Interim Analysis of an Implantable CGM System Longevity during a 365-Day Study

Abstract

Background: Research has been conducted to extend the life of a subcutaneously implanted CGM System (Eversense®, Senseonics, Maryland U.S.A) using several strategies including the use of different configurations of an anti-inflammatory agent and improvement in glucose sensing and calculation methods. The current study investigated the longevity of the Eversense® XL CGM over the first 250 days of the planned 365-day evaluation period. Methods: Thirty-four adult participants with T1D were enrolled in a prospective, unblinded, single-center 365-day study. Sensors were inserted in the upper arm and assessed every 30-60 (±14) days for sensor longevity, safety and effectiveness. An interim analysis of sensor longevity was performed using the Kaplan-Meier method to estimate the probability of sensor survival through 250 days. CGM wear duration was also assessed to monitor subject compliance. Serious adverse events related to the device or insertion or removal procedures were assessed. Results: Participant baseline demographics were 22 males/12 females, 30 ± 7.9 years of age, with BMI of 24 ± 3.6 kg/m2 (mean ± SD). At this interim analysis, all sensors had a range of 124-365 days of use. Survival analysis at post-implant 90, 120, 150, 180 and 250 days showed an estimated probability of sensor survival of 97%, 94%, 84%, 80% and 51%, respectively. Median wear compliance of the subjects was 23.1 hours/day (96% of time). No insertion, removal or device-related serious adverse events were reported. Conclusions: The Eversense XL CGM demonstrated good survival and safety up to 250 days of sensor wear. Disclosure S. Ioacara: Research Support; Self; Senseonics. R. Rastogi: Employee; Self; Senseonics. C. Mdingi: Employee; Self; Senseonics. X. Chen: Employee; Self; Senseonics. K. Tweden: Employee; Self; Senseonics.