976-P: Post Market Clinical Follow-Up (PMCF) Registry to Demonstrate the Long Term Safety of the Eversense CGM System

Abstract

Background: Eversense CGM is the first implantable long-term continuous glucose monitoring system. Prior studies evaluated the safety of the system using a study design of one insertion and removal cycle. The purpose of this prospective PMCF registry was to assess the long-term safety of the Eversense CGM System after repeated insertions. Methods: Eversense users from 15 European countries were followed prospectively until the first 100 participants completed their 4th insertion cycle. Visits were made every 90 to 180 days (dependent on sensor configuration) to replace sensors once sensor end life was reached. At each visit, Adverse Events (AEs) that occurred during the visit or during use since the previous visit were recorded. The primary endpoint was the rate of serious adverse events (SAEs) that were device-related, procedure-related, or drug (dexamethasone acetate) related through the sensor insertion/removal cycles. Results: 3066 participants were enrolled in the study with 43% on 2 or more sensor cycles. There were no device- or procedure-related SAEs reported. A total of 130 potentially-related AEs were reported, of which 106 were adjudicated as related or possibly/probably related to the device or insertion/removal procedure. Conclusion: Repeat insertions of the Eversense CGM confirmed the promising safety profile of prior studies and show it to be safe for long-term continuous use. Disclosure G. Carlson: Consultant; Self; Abbott Laboratories, Edwards Lifesciences Corporation, Senseonics, St. Jude Medical. K.S. Tweden: Employee; Self; Senseonics. C. Mdingi: Employee; Self; Senseonics. H. Haridas: Employee; Self; Senseonics.