First-Ever CGM Cleared for 365-Day Use

The FDA this week cleared Eversense 365, the first continuous glucose monitor (CGM) system that provides 1 year of use, for adults with type 1 and type 2 diabetes, according to Senseonics and Ascensia Diabetes Care. The companies expect to launch the CGM in the US in the fourth quarter this year.

The fully-implantable device eliminates the need for frequent sensor changes, requiring a single insertion each year compared with every 10 to 14 days with short-term CGMs, the companies said. The 12-month "survivability" of the sensor also reduces the risk of data interruptions caused by sensor failure or changes with short-term CGM systems.

An additional burden associated with short-term sensors is eliminated, too, as the implantable Eversense 365 cannot be knocked off, reducing the cost and inconvenience of frequent replacements.

“The approval of Eversense 365 represents a significant leap in CGM innovation,” Tim Goodnow, PhD, president and CEO of Senseonics, said in the announcement. “Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes. Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower [HbA_1c.]”

Benefits that further differentiate the CGM system and may improve disease management and quality of life for people with both T1D and T2D include on-body vibration alerts, consistent accuracy even during compression lows at night, a silicone-based adhesive that causes almost no skin reactions and can be changed daily, and a removeable transmitter which can be taken on or off easily without wasting a sensor or adding a warmup period.

With clearance as integrated CGM (iCGM) system, Eversense 365 can be integrated with compatible devices, such as insulin pumps, as part of an automated insulin delivery (AID) system. Senseonics notes in the press statement that the company is in discussions regarding partnerships with several insulin pump manufacturers.

“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” Brian Hansen, president of CGM at Ascensia Diabetes Care, said in the Senseonics release. “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible.”

Source: Eversense 365 receives FDA clearance: the world's first one year CGM. News release. Sensionics. September 17, 2024. Accessed September 19, 2024. https://www.senseonics.com/investor-relations/news-releases/2024/09-17-2024-120118174