Eversense 365, the world’s first 365-day CGM system, is the only CGM offering a year-long wear time. Market-leading, non-implanted CGMs like Abbott’s and Dexcom’s are worn for around two weeks. For Eversense 365 users, this means no frequent sensor changes and only one insertion and one “Day 1” every year.
The company says its sensor survivability across 12 months reduces the burden of data interruptions from frequent short-term CGM failures or changes. With the sensor resting under the skin, it can not be knocked off, minimizing inconveniences and replacement costs. On the comfort front, users can change its gentle, silicone-based adhesive daily with almost no skin reactions.
Senseonics says its sensor delivers consistent accuracy across one year, with almost zero false alerts from compression lows during the night. It offers the freedom to remove the transmitter device without wasting a sensor or adding a warm-up period. Eversense 365 also has on-body vibration alerts for improved discretion, alerting patients even when their mobile phone is out of sight.
The system also received clearance as an integrated CGM (iCGM) system, meaning it can work with compatible medical devices. Those include insulin pumps as part of automated insulin delivery systems.
In September, the company won FDA clearance for the Eversense 365 one-year implantable CGM. Senseonics and its global distribution partner, Ascensia Diabetes Care, announced the launch for Eversense 365 on Oct. 1. If the system wins CE Mark, Ascensia would distribute the CGM in Europe, too. Senseonics said the list of countries in the European launch would include Germany, Italy, Spain (including Andorra), Poland, Switzerland and Sweden.
Commentary from Senseonics and Ascensia officials
Senseonics President and CEO Tim Goodnow: “Completing the CE Mark submission for Eversense 365 brings us a step closer to improving lives and health outcomes for patients in Europe. Given the success we have had to date with the US launch of Eversense 365 by our partner, Ascensia, we look forward to the opportunity to offer a ‘once a year’ solution for glucose control to the millions of people living with diabetes in the European Union.”
Ascensia Diabetes Care President of CGM Brian Hansen: “The feedback we have received since our US launch from endocrinologists, general practitioners and patients with diabetes has been extremely encouraging. Eversense 365 is having a tangible impact to the lives of many and we hope to have the opportunity to create a similar impact for patients living with diabetes in Europe.”
