FDA Approves Dexcom G5 as Replacement for Most Fingersticks
Federal regulators declare the CGM just as good as fingersticks in making blood sugar management decisions.
People with Type 1 diabetes have been using continuous glucose monitors (CGMs) to eliminate most daily fingerstick tests for years, but the practice has never been officially sanctioned by federal health regulators. That changed today, at least for users of the Dexcom G5 Mobile CGM.
Today, the FDA revised the sanctioned, on-label use of the Dexcom G5 by declaring that the device is an adequate replacement for fingersticks in making blood sugar management decisions for device users ages 2 and up, according to a press release. Those users would still need to do two fingersticks a day to calibrate the G5, however. The move follows earlier recommendations of a FDA advisory committee to expand the permitted use of the device.
This is good news for Dexcom, which weathered a device recall for the G4 and G5 earlier this year. The recall was not for inaccuracy in blood sugar readings, but due to the possibility of faulty alarms. The news should also provide more fodder for those in the diabetes community who are calling on Medicare regulators to declare CGMs necessary medical devices whose costs should be covered by Medicare plans.
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