FDA's decision to permit marketing of the Dexcom G6 integrated continuous glucose monitoring system on Tuesday could streamline the review pathway for similar devices
The US Food and Drug Administration (FDA) has approved the first fully interoperable continuous glucose monitoring system for determining blood sugar levels in children aged two and older and adults with diabetes.
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The FDA's decision to permit marketing of the Dexcom G6 integrated continuous glucose monitoring system on Tuesday could streamline the review pathway for similar devices.
"The ability of this device to work with different types of compatible devices gives patients the flexibility to tailor their diabetes management tools to best meet personal preferences," said Donald St. Pierre of the FDA.
Diabetes impairs the body's ability to make or properly use the blood glucose-regulating hormone insulin.
They must regularly monitor their blood sugar levels since continuously high blood sugar levels can lead to heart disease, stroke, blindness, kidney failure and nerve damage leading to amputation of the toes, feet or legs.
Blood sugar levels can also fall too low, which can cause dizziness, confusion, unconsciousness and, in extreme cases, death.
The Dexcom G6 is a patch device, about the size of a quarter, that is applied to the skin of the abdomen and contains a small sensor that continuously measures the amount of glucose in body fluid.
The device transmits real-time glucose readings every five minutes to a compatible display device such as a mobile medical app on a cell phone and will trigger an alarm when a patient's blood sugar enters a danger zone soaring too high or dropping too low.
If it is integrated with an automated insulin dosing system, a rise in blood sugar would trigger the release of insulin from the pump.
The patch device should be replaced every 10 days.
"We listen closely to people with diabetes and continuously look for ways to empower them to better manage their condition," Dexcom CEO Kevin Sayer said in a statement after the FDA approval of the device.
"We believe the new Dexcom G6 is a significant step forward for Dexcom and our industry," Sayer said.
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