Dexcom G6 CGM System is Approved by the FDA


The U.S. Food and Drug Administration (FDA) just announced its approval for the Dexcom G6 Continuous Glucose Monitor (CGM) System.

Our goal at JDRF is to cure type 1 diabetes (T1D), but innovative technology helps ease the burden of living healthy, and more treatment choices only benefit people with T1D. The new FDA approval delivers the benefit of more choices to the T1D community.

The approval is the first on a number of fronts:

Interoperability: This is the first CGM to be interoperable, meaning that it can be used with other devices, like insulin pumps, mobile apps and artificial pancreas technology. This is particularly important for JDRF’s Open Protocol initiative, which aims to have an insulin pump and a CGM “talk” to each other, regardless of whether they have the same manufacturer—as opposed to devices that are proprietary and not designed for interoperability.

Less-Strict Approval: It is also the first to be classified to a less-stringent approval by the FDA. This is potentially game changing. Now, “integrated CGMs,” or iCGMs, that meet special criteria can go through a more streamlined pre-market review, known as 510(k) clearance.

For Toddlers and Young Children: It is also the first to be approved in children aged 2 and older (the Medtronic Guardian Connect is for 14 years and older; the FreeStyle Libre is for 18+ years).

JDRF has played a pivotal role in novel CGM development, as well as access and adoption, including supporting a clinical trial that conclusively demonstrated that CGM use improved health outcomes for people with diabetes. There are a number of commercially available CGM systems now, which gives people with T1D the freedom to choose the tools and systems that are right for them.

JDRF will continue to monitor the field and push for regulatory pathways that ensure everyone with T1D has the right treatment options, and we won’t ever stop fighting for affordability, choice and coverage on our path to a world without T1D.

About the Dexcom G6: The Dexcom G6 is a 10-day wear, no-fingerstick, real-time continuous glucose monitoring (CGM) system for determining blood glucose levels. It is about the size of a quarter, and is applied to the skin of the abdomen. The device transmits real-time glucose readings every 5 minutes, and it will trigger an alarm when a patient’s blood sugar enters a danger zone, soaring too high or dropping too low.

JDRF was not involved in the studies of Dexcom G6 prior to its approval by the FDA.