Senseonics Holdings, Inc., announced that they received FDA approval for the non-adjunctive indication (dosing claim) for the Eversense Continuous Glucose Monitoring System.
Patients will soon be able to use Eversense as a replacement for fingersticks to make diabetes treatment decisions throughout the day.
To use the non-adjunctive dosing indication, users will have to download a new app which will be available in the coming months.
“Receiving the non-adjunctive indication from the FDA marks a major milestone for Senseonics,” says Tim Goodnow, President, and Chief Executive Officer at Senseonics. “The Eversense CGM will soon be used as a replacement to fingersticks to make treatment decisions.”
Goodnow expects this will allow users to more conveniently and confidently live their lives with fewer interruptions.
“This approval is also another step toward providing access to Eversense CGM for people 65 and older, as non-adjunctive labeling is the first requirement for Medicare coverage,” Goodnow added. “We look forward to working with the Centers for Medicare & Medicaid Services leadership team to explore opportunities for Senseonics to provide Eversense and its benefits to the Medicare population.”
What’s The Eversense CGM System?
The Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends, and alerts.
In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet on-body vibratory alerts for high and low glucose and can be removed, recharged and re-attached to the skin without discarding the sensor.
The sensor is inserted subcutaneously in the upper arm by a health care provider via a brief in-office procedure. With the non-adjunctive claim, the Eversense CGM System will still require 2 finger sticks a day.
“This FDA dosing indication helps reduce the burden that patients face when managing their diabetes,” says Dr. Francine R. Kaufman, endocrinologist and chief medical officer at Senseonics. “Patients have expressed that many of the unique features of Eversense – its long-term use, removable transmitter and predictive, on-body vibe alerts – allow them to be more discreet as they manage their diabetes.”
She says in a recent analysis, they have seen that early Eversense users in the U.S. have experienced a 62% time in the target range for sensor glucose values of 70-180 mg/dL during their first sensor wear.
This non-adjunctive dosing claim is yet another benefit for those patients who want to manage their diabetes with greater ease and freedom, according to Kaufman.
Senseonics plans to launch this new, non-adjunctive product early in the fourth quarter of 2019.