Eversense 365, a 1-Year CGM, Cleared by the FDA
Key takeaways:
- The FDA has approved Eversense 365, a new continuous glucose monitor (CGM) from Senseonics, for people with diabetes who are 18 years of age or older.
- The Eversense 365 has an implantable CGM sensor that only needs to be changed once a year.
- The company is expected to launch the 365 product early in the fourth quarter of 2024.
Eversense 365, a new implantable continuous glucose monitor from Senseonics, has received FDA clearance for use by people with diabetes 18 or older, making it the first CGM to have a sensor that can be worn continuously for one entire year.
“The approval of Eversense 365 represents a significant leap in CGM innovation. 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,” Dr. Tim Goodnow, President and CEO of Senseonics, said in a statement.
While most CGM sensors have a wear time of between 10 and 15 days, Senseonics has focused on long-term implantable continuous glucose monitor options for people with diabetes. In 2018, the FDA cleared the company’s first product, a 90-day implantable CGM. In 2022, Senseonics introduced the Eversense E3, which only needs to be changed every 180 days. It is currently available in the U.S. and Europe.
What is the Eversense 365?
The Eversense 365 is an implantable CGM that provides up to 365 days of continuous blood glucose readings. The components of the CGM include:
- An implantable sensor that must be inserted (and later removed) under the skin of the upper arm by a trained healthcare professional.
- A removable, rechargeable transmitter, placed right above the implanted sensor, that sends glucose readings via Bluetooth to a mobile phone app. It can be put on and taken off by the user using a silicone-based adhesive designed to cause virtually no skin reactions.
- An iOS (Apple) or Android (Google) mobile app, which shows users their glucose data and trends every five minutes and allows them to receive high and low alarms. The Eversense 365 will also feature on-body vibration alerts to keep patients notified even when a mobile phone is out of sight.
Eversense 365 calibrations
Unlike the Eversense E3, which requires fingerstick calibration once daily, the 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.
Potential AID integration options for Eversense 365
Although Eversense 365 has been FDA-cleared as an integrated CGM (iCGM) system, meaning that it can operate with compatible medical devices like insulin pumps as part of an automated insulin delivery system, the announcement did not specify which, if any, compatible insulin pumps would be available to for use as an AID system.
“Our partnership discussions with various pump manufacturers continue to progress as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery systems,” said Brian Hansen, President of CGM at Ascensia Diabetes Care, the diabetes device company that has partnered with Senseonics to distribute Eversense products.
Eversense 365 cost and availability
Prospective users may want to begin asking about the new product as soon as next month, as Eversense 365’s launch is “expected early in the fourth quarter of 2024,” according to a press statement. Those who are interested can stay up to date on details by registering for updates on the Eversense website.
Neither Senseonics nor Ascensia Diabetes Care, which distributes Eversense products, has shared any specifics around pricing for Eversense 365. While it’s unclear whether or not the Eversense 365 will have the same per day cost as the 180-day sensor, the out-of-pocket cost for the 180-day Eversense E3 is estimated to be approximately $2,900, inclusive of the sensor, transmitter and procedure.
Most insurance companies, as well as Medicare, cover the cost of Eversense insertion and removal procedures, as well as that of the device itself. The Eversense Payment Assistance and Simple Savings program also allows qualifying participants to receive a sensor, transmitter, and subsequent sensors for $99.
Eversense 365: The bottom line
The new Eversense 365 will offer another option that is markedly different from other CGM systems and represents a significant leap in diabetes tech innovation for wearers who want an implantable CGM that only needs to be changed once per year.
Though a much smaller percentage of people with diabetes use an Eversense CGM compared to other CGM devices, the convenience of a CGM sensor that only needs to be replaced once a year could be a very attractive alternative.
While Eversense 365 will require a minor surgical procedure and fingerstick calibrations, Advantages compared to other CGM devices potentially include fewer wasted sensors, less skin irritation, more discretion, and fewer compression lows compared to other CGM devices which typically have 10- to 15-day wear times.
As Hansen put it: “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs.”
Learn more about the latest CGM options: