Document is current

Article History

Received: 8 September 2025

Accepted: 1 October 2025

First Online: 6 November 2025

Acknowledgements

: The authors would like to thank the participants of the PETITE-T1D trial and their families, as well as the staff members conducting the trial. Medical writing support was provided by A. Perault and A. E. Todd (IMPRINT Science, New York, NY, USA). This work was presented at the 51st Annual Conference of the International Society for Pediatric and Adolescent Diabetes (ISPAD) in Montréal, Canada, on 5‒8 November 2025.

: Qualified researchers may request access to data. Further details on Sanofi’s data sharing criteria, eligible studies and process for requesting access can be found at: .

: This study and medical writing support were funded by Sanofi. Sanofi designed the study and collected and analysed the data. Sanofi was also involved in interpreting the data, writing the report and approving the report for publication.

: SEG has served on advisory boards for Abata Therapeutics, Genentech, GentiBio, Eli Lilly, Provention Bio, SAB Biotherapeutics, Sana Biotechnology, Sanofi and Shoreline Biosciences; has received support from the National Institutes for Health (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 (formerly known as JDRF) and INNODIA. KS has served on advisory boards for Provention Bio and Sanofi and has received support from the NIH, Breakthrough T1D, Sanofi and Provention Bio for roles as an investigator in clinical trials. JLS consults for Abbott Diabetes, Insulet, Medscape, Medtronic Diabetes, Vertex and Ypsomed; has served on advisory boards for Cecelia Health, Insulet, MannKind, Medtronic Diabetes, StartUp Health T1D Moonshot and Vertex; and has received research support from Abbott Diabetes, Dexcom, Breakthrough T1D, Insulet, Medtronic, NIH and Provention Bio. SBL has consulted for Sanofi. TQ is a consultant for BioMarin, Janssen Research & Development, Merck, Pfizer, Provention Bio and Sanofi and is a Clinical Trial Principal Investigator at the Buffalo site for Ascendis, BioMarin, Janssen, OPKO Biologics, Pfizer, Provention Bio and Sanofi. WER has received grants or contracts from NIH and Provention Bio. BS has consulted for Provention Bio. SMW has received support from NIH, Provention Bio and Sanofi for roles as an investigator in clinical trials. LK, EN, WS and DM are employees of Sanofi and may hold stock in the company. IL is an employee of Cytel and was serving as a vendor to Sanofi at the time of the study. LAD has served on advisory boards for Abata Therapeutics, Tandem and Biomea Fusion; has received research support from NIH, Lilly, MannKind, Provention Bio, Sanofi and Zealand for roles as an investigator in clinical trials; has received study supplies from Dexcom; and serves on data safety monitoring boards for Lilly and Merck for non-diabetes indications.

: SEG, SBL, TQ, WER, BS, SMW and LAD contributed to the acquisition and interpretation of data, drafting the article and reviewing the article critically. KS and JLS contributed to the design of the study, acquisition and interpretation of data, drafting the article and reviewing the article critically. LK, EN and DM contributed to the conception and design of the study, acquisition and interpretation of data, drafting the article and reviewing the article critically. IL contributed to the analysis and interpretation of data, drafting the article and reviewing the article critically. WS contributed to the interpretation of data, drafting the article and reviewing the article critically. All authors gave final approval of the version to be published. LK accepts full responsibility for the work and/or the conduct of the study, had access to the data, and controlled the decision to publish.