Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems

Comparator Data Characteristics and Testing Procedures for the Clinical Performance Evaluation of Continuous Glucose Monitoring Systems

Comparing the performance of different continuous glucose monitoring (CGM) systems is challenging due to the lack of comprehensive guidelines for clinical study design. In particular, the absence of concise requirements for the distribution of comparator (reference) blood glucose (BG) concentrations...

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Autores principales: Manuel Eichenlaub, Stefan Pleus, Martina Rothenbühler, Timothy S. Bailey, Lia Bally, Ronald Brazg, Daniela Bruttomesso, Peter Diem, Elisabet Eriksson Boija, Marion Fokkert, Cornelia Haug, Rolf Hinzmann, Johan Jendle, David C. Klonoff, Julia K. Mader, Konstantinos Makris, Othmar Moser, James H. Nichols, Kirsten Nørgaard, John Pemberton, Elizabeth Selvin, Loukia Spanou, Andreas Thomas, Nam K. Tran, L. Witthauer, Robbert J. Slingerland, Guido Freckmann
Formato: Artigo
Lenguaje:inglés
Publicado: 2024
Acceso en línea:https://doi.org/10.1089/dia.2023.0465
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https://doi.org/10.1089/dia.2023.0465

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