The Food and Drug Administration has given clearance to the first continuous glucose monitoring system with a fully implantable sensor that can be used by adult users with diabetes to regularly measure their blood sugar levels for as long as 90 days.
The Eversense Continuous Glucose Monitoring (CGM) system, manufactured by Senseonics Holdings, leverages a small sensor that is implanted just under the skin by a physician during an outpatient procedure. The sensor takes blood sugar measurements every five minutes and sends information via Bluetooth to a mobile device running an app, which lets users know if the glucose levels are too high or too low.
“The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said Commissioner Scott Gottlieb, MD, in a written statement. “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.”
However, the regulatory agency also stated that the Eversense CGM system has “potential adverse effects related to insertion, removal and wear of the sensor that include allergic reaction to adhesives, bleeding, bruising, infection, pain or discomfort, scarring or skin discoloration, sensor fracture during removal, skin inflammation, thinning, discoloration or redness.” In addition, the FDA noted that other risks associated with use of the system “may include hypoglycemia or hyperglycemia in cases where information provided by the device is inaccurate or where alerts are missed.”
Nonetheless, an FDA advisory committee voted unanimously—8 to 0—that the benefits of the Eversense CGM system outweigh the risks for patients with diabetes, according to the agency. The FDA’s approval decision was based on clinical study data from 125 individuals aged 18 and older with diabetes and its evaluation of the device’s effectiveness by comparing readings obtained by the 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,” according to the FDA. “During these studies, the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1 percent. The safety of this novel system will also be evaluated in a post-approval study.”
“We’re very pleased to receive this FDA approval that allows us to make Eversense available in the United States, as it is in many European markets,” said Tim Goodnow, president and CEO of Senseonics. “With the parallel trends of wearable personal devices and medical implantables for people to manage their health, this product exemplifies the natural evolution for diabetes devices, and Senseonics is excited to help lead the way. More importantly, we believe the unique features Eversense offers will help open up CGM to millions of people with diabetes who, up to this point, have been hesitant to try CGM despite the clear health benefits it provides.”
“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,” added Gottlieb. “We’re advancing a more modern approach for these products that’s carefully adapted to the unique characteristics of these opportunities.”
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