Clinical assessment and acceptance criteria for continuous glucose monitoring (CGM) system performance: A proposed guideline by the IFCC Working Group on CGM
Year: 2025
Type: article
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.
Source: Clinica Chimica Acta
Authors: 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 S. Pemberton, Elizabeth Selvin, Robbert J. Slingerland, Andreas Thomas, Nam K. Tran, Lilian Witthauer, Guido Freckmann
Institutions: Institut für Diabetes-Technologie (Germany), Isala, Örebro University, Mills Peninsula Health Services, Shanghai Jiao Tong University, Shanghai Sixth People's Hospital, KAT General Hospital of Attica, Madras Diabetes Research Foundation, Dr. Mohan's Diabetes Specialities Centre, Vanderbilt University Medical Center, Birmingham Women’s and Children’s NHS Foundation Trust, Johns Hopkins University, University of Pittsburgh, University of Bern, University Hospital of Bern, Diabetes Center Berne
Language: English
Subfield: Endocrinology, Diabetes and Metabolism
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,550
Awards: G357764881, G5031019598
OpenAlex ID: W4416399454