Table 1.
CGM system-inherent factors (intrinsic performance of the
system) • Calibration • Performance of the CGM sensor over time • Sensor to sensor variation • Algorithms and smoothing filters implemented in the CGM systems Not CGM system-inherent factors • Insertion factors (competency of sensor insertion, body site, movement) • Physiological time delay between CGM and BG measurements • Range and distribution of the paired glucose values • Rate of change in glycemia • Study design / study population • Implementation of the study design (controlled vs uncontrolled environment, time of day, day 1 vs day 2-X, dynamic variation in glucose concentration, number of measurements, synchronization of CGM, and comparison method) • Direction of the deviations from the comparison method |