FDA Clears First 1-Year Continuous Glucose Sensor

The US Food and Drug Administration (FDA) has cleared the Eversense 365 (Senseonics), an implanted continuous glucose monitoring (CGM) system that lasts a year. 
The Eversense is inserted subcutaneously into the upper arm by a certified healthcare professional during a brief office procedure. The transmitter is placed on the skin on top of the implanted sensor. Glucose data are automatically sent every 5 minutes to a mobile app on the user’s smartphone. The system includes an on-body vibratory alert as well as alerts on the app for high and low blood glucose values. 
The Eversense 365 will be launched in the last quarter of 2024 by marketing partner Ascensia Diabetes Care. It will be sold alongside the 6-month Eversense E3 that was cleared in 2022. Both will be indicated for adults aged 18 and older with type 1 or type 2 diabetes. 
Both systems are indicated to replace fingerstick blood glucose measurements for diabetes treatment decisions, although such testing is still required for calibration. This should be done once per week after day 14 for the Eversense 365 and once per day after day 21 for Eversense 3, or when symptoms don’t match the CGM readings or when taking tetracycline medications. 
The 1-year lifespan contrasts with that of external CGM systems, which last just 10 to 14 days. 
Eversense 365 has been cleared as an integrated CGM system, meaning it can integrate with compatible medical devices, including insulin pumps, as part of an automated insulin delivery system. Currently, it is not integrated with any specific insulin pump but “the companies are advancing partnership discussions with various pump manufacturers,” according to a company statement. 
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker. 
 
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