Dexcom G6 Integrated Continuous Glucose Monitoring System Gets FDA Approval

Dexcom G6 CGM System
Dexcom G6 CGM System
The FDA reviewed data for the device through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.

The Food and Drug Administration (FDA) has authorized the marketing of the Dexcom G6™ integrated continuous glucose monitoring (iCGM) system for determining glucose levels in patients aged ≥2 years with diabetes. This marks the first type of CGM system permitted for use as part of an integrated system with other compatible medical devices and electronic interfaces such as automated insulin dosing systems, insulin pumps, blood glucose meters or other electronic devices for managing diabetes.

The Dexcom G6 patch contains a small sensor which is applied to the abdomen. It continuously measures glucose levels and transmits readings every 5 minutes to a compatible display device (eg, mobile app). If the patient’s glucose level is too high or too low, it triggers an alarm to alert the patient. If integrated with an automated insulin dosing system, a glucose spike would trigger insulin release from the pump. 

Dexcom G6 was evaluated in 2 clinical studies (N=324) that included adults and children aged ≥2 years with diabetes. During multiple clinical visits over a 10-day period, the system’s readings were compared against a lab test method to measure blood glucose. There were no serious adverse events reported during the trials.

Different from the earlier Dexcom G5 model, the G6 model already comes factory calibrated eliminating the need for a patient fingerstick to calibrate the sensor. Moreover, its updated sensor probe also minimizes interference with concomitant acetaminophen. 

“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 the FDA’s Center for Devices and Radiological Health.

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Formerly a class III medical device (“high risk”), the FDA has classified iCGMs as class II (“moderate risk”) devices with special controls. Special controls refer to the requirements for assuring accuracy, reliability, and clinical relevance of iCGM devices, as well as the type of studies and data required to demonstrate acceptable iCGM performance. This authorization serves to streamline and expedite the regulatory review process for developers of future iCGM systems who are seeking marketing authorization.

Below are 2 testimonials from people using the Dexcom G6 iCGM.

“I’m an insulin dependent diabetic and have a very unique story. My diabetes is the result of serious sports injury at age 18 causing trauma to my pancreas and required emergency surgery. I have spent the greater part of my life trying to understand my condition and properly manage my blood sugar levels. My Dexcom CGM has provided valuable insight into all of the lifestyle factors that affect my blood sugar and now allow me to truly maintain optimal blood sugar levels with an A1c of 5.0.”

-Ryan Lazarus, MSC, CNS, DC, Functional Medicine Practitioner

“I was diagnosed in college after having a hard time recovering from exercise. I went to the doctor with a cold, but my mom asked him to test me for diabetes since she noticed my substantial weight loss and thirst. I did a quick stay in the hospital for a crash course in diabetes and then was off the next weekend for a backpacking trip. 

I love my Dexcom CGM because it lets me pursue longer and harder adventures safely. I have sailed 100 miles solo, swam around Key West, and paddled 100 miles up the Intracoastal Waterways in the Carolinas without hesitation because I knew my Dexcom had my back when it came to my blood sugars. I am never alone with my Dexcom by my side.”

-Erin Spineto, Author of Islands and Insulin – A Diabetic Sailor’s Memoir


FDA authorizes first fully interoperable continuous glucose monitoring system, streamlines review pathway for similar devices [news release]. Silver Spring, MD: U.S. Food and Drug Administration. Published March 27, 2018. Accessed March 28, 2018.

This article originally appeared on MPR