Dexcom won FDA approval to offer its G4 Platinum continuous glucose monitor for use by kids as young as two years. The sensor of the pediatric version of the G4 Platinum can be positioned either in the abdomen or the upper buttock area, and worn for up to seven days of continuous monitoring.
The sensor wirelessly communicates with the display unit that shows glucose trends, can recall historical glucose readings, and warn the user or parent that sugar levels are in dangerous territory.
From an FDA press release:
Before the approval, the FDA reviewed data from a pivotal clinical study of in-clinic and home-use patients to assess the accuracy and precision of the system. One hundred and seventy-six patients ages 2 to 17 wore the G4 Platinum (Pediatric) sensor for seven days (168 hours). The accuracy of the system’s glucose readings was evaluated by comparing them to a clinical laboratory reference method (for patients ages 6 to 17) and to results obtained from finger stick samples on a blood glucose meter (for patients ages 2 to 17).
The pivotal clinical study demonstrated that the G4 Platinum (Pediatric) System performance in pediatric subjects was not as accurate as the performance of the same device in adults. In addition, the performance of the hypoglycemic detection alert in the pediatric study was poor relative to that seen in the adult study, particularly at blood glucose concentrations below 70 milligrams per deciliter of blood. Despite these limitations, the study did demonstrate that the device is effective for tracking and trending to determine patterns in glucose levels, and for alerting patients when glucose values are approaching potentially dangerously high (hyperglycemic) and/or dangerously low (hypoglycemic) levels.
Product page: Dexcom G4 PLATINUM…