The first integrated continuous glucose monitoring system suitable for patients as young as 2 years has received market clearance from the Food and Drug Administration.

The Dexcom G6 is about 28% smaller than its predecessor, the G5, can be worn for up to 10 days – 43% longer than the G5 – and doesn’t require any finger-stick calibrations or treatment decisions. It’s the first FDA-approved integrated continuous glucose monitoring (iCGM) system that can link electronically to other compatible devices, including automated insulin dosing systems, insulin pumps, blood glucose meters, and other electronic devices used for diabetes management, the FDA said in a press statement . Its revamped sensor doesn’t interact with acetaminophen – another distinct advantage over the G5.

The G6 also has a predictive low alert, according to the manufacturer’s website . This new feature “predicts hypoglycemia before it hits to help avoid dangerous low blood sugar events.”

The device will be commercially available sometime this year, the Dexcom website noted.

The device also set a new premarketing review standard for CGM’s, which can now utilize the less-burdensome 510(k) clearance pathway. Until now, they have been treated as the highest-risk Class III medical devices.

According to the FDA statement, the agency “…recognized this as an opportunity to reduce the regulatory burden for this type of device by establishing criteria that would classify these as ‘moderate risk,’ class II medical devices with special controls.”

G6 was approved through this new pathway, dedicated to novel, low-to-moderate-risk devices that are not “substantially equivalent” to an already legally marketed device, the press statement said.

“Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring iCGM devices’ accuracy, reliability and clinical relevance as well as describe the type of studies and data required to demonstrate acceptable iCGM performance. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this device.”

The FDA evaluated data from two 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.

msullivan@MDedge.com

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