Senseonics, a company that develops implantable continuous glucose monitoring (CGM) system for people with diabetes, received FDA approval for the non-adjunctive indication (dosing claim) for its Eversense CGM.
The CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and vibratory alerts for high and low glucose and can be removed, recharged and re-attached to the skin without discarding the sensor. People with diabetes can use this system instead of the traditional finger prick tests to make diabetes-related decisions.
“We are pleased with the results of the European Eversense PMCF registry which demonstrate the safety of the Eversense CGM System in a large group of patients,” said Katherine Tweden, PhD, Vice President of Clinical Sciences at Senseonics. “This post-market study was an opportunity to evaluate the real-world experience of Eversense and Eversense XL CGM as patients wore their first, second, third and fourth sensors. The results, with 3,667 patient-years of wear, demonstrated a strong safety profile over repeat sensor cycles for the first long-term implantable sensor.”
Past clinical studies evaluated the safety of the system using a study design of one insertion and removal cycle. Safety data from 3,066 Eversense users from 15 European countries was collected and reported. Repeat insertions of the Eversense CGM confirmed the safety profile of prior studies and showed it to be safe for long-term continuous use.