The Federal Drug Administration has approved for the first time a continuous glucose monitoring system (CGM) that detects glucose in diabetic patients.
The CGM system, manufactured by the diabetes technology company, Eversense, uses a fully implantable sensor to detect glucose and can be worn for up to 90 days.
The sensor implanted just under the skin during an outpatient procedure, regularly measures glucose levels in diabetic adults for up to 90 days. Once implanted, the sensor uses light-based technology to measure glucose levels and then sends the information to a mobile app. Users receive updates every five minutes if their glucose levels are too high or too low.
Every 90 days the sensor is replaced.
Basis For Federal Drug Administration Approval Of The Eversense CGM
The FDA’s approval was based on the results from 125 individuals aged 18 and older with diabetes. They reviewed the device’s effectiveness by comparing its readings to those obtained by a laboratory-based glucose analyzer.
In addition, the FDA evaluated the implantable sensor as well as the surgical procedure. Here too, the Eversense system aced out. The FDA found that the proportion of individuals experiencing any serious adverse event with the sensor was less than 1%.
CGM App Transmits Data Immediately
The app sends continuous real-time information.
Glucose readings sent to app every 5 minutes
Patient receives alerts indicating direction of glucose levels
Tracks events like meals and workouts and transmits the data to help identify trends
Patient can view summary reports of glucose history and patterns
Patients doctor and family added to receive data