1961-P: Multicenter Performance Evaluation of the True Vie I3 CGM System in Adults in the U.S. and EU

Introduction and Objective: The True Vie I3 continuous glucose monitoring system (i3 CGM, Sinocare Meditech Inc., also approved in Europe as GlucoMen® iCan or iCan CGM system) is a new 15d real-time CGM system. This study evaluated the performance of the factory-calibrated CGM system in adults in the US and EU. Methods: Subjects with T1D or T2D on multi daily insulin injection treatment participated in this study at 6 sites in the US and Germany. Participants attended a screening visit, 4 clinic visits with frequent sampling testing by a YSI glucose analyzer, and a removal visit. The performance evaluation included mean absolute relative difference (MARD), agreement rates (AR) and clinical accuracy for abdomen (ABD) and arm sensors. No overpatch was used. Results: Data from 142 subjects (421 sensors, 19734 matched pairs (MP) ABD; and 19179 MP arm) were analyzed. The overall MARD was estimated to 9.0% for the ABD and 9.4% for the arm sensor, %20/20 AR were 91.9% (91.2) and 91.9% (91.1) respectively with a stable performance (ABD %/arm%) of 89.8/88.9 (beginning, d1-2), 93.1/93.0 (early, d3-7), 92.6/91.6 (late, d 8-13) and 92.7/94.1 (end, d 14-15.5), fulfilling iCGM criteria. Parkes Error Grid analyses for both sensor sites demonstrate that 99.9% of MP fall within Zones A+B. The average sensor wear-life was estimated to 14.4 d for ABD and 14.3 d for arm sensors. There was no device related adverse event reported. Conclusion: The performance here reported for the iCan CGM system is in line with previously reported pivotal data for obtaining the CE mark in adults and in pediatrics in the EU. The data show stable sensor performance within the iCGM criteria, high clinical accuracy long wear-life and a safe wear. Disclosure M. Christiansen: Employee; Current; Biolinq. Stock/Shareholder; Current; AtaCor Medical, Inc. F.E. Broyles: None. B.W. Bode: None. G. Freckmann: Advisory Panel; Current; Abbott Diabetes, Boydsense, Dexcom, Inc. Advisory Panel; Ended; Perfood. Advisory Panel; Current; Pharamsens. Advisory Panel; Ended; Vertex Pharmaceuticals Incorporated. Speaker's Bureau; Ended; Abbott Diabetes. Speaker's Bureau; Current; Insulet Corporation. Speaker's Bureau; Ended; Menarini Group, Roche Diabetes Care, Sinocare. Research Support; Ended; Ascensia Diabetes Care, Bionime, i-SENS, Inc., Roche Diabetes Care. Consultant; Current; Glucoset, i-SENS, Inc., Roche Diabetes Care, Sinocare, Ypsomed AG, Glucomodicum. J. Fei: Employee; Current; Sinocare Inc. J. Zheng: Employee; Current; Sinocare Inc. F. Gao: Employee; Current; Sinocare Inc. A. Gao: Employee; Current; Sinocare Inc. S. Zhu: None. L. Shi: None. P. Strange: Other - Service provider to; Current; Sinocare.