The first continuous glucose monitoring system with a fully implantable sensor has been approved by the US Food and Drug Administration (FDA).
The agency endorsed the Eversense Continuous Glucose Monitoring (CGM) system for use in people aged 18 years and older with diabetes. It is the first FDA-approved CGM system to include a fully implantable sensor to detect glucose. The sensor 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. It 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 an app on a phone or tablet, which alerts users if glucose levels are too high or too low.
To inform its decision, the FDA evaluated clinical study data from 125 adults with diabetes and reviewed the device’s effectiveness by comparing readings from the Eversense CGM system to those obtained by a laboratory-based glucose analyser.
FDA commissioner Scott Gottlieb said: “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.”