WASHINGTON, June 21 (Xinhua) -- The United States Food and Drug Administration (FDA) approved on Thursday the first continuous glucose monitoring system for use in adults with diabetes that included a fully implantable sensor to detect glucose.
The Eversense Continuous Glucose Monitoring (CGM) system uses a small sensor that is implanted just under the skin by a qualified health care provider during an outpatient procedure.
After it is implanted, the sensor regularly measures glucose levels in people 18 years of age and older with diabetes for up to 90 days, according to FDA.
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 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.
During these studies, the proportion of individuals experiencing a serious adverse event with the implanted sensor was less than one percent.
