The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring
Stefan Pleus, Manuel Eichenlaub, Elisabet Eriksson Boija, Marion Fokkert, Rolf Hinzmann, Johan Jendle, David C. Klonoff, Konstantinos Makris, James H. Nichols, John Pemberton, Elizabeth Selvin, Robbert J. Slingerland, Andreas Thomas, Nam K. Tran, L. Witthauer, Guido Freckmann
Abstract
Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems. This standardization should include the comparator device, sample origin, and study procedures. With better aligned CGM readings, CGM-derived metrics will subsequently also align better between systems.