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Estimating the Risk-Based Value of the Diabetes Prevention Program: How well does clinical trial-based cost-effectiveness apply to the real world?

Olchanski N, Weidner SB, Lin CH, Kent DM

medRxiv : the preprint server for health sciences, 2025

Abstract

OBJECTIVES: Many economic evaluations rely on clinical trial data that may not represent real world populations and intervention effectiveness. We compare risk and cost-effectiveness for the original Diabetes Prevention Program (DPP) clinical trial population and a real world population eligible for the National Diabetes Prevention Program (NDPP).

METHODS: We identified National Health and Nutrition Examination Survey (NHANES) subjects eligible for the NDPP and adjusted projections using survey weights to produce real world (US population) representative results. We used clinical predictive models to estimate individual diabetes risk and microsimulation to estimate lifetime costs, benefits, and net monetary benefits (NMB) for lifestyle intervention and metformin. We compared results across the original DPP clinical trial and real world populations.

RESULTS: Only 20% of the NHANES population eligible for NDPP met inclusion/exclusion criteria for the DPP trial. Three-year risk of diabetes onset for trial population (mean 19.7%, median 10.3%) exceeded corresponding risk for the NHANES population (mean 14.6%, median 4.8%). The proportion of individuals with < 10% three-year diabetes risk for the trial population (49%) was less than the corresponding proportion for NHANES (67%). Lifestyle intervention had mean NMB $34,889 for the DPP trial population and $28,652 for NHANES.

CONCLUSIONS: Real world populations eligible for the NDPP include a greater proportion of low-risk…

How strong is the evidence?

Evidence Hub reads this as a cohort study, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.

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