FDA Approves First Implantable Continuous Glucose Monitor
The US FDA yesterday approved the Eversense continuous glucose monitoring (CGM) system for use in people 18 years of age and older with diabetes. This is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose, which can be worn for up to 90 days.
"The FDA is committed to advancing novel products that leverage digital technology to improve patient care," says FDA Commissioner Scott Gottlieb, MD. "These technologies allow patients to gain better control over their health. 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. The FDA is creating a new and more carefully tailored regulatory approach for software products, including mobile medical apps, that will enable efficient oversight of these digital technologies and maintain FDA's gold standard for product review. 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's implanted just under the skin by a qualified health care provider during an outpatient procedure. After it's implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor works with a novel light-based technology to measure glucose levels and send information to a mobile app to alert users if glucose levels are too high (hyperglycemia) or too low (hypoglycemia). The sensor is coated with a fluorescent chemical which, when exposed to blood sugar, produces a small amount of light that's measured by the sensor. Every five minutes, measurements are sent to a compatible mobile device (eg, smart phone or tablet) that's 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 with 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 postapproval study. The FDA held an Advisory Committee meeting to provide an independent assessment of the safety and effectiveness of the Eversense CGM system. In an 8 to 0 vote, the committee recommended that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes.
Potential adverse effects related to insertion, removal, and wear of the sensor include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or skin discoloration, sensor fracture during removal, and skin inflammation, thinning, discoloration, or redness. Other risks associated with use of the CGM system may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate or where alerts are missed.— Source: FDA