Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGM
Stefan Pleus, Manuel Eichenlaub, Pradeep Kumar Dabla, Peter Diem, Elisabet Eriksson Boija, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C. Klonoff, Jingyi Lu, Konstantinos Makris, Viswanathan Mohan, James H. Nichols, John Pemberton, Elizabeth Selvin, Robbert J. Slingerland, Andreas Thomas, Nam K. Tran, L. Witthauer, Guido Freckmann
Abstract
Continuous glucose monitoring (CGM) systems are essential tools for modern diabetes care. However, the assessment of their analytical performance has been hindered by a lack of standardization. This poses challenges for the field, as the choice of study procedures and evaluation methods can influence the observed performance, further complicating the comparisons between CGM systems and confounding the interpretation and use of CGM metrics as research outcomes. To address this issue, the Working Group on CGM of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) has developed a comprehensive guideline for the clinical assessment of CGM systems. The guideline defines requirements for study design and procedures, characteristics of comparator measurements, minimum requirements for accuracy, and performance characterization.