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Article History

Received: 19 December 2024

Accepted: 7 April 2025

First Online: 29 May 2025

Acknowledgements

: The sponsor of the trial was the Type 1 Diabetes TrialNet Study Group. The authors would like to extend their gratitude to the thousands of participants and their families who generously contributed to the study, providing data, samples and information of invaluable importance for the advancement of knowledge about type 1 diabetes.

: The data that support the findings of this study are available from the corresponding author. Restrictions apply to the availability of these data, which were used under license from the TrialNet (USA) for the current study and so are not publicly available. Data are, however, available from the corresponding author upon reasonable request and with permission from the TrialNet Consortium.

: We acknowledge the support of the Type 1 Diabetes TrialNet Study Group’s Pathway to Prevention Study for this TrialNet Ancillary Study. The Type 1 Diabetes TrialNet Study Group is a clinical trials network funded by the National Institutes of Health (NIH) through the National Institute of Diabetes and Digestive and Kidney Diseases, the National Institute of Allergy and Infectious Diseases and The Eunice Kennedy Shriver National Institute of Child Health and Human Development, through the cooperative agreements U01 DK061010, U01 DK061034, U01 DK061042, U01 DK061058, U01 DK085465, U01 DK085453, U01 DK085461, U01 DK085466, U01 DK085499, U01 DK085504, U01 DK085509, U01 DK103180,U01 DK103153, U01 DK085476, U01 DK103266, U01 DK103282, U01 DK106984,U01 DK106994, U01 DK107013, U01 DK107014, U01 DK106993 and Breakthrough T1D (formerly JDRF). The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the NIH or Breakthrough T1D (formerly JDRF).

: The authors declare that there are no relationships or activities that might bias, or be perceived to bias, their work.

: EBo was a member of the TrialNet Study Group and had clinical and scientific responsibility for the conduction of TrialNet studies at the centre. PG was the Trial Coordinator. SM, MRP, RB were the physicians responsible for the contact with participants and families for screening and follow-up. EBi, PG, FR and EBa were responsible for the conduction of screening, follow-up and monitoring procedures, including periodic contact, administration of educational tools, execution of immunological and metabolic tests. ES, AG and FM were responsible for the phone and e-mail contacts during 2023 and 2024 with participants for whom there was no further contact after the first screening and those with no updated information during follow-up. SM, AM, ES and FM designed and conducted the statistical analysis. EBo, SM and AM wrote the manuscript. All authors contributed to discussion and reviewed/edited the manuscript and gave final approval for the paper to be published. EBo is responsible for the integrity of the work as a whole.