Novel Approach for Assessing Outcomes of Type 1 Diabetes Prevention Trials Over a Fixed Time Interval
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.
Authors
- William E. Russell (ORCID: https://orcid.org/0000-0001-7609-0434)
- Colin Mark Dayan (ORCID: https://orcid.org/0000-0002-6557-3462)
- Jay S. Skyler (ORCID: https://orcid.org/0000-0003-1136-8110)
- Kevan C. Herold (ORCID: https://orcid.org/0000-0003-1534-6613)
- MARIA JOSE REDONDO (ORCID: https://orcid.org/0000-0001-5871-4645)
- Emily K. Sims (ORCID: https://orcid.org/0000-0002-4393-954X)
- Heba M. Ismail (ORCID: https://orcid.org/0000-0003-0102-0030)
- Jay M. Sosenko (ORCID: https://orcid.org/0000-0002-7204-8367)
- Peter Nicholas Taylor (ORCID: https://orcid.org/0000-0002-3436-422X)
- Brandon M. Nathan (ORCID: https://orcid.org/0000-0001-6405-3994)
- Alice L. J. Carr (ORCID: https://orcid.org/0000-0003-0704-8843)
- Alfonso Galderisi (ORCID: https://orcid.org/0000-0001-8885-3056)
- David Cuthbertson
- Laura M. Jacobsen (ORCID: https://orcid.org/0000-0002-5144-7836)
Institutions
- University of Minnesota (US)
- University of Miami (US)
- University of Alberta (CA)
- Vanderbilt University (US)
- University of South Florida (US)
- Yale University (US)
- University of Florida (US)
- MNGI Digestive Health (US)
- Texas Children's Hospital (US)
- Indiana University – Purdue University Indianapolis (US)
- Cardiff University (GB)
- Cardiff Metropolitan University (GB)
- Florida College (US)
- University of Wales (GB)
Publication Details
- Journal
- Diabetes
- Published
- 2025-08-28
- DOI
- https://doi.org/10.2337/db25-0310
- Primary Topic
- Diabetes Management and Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Doris Duke Charitable Foundation
- John Templeton Foundation
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases
- National Institute of Diabetes and Digestive and Kidney Diseases
- National Center for Research Resources