Jacob Leach10:27
Pretty incredible story. Actually, in talking to Mason, he was really struggling with baseball when he was in college and it wasn't until he got a Dexcom and was able to manage his diabetes that he became the dominant pitcher that now competes at the highest level. It's stories like Mason's and many of our other over 30,000 warriors around the world that are so important to help us educate people about what this technology can do to help them achieve their life goals in managing diabetes. It's so important because diabetes is one of the largest health crises we have around the globe.
This is data from the International Diabetes Federation projects that by 2050, there going to be more than 850 million people around the world living with diabetes. That is a pretty significant increase from the tremendously large numbers we already have today. And this growing prevalence of diabetes is really placing a pretty significant burden on our health care systems. In the United States, we spend more than one of every four health care dollars treating diabetes. And if you look at the funnel, pre-diabetes is not slowing down. The CDC actually recently updated their numbers. We now have approximately 115 million people in the United States living with pre-diabetes. That's 40% of the US adult population.
So, the question is, how do we extend Dexcom's growth and make a dent in this metabolic crisis? Well, I've laid out three priorities for our organization that are set up to drive this next phase of growth. First, we intend to remain the premier glucose sensor for all people with diabetes. Use that leadership and extend it to be the premier glucose sensing solution for all people. Second, we will set the standard for customer experience in glucose biosensing. And then finally, we have a significant opportunity that we will capitalize on to grow our international market share.
All three of these priorities require us to focus on scale. This is one of the reasons why we're very excited to provide you guys later today with a tour of our high-volume US plant here just down the road. And what's interesting is scale is not just about the manufacturing plants and the number of sensors we make. It's about how we structure the organization going forward. And planning for scalable innovation and for many, many years.
So, over the past several months, we've made some pretty important changes to the internal team structure at Dexcom. The goal here is to increase our pace of innovation and ensure that we never compromise on quality or the trust of our customers. So, first, we're in the process of recruiting a brand new role at Dexcom, a chief product officer. This is a role that's really focused on anchoring in customer focused innovation as well as our product vision, our strategy, and our product release cadence.
We've also made another very important update. We've combined our manufacturing, supply chain, and quality all under a new leader, new to Dexcom. His name is Jeff Sacerdote. He joined Dexcom with significant experience across MedTech and high-volume manufacturing and lean practices. All of this is in a goal to execute on this opportunity in front of us and ensure we meet the needs of this growing customer base.
We're also excited to announce today that we've been working closely with Elliott Management to recruit two new board directors to our board and it was particularly with experience in MedTech and high-volume operations. We've had very constructive conversations with the team at Elliott. We've also decided to repurpose the mandate for our technology committee, one of our four board committees, into the operations and innovation committee. So, that committee will now have oversight over both innovation and technology, but also importantly the operations of the company. These updates to the governance model and the internal structure of Dexcom are being made in an effort to ensure that we're taking advantage of this significant opportunity and really strengthening our capabilities.
So, all these changes in leadership are going to help fortify us as the leader in glucose sensing. All of the leadership in glucose sensing starts with a holistic vision of the diabetes ecosystem. We understand that customers are multifaceted. It's not just the person that wears our CGM, it's also the prescriber, it's their caregivers, it's the payer, and it's the channel partners. All of us are working together to provide an uninterrupted exceptional customer experience.
And to execute on this vision, one of the things we've established is a competitive advantage in connectivity. We're the CGM partner of choice across automated insulin delivery and connected pens, and we were the first to begin integrating digital health apps into our ecosystem to amplify the value of the CGM data we produce. Also, on the clinician side, our Dexcom Clarity software has earned strong recognition as an important tool to help physicians interpret CGM data and make using that data in their practice easier. We're now extending that advantage with direct integration with EHRs. Let's take a little closer look at these advantages.
We established the AID category through a focus on sensor performance, clinical work, and partnerships. And these are some of our most highly retained, highly satisfied customers. And as a result, Dexcom is the leader in connected AID systems with more than 1 million users around the world wearing Dexcom sensors connected to an AID system. Going forward, we are going to extend our leadership here with a focus on accuracy, reliability, connectivity, as well as the overall user experience for our joint customers with pump partners.
But we're also addressing new clinical needs. One of the key struggles with type 2 basal insulin therapy initiation is what often happens is a physician initiates basal insulin therapy for a customer, and they put them at a low dose, and then after a number of months, patient comes back to the clinic, they check the A1C to determine if the dose is right. They often have to make a correction to make it more aggressive. What we see, and as you can see in this clinical study, pretty significant size clinical study, a dramatic increase in A1C once that basal insulin therapy was initiated. And that's because the dose was too low and it wasn't optimized for in this example up to 12 months. It took up to 12 months for this cohort of patients to get to an A1C that was slightly below where they started.
We have a technology, Dexcom Smart Basal, that's designed to solve this problem. It uses real-time data interacting with the clinician and the patient to get to the more effective dose faster and get that A1C for those patients moving in the right direction. Smart Basal is able to change the time it takes to get to the right dose from over 12 weeks to fewer than 30 days. It is a much faster, more efficient solution and more satisfying for both the patient and the clinician. It really fits well into the workflow of the ACP because you do not have to have the patient come back for A1C tests and then use those A1C tests to modify the dose. It's all done automatically by the G7 product in the background giving that user a recommended dose every day.
This technology has already started rolling out. We've got it in a number of clinics around the US. We've learned some great things about the workflow in the clinic. We've already made some changes to how we're managing accounts to fit in with some of the workflows that we've learned about in these primary care offices. And we look forward to rolling it out in the coming months across the US. And then ultimately rolling it out internationally as well. But Smart Basal is just one example of how we're differentiating our products with software.
What's really interesting is despite all of the incredible advancements in automated insulin delivery systems and insulin pumps, approximately 94% of the people around the world that are on real-time insulin are using injections, multiple daily injections. People on intensive insulin have to make all kinds of decisions every day about the carbohydrate intake, how much insulin to take, how much correction to take, making sure they don't go hypoglycemic. And it's no wonder that with all of those decisions, 30 to 40% of these folks suffer from diabetes distress, which is a term we use to assess the mental burden of diabetes. We see a very meaningful opportunity to improve this experience and outcome for these patients.
Dexcom Smart Bolus is designed to make dosing safer and simpler for these MDI users. It incorporates CGM trends, nutrition information, it allows the patients to avoid hypoglycemia risk while also doing a better job of managing their glucose. It really takes the variability and a lot of the math out of everyday life. It's a streamlined experience for those who may not have access to pump therapy. And at the same time, we're going to continue to invest in the clinical data and the clinical physicians experience to enhance the efficiency of their practices, and this is just one more example of how we're doing that.
Another interesting point is that clinicians often can't see CGM data inside the electronic health record, which is where labs and all of the other important clinical information resides. This gap produces friction and creates inefficiencies and extra steps for that physician to actually take that CGM data and turn it into something meaningful for their patient. This is one of the reasons why we believe we're seeing such a strong response to the Dexcom direct EHR integration. This is an API technology, software technology that connects Dexcom CGM directly to the EHR system. It's unique to Dexcom, and it does not come with added costs to the healthcare system like many other integrations do.
We're seeing pretty rapid uptake. We have over 320 health systems that are either integrated or in the process of onboarding. Every time I report this, this number gets bigger. And this is mostly in the US, but we're starting to see uptake outside the US, and it is across multiple EHR systems. Primarily Epic, but we're starting to see some of the other systems in the market adopt this connection as well. We do look forward to sharing more about this particular solution at the plant. When you guys are doing your tour, we've got a full demo of this EHR integration up and running there.
And as we continue to expand the experience for the clinician, we're also continuing to push forward on that core CGM technology. So, we recently launched G7 15-day. It has an optimized algorithm and extended wear time. And we're hearing very strong response from our users and how much they are enjoying the extended sensor wear, as well as that improved accuracies. It's consistently highlighted in their reviews when they talk about the product. And with an improved adhesive that we just got approval for recently, it's beginning to roll out. We've already got customers in the field experiencing this new adhesive. We expect that this experience that they're having now is going to get even better.
The rollout of G7 15-day is going exactly as we expected. In fact, where we are on track to convert nearly half of our US base over to this product by the end of this year. And this month, we're also excited to now have compatibility with Tandem with our 15-day products. So, now Tandem joins Beta Bionics and Insulet in compatibility for 15-day. And then finally, we are working to extend this 15-day wear life to our international markets. We're going to start in the second half of this year, we'll start rolling G7 15-day out across those markets as we continue to get regulatory approvals. And as we think about the future, 15-day sensor wear becomes the baseline for all of our products going forward.
So, as I think back about the history of Dexcom, and I've been privileged to have been part of many of these step changes that the industry has experienced. They've been driven by Dexcom. We were the first to establish glucose alerts and alarms. We were the first to establish the real-time remote monitoring system that for many cases gives parents the first time they can get a good night's sleep. We were the first medical device to integrate directly with a smartphone. We have had industry leadership in accuracy and reliability. We established the first single-digit MARD. We were the first to get the non-adjunctive claim. We eliminated fingersticks, and then ultimately established the iCGM standards. So, these are the types of step changes when I think about the history of the CGM category.
So, the question is, what's the next step change, and how are we going to deliver it? This is one of the fundamental questions that I've been addressing as I've stepped into the role of CEO. I want to make sure that our next product is a step change. And to help figure this out, we go to where we always go, which is our customers and our future potential customers. So, we've been talking to patients, clinicians, people with diabetes, people within the diabetes community, many of which we've had partnerships for a long time. I also recently formed the customer advisory council because I really want my entire team tuned in to the needs of the people that we serve.
And what did we hear consistently from this group? We have heard that the number one thing that this group wants is they want reliable glucose data. They want a product that's accurate, they want a product that's reliable, and they want a product that's easy to use. If you look at the current state of the CGM industry today, the top two reasons that an individual stops using their CGM is because they don't feel that the glucose data is reliable enough. You can see a poignant statement here from a CGM customer from social media. What users like myself really want is the product to be accurate and reliable. And while we have great performance, industry leading performance, for accuracy and reliability in sensor wear with our G7 15-day product, it meets the needs of many users, but not all.
So, we see some pretty significant opportunities to enhance the performance of this product and ensure that it meets the needs of all users. And we hear this across the spectrum. It's not just G7, we hear it from our D1 Plus users in Europe, we hear it from our Stello users here in the United States. Everybody wants these systems to be more accurate and reliable. And so, the question is, how do you actually improve sensor reliability and reduce the variability that we see? Well, to materially improve sensor reliability, there's basically two things you have to control. The first one is the design and the manufacturing process of the sensor. And frankly, today, and you're going to see it when you go to the factory, we pretty much manage this variable. If you look at the way we build our sensors, you're going to see this, you're going to see every step as we do our process controls, and then ultimately you'll see that we factory calibrate and test every single sensor before it goes out the door.
The other source of variability is a little bit harder to control. This variability comes about when you insert the sensor under the skin in a person's body. We all have unique physiologies. We all react to these sensors slightly differently, which produces some variability for that sensor. And at the moment, CGMs have very little ability to adapt to this physiologic change. Well, an interesting thing is that standard CGM today, you can calibrate it, right? You can take a finger stick and enter that into the device to calibrate it when this type of situation occurs. Some users today do that feature, but if you think about it, it's burdensome and it comes with its own problems of what's the accuracy of that finger stick.
So, this really brings me to the next step of how are we going to make a step change performance in CGM? Well, the answer is the G8 product. Dexcom G8 builds on the G7. It's 50% smaller form factor. It has advanced sensing capabilities. It's really about strengthening everything across accuracy, connectivity, system design. It doesn't just represent a small change. This is a step change. It is a completely new product platform. The improvements are very exciting and they're much much more than incremental. G8 is actually going to change everything.
The way that it does this is it is a sensor that's going to adapt to that physiologic variability that I talked about. This data's from a clinical study that G7 and G8. One of the things you'll notice about the G7 is you've got a good distribution of performance there. This is an MARD graph, so a graph of performance. But you can see those outliers over on the side. Those are the most egregious ones and those are the ones that really are generated by some of these physiologic changes that we see when a sensor is inserted. And those are the types of sensors that produce those experiences that cause customers to stop using CGM.
The G8 system has additional technology built in based on a whole new silicon chip design and algorithm. Much of this has been in development for several decades at Dexcom because we've already had this idea of trying to do this, but now we're finally proving feasibility that we can make this happen in the G8 product. And what it's doing is it's measuring additional signals from that sensor beyond just glucose that allows it to adapt to those physiologic changes and reduce the outliers in real time and eliminate them.
The G8 really combines the factory calibration with this adapting system that allows the CGM to self-adapt with every user. It's a precise sensor that's going to adapt to the body over time. And we expect this to really enhance the user experience. Now, our teams are marching rapidly towards submission of this product next year that will facilitate a launch either at the end of '27 or early '28 depending on the regulatory review timing. We have some pretty strong momentum going with G7 10-day and G7 15-day. We intend to carry that momentum forward into the launch of G8 in a multi-faceted view of our customers.
We have purposely focused on ensuring we meet the most important need for users in terms of accuracy and reliability of glucose readings. But right behind that product is a multi-analyte version of G8 that will add to the product portfolio. So, I think what's important to know is about all of this technology being developed for all people with diabetes, not a specific subset. And I think you've all seen it, the coverage momentum for CGM across the world and across a broad spectrum of diabetes is continuing to build.
Clinically speaking, these outcomes have been repeated multiple times by Dexcom. This is data from our type 2 registry where we've been showing reduced A1C, sustained weight loss, as well as greater control and reduction in medications. This is in people with diabetes type 2 that don't take insulin. We've also recently seen a very important update from the American Diabetes Association in their standards of care. They've added a recommendation, a broad recommendation for CGM for all people with diabetes. So, we're really starting to see some good traction here. We also, as you guys heard on our last earnings call, we talked about another PBM, the next largest, starting to cover CGM for all people with diabetes this year. And while we really appreciate this momentum, we're not going to stop. We're going to keep generating the clinical evidence that we need to drive more and more access around the world for this technology.
So, we've set the standard for what clinical evidence in CGM looks like with the DIAMOND study and the MOBILE study. And we're very excited to be doing the next readout of the CONNECT trial. The CONNECT trial, just for a quick summary, the main point of the study is it's looking at A1C reduction in people with type 2 diabetes not on insulin. One of the things you'll notice is there's a nice breadth of medications utilization in the study, so pretty broad spectrum of patients, which we feel is important, including those that aren't even using glucose-lowering medications. We feel that's important to capture the full spectrum and benefit for this population. And we do believe that the study data from this is going to be a real anchor in our access story as we look to expand access to CGM for all people with diabetes both here in the US and internationally.
The readout, the full readout of the study is on Saturday, June 6th, 1:45, the American Diabetes Association in New Orleans. We hope to see many of you there. And so, based on this strong clinical data, we do expect a Medicare coverage decision anytime between now and the end of this year. And what we expect is the coverage to take place and count next year. Because that could kick in at any point. What we've decided in our plans is that we believe that coverage will come the middle of next year. It could come at any point, and when it does, we will be ready. But I want to be transparent about how we're thinking about it. We do expect again to hear before the end of the year on a coverage decision and for the coverage to take impact next year. And John's going to cover this a little more, but this coverage decision will basically double the addressable market here in the United States in terms of those that are covered for CGM. And so, you can see there's a ton of excitement building here, and there's lots ahead. But I do feel like we're still just getting started when you look at where we are as a CGM category and the opportunity that exists both here in the US and abroad.
So, I'm going to close this section by reiterating a very simple point. Everything we do starts with customers. You're going to hear that theme throughout today. And I hope you experience it directly when you meet some more of our team members later this afternoon, as well as some of our Dexcom warriors. And so, when I think about what we at Dexcom need to do, is I've instilled in my team we need to dig in and execute on this amazing opportunity we have to have an impact on people with diabetes. So, at that point, I want to introduce a new team member that joined Dexcom last year. He's going to present greater detail our commercial execution plans. Please welcome John Coleman, our EVP and Chief Commercial Officer to the stage.