FDA clears implantable CGM with sensor that lasts up to 1 year
Click Here to Manage Email Alerts
Key takeaways:
- The FDA has cleared the Eversense 365 CGM for adults with type 1 or type 2 diabetes.
- The system includes an implantable sensor that can be worn for up to 1 year.
The FDA has cleared a continuous glucose monitoring system with an implantable sensor that can be worn for up to 1 year for adults aged 18 years and older with type 1 or type 2 diabetes, according to a press release.
The Eversense 365 (Senseonics and Ascensia Diabetes Care) is a CGM system that includes a sensor placed under the skin. The sensor lasts for up to 1 year, making the system the first FDA-cleared CGM with a sensor lifespan of that length, according to the companies’ press release.
The system also includes a smart transmitter worn over the sensor that sends data to a mobile app on the person’s smartphone every 5 minutes; it is removable and can be taken on and off without removing the sensor, according to the release. The system also sends on-body vibration alerts to the wearer in addition to sending alerts to their smartphone.
The FDA cleared the Eversense 365 as an integrated CGM, allowing the system to be used with other compatible medical devices such as insulin pumps as part of an automated insulin delivery system, according to the release.
“The approval of Eversense 365 represents a significant leap in CGM innovation,” Tim Goodnow, PhD, president and CEO of Senseonics, said in the press release. “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.”
Ascensia announced it plans to launch Eversense 365 in the U.S. during the fourth quarter of 2024. More information about the system and its availability can be found at www.eversensecgm.com.
Perspective
Back to Top
Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES, FADCES, FCCP
We have been using Eversense since the original 90-day version with two required calibrations per day. I remember how COVID-19 threw a wrench into in-person visits, making it more challenging to replace sensors on time. We were thrilled when the 180-day version became available, and calibrations were taken down to just once daily for most of the wear time. Although COVID has eased, the longer wear time is more convenient for patients. The technology to now extend this to 365 days is truly remarkable.
With the sensor placed under the skin, a person doesn’t have to worry about frequent sensor changes or with it getting bumped and falling off early. Wearing something on the skin for extended periods of time can cause skin complications or irritation. With the Eversense, the sensor is under the skin and the outer transmitter can easily be removed any time if desired without having to worry about the expense and warm-up time of a new sensor.
Earlier this year, we heard the announcement about integrated CGM status. I can’t wait to see the future insulin pump collaborations. The 365-day wear time with only once-weekly calibration will making this an enticing option for many people with diabetes. I love having options and I look forward to seeing how this will benefit my patients.
Collapse
Read more about
Click Here to Manage Email Alerts