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  • A simpler model for NIDDM development is this two step one proposed by Bennett and colleagues. Underlying it is the complex model shown previously, but this will be used to focus on several design issues of relevance. After onset, diabetes induces several changes in the network of intermediate traits that are of interest to us.

    1. 1. The Cost of Type 2 Diabetes Prevention in the USA Michael M. Engelgau Division of Diabetes Translation CDC Symposium on Diabetes Economics São Paulo, Brazil, 27 September 2004
    2. 3. Never have doctors known so much about how to prevent and control this disease, yet the epidemic keeps on raging …. Christine Gorman Time 30 November 2003
    3. 4. Today TIME Burden of Diabetes
    4. 5. How can we stop (or slow down) the diabetes Epidemic ?
    5. 6. Rationale for Primary Prevention <ul><li>Scientific </li></ul><ul><li>Economics </li></ul>
    6. 7. Genetic predisposition Preclinical state Normal IGT Disability Death Clinical disease Type 2 DM Disability Death Complications Complications Primary Secondary Tertiary prevention prevention prevention Stages in the Natural History of Type 2 diabetes
    7. 8. Evidence Yes No What is the ?
    8. 9. Major Studies <ul><li>Da Qing IGT and Diabetes Study (China) </li></ul><ul><li>Diabetes Prevention Study (Finland) </li></ul><ul><li>Diabetes Prevention Program (USA) </li></ul><ul><li>STOP NIDDM (Europe, Canada) </li></ul><ul><li>Troglitazone in the Prevention of Diabetes (TRIPOD) (USA) </li></ul>
    9. 10. Benefits <ul><li>Study Reduction in risk (%) </li></ul><ul><li>Lifestyle Drug </li></ul><ul><li>Da Qing 31–46 </li></ul><ul><li>DPS 58 </li></ul><ul><li>DPP 58 31 </li></ul><ul><li>Stop NIDDM 25 </li></ul><ul><li>TRIPOD 55 </li></ul>
    10. 11. Primary prevention works!!!!
    11. 12. Economics $$$$$$$$$
    12. 14. Medical Costs of DPP Interventions (per participant) DPP Research Group, Diabetes Care 2003. ▲ - Placebo 3-Yr. Cost +2,701 +2,463 - 2,780 2,542 79 Lifestyle Metformin Placebo
    13. 16. Is it cost effective? <ul><li>Societal judgement and is not absolute </li></ul><ul><li>Expert panels in developed countries suggest: </li></ul><ul><li><$20,000/QALY ready uptake </li></ul><ul><li>$20-100,000/QALY consider </li></ul><ul><li>>$100,000/QALY less attractive </li></ul>
    14. 17. CE of Primary Prevention DPP* (USA) <ul><li> Within Group LS/ </li></ul><ul><li>DPP Generic Met </li></ul><ul><li>Cost/QALY US$ US$ </li></ul><ul><li>Lifestyle vs Placebo 51,600 27,100 </li></ul><ul><li>Metformin vs Placebo 99,200 35,000 </li></ul>* Societal perspective DPP Research Group, Diabetes Care 2003.
    15. 18. Who should we target? High-Risk vs Entire Population <ul><li>Epidemiology </li></ul><ul><li>PreDM (IGT/IFG) have 10 fold higher risk than NGT </li></ul><ul><li>Only 10% have IGT/IFG but yield 40-50% new DM </li></ul><ul><li>Pathophysiology </li></ul><ul><li>Clinical trials in populations with preDM </li></ul><ul><li>Human behavior </li></ul><ul><li>Health belief model – risk and benefit </li></ul>Narayan et al., BMJ 2002; 325:403.
    16. 19. Participants <ul><li>Eligibility Study </li></ul><ul><li>criteria DaQing DPS DPP Stop TRIPOD </li></ul><ul><li> NIDDM </li></ul><ul><li>Glucose (mg/dl) </li></ul><ul><li>Fasting none none 95-125 100-140 none </li></ul><ul><li>2-hr OGTT 140-199 140-199 140-199 140-199 none </li></ul><ul><li>5 OGTT sum >=625 </li></ul><ul><li>Age (yrs) >25 40-65 >=25 40-70 >=18 </li></ul><ul><li>BMI (kg/m2) none >=24 >=25 25-40 none </li></ul><ul><li>History GDM + </li></ul>
    17. 20. What are the gaps from RCTs? <ul><li>Isolated IFG not studied </li></ul><ul><li>Only one study examined non-overweight persons with IGT </li></ul><ul><li>What is the risk of developing diabetes in these groups? </li></ul>
    18. 21. International Diabetes Federation IGT/IFG Consensus Statement: Report of an Expert Consensus Workshop <ul><li>Combined IGT and IFG have highest risk </li></ul><ul><li>Isolated IFG and IGT have about the same risk </li></ul><ul><li>Isolated IGT is more common </li></ul><ul><li>About a third who develop diabetes have “normal” glucose tolerance at baseline (dependent on length of follow-up) </li></ul>Unwin N et al., Diabetic Medicine 2002; 19: 708.
    19. 22. What are the current policy recommendations? <ul><li>American Diabetes Association </li></ul><ul><li>Pre-diabetes: </li></ul><ul><li>Opportunistic screening for IGT or IFG: </li></ul><ul><li>>= 45 yrs </li></ul><ul><li>Emphasis in those with BMI >25 </li></ul><ul><li>Consider others if are overweight with risk factors </li></ul>ADA Position Statement, Diabetes Care 2004; 27: S47.
    20. 23. What are the current policy recommendations? <ul><li>IDF IGT/IFG Consensus Statement: Report of an Expert Consensus Workshop </li></ul><ul><ul><li>IGT or IFG should receive lifestyle advice </li></ul></ul><ul><ul><li>If lifestyle fails, consider drugs </li></ul></ul><ul><ul><li>Target those at highest risk for DM and CVD. </li></ul></ul>Unwin N et al., Diabetic Medicine 2002; 19: 708.
    21. 24. What are the current policy recommendations? <ul><li>Finnish National Policy </li></ul><ul><ul><li>Prediction models for future risk </li></ul></ul><ul><ul><li>Use fewer screening tests </li></ul></ul><ul><ul><li>Tailor to the individuals level of risk </li></ul></ul>Lindstrom J, Diabetes Care 2003; 26: 725.
    22. 25. How do we do find the at-risk population?
    23. 26. CDC Workshop <ul><li>National and International researchers </li></ul><ul><li>Questions </li></ul><ul><ul><li>What populations not studied </li></ul></ul><ul><ul><li>Health policy for those not studied </li></ul></ul><ul><ul><li>Detection strategies </li></ul></ul><ul><ul><li>Further study </li></ul></ul>Diabetes Therapeutics and Treatments 2004 (in press).
    24. 27. How do we detect targeted populations? <ul><li>Two general approaches: </li></ul><ul><li>Measure glucose levels directly </li></ul><ul><ul><li>Use clinical and demographic charaterisitics to target test </li></ul></ul><ul><ul><li>Determine current glycemic status </li></ul></ul><ul><li>Use individual characteristics (clinical, demographic) </li></ul><ul><ul><li>Predict future risk for diabetes </li></ul></ul><ul><ul><li>Current glycemic status unknown </li></ul></ul>
    25. 28. Detection Strategies: Measuring Glucose Directly <ul><li>Three approaches* </li></ul><ul><li>Combinations of risk factors with various cutpoints </li></ul><ul><li>Statistical models with risk factors </li></ul><ul><li>Risk scores </li></ul>*NHANES (3 studies), Framingham, SAHS, AusDiab , NUDS India, INTER-99, Ely Study, Diabetes in Egypt , ARIC
    26. 29. Detection Strategies: Measuring Glucose Directly <ul><li>Risk factors </li></ul><ul><li>Demographics </li></ul><ul><li>Self-report clinical history </li></ul><ul><li>Current clinical measures </li></ul><ul><li>Administrative data </li></ul><ul><li>Laboratory data </li></ul><ul><li>Metabolic syndrome criteria </li></ul><ul><li>Combinations </li></ul>
    27. 30. Detection Strategies: Measuring Glucose Directly <ul><li>Performance </li></ul><ul><li>Moderately effective </li></ul><ul><li>AUC 0.60-0.80 </li></ul><ul><li>Sensitivity 60-80%; Specificity 70-90% </li></ul>
    28. 31. Detection Strategies: Prediction of Future Risk of Diabetes <ul><li>Method* </li></ul><ul><li>5-10 year risk of diabetes </li></ul><ul><li>Risk score or “clinical” model </li></ul><ul><li>Risk factors </li></ul><ul><li>Demographic, clinical </li></ul><ul><li>Glucose measures not required </li></ul><ul><li>Results </li></ul><ul><li>0.60-0.85 AUC </li></ul><ul><li>Age-dependent performance </li></ul>* Finrisk-87, JACDS-Seattle, SAHS
    29. 32. Economics $$$$$$$$$
    30. 33. Random Capillary Blood Glucose Test All Low-risk population e.g., age < 45 RCBG positive High-risk population e.g., age  45 RCBG negative IFG or IGT or DM OGTT & FPG negative OGTT RCBG test
    31. 34. Cost per Case of Undiagnosed Diabetes or Pre-Diabetes Identified by Random Capillary Glucose Test Zhang et al ADA 2004
    32. 35. Cost per Case Identified at the Most Efficient Cutoff Point (single-payer perspective) Zhang et al ADA 2004 5.0% 100 mg/dl 100 mg/dl Cutoff point Screening for pre-diabetes & diabetes $153 $127 $125 $/case $/case Cutoff point $578 110 mg/dl FPG $590 5.7% A1C $392 120 mg/dl RCBG Screening for diabetes alone Test
    33. 36. 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.
    34. 37. Criteria for Diabetes and Pre-Diabetes Fasting glucose 2-hour glucose Cutpoint lowered to >=100
    35. 38. Fasting Glucose Distribution Glucose level (mg/dl) Number 100 110 126
    36. 39. 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
    37. 40. Detection Issues <ul><li>Sensitivity, specificity trade-offs </li></ul><ul><li>Program goals </li></ul><ul><li>Use of resources </li></ul><ul><li>Targeted population </li></ul><ul><li>New IFG criteria* (adding 100-110 mg/dl) </li></ul><ul><ul><li>Benefit unknown/small </li></ul></ul><ul><ul><li>89% w 100-109 have other indication for LS </li></ul></ul><ul><ul><li>“ False positive” and label side-effect </li></ul></ul>Schriger and Lorber Diabetes Care 2004; 27: 598.
    38. 41. Tomorrow Today TIME Burden of Diabetes
    39. 42. Knowing it not enough; we must apply. Willing is not enough; we must do. - Goethe