Continuous glucose monitoring system approved to direct therapy, but daily fingersticks still needed

The G5 Mobile Continuous Glucose Monitoring System is now approved for use by patients ages 2 and older without confirmation from traditional fingerstick blood glucose testing, the FDA announced on Dec. 20. In effect, patients and clinicians can use results directly from the device to make diabetes treatment decisions, according to an FDA press release.

Prior to the expanded approval, the system (which still requires calibration with at least two fingersticks per day) was approved to complement, not supplant, fingerstick testing, according to the release. The device measures and monitors glucose levels with a small, subcutaneous sensor wire and provides real-time results every five minutes, the release stated.

The FDA based its approval on two clinical trials of 130 patients that compared the system's readings over a seven-day period with blood glucose meter values and a laboratory test method. Risks include hypoglycemia or hyperglycemia if results are inaccurate or if the device's alarms are disabled, as well as skin irritation or redness around the adhesive patch, according to the FDA, which also noted the potential for falsely raised glucose readings with acetaminophen use.