Eversense 365 Continuous Glucose Monitoring System Receives FDA Clearance: The First One-Year CGM

On September 17, 2024, Senseonics Holdings, Inc., in collaboration with Ascensia Diabetes Care, announced that the U.S. Food and Drug Administration (FDA) has cleared the Eversense 365 Continuous Glucose Monitoring system.

This groundbreaking CGM is the first in the world to offer a sensor that lasts a full year, marking a revolutionary step in diabetes management.

The Eversense 365 Continuous Glucose Monitoring system (Eversense 365) is designed for adults with type 1 and type 2 diabetes, providing them with a more convenient, long-lasting option.

Unlike traditional CGMs—which require frequent sensor changes every 10-14 days—Eversense 365 only requires one sensor insertion per year. This feature minimizes disruptions and simplifies diabetes management, allowing users to focus more on living life rather than managing their condition.

“The approval of Eversense 365 represents a significant leap in CGM innovation,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “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,”

Key Benefits of Eversense 365

• Longest-lasting CGM: With a 365-day sensor, users only need one sensor insertion per year, reducing the hassle of frequent changes.
• Increased reliability: The system reduces the risk of data interruptions common with shorter-term CGMs.
• Trusted alerts: Exceptional accuracy with almost no false alarms, especially during nighttime.
• Improved comfort: The gentle adhesive is designed to minimize skin reactions, while the removable transmitter offers more flexibility and freedom.
• Discreet and convenient: Vibration alerts notify users even when their phone is out of reach.

Commercial Availability and Future Integration

The Eversense 365 launch is expected in the fourth quarter of 2024, with efforts underway to secure insurance coverage for widespread availability.

Additionally, the system has been cleared as an integrated CGM (iCGM), meaning it can work with insulin pumps as part of automated insulin delivery (AID) systems.

Ascensia and Senseonics are working on partnerships to expand these integration capabilities, further enhancing diabetes care.

For more information on Eversense 365 and its availability, visit www.eversensecgm.com.

WRITTEN BY Daniel Trecroci, POSTED 09/17/24, UPDATED 09/17/24

Dan has written about diabetes for more than 20 years. He was one of Diabetes Health's first recruits, and throughout his 10 + years as Managing Editor he wrote/published thousands of articles and helped establish Diabetes Health as the premiere resource for people with diabetes. He later became the Content Manager for OneTouchGold—Johnson & Johnson/LifeScan’s official digital publication for its metering-technology customers. Under his leadership, OneTouchGold received the Web Marketing Association’s award for “Best Health & Wellness" web site. Dan has also written for the Diabetes Research Institute, dLife, diaTribe, Healthline, CareDx, Pendulum Therapeutics, and Hero Bread.