by John Gever
Managing Editor, MedPage TodayDecember 20, 2016
WASHINGTON -- The FDA has approved an expanded indication for Dexcom's G5 Mobile continuous glucose monitor, allowing it to be used alone without supplementary fingerstick glucose testing.
"This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test," the agency said in announcing the decision. Previously, the system had been approved as an adjunct to fingerstick testing.
But the new approval does not mean patients can forget about fingerstick testing entirely. "Users are warned that the system must be calibrated using a fingerstick blood sample at least once every 12 hours," the FDA stressed.
In deciding to expand the indication, the FDA relied on findings from two 7-day clinical trials involving a total of 130 adults and children as young as 2. Results from the continuous monitor were compared with those from standard fingerstick meters and from lab tests of blood glucose. Those studies indicated that the continuous monitor was accurate enough to be used alone to guide treatment.
The FDA noted that the device still comes with risks including hyper- and hypoglycemia stemming from inaccurate readings. Also, redness and irritation may occur at the site where the device's skin patch is applied.
The agency also indicated that acetaminophen-containing products can "falsely raise glucose readings" from the device.