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

Abstract

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