FDA Clears Eversense 365, Marking First 1-Year CGM Option in Diabetes

Credit: US Food and Drug Administration

The diabetes community has entered a new era in continuous glucose monitoring with the US Food and Drug Administration's (FDA) clearance of the Eversense 365 system—the world’s first 1-year continuous glucose monitor (CGM).

Announced on September 17, 2024, the clearance of the Eversense 365 CGM system indicates the system for use in people with type 1 and type 2 diabetes aged 18 years and older. According to Ascension and Senseonics, the US launch of Eversense 365 is expected to initiate in the fourth quarter of 2024.¹

“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,” said Tim Goodnow, PhD, president and chief executive officer of Senseonics.¹ “Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365-day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.”

This is not the first time an Eversense CGM system has made history in recent years. In February 2022, the Eversense E3 CGM System, a 6-month CGM, received clearance from the FDA based on the results of the prospective, multicenter PROMISE study.²

As highlighted by Ascensia and Senseonics, Eversense 365, a fully-implantable, long-term CGM option, offers several advantages compared to short-term CGMs. Features highlighted in their release included the 12-month sensor survivability and implantable sensor, which allow for fewer data interruptions, less waste, and lessened burden on quality of life. Other features include a silicone-based adhesive that can be changed daily, a removable transmitter that can be taken on and off without wasting a sensor or adding a warmup period, and on-body vibration alerts to keep patients notified when away from their phone.¹

Ascensia and Senseonics pointed out Eversense 365 had been cleared as an integrated CGM system, which allows for integration with compatible medical devices, including insulin pumps as part of an automated insulin delivery system.¹

“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” said Brian Hansen, president of CGM at Ascensia Diabetes Care, a subsidiary of PHC Holdings Corporation (TSE 6523).¹ “Eversense 365 allows people with diabetes to focus on living their lives, rather than managing the limitations that many experience with short-term CGMs. We are very excited about Senseonics’ ability to once again bring true innovation to the CGM space and are working closely with our partner to make Eversense 365 commercially available as soon as possible.”

More information on the system, including updates on availability are available at: www.eversensecgm.com. Ascensia and Senseonics have also created a website for healthcare providers interested in prescribing the system to learn more: https://www.ascensiadiabetes.com/eversense/become-a-provider/.

References:

1. Senseonics. Eversense 365 Receives FDA Clearance: The World’s First One Year CGM. Senseonics . September 17, 2024. Accessed September 18, 2024. https://www.senseonics.com/investor-relations/news-releases/2024/09-17-2024-120118174.
2. Campbell P. US FDA approves Eversense E3 CGM System, allows use for up to 6 months. HCP Live. February 11, 2022. Accessed September 18, 2024. https://www.hcplive.com/view/us-fda-approves-eversense-e3-cgm-system-allows-use-for-up-to-6-months.