The U.S. FDA cleared Senseonic Holdings Inc.’s Eversense 365, the first continuous glucose monitor (CGM) to last a full year with a single sensor rather than the 10 days to two weeks typical for wearable sensors such as those offered by Abbott Laboratories and Dexcom Inc. The implantable device is indicated for adults with type 1 or 2 diabetes and comes with an iCGM designation signaling its approval for integration as part of an automated insulin delivery system.

“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, president and CEO of Germantown, Md.-based Senseonics.

Senseonics’ Eversense E3 model lasted 180 days, so the Eversense 365 more than doubles its longevity, a significant improvement in an implanted device.

“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,” added Goodnow.

Senseonics plans to roll out the new CGM during the fourth quarter of 2024 in conjunction with its global commercial partner, Ascensia Diabetes Care Holdings AG.

“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,” said Brian Hansen, president of CGM at Basel, Switzerland-based Ascensia, a subsidiary of PHC Holdings Corp.

Senseonics has been signaling an expected approval to the market for some time and the clearance came about when expected. “The company has already been preparing for the commercial launch via consumer and professional marketing initiatives to build awareness, and is working to transition coverage availability as well,” said Marie Thibault of BTIG.

To support the launch of the new device and make switching to an implantable CGM easier for patients and clinicians, Senseonics has created a group to facilitate implantations.

“Additionally, Senseonics established a wholly owned subsidiary called Eon Care Services in an effort to help increase conversion rates,” Thibault wrote in August. “This in-house insertion network will complement the Nurse Practitioner Group (NPG) and aims to increase patient access to Eversense. This move makes both strategic and financial sense to us. The NPG has had success in recent years, reaching about 25% of insertions as of earlier this year. The existing CPT codes for the insertion are expected to make this business model self-sustaining, with minimal set-up costs that are already assumed in the operating expense guidance.”

The company hopes to integrate its CGM with insulin pumps in the near term as well.

“In parallel, our partnership discussions with various pump manufacturers continue to progress, as we look to leverage Eversense 365’s unique potential to simplify life with integrated automated insulin delivery systems,” Hansen said.