FDA Clears First 1-Year CGM for Diabetes

The FDA has given clearance to the continuous glucose monitor (CGM) Eversense 365 for adult patients with type 1 and type 2 diabetes, Senseonics and Ascensia Diabetes Care announced in a release.¹ Ascensia said that it anticipates a launch of the product to occur in the United States in the fourth quarter of this year.

FDA Clears First 1-Year CGM for Diabetes / wladimir1804 - stock.adobe.com

The Eversense 365 is the world’s first long-term CGM that provides patients with 1 year of use. The fully-implantable device allows for minimal life disruption compared to short-term CGMs, which typically last around 10 to 14 days. The CGMs 12-month survivability also reduces data interruptions that occur with shorter lasting devices due to sensor failures or changes.

READ MORE: Dexcom’s OTC Continuous Glucose Monitor Now Available in US

“The approval of Eversense 365 represents a significant leap in CGM innovation,” Tim Goodnow, PhD, president and CEO of Senseonics, said in a release.¹ “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 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.”

Key features of the Eversense 365 CGM include a tiny sensor that rests under the skin that can’t be knocked off, on-body vibration alerts, consistent accuracy even during compression lows at night, a silicone-based adhesive that causes almost no skin reactions and can be changed daily, and a removeable transmitter which can be taken on or off easily without wasting a sensor or adding a warmup period.

Eversense 365 was cleared as an integrated CGM (iCGM) system, which means the CGM can be integrated with compatible medical devices. Such medical devices include insulin pumps as part of an automated insulin delivery (AID) system. In the release, Senseonics said the CGM was well suited to address common limitations of AID systems and that the company is currently working on furthering discussions with different pump manufacturers.

“Managing diabetes can be stressful and it is important for technology to disrupt life as little as possible to limit this burden,” Brian Hansen, president of CGM at Ascensia Diabetes Care, said in a release.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.”

READ MORE: Continuous Glucose Monitoring Resource Center

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References

1. Eversense 365 Receives FDA Clearance: The World’s First One Year CGM. News Release. Senseonics. September 17, 2024. Accessed September 18, 2024. https://www.senseonics.com/investor-relations/news-releases/2024/09-17-2024-120118174