The US Food and Drug Administration (FDA) has approved a "nonadjunctive" indication for the implantable continuous glucose monitor (CGM) Eversense (Senseonics), so patients will no longer need to perform confirmational fingerstick glucose checks in order to make insulin dosing decisions.
Eversense still requires twice daily calibrations, which means Senseonics will no longer have to educate patients to take fingersticks before treatment decisions.
In addition to improved convenience, the new indication is important for Medicare beneficiaries because the "nonadjunctive" indication is required for coverage of CGM devices by the Centers for Medicare & Medicaid Services (CMS).
"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," Senseonics President and Chief Executive Officer Tim Goodnow, PhD, said in a company statement.
"We expect this will allow our users to more conveniently and confidently live their lives with fewer interruptions," he added.
Francine R. Kaufman, MD, endocrinologist and chief medical officer at Senseonics, concurred, noting in the statement: "This FDA dosing indication helps reduce the burden that patients face when managing their diabetes."
First approved by the FDA in June 2018, Eversense consists of a fluorescence-based sensor that is implanted subcutaneously in the upper arm by a physician during a short office procedure, a transmitter worn above the sensor, and a mobile app that displays glucose values and trends and issues alerts of high and low blood glucose values. The transmitter also issues on-body vibration alerts.
In contrast to current CGMs that need to be replaced every 7 to 14 days, the Eversense lasts up to 3 months, after which it must be removed by a physician during another short office procedure and placed on the opposite upper arm.
Two other currently marketed CGM systems, the Dexcom G6 and FreeStyle Libre (Abbott), also have approved nonadjunctive indications.
Those devices also don't require fingerstick glucose tests for calibration, whereas the Eversense still requires this twice daily.
Senseonics plans to launch Eversense early in the fourth quarter of 2019.
And, for the new functionality, patients will need to download a new app that will be available later in 2019. Patients can sign up for the Eversense here.
FreeStyle Libre App Now Available on Android and iPhone Devices
Separately, the FreeStyle Libre app for Android devices has been approved by the FDA and is available through the Google Play store.
This follows approval of the same app for use with iPhones last November.
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Cite this: Avoid Fingersticks for Diabetes Dosing Decisions With Eversense - Medscape - Jun 07, 2019.
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