPOD
NIDDMNIDDM
Glucose (mg/dl)Glucose (mg/dl)
FastingFasting none none none 95-125 100-140 none none 95-125 100-140 none
2-hr OGTT2-hr OGTT 140-199 140-199 140-199 140-199 none 140-199 140-199 140-199 140-199 none
5 OGTT sum5 OGTT sum >=625 >=625
Age (yrs)Age (yrs) >25 40-65 >25 40-65 >=25 40-70 >=25 40-70 >=18>=18
BMI (kg/m2)BMI (kg/m2) none none >=24 >=25 25-40 none >=24 >=25 25-40 none
History GDMHistory GDM ++
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What are the gaps from What are the gaps from RCTs? RCTs?
Isolated IFG not studiedIsolated IFG not studied
Only one study examined Only one study examined non-overweight persons with IGTnon-overweight persons with IGT
What is the risk of developing What is the risk of developing diabetes in these groups? diabetes in these groups?
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International Diabetes Federation IGT/IFG International Diabetes Federation IGT/IFG Consensus Statement: Consensus Statement:
Report of an Expert Consensus WorkshopReport of an Expert Consensus Workshop
Combined IGT and IFG have highest riskCombined IGT and IFG have highest risk
Isolated IFG and IGT have about the same riskIsolated IFG and IGT have about the same risk
Isolated IGT is more commonIsolated IGT is more common
About a third who develop diabetes have About a third who develop diabetes have “normal” glucose tolerance at baseline “normal” glucose tolerance at baseline (dependent on length of follow-up)(dependent on length of follow-up)
Unwin N et al., Diabetic Medicine 2002; 19: 708.
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What are the current policy What are the current policy recommendations? recommendations? American Diabetes AssociationAmerican Diabetes Association
Pre-diabetes:Pre-diabetes:
Opportunistic screening for IGT or IFG:Opportunistic screening for IGT or IFG:
>= 45 yrs>= 45 yrs
Emphasis in those with BMI >25 Emphasis in those with BMI >25
Consider others if are overweight with Consider others if are overweight with risk factorsrisk factors
ADA Position Statement, Diabetes Care 2004; 27: S47.
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What are the current policy What are the current policy recommendations? recommendations?
IDF IGT/IFG Consensus Statement:IDF IGT/IFG Consensus Statement:Report of an Expert Consensus WorkshopReport of an Expert Consensus Workshop
e IGT or IFG should receive lifestyle adviceIGT or IFG should receive lifestyle adviced If lifestyle fails, consider drugsIf lifestyle fails, consider drugsl Target those at highest risk for DM and Target those at highest risk for DM and
CVD.CVD.
Unwin N et al., Diabetic Medicine 2002; 19: 708.
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What are the current policy What are the current policy recommendations? recommendations?
Finnish National PolicyFinnish National Policy
Prediction models for future riskPrediction models for future risk
s Use fewer screening testsUse fewer screening tests
i Tailor to the individuals level of riskTailor to the individuals level of risk
Lindstrom J, Diabetes Care 2003; 26: 725.
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How do we do find the at-risk population?
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CDC WorkshopCDC Workshop
National and International researchersNational and International researchers
QuestionsQuestionsM What populations not studiedWhat populations not studied Health policy for those not studiedHealth policy for those not studiedr Detection strategiesDetection strategiesg Further studyFurther study
Diabetes Therapeutics and Treatments 2004 (in press).
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How do we detect targeted How do we detect targeted populations? populations? Two general approaches:Two general approaches:
3.3. Measure glucose levels directlyMeasure glucose levels directly• Use clinical and demographic charaterisitics to Use clinical and demographic charaterisitics to
target testtarget test• Determine current glycemic statusDetermine current glycemic status
5.5. Use individual characteristics (clinical, demographic)Use individual characteristics (clinical, demographic)
• Predict future risk for diabetesPredict future risk for diabetes• Current glycemic status unknownCurrent glycemic status unknown
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Detection Strategies:Detection Strategies:Measuring Glucose DirectlyMeasuring Glucose Directly
Three approaches*Three approaches*
Combinations of risk factors with Combinations of risk factors with various cutpointsvarious cutpoints
Statistical models with risk factors Statistical models with risk factors
Risk scores Risk scores
*NHANES (3 studies), Framingham, SAHS, AusDiab, NUDS India, INTER-99, Ely Study, Diabetes in Egypt, ARIC
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Detection Strategies:Detection Strategies:Measuring Glucose DirectlyMeasuring Glucose Directly
Risk factorsRisk factors
DemographicsDemographics
Self-report clinical historySelf-report clinical history
Current clinical measuresCurrent clinical measures
Administrative dataAdministrative data
Laboratory dataLaboratory data
Metabolic syndrome criteriaMetabolic syndrome criteria
CombinationsCombinations
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Detection Strategies:Detection Strategies:Measuring Glucose DirectlyMeasuring Glucose Directly
Performance Performance
Moderately effectiveModerately effective
AUC 0.60-0.80AUC 0.60-0.80
Sensitivity 60-80%; Sensitivity 60-80%; Specificity 70-90%Specificity 70-90%
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Detection Strategies:Detection Strategies:Prediction of Future Risk of Diabetes Prediction of Future Risk of Diabetes
Method* Method*
5-10 year risk of diabetes 5-10 year risk of diabetes
Risk score or “clinical” modelRisk score or “clinical” model
Risk factors Risk factors
Demographic, clinical Demographic, clinical
Glucose measures not requiredGlucose measures not required
ResultsResults
0.60-0.85 AUC0.60-0.85 AUC
Age-dependent performanceAge-dependent performance
*Finrisk-87, JACDS-Seattle, SAHS
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EconomicsEconomics
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Random Capillary Blood Glucose TestRandom Capillary Blood Glucose Test
All
Low-risk populatione.g., age < 45
RCBG positive
High-risk populatione.g., age e 45
RCBG negative
IFG or IGT or DM OGTT & FPG negative
OGTT
RCBG test
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50
250
450
650
850
75 85 95 105 115 125 135 145Cutoff value (mg/dl)
Co
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ca
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)Screening for pre-diabetes & diabetesScreening for diabetes alone
Cost per Case of Undiagnosed Diabetes or Pre-Diabetes Identified by Random Capillary Glucose Test
Zhang et al ADA 2004
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Cost per Case Identified at the Most Efficient Cost per Case Identified at the Most Efficient Cutoff PointCutoff Point (single-payer perspective)(single-payer perspective)
5.0%
100 mg/dl
100 mg/dl
Cutoff point
Screening for pre-diabetes & diabetes
$153
$127
$125
$/case $/caseCutoff point
$578110 mg/dlFPG
$5905.7%A1C
$392120 mg/dlRCBG
Screening for diabetes alone
Test
Zhang et al ADA 2004
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Follow-up Report on the Diagnosis of Diabetes Mellitus
The Expert Committee on the Diagnosis and Classification of Diabetes Mellitus
Diabetes Care 2003; 26: 3160.
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Criteria for Diabetes and Pre-Diabetes Criteria for Diabetes and Pre-Diabetes
Fasting glucose
2-hour glucose
Cutpointloweredto >=100
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Fasting Glucose Distribution
Glucose level (mg/dl)
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100 110 126
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Pre-Diabetes in the US population 40–74 years of Age by Old and New Criteria, 2000
Total = 20 million Total = 41 million
Benjamin et al., CDC unpublished; CDC National Diabetes Fact Sheet.
13 M (4 M) 15 M 35 M (5 M) 16 M
OLD NEW
IFG IGT & IGT IFG
IFG IFG & IGT IGT
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Detection IssuesDetection IssuesSensitivity, specificity trade-offsSensitivity, specificity trade-offs
Program goalsProgram goals
Use of resourcesUse of resources
Targeted populationTargeted population
New IFG criteria* (adding 100-110 mg/dl)New IFG criteria* (adding 100-110 mg/dl)
* Benefit unknown/small Benefit unknown/small
s 89% w 100-109 have other indication for LS89% w 100-109 have other indication for LS
v ““False positive” and label side-effectFalse positive” and label side-effect
Schriger and LorberSchriger and Lorber Diabetes Care Diabetes Care 2004; 27: 598.2004; 27: 598.
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TIMETIME
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TomorrowTomorrowTodayToday
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Knowing it not enough; Knowing it not enough; we must apply.we must apply.
Willing is not enough; Willing is not enough; we must do.we must do.
- Goethe
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