USA – The US Food and Drug Administration (FDA) has approved a major advancement in diabetes management with the clearance of Eversense 365, an innovative continuous glucose monitoring (CGM) system.
Developed by Senseonics, the Eversense 365 is a unique CGM system designed to be implanted and last up to a full year, offering significant improvements in ease and efficiency for diabetes patients.
This innovative device lasts up to one year, offering significant convenience and reliability to diabetes patients compared to current CGM systems that typically require sensor changes every 10-14 days.
What makes Eversense 365 stand out?
Eversense 365 is inserted just beneath the skin of the upper arm by a healthcare professional in a short, in-office procedure.
Once implanted, a small transmitter is worn externally over the sensor, continuously sending glucose readings every five minutes to a smartphone app.
This real-time monitoring is enhanced with both on-body vibration alerts and smartphone notifications for high or low blood sugar levels, ensuring users are always informed.
The CGM system’s one-year lifespan is a key differentiator from other external CGMs, offering fewer sensor changes and reducing the inconvenience of frequent replacements.
It also marks a significant leap forward in patient convenience and clinical outcomes by minimizing disruptions caused by sensor failures or data loss.
Integration with insulin delivery systems
The FDA has approved Eversense 365 as an integrated CGM (iCGM) system, meaning it can be paired with compatible medical devices like insulin pumps.
While current versions of Eversense are not yet integrated with specific insulin delivery systems, Senseonics and their marketing partner, Ascensia Diabetes Care, are actively discussing partnerships with various insulin pump manufacturers.
This integration is expected to be a significant step forward in automating insulin delivery for patients with both type 1 and type 2 diabetes, potentially reducing the need for manual intervention.
Ease of use and maintenance
Eversense 365 includes a removable transmitter, which allows users to take it off and reapply it without wasting the sensor or needing an additional warm-up period.
This flexibility makes it ideal for daily life, ensuring that patients receive glucose alerts even if their phone is out of reach.
The system also uses a silicone-based adhesive, which can be replaced daily to enhance comfort and adherence.
Additionally, the Eversense 365 requires only once-per-week calibration after the first two weeks of use, a major improvement over other CGM systems that may require daily calibrations.
This reduced maintenance adds to its user-friendly appeal, particularly for people with busy lifestyles.
Planned launch and competition in the CGM market
Ascensia Diabetes Care has announced plans to launch Eversense 365 in the fourth quarter of 2024.
It will be marketed alongside the 6-month Eversense E3, providing patients with more options depending on their individual needs.
Both systems are approved for adults aged 18 and older with type 1 or type 2 diabetes and are designed to replace traditional fingerstick blood glucose measurements for treatment decisions.
The CGM market is highly competitive, with companies like Dexcom and Medtronic leading the space.
Dexcom’s G7 CGM sensor received FDA approval in December 2022, and Medtronic has recently partnered with Abbott to integrate their FreeStyle Libre CGM technology with Medtronic’s automated insulin delivery systems.
However, with the innovative features and extended lifespan of Eversense 365, Senseonics is well-positioned to make a strong impact in this growing market.
Looking ahead
In addition to the Eversense 365, Senseonics is developing other groundbreaking diabetes technologies.
The company is testing the Gemini System, a fully implantable, self-powered device that aims to simplify diabetes management even further.
The Gemini System is designed for people with type 2 diabetes and features a flash glucose monitor without any external components.
