Perspectives on prevention of type 1 diabetes and heterogeneities
Authors' conclusion
While such a trial is conceivable, it would demand robust safety data before initiation.
Study context
- Population
- Type 1 diabetes prevention trials (TN10 teplizumab trial as example)
- Outcome
- Simulated implications of heterogeneity and chance for T1D prevention trials
Methodological detailssimulations
- Simulations
Main finding
As reported in the abstract
- Robust identification of treatment effect heterogeneity may require sample sizes ≈4 times larger than for overall efficacy in certain scenarios
- approximately four times larger
- Infant general-population prevention trial with multivalent antiviral vaccine will likely need participants
- over 50,000
Original publication
Perspectives on prevention of type 1 diabetes and heterogeneities. Diabetologia. Published 6 August 2025. doi:10. 1007/ s00125-025-06512-5
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