Introduction and Objectives: The iCan CGM system, developed by Sinocare Meditech Inc. is equipped with an innovative sensor technology. Data presented here are from a multicenter study which assessed accuracy of the iCan CGM system; conducted in China according to international standards and which resulted in regulatory submission. The iCan CGM system received regulatory clearance 2023 in People’s Republic of China and EU for a wear time of 15 days.

Methods: The study had a single arm, prospective multicenter design and evaluated the iCan CGM system in one of 2 subgroups. There were 60 patients with T1D and T2D aged ≥18yrs enrolled into this subgroup and at days 2, 7-9 and 15 the performance of the device was assessed by comparison to YSI readings. The data were analyzed according to generally accepted procedures.

Results: For per protocol set (PPS) the surveillance error grid analysis shows 100% of the data pairs in the none to slightly lower/higher degree of risk zones (none 94.12% (95%CI: 86.96% - 100%), slightly lower 5.76% (95%CI: 0% - 12.86%), slightly higher 0.12% (95%CI: 0% - 1.15%). Also, the Clarke error grid confirms this high correlation with the reference method with 99.22% (95%CI: 98.67% - 99.58%) in Zones A+B. The full analysis set (FAS) analysis shows a MARD 8.88% (95%CI: 7.98% - 9.77%) which is similar the previously reported MARD of 8.71% (95%CI: 7.86 - 9.55%) from the PPS analysis, and stays below a MARD of 8% for the complete wear life. The average wear life was estimated to 14.76 (1.26) days. There were no SAEs, devices related AEs and no skin related AEs reported during the study.

Conclusion: The iCan CGM system, becoming available on the worldwide markets, demonstrated in a multicenter trial overall accuracy performance on par with established devices, high EGA correlation as well as single digit MARD throughout 15 days, in combination with an outstanding sensor wear life. (NCT0599575)

Disclosure

L. Ji: None. F. Flacke: Consultant; BOYDSense SAS, Sinocare Meditech Inc., embecta. F. Gao: Employee; Sinocare Inc. Y. Yu: Employee; Sinocare Inc. J. Zheng: Employee; Sinocare Inc. A. Gao: Employee; Sinocare Inc. J. Fei: Employee; Sinocare Inc.

© 2024 by the American Diabetes Association
2024
Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.