The FDA has recently approved the Dexcom G4 PLATINUM (Pediatric) Continuous Glucose Monitoring System to be marketed. The system is an externally-worn glucose sensor that continuously measures and displays glucose values. In addition to reporting glucose values every 5 minutes, the system reports trending information in real-time for up to seven days (the life of each sensor).
This supplement updates the software in the pediatric version that calculates the glucose values from the sensor signal. The updated software has improved the accuracy of the system, primarily for glucose values less than or equal to 70 mg/dL. This allowed for the removal of performance warnings from the device receiver and labeling.