Senseonics Holdings announced that they received FDA approval for the non-adjunctive indication (dosing claim) for the Eversense Continuous Glucose Monitoring System.
Image: The US FDA’s Center for Devices and Radiological Health. Photo: courtesy of The U.S. Food and Drug Administration.
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 coming months.
“Receiving the non-adjunctive indication from the FDA marks a major milestone for Senseonics. The Eversense CGM will soon be used as a replacement to fingersticks to make treatment decisions,” said Tim Goodnow, President and Chief Executive Officer at Senseonics.
“We expect this will allow our 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. 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.”
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 fingersticks a day.
“This FDA dosing indication helps reduce the burden that patients face when managing their diabetes,” said Francine R. Kaufman, MD, Endocrinologist and Chief Medical Officer at Senseonics. “Patients have expressed that many of the unique features of Eversense – its long-term use, removeable transmitter and predictive, on-body vibe alerts – allow them to be more discreet as they manage their diabetes. In a recent analysis, we have seen that early Eversense users in the US have experienced 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.”
Senseonics plans to launch this new, non-adjunctive product early in the fourth quarter of 2019.
The Eversense Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days.
The system is indicated for use to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements are still required for calibration twice per day, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider.
Source: Company Press Release