FDA approves nonadjunctive indication for Eversense CGM
The FDA on Thursday approved a nonadjunctive indication for the Eversense continuous glucose monitoring system, allowing patients to use the implantable device as a replacement for finger sticks to make diabetes treatment decisions throughout the day, according to a press release from Senseonics.
To use the nonadjunctive dosing indication, users will have to download a new app that will be available in coming months, according to the release.
“Receiving the nonadjunctive indication from the FDA marks a major milestone for Senseonics,” Tim Goodnow, president and CEO at Senseonics, said in the release. “The Eversense CGM will soon be used as a replacement to finger sticks to make treatment decisions. We expect this will allow our users to more conveniently and confidently live their lives with fewer interruptions.”
Goodnow said the approval is another step toward providing access to Eversense CGM for older adults, as nonadjunctive labeling is the first requirement for Medicare coverage.
“We look forward to working with the CMS leadership team to explore opportunities for Senseonics to provide Eversense and its benefits to the Medicare population,” Goodnow said.
Considered both the first long-term and implantable CGM, the Eversense device is inserted subcutaneously in the upper arm by a health care provider via an in-office procedure and can be used for up to 90 days before replacing. The device measures glucose levels via a fluorescence-based sensor and transmits that data every 5 minutes to a mobile application to help control hypoglycemia and hyperglycemia in adults with diabetes.
With the nonadjunctive claim, the Eversense CGM System will still require two finger sticks a day, according to the release.
As Endocrine Today reported in March, Senseonics and Glooko entered a partnership whereby data from the Eversense CGM system will be integrated into Glooko’s mobile and web-based diabetes data management platforms. Data from the Eversense CGM, which was approved for use in adults with diabetes by the FDA in June 2018, can be transmitted to Senseonic’s cloud storage platform. That data will now be shared with Glooko’s management platform, allowing users and health care providers the ability to monitor historical glucose information through mobile and web-based applications.
Senseonics plans to launch the nonadjunctive product early in the fourth quarter, according to the company. – by Regina Schaffer
Disclosure: Goodnow is president and CEO at Senseonics.