Yesterday Dexcom got the nod from the FDA to market their Dexcom G6, an integrated continuous glucose monitoring system (iCGM), making it the first interoperable CGM to get the designation.
“We are a company of firsts, almost everything that has been done in our industry has been done by us first,” Dexcom CEO Kevin Sayer told MobiHealthNews, citing that Dexcom was the first company to have a seven day sensor and to connect to a smartphone. “This is just another first for us.”
As of today the Dexcom G6 is the only FDA authorized iCGM that can integrate with other compatible medical devices and electronic interfaces, such as automated insulin dosing systems, insulin pumps, blood glucose meters, or other electronic devices used for diabetes management, according to a statement released by the FDA.
“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,” 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, said in a statement. “In addition, the FDA has taken steps to expedite the review process for similar [iCGMs] and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability.”
The Dexcom G6 was classified as a moderate risk class II medical device with special controls; however, CGMs typically that go through the FDA’s premarket approval pathway are reviewed as a highest risk class III medical device. The FDA cited the fact that the Dexcom G6 is intended for “seamless integration with other diabetes devices” and said that it “recognized this as an opportunity to reduce the regulatory burden for this type of device.” This opens up the opportunity for other iCGMs that meet the special criteria to go through the 510(k) process as well.
The new technology does not use a fingerstick. Instead, the Dexcom G6 is a small patch that users put on their abdomen. It contains a sensor that continuously measures glucose in body fluid, and then transmits glucose readings every five minutes to an app on the smartphone. Additionally, it is about one third smaller than Dexcom's last version, the G5.
The system sends users’ smartphones alerts when their blood sugar is too high or low. It can also be integrated with an automated insulin dosing system so that if a user’s blood sugar is too low it will administer the medication.
Each sensor can be worn for up to 10 days and is water resistant. The system is intended for individuals aged two years. An individual's glucose data can be shared with up to five followers.
Dexcom has been working on the G6 for over a year. In an earnings call early last year, Sayer revealed that the technology would be submitted to the FDA in in Q3 2017 with a launch intended for 2018.
In 2016 the FDA cleared the Dexcom G5, which also worked as a CGM to inform treatment decisions without the use of a fingerstick glucometer (outside of manual calibrations).
"We listen closely to people with diabetes and continuously look for ways to empower them to better manage their condition. The FDA’s special controls set a rigorous, new standard in our industry and clearly define the process by which other CGM systems may be approved,” Sayer said in a statement. “We believe the new Dexcom G6 is a significant step forward for Dexcom and our industry.”