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Article History

Received: 30 September 2025

Accepted: 5 December 2025

First Online: 3 February 2026

Acknowledgements

: The authors acknowledge the Spanish Society of Diabetes (Sociedad Española de Diabetes) for its decisive support of this project through the ‘XV Ayudas SED a Proyectos de Investigación en Diabetes Dirigidos por Jóvenes Investigadores’.

: Data sharing of de-identified participant data will be considered upon reasonable request after approval of a protocol and signing of a data transfer agreement with the corresponding author after publication of all secondary outcomes of this trial. Related documents are available from the corresponding author.

: Open Access funding provided thanks to the CRUE-CSIC agreement with Springer Nature. This work was funded by the Proyectos de Investigación en Salud PI19/00584, PI22/01404, and PMP22/00021 (funded by the Instituto de Salud Carlos III) and iTIRONET-P2022/BMD7379 (funded by the Comunidad de Madrid), and co-financed using funds provided to MM by the European Regional Development Fund (ERDF). The funders had no role in the study design, data collection, data analysis, data interpretation or writing of the report.

: The authors declare that none of them received financial support, payments or benefits from the manufacturer of the smart cap device. All potential competing interests unrelated to the present work are detailed below. FS-V has received congress registration fees and travel support from Menarini, Novo Nordisk, Lilly, Insulcloud and Abbott, with no personal payments. CS-LG has received congress registration fees and travel support from Novo Nordisk, Lilly, Abbott, Fresenius and Sanofi, with no personal payments. AJE has received honoraria for presentations or manuscript preparation from Abbott, Ambos, AstraZeneca, Boehringer, Clover SGM SL, Echosens, Fresenius, FSEEN, Fundesalud, K ACCESS, Lilly SAU, Nestlé, Novo Nordisk, Nutricia, Outcomes’10 SLU, Persei Vivarium SL, Profármaco 2-SL, Sanidad y Ediciones SL, Sanofi, Sendimad, and You & Us SA. She has also received congress registration fees and travel support from Medtronic-IQVIA, Novo Nordisk, Lilly and Fresenius, with no personal payments. SJ-B has received honoraria for lectures from Menarini, Sanofi and Novo Nordisk. She has also received support for congress attendance from Novo Nordisk, Lilly and Sanofi (registration, transportation and accommodation; no direct payments). She also declares receiving educational collaboration and free drug samples from Novo Nordisk, Bayer, Lilly and Menarini (no personal payments). VN-M has received honoraria from Novo Nordisk for presentations and from Nestlé Health Science, Nutricia and Fresenius Kabi for expert surveys. He has also received congress registration fees and travel support from Menarini, Novo Nordisk, Lilly, Dexcom and Abbott Nutrition, with no personal payments. JAAM has received congress registration fees and travel support from Menarini, Novo Nordisk, Lilly, Novalab, Abbott and Dexcom, with no personal payments. MM has received congress registration fees and travel support from Ascendis and Pfizer, and serves on advisory boards for Lundbeck and Amgen (not related to the present manuscript). The authors declare that there are no other relationships or activities that might bias, or be perceived to bias, their work.

: FS-V and CS-LG substantially contributed to the conception and design of the study. FS-V, CS-LG, AJE, SJB, VN-M and JAAM were responsible for the acquisition of data. FS-V performed the statistical analyses. FS-V, CS-LG and MM contributed to the analysis and interpretation of the data. FS-V drafted the first version of the manuscript. CS-LG, AJE, SJB, VN-M, JAAM and MM critically revised the manuscript for important intellectual content. All authors approved the final version of the manuscript to be published and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. FS-V and CS-LG are the guarantors of this work and, as such, had full access to all the data in the study, take responsibility for the integrity of the data and the accuracy of the data analysis, and had final responsibility for the decision to submit for publication.