Accuracy and Safety of the 15-Day CareSens Air Continuous Glucose Monitoring System

Abstract

Background: We evaluated the accuracy and safety of the CareSens Air, a novel real-time continuous glucose monitoring system (CGMS), during 15 days of use in adults with diabetes. Methods: Adults with either type 1 diabetes or type 2 diabetes requiring intensive insulin therapy participated at four sites in South Korea. All participants wore the sensor for 15 days. Participants were scheduled for four 8-h clinic sessions on Day 1, 5 +/- 1, 10 +/- 1, and 15. Accuracy was evaluated based on the proportion of continuous glucose monitoring (CGM) values within 15% of YSI values >= 100 mg/dL or within 15 mg/dL of YSI values <100 mg/dL (%15/15), along with the %20/20, %30/30, and %40/40 agreement rates. The mean absolute relative difference (MARD) between the CGM and YSI values was calculated. Results: Data from 83 participants (83 sensors, 10,029 CGM-YSI matched pairs) were analyzed. The overall MARD was 10.42%, and the overall %15/15, %20/20, %30/30, and %40/40 accuracy were 78.55%, 89.04%, 96.47%, and 98.87%, respectively. The consensus error grid analysis showed that 99.92% of CGM values fell into Zone A or B (Zone A: 89.83%, Zone B: 10.09%). The %20/20 accuracy of CGMS was 88.11% on Day 1, 90.11% on Day 3-5, 92.09% on Day 8-10, and 85.63% on Day 15. No serious adverse events were reported. Conclusions: The CareSens Air demonstrated accurate performance across the wide glycemic range and was well tolerated during the 15-day sensor use period.