FDA approves pediatric continuous glucose monitor

Today the FDA announced approval of a continuous glucose monitoring system for children and adolescents with diabetes aged 2 to 17 years. The monitor was previously indicated for adults aged 18 years and older.

The G4 Platinum Continuous Monitoring System (Dexcom) is worn externally for up to 7 days, and estimates blood glucose levels, as well as the direction and rate of glucose level changes, according to an FDA press release. The system is not intended to replace information gained from standard home glucose monitoring devices.

The new system's sensor, designed specifically for pediatric patients, can be inserted in the upper buttock or abdomen; the sensor and transmitter are unmodified.

“This device can provide valuable glucose trend information to children with diabetes and their families, but it is important that those using this device understand the expected performance of this device compared to blood glucose meters, especially for detecting low glucose, in pediatric patients,” Alberto Gutierrez, PhD, director, Office of In Vitro Diagnostics and Radiological Devices in the FDA’s Center for Devices and Radiological Health, said in a press release. “This approval for expanded use is part of the FDA’s work to meet the needs of children living with diabetes.”

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 aged 2 to 17 wore the G4 Platinum (Pediatric) sensor for 7 days (168 hours). The accuracy of the system’s glucose readings was evaluated by comparing them with a clinical laboratory reference method (for patients ages 6 to 17) and with results obtained from finger-stick samples on a blood glucose meter (for patients aged 2 to 17).

Although pivotal clinical study findings demonstrated the system was not as accurate in pediatric patients as in adults, the system did effectively track patterns in glucose levels and alerted patients to risk for potential hyper- or hypoglycemia.

Because of this, the labeling includes two warnings displayed on the receiver screen when a new sensor session is started or the alert thresholds are changed:

In a pediatric clinical study, larger differences were observed between this CGM device and actual blood glucose values compared with those differences observed in the adult clinical study. Use your blood glucose meter for treatment decisions.
In a pediatric clinical study, a significant number of low glucose events were not detected by CGM. Do not rely solely on CGM alerts to detect low glucose.