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How Dexcom looks to extend its mission beyond diabetes

Sep 02, 2023Sep 02, 2023

January 13, 2023 By Sean Whooley

Dexcom (Nasdaq:DXCM) ended 2022 strong, receiving FDA clearance for its next-generation G7 continuous glucose monitor (CGM). With a U.S. launch imminent, the company could keep its efforts centered on the diabetes space.

Instead, the company plans to broaden its focus even wider.

“We’ve revised our mission statement,” Sayer told Drug Delivery Business News. “In the past, we always talked about enabling people to take control of diabetes. We’ve changed diabetes to health. We’re enabling people to take control of their health because metabolic health and glucose values and the information we can provide are very much synonymous.”

Sayer shared the company’s revised mission in a presentation at the J.P. Morgan Healthcare Conference this past week.

He highlighted the buzz generated by new diabetes “wonder drugs.” While they represent great innovations, he said, before spending money on the drugs, a feedback loop for how they work “is a really good idea.” The same goes for a feedback loop on behavioral changes related to those drugs. Sayer explained that Dexcom plans to make progress on both fronts.

“People all over are clamoring for CGM data to be used in their apps to give their customers feedback as to what’s going on with their health and in their lives,” Sayer said. “It’s a very good marker and a very good indicator for that.”

The wheels have been in motion over the past several years. The FDA issued temporary guidance in April 2020 allowing for increased remote monitoring of hospital patients to limit contact with hospital staff and opportunities for COVID-19 transmission. That guidance extended to CGMs for the remote monitoring of people with diabetes.

Last year, Dexcom received FDA breakthrough device designation for the use of its CGM in a hospital setting. There is a lot of space into which the CGM can expand, experts say.

One area Sayer mentioned is pregnancy, as standards exist for a person’s time in range while pregnant, he said. Another space is gestational diabetes, Sayer added.

“There’s a number of opportunities on the overall health side that touched diabetes, but we’ll move a little further out with this technology going forward,” Sayer explained. “It’ll be a good year of laying the foundation for the future.”

Speaking to Drug Delivery Business News last month, Dexcom Chief Operating Officer Jake Leach said the international G7 rollout gave Dexcom a chance to run limited launch scenarios overseas. That experience allows the company to initiate a full launch of G7 straight away in the U.S. in 2023.

“We’ve got quite a bit of inventory already and we’re continuing to build more,” Leach said. “We’re feeling really good about being ready to go.”

Sayer added that the launch is due to begin during the first quarter. The company has plenty of capacity he said, as well as confidence.

Perhaps the biggest step of 2023 comes from a proposed local coverage determination (LCD) from CMS, first published in October. The LCD modifies coverage criteria for CGMs. This modification includes people with diabetes who receive insulin treatment or have a history of problematic hypoglycemia.

After CMS published the LCD, BTIG analyst Marie Thibault said CGM makers like Dexcom would benefit. She noted that both Abbott and Dexcom at ADA 2022 in June expressed hope for improved Medicare coverage. They wanted coverage for CGM in type 2 diabetes basal-only patients as soon as 2023.

Thibault cites an estimated 3 million U.S. basal-only patients as a representation of who could benefit from the decision. Sayer said it doubles the addressable population for Dexcom to reach.

He added that Dexcom’s Mobile study, which had results published in mid-2021, served as “the primary evidence” for the CMS ruling. Evidence showed that basal insulin patients who stayed engaged with their CGM demonstrated “far and away the best outcomes.” More access to CGMs will only highlight that, he explained, and it likely plays into Dexcom’s decision to go beyond diabetes.

“I think it’ll show great utility in CGM, not just as a safety device but as a cost prevention tool,” Sayer said. “As a progression of disease prevention tool as well. We’re very excited about this opportunity.”

Last month, Leach explained that the Dexcom G7 “was well under development” when the company launched its G6 platform. The company is always keeping an eye on the next generation of its technology and innovating on the technology at its disposal.

The first innovation on the to-do list for Dexcom is extending the life of the sensor. It currently has a 10-day wear time, but Sayer wants to increase that to 15 days.

“We think a longer experience provides a better experience for customers,” he said. “It also provides a better model for us as far as engaging more people and having more capacity. That is a very acute scientific need and something that we’ll work on.”

Next on the list is accuracy. The Dexcom G7 is the company’s most accurate CGM offering. It registered a mean absolute relative difference (MARD) — the foremost measure of glucose monitor accuracy — of 8.2%. Perhaps it can improve even more.

“We know we’re moving up,” declared Sayer. “We won’t ever go backward with respect to sensor performance and we always want to go forward.”

Starting in 2023, Dexcom also plans to make big investments on the software side of its offerings. Sayer wants to integrate more on the software side to improve user experience. He said the company brought in “high-powered” software engineers from the tech world to bring different views on ways to iterate and innovate.

Data and that relationship with APIs is another space Dexcom wants to innovate. Sayer expects “good progress” on all these fronts.

What I see now versus years before is, this industry has become so big,” he said. “It’s much more about scale than it is just about technology. We serve so many customers now that we can’t do it on the same platform as we did when we were only building a million sensors a year versus millions of sensors a month.

“It’s changed dramatically. And I think our scale for our company will put us in a much better position.”

Filed Under: Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Technology Tagged With: Dexcom

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