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Kyung-Soo Kim, Seung-Hwan Lee, Won Sang Yoo, and Cheol-Young Park have nothing to disclose. Guido Freckmann is general manager and medical director of 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 and\/or IfDT received research support and\/or speaker fees and\/or consultancy honoraria from Abbott, Ascensia, Bionime, Boydsense, Dexcom, Glucoset, Insulet, i-SENS, Lilly, Menarini, Perfood, Pharmasens, Roche, Sinocare, Vertex, Ypsomed.","order":1,"name":"Ethics","label":"Conflict of Interest","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"All studies were conducted in agreement with the Good Clinical Practice guidelines, the Declaration of Helsinki, and applicable national laws and regulations. For each study, ethical approval as well as the necessary consents from the participating subjects were obtained separately. The Korean pivotal study was approved by the Institutional Review Boards of CHA University School of Medicine (approval number CHAMC 2021-12-017 and date of approval February 4, 2022), The Catholic University of Korea (approval number KC22DDDT0109 and date of approval April 19, 2022), Dankook University College of Medicine (approval number DKUH 2022-02-010 and date of approval February 24, 2022), and Sungkyunkwan University School of Medicine (approval number KBSMC 2022-01-049 and date of approval July 14, 2022). The German pivotal study was approved by the ethics committee at the Landes\u00e4rztekammer Baden-W\u00fcrttemberg (MDR-2021-006, 02 Jun. 2022). The German PMCF study was approved by the ethics committee at the Landes\u00e4rztekammer Baden-W\u00fcrttemberg (MDR-2025-008, 04 Sep. 2025).","order":2,"name":"Ethics","label":"Ethical Approval","group":{"name":"EthicsHeading","label":"Declarations"}}]}}