Research to be presented at AMCP Nexus 2019 suggests that the Eversense Continuous Glucose Monitoring (CGM) System is an effective tool for managing patients with diabetes.
This Eversense CGM was approved by the FDA in June 2018 for use in patients aged 18 years or older with diabetes. The system uses a 90-day implanted sensor that leverages fluorescent technology and demonstrated its accuracy [mean absolute relative difference (MARD) 8.5%] and safety in three trials. To evaluate the real-world experience and performance of this CGM system, researchers analyzed data from 205 patients who completed a full 90-day sensor wear period using the device.
Patient sensor glucose (SG) data from August 2018 to May 2019 were assessed using the Eversense Diabetes Management System (DMS). The SG average, coefficient of variation (%CV), standard deviation (SD), glucose measurement index (GMI; a mathematical estimate of the HbA1c), and percent and time at various SG ranges, were all calculated. The accuracy of the sensor was analyzed using paired SG and self-monitored blood glucose (SMBG) measurements for calibrations that were done twice daily. The researchers also assessed the sensor reinsertion rate 120 days after the initial insertion date and the median wear time of the transmitter in patients with data beyond 30 days after the insertion.
A total of 205 patients were recruited (110 male, 94 female, 1 unreported). Of these, 129 participants identified as type 1 diabetics, 18 as type 2 diabetics, and 58 as unreported. A total of 50 of the patients reported not having experience with CGM, 112 had prior experience with the technology, and 43 were unreported. According to the study abstract, SG, SD, %CV, and GMI were found to be 161.8 mg/dL (57.4 mg/dL), 0.35 (0.06), and 7.18% (0.80), respectively. The percentage of time spent in ranges below 54 mg/dL was 1.2% (18.0 min/day); between 54 and 70 mg/dl, 2.9% (41.8 min/ day); between 70 and 180 mg/dL, 62.3% (897.7 min/day); between 181 and 250 mg/dL, 21.9% (315.8 min/day); and more than 250 mg/dL (severe hyperglycemia), 11.6% (166.7 min/day).
The was found to be 11.2% (11.3%), the sensor reinsertion rate was 76.9%, and the median time of transmitter wear was 83.6% in participants with a minimum of 30 days of data (92% of the entire population).
“Real-world data from the first 205 patients in the U.S. who completed a 90-day sensor wear period showed promising glycemic results,” the authors concluded in their study. “These data suggest that the implanted Eversense CGM system is a valuable tool for management of diabetes.”
This work was sponsored by Senseonics.
Sanchez P, Ghosh-Dastidat S, et al. Real-World Data from the First Commercial U.S. Long-Term Implantable Continuous Glucose-Monitoring System. Presented at: AMCP Nexus 2019; October 29 – Nov 1; National Harbor, MD.