Dexcom is continuing to build upon its continuous glucose monitoring (CGM) story with a new nod from FDA. The San Diego-based company received clearance from the federal agency for the Dexcom G6 Pro CGM System for healthcare professionals to use with their patients, ages two years and up.
The pro-version builds off the Dexcom G6, which won a nod from FDA last year. It was considered a milestone decision by FDA because it classified Dexcom's CGM system as a less-stringent class II medical device -interoperable with other technologies, therefore, enabling a speedier review for similar future systems.
Tomas Walker, Dexcom’s US Medical Director, said the difference between the two devices is that the Dexcom G6 Pro is designed to be used in collaboration with the healthcare professional.
“The G6 Professional is the only professional CGM that allows the option of being completely blinded so that you can start it and turn it on and the patient never interacts with it,” Walker told MD+DI. “The G6 gives a glucose reading every five minutes – 288 glucose readings a day for 10 days. You get a very dense glucose pattern.”
In blinded mode, real-time glucose data is hidden from the patient and reviewed retrospectively with their healthcare professional at the end of the session. In unblinded mode, patients can see their glucose data throughout the 10-day sensor wear to gain insights and make treatment decisions in real-time.
“The idea is to give maximum flexibility for the patient and the healthcare provider to do the best job they can to help manage the diabetes,” he said. “Before joining Dexcom I had a practice for 20 years and I used to tell my patients diabetes is a disease of self-management. You have to make the decision and changes every day. I can give you tools; I can give you information, but you have to make the changes.”
CGM is becoming the story in diabetes. During an earnings call in August, Dexcom’s CEO Kevin Sayer stressed the importance of CGM even going so far as to say it was the “future” of diabetes care.
However, that future isn’t without competition. Abbott Laboratories has been a solid competitor for Dexcom. Abbott’s Freestyle Libre was approved by FDA in 2017 and was called a gamechanger because it eliminates routine finger sticks.
The Abbott Park, IL-based company has developed Freestyle Libre 2, which received CE mark in Oct. of 2018. There is no word yet on plans for the US.
Dexcom has communicated some features of the next generation of its CGM. The company said the device’s features would include extended sensor wear; be fully disposable; have a simple application; be factory calibrated, and have a significant cost-reduction.