Dexcom is preparing to launch a 15-day version of its G7 continuous glucose monitor, based on data presented Thursday at the Advanced Technologies & Treatments for Diabetes conference. 

Dexcom pointed to data claiming its updated CGM is the most accurate. The results show a mean absolute relative difference of 8% — a widely used measurement comparing CGM results to blood glucose readings. Dexcom has submitted an application for the 15-day sensor to the Food and Drug Administration for clearance.

Using technology to manage Type 2 diabetes was also a focus at the conference. Dexcom shared results of a survey of 664 healthcare providers in Germany, Italy, the Netherlands, Saudi Arabia, Spain and the U.K. Half of the group said that CGMs should be the standard of care for people with Type 2 diabetes, regardless of insulin use, and 96% supported using CGMs for people taking multiple daily injections of insulin. 

MedTech Dive caught up with Dexcom Chief Operating Officer Jake Leach to discuss the 15-day sensor launch timing, a warning letter the company received earlier this month and Type 2 diabetes coverage.

This interview has been edited for length and clarity. 

MEDTECH DIVE: What’s the significance of this 15-day G7 sensor for Dexcom? 

JAKE LEACH: Our first 15-day product was Stelo, the over-the-counter CGM we launched last year. The millions of people that use G7 will have access to a 15-day sensor. That product is under review by the FDA right now. We're hoping to launch it later this year. 

Do you have more details on when you plan to launch that updated sensor?

It's really dependent on FDA approval. We submitted for review last year, and we just wrapped up answering a number of questions with the FDA. We do expect to hear back sometime in the Q2 timeframe. Sometimes, they just approve it; sometimes they'll ask more questions — it just depends. 

But we feel really good about the submission. Assuming approval here sometime in Q2, that would allow us to launch the product in the second half of the year.

Earlier this month, Dexcom disclosed it had received an FDA warning letter. Can you share more context, and do you anticipate any impact on the 15-day sensor submission?

The warning letter doesn't preclude us from getting things approved. It doesn’t preclude us from making sensors. There’s no need to recall product at this point in time. 

The FDA inspected two of our manufacturing sites in the United States but spent a lot of time looking at how our design documents traced all the way through to our production testing, and how we build our sensors. They had some concerns about how we were doing that. We answered those concerns with better documentation around how we build sensors and why we do the testing we do. 

The warning letter is their response saying, “You've answered a lot of our questions, but there's still some that we have open that we need to work together on.”

We're committed to working very closely with the FDA. It's something we're extremely focused on, making sure that we answer those questions.

You shared a survey on CGMs for people with Type 2 diabetes. Have you seen improvements in insurance coverage or physician uptake?

We were very pleased with the results of that survey. The strong feedback was that CGMs should be the standard of care for people with diabetes. And we as a healthcare ecosystem need to promote greater access to CGM because there are still many countries around the world where only Type 1 or some Type 2 intensive insulin users have access to CGM. 

The vast majority of people with diabetes, two-thirds at least, don't treat their diabetes with insulin. And so in most countries, they don’t have access to CGM.

I was pleased to see that the primary care physicians … recognize the benefit of CGM. The clinical evidence we've been generating over time is starting to be recognized.

Why did you focus on Europe and the Middle East for this survey?

We felt that it was important to understand because there are some countries in the EMEA region that have good access to CGM, like France; anybody who’s an insulin user is covered. But even with that coverage, the majority of people with Type 2 diabetes [in France] don't have access to CGM. 

And so we felt like it's the next place to make sure that our access message is being heard. We're on the verge of better coverage. It improves every year. But there’s still a long way to go.

How is coverage in the U.S.?

With the previous decisions for intensive insulin users and basal insulin users, about a third of the people that have diagnosed diabetes in the U.S. now would have coverage.

We're actually seeing some of the private insurers go first on coverage for non-insulin users with diabetes — so anybody with diabetes. The two largest PBMs that manage pharmacy plans for most of the private payers … they’re now covering CGM. There's more work to do there too, to continue to get to all of the private insurers, but it's definitely moving, and we still have to work with Medicare to get coverage for non-insulin users. My perspective is it's a matter of time.