Evaluation reveals that binary metabolic end points improve detection of treatment effects in type 1 diabetes prevention trials, suggesting enhanced design methods.
Challenges in time to event type 1 diabetes (T1D) prevention trial design can yield negative results even for treatments that may actually improve disease pathology. We evaluated whether a binary metabolic end point for 12-month change from baseline to 1 year postrandomization could be useful in T1D prevention trials. This approach detected treatment effects at least as well as standard primary end points with shorter follow-up. Fixed interval metabolic end points should be used in combination with traditional T1D end points to better understand treatment effects of preventive agents.
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Sims et al. (2025) studied this question.
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