The US Food and Drug Administration (FDA) has approved the Dexcom G6 integrated continuous glucose monitoring (iCGM) system, the first such device designed to work with a range of other compatible medical devices.
The Dexcom G6 is approved for use in adults and children (2 years of age or older) with diabetes. It is authorized to be interoperable with different types of compatible devices and electronic interfaces, such as insulin pumps, blood glucose meters, or other electronic devices used for diabetes management.
Compared with the current Dexcom G5 CGM, the G6 eliminates the need for fingerstick calibration, can be worn for up to 10 days rather than just seven, and has an updated sensor probe that minimizes interference with acetaminophen.
The G6 approval also shifts the classification of the Dexcom from the G5’s class III (“highest risk”) to class II (“moderate” risk, with special controls to ensure acceptable performance). “This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible,” the FDA said in a statement.
The approval was based on data from two 10-day clinical studies involving 324 adults and children with diabetes. Accuracy was determined by comparison with laboratory blood glucose values during multiple clinic visits. No serious adverse events were reported.
Possible risks of the system include hyper- or hypoglycemia in cases where the device is inaccurate and is used to make treatment decisions, or where hardware or set-up issues disable alarms and alerts. Skin irritation or redness around the device’s adhesive patch may also occur.
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