Dexcom Chief Technical Officer Leach discusses G7 launch in Europe and FDA review, Dexcom One expansion

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Dexcom’s latest continuous glucose monitoring system, called the G7, was released last quarter after receiving a CE marking in March.

While the product was originally expected in 2021, the company has had to delay the launch as the regulatory review continues.

Dexcom released the G7 for the first time in the UK and will expand the launch across Europe throughout 2022. Meanwhile, the CGM is currently under review with the Food and Drug Administration for eventual release in the US.

Jake Leitch, Dexcom’s chief technology officer, said in an interview that the FDA’s decision likely won’t come until after the American Diabetes Association’s annual conference in June.

“But we expect to release it this year,” Leach noted.

CEO Kevin Sayer told investors on an earnings call on April 28 that the company will be making a “meaningful” US release this year. He declined to give a specific date for the decision, but said there were no “offs” who showed up in conversations with the Food and Drug Administration.

Other factors will also influence the adoption of the G7, such as Insulet and Tandem Diabetes Care after its insulin pumps were reviewed by regulators for compatibility with G7 for use in automated insulin delivery systems, according to Leitch.

The CEO also discussed Dexcom One’s expansion into new countries and new market capture with the product as well as expanding the use of CGM for non-diabetic users.

This interview has been edited for clarity and brevity.

MEDTECH DIVE: Can you provide an update on the launch of the G7 in Europe, and talk about how the filing with the FDA is progressing?

Jake Leach: We have already started our limited release. We started in the UK, so we have had customers on the product for several weeks now. It’s kind of our own test run, to make sure we didn’t miss anything in terms of product performance, technical support – all the things needed to support a completely new system.

The limited release is going great. We plan to roll it out across Europe in the coming quarters, definitely this year.

Presenting the United States is going great. We’re in a back-and-forth period with the Food and Drug Administration, answering a lot of questions. It’s a big dispatch because we’ve changed a lot of parts of the system. We expect approval and a meaningful launch here in the US this year. There is probably no approval until after the ADA, just based on the timing. But we expect to launch it this year.

What are some of the questions the Food and Drug Administration has returned to you?

leakage: Nothing is specific. All questions revolve around any of the new components of the system. They just want to understand them. We provide a great deal of information about product validation to ensure that it meets all safety and efficacy requirements. So, often in those, they just have more questions, make it clear that the test has been done and make sure they are comfortable meeting the requirements.

We’ve been doing this for decades now, so we’re pretty good at these submissions. It’s just a normal process to go through.

In Europe, are you planning to go to one country after another? Or will you get to the point where you can launch in multiple countries at the same time?

leakage: We usually do this in waves. We have countries grouped together into categories, and most often it has to do with language, the language that is spoken in the country.

We plan to replace the G6 system in all markets with the G7. We’re looking to upgrade all of those markets with the G7 as soon as we can. So, faster than we did with the G6.

The G6 has been launched in various geographies over the past three years, or nearly four years now. So, we plan to make the G7 much faster than that.

How long will it take before the G7 completely replaces the G6?

leakage: There are two things that dictate that. When we get approvals in different regions – once you get the CE mark you have to do some work inside the country. The biggest thing, in fact, that will drive G7 adoption is compatibility with automated insulin delivery systems. The G6 is compatible with both the Omnipod 5 from Insulet as well as with Tandem Intelligent Control technology.

We are working with both groups to upgrade to the G7. Therefore, we will definitely support the G6 for as long as we need to. Once we get G7 approval, those people will apply for G7 approval using their own algorithm. There will be very little time there, so this is a key component of the G7 launch schedule.

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