In 2024, the company became the first to receive FDA approval for an over-the-counter (OTC) continuous glucose monitor (CGM), the Stelo device.
Meanwhile, Dexcom continues to advance its G7 platform, its latest-generation CGM offering. In 2024, the company launched a new capability, as G7 can now connect directly to the Apple Watch in the U.S.
The company also continues to expand options for automated insulin delivery users, as G7 can now connect to several pumps: First, Tandem Diabetes Care announced the integration of G7 with its t:slim X2 pump in December 2023. 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, in May. Finally, in June, Insulet began the full launch of its latest-generation Omnipod 5 with G7 in the U.S.
Dexcom also sent its CGM to space, submitted a 15-day CGM to the FDA for review, launched generative AI integration with its sensors and inked a deal with health monitoring technology company Oura.
“We’re very excited about all those things going on,” Sayer told Drug Delivery Business News in a recent interview. “Our [outside the U.S.] opportunities are still really big and we continued our U.S. growth and margin expansion. 2025 is really shaping up to be a good year for us.”
The San Diego–based company — the second-largest diabetes tech company in the world — just reported preliminary 2024 revenues of $4.032 billion for an 11% increase over 2023.
“[I just like to] make everybody remember what a great position this company is in,” Sayer said. “We’ve accomplished a lot. We have much, much more to do.”
What to look forward to — including a next-gen CGM?
Sayer says the latest quarter rounded out a solid year and “stabilized” the business following an especially difficult second quarter that fell shy of “high standards.”
The company opened 2025 with a new partnership with Life Time, a “health and wellness pioneer” with more than 170 athletic country clubs across the U.S. Sayer also anticipates word from the FDA on the 15-day CGM submission soon, too.
“We did file our 15-day product with the FDA and don’t have it approved yet,” he said. “We expect to launch that in 2025.”
Notably, Dexcom continues to innovate, with a future iteration of its CGM on the way. Sayer described the next-generation sensor as 50% smaller than the G7, with a thinner, lower-circumference form factor. He said the much smaller platform features more powerful electronics.
“The platform we’re building with our next-gen wearable is much smaller than the current one,” Sayer said. “The more powerful electronics means it can handle three different readings at the same time. … It’ll be a while, like a couple years before that is through all of our work process, but these things are all happening.”
The company also reported record new patient levels in the third and fourth quarters and Sayer expects more in the U.S. and abroad. He specifically pointed to outside-the-U.S. markets that could still get coverage for CGM for those with type 2 diabetes.
Sayer said there’s plenty of room to grow with insulin users who still don’t use CGM, calling it a “huge opportunity.” With that, the company continues to expand its automated insulin delivery connectivity options.
According to Sayer, AID adoption is increasing, with new coverage and directives on the technology all around the world.
“These systems now do what they promised to do years ago, helping you manage your diabetes without having to manage it all the time,” he said. “We’re partnering with some good companies that are doing some good things.”
Stelo and AI are hot topics at Dexcom
With the launch of generative AI for Stelo in December 2024, Dexcom said it became the first CGM manufacturer to integrate GenAI into this technology. The new platform analyzes individual health data patterns. It could reveal a direct association between lifestyle choices and glucose levels and provide actionable insights to improve metabolic health.
Sayer said the addition of GenAI, while potentially groundbreaking, is coming in baby steps. Between working with the FDA to ensure the company is taking the proper steps and adding capabilities to identify new biomarkers, the company is moving slowly with AI, but Sayer believes Dexcom has the infrastructure to build this out.
“If you sit in a room around a bunch of people who’ve battled diabetes for several years, there’s no limit to the features they want to put in a product,” Sayer said. “They would put everything in that you could possibly imagine. Then you launch them, and people literally go, ‘why’d they do this? Why does this matter?’ So, what we’re really trying to do is take an approach — with Stelo in particular — and our G7 app going forward, whereby we listen to what they need.”
Sayer attributed the ability to do this to the maturity of Dexcom’s software team. Prior to the G7 app — on which Stelo is built — he said the company wasn’t “really much of a software company.” G6 had an architecture that required dozens of separate updates just to make one uniform change to the app.
“Those things are happening for Stelo to create the ability for people to engage,” he said.
Exploring new ways to reach customers through Oura, Amazon
GenAI, OTC, new form factors and more are on Dexcom’s list of ways to reach more people in a meaningful way. The company is also looking at adding multiple biomarkers to its sensors, with trials set to commence this year. That could potentially influence the next-generation CGM as well.
The two companies announced a plan to launch integrations enabling data to flow between their products. That includes Dexcom glucose biosensors and apps, along with the Oura Ring and Oura App. With this integration, users can track glucose levels and understand the impact of behaviors and biology on their metabolic health. This comes with a significant investment from Dexcom, too.
“We can merge activity data from whatever activity source you have — Apple Watch, FitBit, and of course the Oura Ring,” Sayer said. “They’ll be bringing Stelo data into Oura Rings before we’ll get Oura data into Stelo, but we’re very excited about that.”
On top of new insights through Stelo, Dexcom is exploring new ways to bring Stelo to users. The company began selling Stelo through its own e-commerce platform, but is looking to expand to the Amazon marketplace. He expects that to occur before the end of the first quarter, making it even easier to buy the product.
That adds to the deal with Life Time as the gym brand’s official biosensor, which will lead to co-marketing and eventually a distribution channel.
Sayer said that the experience of seeing patients order their OTC product and receive it within a day was new, but left users “absolutely thrilled.”
“Everybody on the outside is all worried about revenue numbers, and you always want to sell as much as you can,” Sayer said. “But, honestly, the most important thing here was to learn.”