The U.S. Food and Drug Administration (FDA) has approved Eversense 365, the first and only continuous glucose monitoring (CGM) system designed to function for an entire year, according to a company press release. Developed by Senseonics and Ascensia Diabetes Care, the device represents a significant advancement in long-term glucose monitoring technology.
Eversense 365 is an implantable CGM system, inserted under the skin of the upper arm during a brief in-office procedure performed by a certified healthcare professional. The sensor transmits glucose data every five minutes to a mobile app, allowing users to track their glucose levels in real-time.
Key features of Eversense 365 Year-Long Continuous Glucose Monitoring System include:
Extended Wear Time: The sensor lasts 365 days, reducing the need for frequent sensor changes, which are typically required every 10-14 days in short-term CGM systems.
Improved Accuracy: The system provides year-long accuracy and reduce false alerts from low compression during sleep to almost none.
Reduced Calibration: After the initial two weeks, the device only requires weekly calibration, a decrease from daily calibration required in the previous Eversense E3 system.
Flexible Wear: The external transmitter can be removed and reapplied without requiring a sensor warm-up period.
Discreet Alerts: On-body vibration alerts notify users of high or low glucose levels without the need to check a phone.
Skin-Friendly Design: A gentle silicone-based adhesive designed to minimize skin reactions and can be changed daily.
Integration Capability: Eversense 365 is cleared as an integrated CGM system, meaning it could potentially work with compatible insulin pumps and automated insulin delivery systems in the future.
The approval addresses several challenges faced by diabetes patients, including the inconvenience of frequent sensor changes, accidental dislodgement, and data interruptions.
Dr. Tim Goodnow, President and CEO of Senseonics, emphasized the significance of the approval, stating, “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.”
Eversense 365 is approved for adults aged 18 and older with type 1 or type 2 diabetes. It is designed to replace traditional blood glucose monitoring via fingerstick measurements, except for the required calibrations.
Ascensia Diabetes Care plans to launch Eversense 365 in the United States during the fourth quarter of 2024. It will be available alongside the 6-month Eversense E3 system, providing patients with additional options for long-term glucose monitoring.
As CGM technology evolves, Eversense 365 marks a notable milestone in offering more convenience and flexibility for diabetes management.
