Real-World Data from the First U.S. Commercial Users of an Implantable Continuous Glucose Sensor

Abstract

Background: The Eversense Ò Continuous Glucose Monitoring (CGM) System, with the first 90-day implantable sensor, received FDA (Food and Drug Administration) approval in June 2018. No real-world experience has been published. Methods: Deidentified sensor glucose (SG) data from August 1, 2018 to May 11, 2019 in the Eversense Data Management System (DMS) were analyzed for the first 205 patients who reached a 90-day wear period on the Eversense CGM system. The mean SG, standard deviation (SD), median interquartile range, coefficient of variation (CV), glucose measurement index (GMI), and percent and time in minutes across glucose ranges were computed for the 24-h time period, the nighttime (00:00-06:00), and by 30-day wear periods. Sensor accuracy, sensor reinsertion rate, transmitter wear time, and safety data were assessed. Results: Of the 205 patients, 129 identified as type 1, 18 as type 2, and 58 were unreported. Fifty were CGM naive, 112 had prior CGM experience, and 43 were unreported. The mean SG was 161.8 mg/dL, SD was 57.4 mg/dL, CV was 0.35, and GMI was 7.18%. Percent SG at <54 mg/dL was 1.2% (18 min), <70 mg/dL was 4.1% (59.7 min), time in range (‡70-180 mg/dL) was 62.3% (897.7 min), >180-250 mg/dL was 21.9% (315.8 min), and >250 mg/dL was 11.6% (166.7 min). Nighttime values were similar. The glucometric values were similar over 30-day time periods of the sensor wear. The mean absolute relative difference (SD) using 27,708 calibration paired points against home blood glucose meters was 11.2% (11.3%). The sensor reinsertion rate was 78.5%. The median transmitter wear time was 83.6%. There were no related serious adverse events. Conclusion: The Eversense real-world data showed promising glycemic results, sensor accuracy, and safety. These data suggest that the Eversense CGM system is a valuable tool for diabetes management.

Review of the Long-Term Implantable Senseonics Continuous Glucose Monitoring System and Other Continuous Glucose Monitoring Systems

“…The CGM system is designed to replace finger stick blood glucose testing for diabetes treatment decisions. 9,30,43,66-73…”

A Review of the First Long-term Implantable Continuous Glucose Monitoring System Available in the United States

“…2,[20][21][22] Using de-identified glucose data (Eversense LTI CGM) from the Eversense data management system, Sanchez et al found that the percentage of sensor glucose readings at <54 mg/dL was 1.2%, <70 mg/dL was 4.1%, time in normal glycemic range (70-180 mg/dL) was 62.3%, >180-250 mg/dL was 21.9%, and > 250 mg/dL was 11.6% at 90 days. 23 The median transmitter wear time in this analysis utilizing postmarketing data was 83.6%. 23 This real-world analysis suggests that the Eversense LTI CGM may provide similar benefits to isCGM and conventional rtCGM, although additional comparative efficacy analysis is lacking at this time.…”

“…23 This real-world analysis suggests that the Eversense LTI CGM may provide similar benefits to isCGM and conventional rtCGM, although additional comparative efficacy analysis is lacking at this time. 23 However, there are several ongoing clinical trials designed to further evaluate the glycemic efficacy of the Eversense LTI CGM ( Table 2). 24…”

7. Diabetes Technology: Standards of Medical Care in Diabetes—2021

“…Identifying and eliminating tape allergens is important to ensure comfortable use of devices and enhance patient adherence (102-105). In some instances, use of an implanted sensor can help avoid skin reactions in those who are sensitive to tape (106,107 (108,109), although inhaled insulin is also available. Others use insulin pumps or automated insulin delivery devices (see sections on those topics below).…”