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Authors
Mader, Julia K.
Baumstark, Annette
Tüting, Johannes
Sokol, Günter
Schuebel, Ruth
Tong, Yuhong
Roetschke, Julia https://orcid.org/0000-0003-3739-9695
Slingerland, Robbert J.
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Funding
Funding for this research was provided by:
Roche Diabetes Care
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Article History
Received: 16 September 2024
Accepted: 17 October 2024
First Online: 28 October 2024
Declarations
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: Julia K. Mader is a member of advisory boards of Abbott Diabetes Care, Becton-Dickinson, Boehringer Ingelheim, Eli Lilly, Embecta, Medtronic, NovoNordisk A/S, Roche Diabetes Care, Sanofi-Aventis, and Viatris. She has received speaker honoraria from A. Menarini Diagnostics, Abbott Diabetes Care, AstraZeneca, Boehringer Ingelheim, Dexcom, Eli Lilly, Medtrust, MSD, NovoNordisk A/S, Roche Diabetes Care, Sanofi, Servier, Viatris, and Ypsomed. Julia K. Mader is a shareholder of decide Clinical Software GmbH and elyte Diagnostics and serves as CMO of elyte Diagnostics. Annette Baumstark is an employee of the Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT), which carries out clinical studies, for example, with medical devices for diabetes therapy on its own initiative and on behalf of various companies. Johannes Tüting and Günter Sokol have no conflicts of interest to declare. Robbert J. Slingerland is chair of the Clinical Chemistry Department of Isala, which carries out clinical studies, for example, with medical devices for diabetes therapy on its own initiative and on behalf of various companies. Robbert J. Slingerland has received speakers’ honoraria or consulting fees in the last three years from Roche and Menarini. Ruth Schuebel, Yuhong Tong, and Julia Roetschke are employees of Roche.
: The study protocol was approved by the appropriate health authorities according to local guidelines and by an Institutional Review Board/Independent Ethics Committee. The Ethics Committees included: Ethikkommission of the State Medical Association of Baden-Wuerttemberg, Stuttgart (AZ MP-2018-10) for the center in Ulm, Germany; and the Ethikkommission of the Medical Association of Lower Saxony, Hanover (AZ Bo/05/2018) for the center in Cloppenburg, Germany. Approval for conducting the study at the centers in Vienna and Graz in Austria was given by the Austrian Agency for Health and Food Safety (AGES). Study approval for the center in Zwolle, The Netherlands, was given by the local authority. The study was conducted in accordance with the Declaration of Helsinki of 1964 and its later amendments. Study participants provided written informed consent.
