Early this month, at the 82nd annual Scientific Sessions diabetes conference, Diabetes Daily was lucky enough to sit down with the CEO of Dexcom, Kevin Sayer. Sayer has been with the company for 11 years, and has served as its chief executive since 2015. The company has grown exponentially under his leadership, and its continuous glucose monitor (CGM) has become the gold standard for type 1 diabetes management. If Sayer has his way, it will soon be obligatory for type 2 diabetes, too.
In a wide-ranging interview, Sayer talked about the upcoming release of the G7, the company’s long-term vision for reaching the broader type 2 diabetes market, and why he believes that his sensor is more accurate than those of the competitors.
If you are looking for a more technical interview on what features the G7 will and will not have, please check out our earlier article: What’s Going on with the Dexcom G7?
Question: I have to begin with the question that our readers care the most about. When will the Dexcom G7 be available for customers in the United States?
Answer: We’ve made it a policy of not giving dates and we’ll stick with that. We are still in the same place – we’ve got a back-and-forth going on with the FDA, and we’ve not seen anything to indicate that we won’t get this product approved as a real-time CGM. It’s just getting through the process with the regulators. They were busy during COVID. We just have to be patient. And I don’t love being patient, trust me.
Q: Tell us about the limited launch in the United Kingdom.
A: The impressions are pretty overwhelmingly positive. It’s just gone wonderfully, and we’re very excited to get it out.
Q: Assuming that you get that FDA approval, can you tell me what the rollout will look like?
A: The rollout will coincide with the reimbursement process. We’ll launch it as we get the reimbursement channels to go.
So, if you get your sensor through CMS and you’re a Medicare patient, for example, it takes a 90- to 120-day window from approval to get CMS to cover it. We’ll have the same issue with the state insurance programs. On the payers’ side, that takes a little longer to renegotiate those contracts.
The limiting factor will not be our ability to build it. The limiting factors will be the payers and the PBMs, and getting all those contracts squared away.
As far as manufacturing capacity, we’ve got more than enough to support the launch, both abroad and in the US. Our foreign launch will be rolled out a little more slowly. You’ll see us launch in our largest European markets in the next 2 to 6 months.
Q: Can you assume that any payer that’s covering the G6 will cover the G7?
A: I think they will. The question is whether they view it as a negotiating opportunity.
Q: Will the G7 be ready to integrate with Omnipod and Tandem insulin pumps immediately?
A: It won’t be ready out of the gate. Both of our insulin pump partners have their engineering teams working to integrate it. That’s on their end. We offer whatever resources we can to help them.
Q: When we spoke to Chief Technology Officer Jake Leach, he told us that the G7 will eventually be rated for 15 days of use. Do you still have that plan?
A: We do. The reason we’ve stopped at 10 days – and we have a 12-hour grace period at the end of the 10 days – is that it isn’t a good experience for somebody to get 12 and a half days out of a 15-day sensor. We felt the best experience we could give our customers right now was 10 days plus 12 hours.
We’re looking at sensor technology tweaks, some algorithm modifications, and also the adhesive. We are working on numerous adhesive solutions. If you make it not sticky enough, there are fewer allergies, but it falls off. If you make it too sticky, there are allergies. And then just seeing what we can do to enhance the sensor life.
But we’ve been in 15-day studies. We hope to get there soon.
Q: Abbott claims that the Freestyle Libre 3, which is rated for 14-days, reaches its peak in accuracy around day number 10.
A: I have a lot I can say about that. These studies are … there’s a lot of variables in a glucose sensor study. I’ve been at this for 11 years. Every time there’s been a launch of a competitor’s technology, they claim to be more accurate than we are. And every time we get out into the real world, they are not.
This product is still a Libre, it’s still a Libre 2, it’s not a different sensor. So to expect a different outcome means, what?
Sensors do burn in over time. With our sensors, if you look at our data, days one and two are less accurate than the mid-range. Even ours, if you go out into the 15-day range, it’s still very accurate, it’s just a question of how many of them would fall off. Their [Abbott’s] survivability rate in their study, I believe, was something like 71%. Well, we have a very high standard of what we want this product to be. We don’t want our customers to call us because they lost two or three sensor days. We want them to call us because they love the product and want to order more.
Q: So the Dexcom G6 and G7 both be available for some time?
A: Yes. We’ll use the G6 platform where it makes sense, and we’ll switch over to G7 where it makes sense.
We just got G6 approved in Australia and Japan. There’s no need to switch those markets today, because they haven’t even seen G6 yet.
Q: Many Americans with type 2 diabetes that use intensive insulin treatment can now get the Dexcom G6 covered by insurance. Tell me about the plan to get Dexcom sensors into the hands of everyone else with type 2.
A: I think basal insulin users are the next big win. There are something like 3-4 million people in the US with type 2 diabetes that use basal insulin. There are a lot of them. First of all, we’ll learn a tremendous amount about these customers when they get on sensors. I think it’ll be a great science exercise.
Our data in the MOBILE study is every bit as powerful as it is for the type 1 studies, as far as A1C reduction and time-in-range. For every variable that you measure, basal insulin users do better if they’re on a sensor than if they’re not.
Q: What about people with type 2 that do not use insulin?
A: In our studies, patients who use a CGM full-time, even if they’re not on insulin, do better. But it’s not as complicated an issue. They need an experience that’s geared more toward them, and an experience that the payers can see and say “I’m willing to reimburse for this.” And so, we need to gather more data.
The problem we’re solving is engaging with your health. I think these types of insights are beyond valuable.
Q: Would Dexcom release a unique type 2 sensor that doesn’t have alarms or remote-following features, for example?
Those are the types of things we’re talking about in our product pipeline. The Dexcom One is streamlined from the G series – the question is, what more streamlining do we do? Or what features do we add?
I know we can build the app that will engage people. Our customer satisfaction is higher than anyone else’s. It’s almost higher than anyone else’s in any other industry. People love this company, which is why they’re so passionate if we ever do anything wrong. They let us know. It’s because we engage people.
If you look at the number of times a day that one of our customers looks at our screen, versus our competitors, it’s night and day, because they really engage with what we do.
So, the question becomes, how do we build the case to get payers to cover it?
Q: Do you think you will prove that a CGM is cost-effective for people with diabetes that do not use insulin?
A: The first thing you have to do is get a product out there. Then you’re generating engagement, and you’re generating excitement and buzz. And then you go get it reimbursed.
It’s going to be a process, but I think it will go very fast. It took us a long time to get this technology paid for. We had to make it better. The reason we got it reimbursed is because it was so good. When we went to G4, it was so much better than the CGMs that came before it, people had to take us very seriously.
I think you’ll see the same thing happen with type 2 diabetes. We structured our entire organization to generate engagement like that. I’m pretty confident we can get there.
If you can take the timeline of somebody’s life, and avoid those big diabetes treatment cost increases, or even delay them for three years, you have saved the system so much money.
If we delay dialysis for three years for somebody, that’s a $300,000 savings to Medicare.
Q: Would Dexcom ever create a CGM for people without diabetes? Blood sugar measurement has become very trendy among health nuts.
A: There will come a time when we have a consumer-related offering, when somebody could walk into a drug store and just pick one up. We’re not there yet.
Q: Finally, I have to ask. A few weeks ago there was a rumor that Dexcom planned to acquire Insulet, the maker of the Omnipod. Is that true?
A: I’ll stand by our public comment. We typically don’t comment on deals and rumors, but we indicated that we are not merging with or acquiring anybody right now.
Read more about A1c, Abbott, continuous glucose monitor (CGM), Dexcom, Dexcom G7, exercise, freestyle, Insulet, insulin, insulin pumps, Intensive management, libre, Omnipod, Tandem, U.S. Food & Drug Administration (FDA).