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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.
How did the Dexcom One launch go? It is a new product, but it is spreading to new countries. Was the response surprising?
leakage: It’s new to Dexcom. It is an approach we are already taking to expand our global footprint. For many years, Dexcom CGMs have been available globally, but they have been available to a subset of the market that is considered high risk, such as children or people who are unaware of hypoglycemia, which is when they cannot feel their glucose level being low. Therefore, G6 is an ideal product for them as it has features such as automated insulin delivery and remote monitoring.
But there was a large population that did not have access to CGMs. Dexcom One has really been targeted as the right product for a broader customer segment.
We were not surprised by the success, but we were very encouraged. We originally launched it last year in Bulgaria, Estonia, Lithuania and Latvia, and have seen great patient uptake and improvements in the time they spend in the range wearing the product. But now that the product is available at a lower price in some of these countries, there is compensation to come. Therefore, this opening is a little faster than we expected.
Did Dexcom determine how big that market the Dexcom One could reach, or predict what the product could add in terms of revenue?
leakage: I don’t have exact numbers, but I can tell you that just this year, we expanded access to CGM by more than 1 million people in these core and additional global markets. This is a trend we expect to continue as we continue to open more and more access to continuous glucose monitoring as the standard of care worldwide.
The UK recently updated its guidance. Previously, continuous, real-time diabetes monitoring was only available to a certain type 1 population. Now, they have basically said that all people with type 1 diabetes in the UK should get the product. It’s in line with what we’ve seen in the United States.
Will the Dexcom One e-commerce platform allow the company to continue building on it, and possibly offer all of its products directly to consumers?
leakage: This is kind of a futuristic vision of where we think it’s headed – this e-commerce platform is specifically designed to be scalable worldwide. We’ve already started doing that. In some countries, the products require prescriptions. In those environments, we feel that the pharmacy is probably a better way to get it. In the United States, customers can access a large portion of our products through the pharmacy.
Every country is a little different, but we feel e-commerce is a really important part of the offer to make products available to more and more people who can benefit.
Will Dexcom One be offered in every market the company is in?
leakage: I don’t know if I’d say it’s going to be every market, but we’re definitely evaluating all the different opportunities now that we have a multi-product environment and a range of products.
We are looking to see where to go next. There are a lot of opportunities out there. Dexcom One is still in the early stages of being rolled out worldwide. I think there are many countries where it would make sense to have both products available, and therefore, there is more to come.
Is the company looking to expand to non-diabetic CGM users?
leakage: It is definitely an opportunity. Today, we place a heavy emphasis on diabetes, and are truly working to reach and grow our client base worldwide. But as that continues to expand, you begin to look at opportunities in the non-diabetic field. I think there is a huge opportunity to unlock it.
One of the things that CGMs provide is real-time feedback and allow you to make changes in behavior based on what you eat, how you eat, diet and exercise. It gives you instant feedback on how the choices you make affect glucose, something not many people have. If you are not wearing a CGM, you do not have this information. I think there is a great opportunity to help people live healthier lives by giving them that feedback.
And in athletics, as I mentioned, it’s similar, where you can really look at performance and recovery based on glucose trends.
This is still in the early days of these types of population, but there are groups doing research out there. We stay very close to him and expect him to be a part of Dexcom’s future for sure.