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Article History

Received: 15 April 2025

Accepted: 6 January 2026

First Online: 12 March 2026

Acknowledgements

: We thank E. Anderson-Baucum (Department of Pediatrics, Indiana University School of Medicine) for her helpful edits and comments.

: TrialNet clinical trials data are publicly available, and can be obtained by application to the NIDDK Central Repository at . Immune Tolerance Network clinical trials data are also publicly available at . Data from the imatinib study are available from SEG per data sharing statements from the original publication [ ]. Requests for any additional data may be made by contacting the corresponding author.

: This work was supported by NIH grant R21 DK119800-01A1 (to EF, SEG and CE-M) and NIH grant P30 DK097512 (to CE-M). The funding source played no role in the study design, collection, analysis and interpretation of data, the writing of the report, or the decision to submit the paper for publication.

: CE-M has served on advisory boards related to type 1 diabetes research clinical trial initiatives: Isla Technologies, Neurodon and DiogenX. CE-M receives in-kind research support from Bristol Myers Squibb and has received investigator-initiated grants from Lilly Pharmaceuticals and Astellas Pharmaceuticals. CE-M owns a patent (16/291,668): ‘Extracellular Vesicle Ribonucleic Acid (RNA) Cargo as a Biomarker of Hyperglycaemia and Type 1 Diabetes’, and a provisional patent (63/285,765): ‘Biomarker for Type 1 Diabetes (PDIA1 as a biomarker of beta cell stress)’. SEG has served on advisory boards for Abata Therapeutics, Genentech, GentiBio, Provention Bio, SAB Biotherapeutics, Sana Biotechnology, Sanofi and Shoreline Biosciences, has received support from the NIH, Provention Bio and Sanofi for roles as an investigator in clinical trials, and serves on data and safety monitoring boards for Diamyd Medical, Breakthrough T1D and INNODIA. AM is a consultant for Eli Lilly & Co. and Novo Nordisk (on GIP/GLP-1RAs). EF is a member of the Scientific Advisory Board for Eli Lilly & Co. and Oramed, has given talks at Eli Lilly & Co. and Boehringer Ingelheim, and receives research grant support from Janssen, Oramed and the NIDDK.

: CE-M, SEG, AM and EF conceived the study, reviewed the data, and wrote the manuscript. EF and AM conducted the data analysis. CE-M and EF are the guarantors of this work and take full responsibility for the work as a whole. All authors approved the final version to be published.