Evaluation of the performance and usability of a novel continuous glucose monitoring system

Abstract Background Continuous glucose monitoring (CGM) can help manage diabetes mellitus (DM) and prevent hypoglycemia. This study aimed to evaluate the performance usability of a novel SiJoy GS1 CGM system. Methods multicenter trial enrolled participants with DM. Based on comparison values measured by venous blood test, 20/20% consistency mean absolute relative difference (MARD%) were calculated, as well Clarke consensus error grid analysis. Product was evaluated questionnaire completed participants. Any occurrence adverse events (AE) documented. Results Seventy included in study. The age 41.5 ± 13.2 years, among which 29 (42.0%) male, DM course 8.6 7.5 years. A total 39 (56.5%) them had type 1 DM, 24 (34.8%) 2 6 (8.7%) others for achieved 91.82%, higher than target 65%. percentage + B zones 99.22% 99.90%, respectively. MARD value 8.83% 4.03%. score 86.59 5.17 out 90. AE observed only one participant (mild fever), no severe AEs occurred. Conclusions system satisfactory usability. No occurred mild reported case.