SILVER SPRING, Md. ‑ The U.S. Food and Drug Administration has approved Senseonics’ Eversense for use in people 18 years of age and older with diabetes, making it the first FDA-approved continuous glucose monitoring system to include a fully implantable sensor to detect glucose.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said Dr. Scott Gottlieb, FDA Commissioner, in a statement. “This approval of a more seamless digital system that gives patients the ability to effectively manage a chronic disease like diabetes is a vivid illustration of the potential for these mobile platforms. We’re advancing a more modern approach for these products that’s carefully adapted to the unique characteristics of these opportunities.”
The Eversense CGM system uses a small sensor that is implanted just under the skin and regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high or too low. The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that is measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device that is running a device-specific mobile app.
The FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes and reviewed the device’s effectiveness by comparing readings obtained by the Eversense CGM system to those obtained by a laboratory-based glucose analyzer. The safety of the Eversense CGM system’s 90-day implantable sensor, and the procedure used to implant it, was also evaluated during the clinical studies. During these studies, the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1%.
The safety of this novel system will also be evaluated in a post-approval study.