Evaluation of Accuracy and Safety of the 365-Day Implantable Eversense Continuous Glucose Monitoring System: The ENHANCE Study.

Abstract

The implanted Eversense Continuous Glucose Monitoring (CGM) System transitioned from 90- to 180- to 365-day durations marketed today. This report summarizes the 365-day clinical study. ENHANCE was a prospective, multicenter study evaluating the accuracy and safety of the Eversense 365 CGM system through 1 year in adults with diabetes. Accuracy and adverse events (AEs) were assessed during 14 in-clinic visits comparing CGM and Yellow Springs Instrument reference glucose measurements, including during hyperglycemia and hypoglycemia challenges. In total, 110 participants were implanted with the Eversense 365 CGM System. The overall mean absolute relative difference was 8.8% with primarily one calibration per week. The confirmed alert detection rate at 70 mg/dL was 96.6%, and at 180 mg/dL, it was 97.9%. Ninety percent of the sensors survived 365 days. Interoperable CGM special controls were met. No related serious AEs were reported. The Eversense 365 CGM was shown to be safe and accurate through 1 year with primarily one calibration per week.