Diabetes technology company Eversense has announced that its Continuous Glucose Monitoring (CGM) system has been approved by the FDA.
Diabetes insulin
It is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose and can be worn for up to 90 days.
The Eversense CGM system uses a small sensor that is implanted just under the skin during an outpatient procedure. After it is implanted, the sensor regularly measures glucose levels in adults with diabetes for up to 90 days. The implanted sensor uses light-based technology to measure glucose levels and send information to a mobile app to alert users if their glucose levels are too high or too low.
The sensor is coated with a fluorescent chemical which produces a small amount of light that is measured by the sensor when exposed to blood sugar. Measurements are sent to a user’s mobile every five minutes through the compatible app.
The device was approved after the FDA evaluated clinical study data from 125 individuals aged 18 and older with diabetes. The FDA reviewed the device’s effectiveness by comparing it to readings to those obtained by a laboratory-based glucose analyser.
The device’s 90-day implantable sensor and the procedure used to implant it were also evaluated during the clinical studies. The FDA found that the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than 1%.
FDA Commissioner Scott Gottlieb, said: “The FDA is committed to advancing novel products that leverage digital technology to improve patient care. 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.”