First continuous glucose monitoring system with fully implantable glucose sensor approved
The sensor is coated with a fluorescent chemical that produces a small amount of light when exposed to blood glucose. Every five minutes, it sends glucose measurements to a compatible device that is running a device-specific mobile app.
The first FDA-approved continuous glucose monitoring system with a fully implantable glucose sensor has been cleared for use in adults with diabetes, the agency announced on June 21.
The Eversense Continuous Glucose Monitoring system uses a small sensor, implanted subcutaneously by a qualified clinician during an outpatient procedure. The sensor is coated with a fluorescent chemical that produces a small amount of light when exposed to blood glucose. Every five minutes, it sends glucose measurements to a compatible device (e.g., smartphone or tablet) that is running a device-specific mobile app. Patients may wear the sensor for up to 90 days.
In clinical studies, fewer than 1% of participants experienced a serious adverse event with the implanted sensor. Potential adverse effects associated with 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, skin inflammation, thinning, discoloration, and redness. Other risks associated with use of the device include hypoglycemia or hyperglycemia if information provided by the device is inaccurate or alerts are missed.