FDA approves first-of-its kind diabetes management device
FDA okayed the marketing of a new continuous glucose monitoring system for diabetics-the first to be used as part of an integrated system with other compatible medical devices and electronic interfaces.
FDA okayed the marketing of a new continuous glucose monitoring system for diabetics-the first to be used as part of an integrated system with other compatible medical devices and electronic interfaces.
The G6 integrated continuous glucose monitoring (iCGM) system (Dexcom), which determines blood glucose levels in children aged two and older and adults with diabetes, can be used with automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices used for diabetes management.
FDA also classified this new type of device in class 2, which subjects it to certain criteria called “special controls”, FDA said in a statement. “This enables developers of future iCGM systems to bring their products to market in the least burdensome manner possible,” FDA said.
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“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, acting director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health, in the statement. “In addition, the FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”
In early 2017, FDA also expanded approval of Dexcom’s G5 Mobile Continuous Glucose Monitoring System to allow for replacement of fingerstick blood glucose (sugar) testing for diabetics.
“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,” FDA said in a statement at the time. The system was previously approved to complement, not replace, fingerstick testing for diabetes treatment decisions.
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Meanwhile, the Dexcom G6 is a patch device, about the size of a quarter, which 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.
FDA evaluated data from 2 clinical studies of the Dexcom G6, which included 324 adults and children aged 2 years and older with diabetes. Both studies included multiple clinical visits within a 10-day period where system readings were compared to a laboratory test method that measures blood glucose values. No serious adverse events were reported during the studies.
