FDA approves Eversense 365 CGM

      The next-generation Eversense 365 (Senseonics) continuous glucose monitoring (CGM) system has received FDA approval for individuals with type 1 or type 2 diabetes aged 18 years or older, making it the first CGM with a sensor that can be worn continuously for one year. The system is fully implantable, and reduces the burden of data interruptions, sensor failures, or changes. The accuracy is consistent for one year, with almost no false alerts from compression lows reported during the night. The main components in addition to the sensor include a removable, rechargeable transmitter and an iOS(Apple) or Android (Google) mobile app. Eversense 365 will require fingerstick measurements weekly to calibrate after day 14, as well as when symptoms do not match CGM information or if users are taking certain medications. The CGM’s accuracy and safety was evaluated in the PRECISE II (NCT02647905) trial.