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 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.