Compliance With FDA iCGM Special Controls is Dependent on Study Design and Procedures.

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Title: Compliance With FDA iCGM Special Controls is Dependent on Study Design and Procedures.
Authors: Eichenlaub M; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany., Waldenmaier D; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany., Pleus S; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany., Haug C; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany., Brandt D; Diabetes Center Berne, Bern, Switzerland., Freckmann G; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
Source: Journal of diabetes science and technology [J Diabetes Sci Technol] 2025 May; Vol. 19 (3), pp. 850-852. Date of Electronic Publication: 2025 Apr 02.
Publication Type: Letter
Journal Info: Publisher: Sage Country of Publication: United States NLM ID: 101306166 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1932-2968 (Electronic) Linking ISSN: 19322968 NLM ISO Abbreviation: J Diabetes Sci Technol Subsets: MEDLINE; In Process
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  Data: Compliance With FDA iCGM Special Controls is Dependent on Study Design and Procedures.
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  Data: <searchLink fieldCode="AU" term="%22Eichenlaub+M%22">Eichenlaub M</searchLink>; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.<br /><searchLink fieldCode="AU" term="%22Waldenmaier+D%22">Waldenmaier D</searchLink>; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.<br /><searchLink fieldCode="AU" term="%22Pleus+S%22">Pleus S</searchLink>; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.<br /><searchLink fieldCode="AU" term="%22Haug+C%22">Haug C</searchLink>; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.<br /><searchLink fieldCode="AU" term="%22Brandt+D%22">Brandt D</searchLink>; Diabetes Center Berne, Bern, Switzerland.<br /><searchLink fieldCode="AU" term="%22Freckmann+G%22">Freckmann G</searchLink>; Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm, Ulm, Germany.
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  Data: <searchLink fieldCode="JN" term="%22101306166%22">Journal of diabetes science and technology</searchLink> [J Diabetes Sci Technol] 2025 May; Vol. 19 (3), pp. 850-852. <i>Date of Electronic Publication: </i>2025 Apr 02.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Sage%22">Sage </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>101306166 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1932-2968 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2219322968%22">19322968 </searchLink><i>NLM ISO Abbreviation: </i>J Diabetes Sci Technol <i>Subsets: </i>MEDLINE; In Process
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        Value: 10.1177/19322968251329879
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              Text: 2025 May
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