First CGM System With Implantable Glucose Sensor Approved
The device is intended to complement, and not replace, fingerstick blood glucose monitoring.
The Food and Drug Administration (FDA) has approved the first continuous glucose monitoring (CGM) system with a fully implantable glucose sensor that utilizes novel light-based technology. The Eversense Continuous Glucose Monitoring system includes a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a compatible mobile app for displaying glucose values, trends, and alerts. The implantable sensor is inserted subcutaneously in the upper arm by a clinician and can be worn for up to 90 days.
The sensor is coated with a fluorescent chemical which produces a small amount of light when exposed to blood glucose. The light is measured by the sensor and every 5 minutes the measurements are sent to the Eversense mobile app via the smart transmitter, which also provides on-body vibratory alerts when glucose levels are low or high.
The FDA approval was based on a clinical study which compared readings from the Eversense device and a lab-based glucose analyzer in 125 patients ≥18 years old with diabetes. The study demonstrated the system's safety and efficacy over 90 days of continuous glucose sensor wear. Less than 1% of participants who had the device implanted experienced adverse events.
"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," said FDA Commissioner Scott Gottlieb, MD.
The Company says the device is intended to complement, and not replace, fingerstick blood glucose monitoring. It is only available by prescription.
For more information visit Eversensediabetes.com.