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Article History

Received: 27 May 2025

Accepted: 10 February 2026

First Online: 1 May 2026

Acknowledgements

: Members of the EDENT1FI consortium:C. Mathieu, P. Gillard, K. Casteels, B. van der Schueren, L. Overbergh, J. Vercauteren (KU Leuven, Leuven, Belgium);A. G. Ziegler, P. Achenbach, F. Haupt, C. Winkler, S. Hummel (Helmholtz Zentrum Muenchen, Munich, Germany);F. Reschke, O. Kordonouri, T. von dem Berge, K. Lange (Hannoversche Kinderheilanstalt, Children's Hospital AUF DER BULT, Hannover, Germany);T. Pieber, J. Mader, S. Moitzi (Medical University Of Graz, Graz, Austria);S. Del Prato, B. Torbeyns (European Diabetes Forum, Brussels, Belgium);Z. Sumnik, O. Cinek, V. Neuman, B. Berka (University Hospital Motol, Prague, Czechia);F. Pociot, B. Petersen, J. Antvorskov, J. H. Klaebel (Steno Diabetes Center Copenhagen, Region Hovedstaden, Denmark);R. Lahesmaa (University of Turku, Turku, Finland);H. Hyöty (Tampere University and Tampere University Hospital, Tampere, Finland);J. E. Laiho (Tampere University, Tampere, Finland);E. Bonifacio, R. Berner, A. Hommel, A. Loff, G. Gemulla, N. Zubizarreta (Technische Universität Dresden, Dresden, Germany);E. Bosi, L. Piemonti, V. Lampasona (IRCCS Ospedale San Raffaele, Milan, Italy);F. Dotta, G. Sebastiani (Università degli Studi di Siena, Siena, Italy);A. Szypowska, K. Karczewski (Medical University of Warsaw, Warsaw, Poland);P. Jarosz-Chobot (Medical University of Silesia, Katowice, Poland);J. F. Raposo, R. Ribeiro, R. Coelho (Associacao Protectora dos Diabeticos de Portugal, Lisbon, Portugal);M. Peakman, E. Niemoeller, M. Baccara-Dinet (Sanofi, Paris, France);J. Van Rampelbergh (Imcyse SA, Liège, Belgium);R. Bergholdt, K. Fogh (Novo Nordisk A/S, Bagsværd, Denmark);O. Cohen, M. I. Buompensiere (Medtronic Bakken Research Center B.V, Maastricht, the Netherlands);C. Hurtado del Pozo, E. Latres (Breakthrough T1D, New York, NY, USA);G. Agiostratidou, A. Koralova (The Leona M. and Harry B. Helmsley Charitable Trust, New York, NY, USA).Associated partners of the EDENT1FI Consortium:J. Jackson, D. Darrock, H. Tewson (Digostics Limited, Didcot, UK);S. Nagallas (Diabetomics, Inc., Hillsboro, OR, USA);J. Hedrick, K. Collins (Critical Path Institute, Tuscon, AZ, USA);T. Tree (King’s College London, London, UK);C. Dayan, K. Hood, J. Townson, R. Playle (Cardiff University, Cardiff, UK);R. Besser (University of Oxford, Oxford, UK);P. Narendran, I. Litchfield, S. Greenfield, R. Dias (The University of Birmingham, Birmingham, UK);S. Chen, Marie Amoroso (RSR Limited, Cardiff, UK);D. Agardh (University of Lund, Lund, Sweden).

: The datasets generated during this study are available from the corresponding author upon reasonable request.

: The European action for the Diagnosis of Early Non-clinical Type 1 diabetes For disease Interception (EDENT1FI) is supported by the Innovative Health Initiative Joint Undertaking (IHI JU) under grant agreement no. 101132379. The JU receives support from the European Union’s Horizon Europe research and innovation programme, The Leona M. and Harry B. Helmsley Charitable Trust, Breakthrough T1D, EFPIA, COCIR, Vaccines Europe, EuropaBio and MedTech. Additional funding is provided to associated UK partners through the UK Research and Innovation (UKRI) Guarantee Fund. Views and opinions expressed are those of the author(s) only and do not necessarily reflect those of the European Union, the private members, and contributing partners of the IHI JU. Neither of these parties can be held responsible for them.

: RPD received honoraria from Sanofi for advisory board participation (speaker fee). MP and JLD are employees of Sanofi. CM has the following disclosures: (1) consulting fees from Novo Nordisk, Sanofi, Eli Lilly and Company, Novartis, Dexcom, Boehringer Ingelheim, Bayer, Roche, Abbott, Medtronic, Insulet, Biomea Fusion, SAB Bio and Vertex; (2) honoraria from Novo Nordisk, Sanofi, Eli Lilly and Company, Dexcom, Boehringer Ingelheim, Bayer, Roche, Abbott, Medtronic and Vertex; (3) data safety monitoring/advisory board of Novo Nordisk, Sanofi, Eli Lilly and Company, Novartis, Dexcom, Boehringer Ingelheim, Bayer, Roche, Abbott, Medtronic, Insulet, Biomea Fusion, SAB Bio and Vertex; and (4) President of EASD and Vice-President of EUD. EB has the following disclosures: (1) Helmsley Charitable Trust, EU – European Commission Funding for the EDENT1FI project; (2) Helmsley Charitable Trust - Grants for newborn genetic screening and primary prevention trials and grant for islet autoantibody screening; (3) BMBF (The Federal Ministry of Education and Research) - Grant for islet autoantibody screening; (4) Sanofi Honoraria for Speaker, Sanofi, Madrid 2024 and honoraria for speaking to Sanofi employees; (5) Pharmaceutical Consulting GmbH, China 2024 - Honoraria for two online lectures; and (6) Sanofi - Travel for attending the 2024 EASD meeting, Madrid. AGZ has the following disclosures: (1) Horizon Europe, IHI Innovative Health Initiative, EDENT1FI, grant no. 101132379; (2) The Leona M. & Harry B. Helmsley Charitable Trust, EDENT1FI, grant no. 2302-06621; served as a member of the advisory boards for (3) Sanofi-Aventis France; (4) Georg Thieme Verlag KG; (5) Novo Nordisk Norway AS; (6) Deutschen Diabetes Gesellschaft e.V. (DDG); (7) Provention Bio (Rho. Inc.) Sanofi; (8) Sanofi US Services Inc.; (9) ITB-Med; and (10) Sanofi-Aventis US and received support to give lectures sponsored by Sanofi-Aventis. The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.

: LMQ, DS and OB researched data, contributed to discussion, wrote the first draft of the manuscript and reviewed and edited the manuscript. FM, GP, MJR, FG, AC, LBD, RS, MA, AGZ, EB, CM, MP, JLD, CH, JV, LO, EB, VEDM, KB, KL, RPD, IL, SMG, FKB and PN contributed to discussion, reviewed and edited the manuscript. All authors approved the final version of the manuscript. LMQ is the guarantor of this work and, as such, had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.