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FDA approves integrated Continuous Glucose Monitors

Date Posted: Wednesday, March 28, 2018


Dexcom G6 Continuous Glucose Monitor

The U.S. Food and Drug Administration has approved new technology to help people with diabetes control their blood glucose.  The Dexcom G6 is the first continuous glucose monitor (CGM) allowed by the FDA to be used as part of an integrated system with other compatible medical devices and electronic interfaces.   


The device integrates with insulin pumps, blood glucose meters or other electronic devices used for diabetes management.  The patch device is about the size of a quarter and gets applied to the skin of the abdomen.  It contains a small sensor that measures and transmits real-time glucose readings every five minutes to a compatible display device, such as a smartphone.  It does not require finger-stick calibration, and will trigger an alarm when blood sugars go too high or too low.  When integrated with an insulin pump, a rise in blood glucose will automatically trigger the release of insulin from the pump.  The G6 device should be replaced every 10 days.    

“Continuous glucose monitoring has greatly improved over the past few years,” said Dr. Michael Thompson, Chief, Adult Diabetes Clinical Research, Ambulatory Physician Leader at the UMass Diabetes Center of Excellence.  “Patients who once did not want a device attached to them, now find it indispensable.  A common comment I hear is that they feel like they had previously been ‘operating in the dark.’ " 

FreeStyle Libre 

Last Fall, the FDA approved Abbott’s FreeStyle Libre Flash Glucose Monitoring System, as the first CGM to not require daily fingerstick calibrations.  It should be replaced every 10 days, and its real-time readings and trends can be used for insulin dosing. 


“The fact these new devices completely eliminate the need for fingerstick glucose testing for calibration is a game changer for those who are unable to test due to needle phobia or the discomfort associated with finger sticks,” said Dr. Samir Malkani, Outreach Director at UMass Diabetes Center of Excellence.  “The convenience of using their smartphone as a receiver is another big advantage.”

Future continuous glucose monitor technology

In addition to approving these new devices to help people manage their blood sugars, The FDA has also taken steps to expedite the review process for future similar integrated CGMs (iCGM). 


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