Accuracy, safety, and usability of a real‐time continuous glucose monitoring system in pediatric diabetes management

Abstract

ABSTRACT Background The purpose of the study was to evaluate the accuracy, safety, and usability of a real‐time Continuous Glucose Monitoring (CGM) system compared with venous blood glucose (vBG) in children and adolescents. Methods The study enrolled 81 participants aged from 3 to 17 at three sites in China. Two sensors (GS1, SiBionics, Shenzhen) were inserted on the back of each upper arm for up to 14 days for each participant. A variety of analyses were conducted for evaluating accuracy by comparing the CGM readings and vBG values, including 20%/20 agreement rate, the mean absolute relative difference (MARD), the Clarke error grid, and consensus error grid analyses. Safety was measured by adverse event (AE) monitoring. AEs were documented, and the incidence rate was calculated. Usability was evaluated by self‐reported questionnaires. Results Data from 80 participants were analyzed. Our results demonstrated high accuracy of the real‐time CGM system. The 20%/20 agreement rate across all glycemic ranges was 93.9%. The MARD value was 8.7%. The results of the Clarke and consensus error grid analyses in zone A + B were 99.6% and 100%, respectively. The average score of usability was 95.3 ± 7.6, reflecting high satisfaction. The CGM also showed high safety, given that only 3 device‐related AEs in 2 participants were reported , and no serious adverse events (SAEs) were reported. Conclusion The real‐time CGM system demonstrated high accuracy, safety, and usability in the glycemic monitoring of children and adolescents.