Introduction and Objective: The iCan CGM system is equipped with 3rd generation sensor technology and based on a different enzyme (GDH-FAD) than other FDA approved CGM systems in US. This 15d factory calibrated sensor is available in many regulated markets worldwide and was evaluated in a multi-center study for iCGM compliance in a pediatric sample under the name True Vie iCan 3 CGM in the US.Methods: This study was conducted in 6 centers enrolling participants with T1D, 2-17 yrs, familiar with carb-counting for insulin dosing. Participants attended a screening visit, clinic visits with frequent blood sampling – YSI glucose analyzer (7-17 yrs) or SMBG (2-6 yrs) as reference, 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: The results are shown for age group 7-17 yrs with YSI as reference. In the study 6072 matched pairs (MP) for ABD and 4974 MP for arm sensors were evaluated. The overall 20/20% AR was calculated at 93.8% and 93.5% respectively. The sensor stability over lifetime (20/20% AR at beginning (d 1), middle (d 8) and end (d 15) ABD/arm) was calculated to be 92.9%/91.7%, 95.8/94.4% and 92.1%/96.0%. The MARD calculated for the 2 wear sites was 8.5% for ABD and 8.6% for arm. There was a strong clinical performance with >99.9% in Zones A+B of the Parkes Error Grid. There were 5 AEs related to device handling and skin exposure, and 2 hypoglycemia SAEs not related to device.Conclusion: The iCan system demonstrated high performance and compliance with iCGM standards in this US trial with stable sensor performance over the sensor lifespan and a good safety profile.
B.W. Bode: None. M. Kipnes: None. L.M. Laffel: Other – Travel support for scientific presentations; Ended; Boehringer Ingelheim International GmbH. Other – DSMB Chair; Ended; Janssen Pharmaceuticals, Inc. Consultant; Current; Dexcom, Inc. Advisory Panel; Current; Medtronic, Sequel, Tandem Diabetes Care, Inc. Consultant; Current; Roche Diabetes Care, Sinocare. Advisory Panel; Ended; Sanofi. Advisory Panel; Current; MannKind Corporation. R. Lal: Consultant; Current; Abbott Diabetes, Adaptyx Biosciences. Consultant; Ended; Biolinq, Capillary Biomedical, Deep Valley Labs. Consultant; Current; Gluroo, Portal Diabetes, Tidepool. Advisory Panel; Ended; ProventionBio, Lilly, Sanofi, Rezolute. 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.
Source link
Leave a Reply