Eversense 365, an implantable continuous glucose monitor (CGM), is indicated for people with type 1 and type 2 diabetes aged 18 years and older.
Senseonics announced last month that it received FDA clearance for Eversense 365. With the clearance, it became the world’s first 365-day CGM system, according to the company.
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. Senseonics and Ascensia, its global commercial partner, have discussions ongoing with various pump manufacturers.
Senseonics and Ascensia plan to launch the CGM alongside a new Payment Assistance and Simple Savings (PASS) program. Eligible individuals can pay as little as $199 out of pocket for one year of continuous glucose monitoring.
“Eversense offers a completely differentiated CGM experience, overcoming many of the frustrations experienced with traditional short-term CGMs, such as early failure, disruptive false alerts and skin irritation,” said Hansen. “With only one CGM replacement a year, fewer failed or wasted sensors, and alerts you can trust, Eversense 365 allows patients to live life uninterrupted by their diabetes technology. We can’t wait to get this game-changing product to people with diabetes and healthcare providers across the country.”
More about the Senseonics Eversense 365 CGM
With the launch, Eversense 365 becomes only CGM offering a year-long wear time. Market-leading, non-implanted CGMs like Abbott’s and Dexcom’s have wear times 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. The sensor rests under the skin, meaning it can not be knocked off, minimizing inconveniences and replacement costs. In terms of comfort, 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.
