With the G7 nearing FDA clearance, Dexcom leadership foresees major innovations for integrated automated insulin delivery down the line.

Kevin Sayer began thinking about automated insulin delivery all the way back in 1994 when he was working at MiniMed. Nearly 30 years later, as CEO of Dexcom (Nasdaq:DXCM), that space continues to pique his interest.

In the ’90s, MiniMed ran trials with a fully implantable system before Medtronic bought the company. Sayer admits the system with an implantable pump and sensor wasn’t particularly practical, but it planted the seeds for what could grow.

Now with Dexcom, the maker of the leading G6 continuous glucose monitoring (CGM) system — and the next-generation G7, which is expected to receive FDA clearance soon — Sayer has seen the integration of CGM with automated insulin delivery through partnerships with Insulet and Tandem Diabetes Care. He believes room for growth remains, with pump penetration not yet passing 50% of intensive insulin users.

“I’ve been around the fringes of this for a very long time,” Sayer told Drug Delivery Business News during the American Diabetes Association (ADA) Scientific Sessions this week. “I’ve often asked myself the question, ‘How big does this get?’ The feedback I’m hearing from users of both Tandem’s system and [Insulet’s] Omnipod 5 is incredibly positive. I think this is going to be a very important part of our business going forward.”

Sayer said G7 offers an even better opportunity over time because it is 60% smaller than the G6, which “decreases the amount of real estate on the body.” Once it garners FDA clearance, the integration into Tandem’s and Insulet’s systems will further highlight the benefits of the next-generation CGM.

Dexcom owns the algorithm that represents the basis of Tandem’s t:slim X2 insulin pump. Sayer said he sees the analytics angle as a “bright” future component of what the company does.

Dexcom has to incorporate artificial intelligence algorithms with data collected from its technology to find new and improved ways to help people manage their diabetes, he said.

“I think you’ll see a science boom over the next 10 years with this stuff,” Sayer said. “It can give people opportunities to pretty much get out of their diabetes care and let systems do it. Right now, we’re not there, and there’ll be a lot of trials and a lot of pain.

“So, then, how does Dexcom play into this? The most important element is giving somebody an accurate glucose reading that is communicated on a timely basis. The second-most important element is an algorithm that can drive that outcome, and we’ve got access to both, and we’ve got partners who can use it. We’re very excited about the future here.”

Rumors in recent weeks put Dexcom in the mix to enter the automated insulin delivery space itself, with Bloomberg reporting that the company was in talks to acquire Insulet.

Suggestions of a merger between the two diabetes tech giants were quickly put to rest when Dexcom issued a statement saying it is not in active discussions regarding any such transaction. The company said it did not intend to comment further on the matter, and Sayer declined to offer a comment a week after the fact.

“Our focus will be on supporting our partners and helping the technologies that can best serve that space,” he said.

G7 excitement

Plenty of focus remains on Dexcom’s next-generation G7, which could be picking up FDA clearance any day now. Sayer earlier this year said clearance may come after ADA.

“It’s a give and take, back and forth, and the FDA has been very involved with us in discussions,” Sayer said this week. “Would we like to be in all these discussions? No. Would we like to be done? Absolutely. But, we understand that, if they’re going to grant us all-iCGM status where we’re integrated with insulin delivery systems, they’re entitled to ask a bunch of questions, because people’s lives depend on this.”

The platform features a nearly two-thirds size reduction, a 30-minute warmup period (down from waiting two hours for glucose readings to begin in the past) that offers reliable data after just that half-hour period, more information in one place with personalized insights, extended-wear design and more.

Over Zoom, Sayer demonstrated the simplicity of the G7 experience, with the process containing very few steps. He opened a box, unscrewed a cap and showed that all the user has to do is place the apparatus on their body and push a button to apply the sensor.

“Everybody who’s on it, they’re never going back to what they had before,” Sayer said. “Nobody’s going back to G6. Nobody’s going back to wearing no sensor. They absolutely love it. I think it’ll be a wonderful product for us.”

Dexcom’s expanded portfolio

G7 isn’t the only exciting technology at Dexcom, as Jake Leach, the company’s chief technology officer, told Drug Delivery Business News recently.

“We are producing a portfolio of products,” Leach said. “We’re differentiating our portfolio.”

Sayer echoed Leach’s sentiment, pointing to the launch of Dexcom One — an easy-to-use, real-time CGM (rt-CGM) that it aims to make more affordable and accessible with a wearable sensor and transmitter to continuously monitors glucose levels and send real-time values wirelessly to a compatible smart device via the Dexcom One mobile app. Dexcom One was recently launched in the United Kingdom, and Sayer said there’s a coming launch in Spain, too.

The company also received FDA breakthrough device designation for the use of CGM in hospitals. Sayer said they’ve assembled a team that features hospital device experience so Dexcom will be ready for full approval.

And while clearance for G7 looms, G6 is still performing at a high level, with one study presented at ADA highlighting users in Belgium who switched from Abbott’s FreeStyle Libre to Dexcom’s G6 and experienced marked improvement over three years, Sayer noted.

Analysts are optimistic about Dexcom and its upcoming offerings. BTIG’s Marie Thiabult wrote that the company is experiencing strong adoption trends as the introduction of G7 in the U.K. is “going well.”

“Underlying business indicators are stable,” Thibault said. “We remain bullish on long-term, broad-based growth for CGM adoption.”

Sayer agrees.

“Everywhere I walk [at ADA] and everybody I talk to, Dexcom has become part of their company, part of their lives,” Sayer said. “We really are dialed in here and have made a lot of progress. I think the future looks amazing.”