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Article History

Received: 24 September 2025

Accepted: 1 December 2025

First Online: 29 December 2025

Declarations

:

: Nina Jendrike, Manuela Link, Sükrü Öter, and Manuel Eichenlaub are employees of the Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT), which carries out clinical studies, e.g., with medical devices for diabetes therapy on its own initiative and on behalf of various companies. Guido Freckmann is the general manager and medical director of IfDT. Guido Freckmann/IfDT have received research support, speakers’ honoraria or consulting fees in the last 3 years from Abbott, Ascensia, Bionime, Boydsense, Dexcom, Insulet, I-Sens, Lilly, Menarini, Novo Nordisk, Perfood, Pharmasens, Roche, Sinocare, Terumo, Vertex, Ypsomed. Leon Shi and Poul Strange are employees of Integrated Medical Development, which plans and executes clinical studies and is a contractor of Sinocare. Frank Flacke is employee and owner of Flacke Consulting GmbH providing strategy advise, medical affairs and clinical affairs services and is or was within the past 3 years a contractor of Sinocare, BOYDSense, embecta, Sanofi, Glucoset. Jiangfeng Fei, Jiyun Zheng, Fei Gao, Ao Gao, and Siting Zhu are all employees of Sinocare.

: Study was registered under ClinicalTrials.gov (ID: NCT05806554). Ethical approval for this study was obtained by the Ethics Committee of the State Medical Association of Baden-Württemberg (Ethik-Kommission der Landesärztekammer Baden-Württemberg, Stuttgart, Germany). The study was performed in accordance to the declaration of Helsinki. All study participants provided written informed consent.