Last week Barcelona hosted ATTD 2022, a major global diabetes technology conference, and Dexcom was there. We had an opportunity to speak to Jake Leach, Dexcom’s Chief Technology Officer, and we’ve got the updates you need.
When Will the G7 Launch in the United States???
The long-awaited Dexcom G7—its debut has been significantly delayed by the pandemic—should launch this year in the United States.
“We’re in the middle of our back and forth review with the FDA, and it’s going really well, we’re really happy. We know they’re super busy, and they’re spending a good amount of time with us.”
“Right now we’re saying it’s probably not going to be approved before ADA conference [in early June], but we definitely expect approval at some point soon and the ability to launch it this year.”
Jake cautioned me that while the rollout will be conducted as quickly as possible, the G7 will not be instantly available for everyone. It takes a while to get all the new insurance contracts sorted out, as it does to secure looping interoperability with the insulin pumps that the G6 is already approved for use with.
The global debut of the G7 was just several weeks ago: a limited release in the United Kingdom is now well underway, and Jake reports that consumers are delighted with the performance of the new system.
One of Dexcom’s big announcements at the ATTD conference was the release of new accuracy data in children. A new study showed that the G7 was extremely accurate for adolescents aged 7 to 17, when worn on either the arm or the abdomen. An earlier study proved that the device is similarly accurate for adults.
Jake called the data “a significant improvement in performance” above the G6.
G7 Sensor Life
When the G7 goes on the market in America, it will have a 10-day sensor life. (Actually, 10 and a half days: an additional 12-hour “grace period” is intended to give the user a little wiggle room to replace their sensor.)
In the past, Dexcom has publicly committed to a goal of a two-week sensor life—a goal that their major competitor, Abbott’s Freestyle Libre, has already achieved. When we began reporting that the G7 would last only 10 days, we weren’t sure if Dexcom had abandoned that goal or not.
Now we know: Dexcom still hopes to extend the G7 to 15 days. Jake Leach told me that extending the sensor length is “our number one priority once we get the G7 launched.” He believes that the new sensor is already capable of delivering 15 days of accurate data for most users, but the business needs to be sure that it gets to the finish line in “the vast, vast majority” of sessions.
“We’ll extend it to 15 days here as soon as we finish the clinical study.”
Introducing The Dexcom ONE
The Dexcom G6 has been called “the killer app” of continuous glucose monitors, and as demand increased exponentially, Dexcom raced to expand its manufacturing capabilities again and again. What’s the company going to do now that it’s on the verge of releasing a new product that will eventually make the G6 obsolete?
The familiar G6 hardware—“the exact same sensor and transmitter combo”—is being paired with a “completely redesigned mobile app” to create a brand new product: the Dexcom ONE.
You can think of the Dexcom ONE as a kind of budget CGM. It will have fewer features (for example, no pump integration or remote following), but its lower cost will allow it to penetrate parts of the world where CGMs are unavailable to most. It has already launched in parts of Eastern Europe, and the company hopes it can bring it to many other new countries.
“It’s all about a simple CGM that’s accessible to a much broader population, mostly folks that have never experienced life without fingersticks.”
Dexcom hasn’t finalized (or isn’t sharing) its plans for the Dexcom ONE in the United States—the team is completely focused on making the G7 available, and Jake couldn’t tell me if Americans would ever see the Dexcom ONE. But the new lower-cost CGM will soon be released in both Spain and the United Kingdom, and the company no doubt will be eagerly following its adoption in those countries with an eye toward its global strategy.
Today in the United States, most people with diabetes that use intensive insulin therapy can receive some insurance coverage for a Dexcom G6. The business hopes that its flagship devices will soon also be available for Americans with type 2 diabetes that use basal insulin. A 2021 study showed that this population can enjoy major diabetes control benefits from continuous glucose monitoring. Eventually, the company would like to win CGM coverage for all patients with diabetes, a solution that may or may not involve a streamlined tech solution like the Dexcom ONE.
“We firmly believe that anyone with diabetes that wears a Dexcom CGM will benefit from it.”
You haven’t used a G7 yet, but you can bet that company is already working on the next generation too. I’ve been speaking to Dexcom representatives for years now, and this was the first time I heard one utter the name “G8.” Jake couldn’t give me any details, but he described the next next Dexcom as “even better comfort, ease of use, and lower cost.” It’s unknown if the next iteration will involve another complete redesign, as did the G6 and G7, but we’ll keep you updated as well as we can.
Read more about continuous glucose monitor (CGM), Dexcom, Dexcom G7, freestyle, insulin, insulin pumps, Intensive management, libre, U.S. Food & Drug Administration (FDA).