993-P: Performance of iCan CGM System in a Pediatric Population

Introduction and Objective: The iCan CGM system, developed by Sinocare Meditech Inc. is equipped with GDH-FAD based 3rd generation sensor technology. After receiving CE-mark for a wear-time of 15d in an adult population the next step was to conduct a regulatory performance study in a pediatric population. This study was conducted according to international standards in three leading hospitals in China. Methods: The study has a single arm, prospective multicenter design. The full analysis set includes 76 subjects, age 2-17 yrs. with 16 subjects aged 2-5 yrs. The majority of all subjects were people with T1D (86.8%). At days 1-2, 6-8 and 15 the performance of the device was assessed by comparison to laboratory reference device. The data were analyzed according to generally accepted procedures. Results: We report the per protocol analysis of a single sensor with an overall MARD of 8.30%, and a 20/20% performance of 96.40%. The MARD results at the 3 accuracy testing visits were estimated to 8.46% (1-2d), 7.52% (6-8d), and 8.98% (14-15d). The 20/20% performance for the same visits were estimated to 95.18%, 98.17% and 95.82% respectively. The Consensus error grid analysis shows 100.0% (95%CI: 99.8% - 100.0%) of the paired readings in Zones A+B. There were no device related and skin related adverse events reported in the safety data set. Conclusion: This first regulatory performance study of the iCan CGM System in a pediatric population demonstrates high overall accuracy and a single digit MARD below 9.0% at each accuracy testing visit together with a 20/20% performance consistently above a 95% threshold throughout the 15d wear-time. The overall performance of the iCan CGM System in this population confirms the consistent performance previously seen and reported in adults. Disclosure J. Zheng: Employee; Sinocare Inc. J. Fei: Employee; Sinocare Inc. Board Member; Trividia Health Inc. F. Gao: Employee; Sinocare Inc. Y. Yu: None. A. Gao: Employee; Sinocare Inc. Z. Qian: Employee; Sinocare Inc. F. Flacke: Consultant; Sinocare Inc, BOYDSense SAS, embecta, Sanofi-Aventis Deutschland GmbH. W. Haiying: None. D. Shuxia: None. O. Wenxian: None.