February 3, 2014 -- The U.S. Food and Drug Administration today approved the expanded use of the Dexcom G4 Platinum Continuous Monitoring System for patients with diabetes ages 2 to 17 years. The G4 Platinum System, which monitors blood glucose levels in people with diabetes, had been approved for patients ages 18 and older.
Diabetes is a serious, chronic metabolic condition in which the body is unable to adequately manage blood sugar levels. An estimated 25.8 million people – about 215,000 of them under age 20 – in the United States have diabetes. If left untreated, high blood glucose levels (hyperglycemia) can lead to serious long-term problems such as stroke, heart disease, and damage to the eyes, kidneys, and nerves.
A continuous glucose monitor (CGM) is a device that includes a small wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels in the fluid around the cells (interstitial fluid). When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The FDA has not approved the use of CGM values alone 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 by a single patient for up to seven 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.
“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, Ph.D., 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.”
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.
To communicate the reduced accuracy in pediatric patients to users, two warnings are included in the labeling, and are 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 to 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.
Research on CGMs is underway 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, Calif.
