FDA Approves Continuous Glucose Monitor for Children
Miriam E. Tucker Disclosures
February 04, 2014
The US Food and Drug Administration (FDA) has expanded the approval of the Dexcom G4 Platinum continuous glucose monitoring (CGM) system to include use in children aged 2 to 17 years of age, despite reduced accuracy compared with adults.
The G4 Platinum (Pediatric) system is the first CGM system approved for young children. The G4 Platinum system had previously been approved only for adults aged 18 years and older.
Another currently available CGM system, Medtronic's Enlite, is approved for ages 16 and older but is being studied in children as young as 2 years.
As with other CGM systems, the G4 Platinum (Pediatric) system continually displays estimated blood sugar readings and their direction and rate of change. The sensors, inserted just under the skin, detect glucose levels in interstitial fluid for up to 7 days before they need to be changed. With the new pediatric version, sensors can be worn on the upper buttocks as well as the abdomen.
The wireless system is personalized with individual glucose targets and alerts and includes an alarm feature for when blood glucose levels fall or rise beyond recommended thresholds.
Also, as with other CGM systems, the Dexcom G4 Platinum is not approved for use in making insulin-dosing decisions. Finger-stick blood glucose monitoring is still required both for calculating mealtime boluses and for calibration of the CGM system.
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Information from Industry
In a statement, the FDA cautions that the Dexcom G4 Platinum CGM was not as accurate as it had been in adults in studies involving 176 children aged 2 to 17 years. Moreover, the ability of the device to issue an alert at glucose levels in the hypoglycemic range (below 70 mg/dL) was "poor" compared with that of the same device used in adults, it states.
Warnings about these 2 limitations will be included in the product label and will also be displayed on the receiver screen at the time a new sensor is activated and any time an alert threshold is changed. The notices will also include reminders about using finger-stick meters for treatment decisions and for hypoglycemia detection.
Nonetheless, FDA says, "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."
Along with insulin pumps, CGMs are essential components of an automated "artificial pancreas device system," currently under development by several manufacturers
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