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Over-the-counter continuous glucose monitors empower consumers with valuable health insights without the need for a doctor’s prescription. ... But a CGM is simply a device that monitors a health ...
Today’s clearance expands access to these devices by allowing individuals to purchase a CGM without the involvement of a health care provider,” said Jeff Shuren, director of the FDA’s Center ...
Continuous glucose monitors (CGM) are about to become more accessible, as the Food and Drug Administration announced clearing the first over-the-counter device on March 5. The Dexcom Stelo Glucose ...
The G5 was approved in 2016 by the FDA for use as a standalone device, while the G6 gained approval in 2018. [9] Dexcom's first G-series CGM, the G4 Platinum, received a CE mark [10] and FDA approval in 2012 [11] for adults ages 18 and over. This device improved hypoglycemic accuracy by 30%. [11]
Blood glucose monitoring is the use of a glucose meter for testing the concentration of glucose in the blood ().Particularly important in diabetes management, a blood glucose test is typically performed by piercing the skin (typically, via fingerstick) to draw blood, then applying the blood to a chemically active disposable 'test-strip'.
Continuous glucose monitoring has some important limitations: CGM systems are not sufficiently accurate for detecting hypoglycemia, a common side-effect of diabetes treatment. [ 5 ] This is especially problematic because some devices have alarm functions to warn users about a hypoglycemic condition, and people might rely on those alarms.
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