When the company first began planning a glucose monitor for the type 2 diabetes population not using insulin, there were questions about reimbursement, the impact of GLP-1 drugs and other causes for concern.
“It made us all uncomfortable,” Sayer said. “In all fairness, it made our whole entire company uncomfortable. There were many pro and con debates about this.”
Dexcom announced a new sensor product at an investor day event just one year ago. In January, the company submitted the sensor, called Stelo, to the FDA. At that point, though, it remained tight-lipped over any potentially noteworthy indication.
Stelo became the first CGM to receive over-the-counter clearance from the FDA less than two months later in March. Approval took just 75 days.
Dexcom estimates that approximately 25 million people in the U.S. with type 2 diabetes don’t use insulin but could benefit from CGM use. Speaking to Drug Delivery Business News at the American Diabetes Association Scientific Sessions in Orlando, Florida, Sayer said Stelo is an option that the company is excited to get to market.
“Once again, we’re first here — we got that first approval, and that’s a part of our culture that’s been very important to us,” Sayer said. “We decided that, for this group, it was really important. We’re very comfortable now. We certainly made the right choice. Maybe there’ll be a little pain for a year or two as we figure it out. I hope not, but I know five years down the road, we’ll look at this as a landmark moment in our industry.”
More about Stelo and Dexcom’s plans for the new sensor
The small, wearable sensor is indicated for those 18 years and older who are not using insulin therapy. Worn on the back of the arm, the sensor provides insights directly to a user’s smartphone.
Stelo features a 15-day wear based on the G7 platform. It offers a software experience tailored specifically for non-insulin users. The company said it makes it easier for the target population to access CGM and offers an option for those who don’t have insurance coverage for CGM.
Initially, Dexcom plans to make Stelo available for purchase online without a prescription, with late August earmarked for the launch. As far as potentially competition goes, Abbott received FDA clearance for the over-the-counter Libre Rio earlier this month. Libre Rio targets adults with type 2 diabetes who aren’t on insulin and manage diabetes through lifestyle modifications.
The move to over-the-counter appears to be a popular one, and for good reason.
The initial launch is taking place through a Dexcom-controlled website but the company is going through the paces in terms of readying itself for a broader launch. Sayer said it’s building “boatloads” of inventory before it starts rolling out the sensor.
Dexcom wants to target “25 million people with diabetes who need a better tool now,” Sayer explained. Over time, it plans to gather data and demonstrate the improvements in those people’s lives. Beyond that, he hopes for reimbursement on the back of that potential data.
According to Sayer, the target demographic’s biggest goal in life with type 2 diabetes is combatting long-term complications. Someone who currently has insulin dependence has to worry about controlling glucose in the present. A person who doesn’t use insulin may not face complications today, but Sayer says they worry about blindness, heart attacks, kidney failure and amputations.
“If they can drive their A1c down and increase their time in range, that extends their life significantly, and it makes their meds more valuable to them,” Sayer said. “It’s going to be a really good product for us.”
New direct-to-watch feature headlines a number of G7 improvements
Earlier this month, Dexcom launched a new capability: its latest-generation G7 CGM can now connect directly to the Apple Watch in the U.S.
The official launch made G7 the first and only CGM available with a direct-to-Apple-Watch feature. It offers users the freedom and convenience of real-time glucose readings even without an iPhone readily available.
Sayer said this feature was seven years in the making.
“It’s being incredibly well-received by the community,” he said. “We purposely designed our system so [users] can get their data wherever they want.”
He said the happiest group is athletes who no longer need to take their phones with them to receive glucose data while exercising. Another demographic is mothers of kids with diabetes. They used to send their kids to school with cell phones to track their glucose. Now, they don’t have to.
Dexcom has work underway on more capabilities around cellular connectivity to make the integration full-service as well.
“Our first set of users back in the day were very stringent, compliant people with type one diabetes,” Sayer said. “Now, as we’re entertaining more and more broad patient bases, we have to meet them where they are and we have to offer them the features that make it easy for them to use. And direct-to-watch is one that they’ve been clamoring for, for a long time. We’re really happy to finally get it out.”
The G7 innovation doesn’t end there, though. Dexcom has also added medication and event logging capabilities while expanding G7’s connectivity range and making software revisions for fast reconnection if the CGM loses connectivity to its companion device.
“These are pretty big software features,” Sayer said. “We’ve been updating that app literally every four to six weeks ever since we launched. It’s it’s a good piece of software and much better than what we had as our software team has really grown and matured.”
Dexcom also progresses on automated insulin delivery
The past seven months have brought significant developments for Dexcom with regard to automated insulin delivery integration. For years, commercial automated pumps had paired with the G6, but with G7 hitting the market in early 2023, the companies had to work to bring the new combination to the diabetes population.
“We’re always excited to get G7 to these users,” Sayer said. “They’ve done very well with G6 for quite some time, but G7 just offers a much better experience from a wear perspective. It’s the most accurate sensor on the market still, and will remain so. The more accurate the data you put into the system, the better care you’re going to get, and G7 is noticeably better than G6 was, at least clinically.”
First, Tandem Diabetes Care announced the integration of G7 with its t:slim X2 pump in December. Beta Bionics began rolling out its iLet bionic pancreas with G7 a day later. Tandem later added G7 to its second pump, the small, durable Mobi system, last month. Finally, just last week, Insulet began the full launch of its latest-generation Omnipod 5 with G7 in the U.S.
“We know people on insulin with CGM do better,” Sayer said. “We know people on [automated insulin delivery] systems do better. The systems are getting better as we go.”
Sayer said the next step is to see how the algorithms develop and potentially learn from individual physiology. Over time, he said the automated insulin technology may incorporate more of those characteristics to better personalize outcomes.
He believes that, with G7 and the latest pumps, users will have better data and the systems will be better driven and perform at a higher level.
“Overall, their data will be better and these systems will be driven well and do really well,” Sayer said. “The integrations have been really good.”
