Longitudinal Analysis of Real-World Performance of an Implantable Continuous Glucose Sensor Over Multiple Sensor Insertion and Removal Cycles.

BACKGROUND: The Eversense CGM System, with the first long-term implantable glucose sensor, has been commercially available in Europe and South Africa since 2016 for adults with diabetes. The performance of the sensor over multiple, sequential 90- or 180-day cycles from real-world experience and clinical studies has not been previously published.

METHODS: The Eversense Data Management System (DMS) was used to evaluate the accuracy of GDPR-compliant sensor glucose (SG) values against self-monitored blood glucose (SMBG) from June 2016 through August 2019 among patients with at least four sensor cycles from European and South African health care practices. Mean SG and associated measures of variability, glucose management indicator (GMI), and percent and time in various hypoglycemic, euglycemic, and hyperglycemic ranges were calculated for the 24-hour time period over each cycle. In addition, transmitter wear time was evaluated across each sensor wear cycle.

RESULTS: Among the 945 users included in the analysis, the mean absolute relative difference (MARD) (SD) using 152,206, 174,645, 206,024, and 172,587 calibration matched pairs against SMBG was 11.9% (3.6%), 11.5% (4.0%), 11.8% (4.7%) and 11.5% (4.1%) during the first four sensor cycles, respectively. Mean values of the CGM metrics over the first sensor cycle were 156.5 mg/dL for SG, 54.7 mg/dL for SD, 0.35 for CV, and 7.04% for GMI. Percent SG at different glycemic ranges was as follows: <54 mg/dL was 1.1% (16 minutes), <70 mg/dL was 4.6% (66 minutes), ≥70 to 180 mg/dL (time-in-range) was 64.5% (929 minutes), >180-250 mg/dL was 22.8% (328 minutes) and >250 mg/dL was 8.1% (117 minutes). The median transmitter wear time over the first cycle was 83.2%. CGM metrics and wear time were similar over the subsequent three cycles.

CONCLUSION: This real-world evaluation of adult patients with diabetes using the Eversense CGM in the home setting demonstrated that the implantable sensor provides consistent, stable accuracy and CGM metrics over multiple, sequential sensor cycles with no indication of degradation of sensor performance.