The Food and Drug Administration has approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for children with diabetes ages 2 to 17 years. The continuous blood glucose monitor (CGM) had previously been approved for adults (18 years and older).
“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,” said Alberto Gutierrez, PhD, director, Office of In Vitro Diagnostics and Radiological Devices in the FDA’s Center for Devices and Radiological Health. “This approval for expanded use is part of the FDA’s work to meet the needs of children living with diabetes.”
The agency emphasized that the use of CGM values alone “should not be used to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions such as insulin dosing should be based on readings from a blood glucose meter.”
The G4 Platinum System is an externally worn system that continuously displays an estimate of blood glucose levels and the direction and rate of change of these estimates. The device is intended to be worn for up to 7 days. It requires a prescription and is meant to complement, not replace, information obtained from standard home glucose monitoring devices.
The previously approved G4 Platinum System is for insertion of the sensor in the abdomen only. The new G4 Platinum (Pediatric) System, the first approved CGM system for use in patients 2 to 17 years of age, includes the upper buttock in addition to the abdomen as sensor insertion sites. The device system components (sensor and transmitter) are unmodified from the previous system.
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 7 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 study found that the CGM’s 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 < 70 mg/dL. Despite these limitations, the agency reported that 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.
To let the public know about the limitation of the device, the FDA is requiring that two warnings be included in the labeling, and displayed on the receiver screen when a new sensor session is started or the alert thresholds are changed:
Further research on CGMs is continuing as part of a developmental artificial pancreas device system (APDS) for people with Type 1 diabetes, a device that includes a CGM and an insulin pump. An artificial pancreas system would monitor glucose levels and automatically pump the appropriate amount of insulin as determined by a computer algorithm.
The G4 Platinum (Pediatric) System is manufactured by Dexcom, Inc., located in San Diego, California.