After plenty of anticipation — and a bit of waiting — the next-generation Dexcom G7 continuous glucose monitor is finally here.
In mid-2021, Dexcom (Nasdaq:DXCM) CEO Kevin Sayer told Drug Delivery Business News that its next-generation CGM would be “wonderful.” At the time, he said enthusiasm over the Dexcom G7 sat at an all-time high.
About 18 months later, the Dexcom G7 finally arrived in the U.S. The FDA granted clearance to the device earlier this month.
The Dexcom G7 demonstrated exciting results in glucose monitoring in a number of clinical trials. One study highlights its accuracy, and another demonstrates success with pediatric users. Dexcom announced its international rollout for G7 in October. The system won CE mark in March.
In order to pick up FDA clearance, Dexcom had to apply software tweaks based on FDA feedback earlier this year. This threw a wrench in the expected timelines for FDA 510(k) clearance and the subsequent U.S. launch.
Now that the long-awaited FDA clearance arrived, COO Jake Leach shared the company’s excitement.
“It’s one of those milestones that you remember,” Leach told DDBN. “All along the product development, you’re working towards getting approval from a regulatory agency so you can market it. We got [the] CE mark earlier this year, and then it was really nice to get FDA clearance before the end of the year. It sets us up really well to launch the product early next year.”
About the Dexcom G7
San Diego-based Dexcom’s device includes a 60% size reduction from the previous generation, the G6 that hit the market in 2018. The G7 features a 30-minute warmup period. That represents a significant improvement from waiting two hours for glucose readings to begin in the past.
The G7 provides more information in one place with personalized insights and extended-wear design. It features a simple wear experience, starting with unscrewing a cap. The user then puts the sensor on their body and pushes a button. The device is then turned on and can be paired with a smartphone.
Leach is particularly impressed with one specific improvement of the G7: ease of use. He said feedback following the commercial rollout in Europe solidifies that.
“The one that’s a really huge leap is the ease of use,” Leach said. “[Users in Europe say] this thing is so easy to use because its design was all about removing user steps and simplifying things. … Some of the older systems have a bit of a learning curve. With G7, we can eliminate a lot of that. That’s a big step.”
Other improvements for the Dexcom G7 include enhanced alerts, reduced environmental waste with packaging and a new receiver.
Leach also pointed to accuracy as another leap forward.
“It’s the most accurate system we’ve ever developed,” he said. “We’re always pushing to improve the reliability and the performance of the product.”
About the software update
One of the biggest questions over the Dexcom G7 surrounded the software update that delayed its clearance.
Initial suggestions from analysts had clearance slated for some time in the summer. Backlog at the FDA around the COVID-19 pandemic affected things, then Sayer announced on the company’s second-quarter earnings call that he anticipated clearance by the end of the year due to the FDA’s request for a software update on G7.
Leach said the request came as a result of Dexcom’s effort to design G7 as a broader, global product. He said the company redesigned its mobile app architecture, mainly to bring it to market faster. The FDA came to the company with questions over the architecture’s “silence all” feature. This feature silences alerts, particularly glucose alerts over a period of time if a user desires.
“The FDA just wasn’t super comfortable with that,” Leach said. “They wanted to see some more testing. They wanted us to do a little more work on it. In order to get the product up faster, we said we’ll pull that feature out for now. The G7 architecture allows us to do that. We’re going to put it right back in as fast as we can once we get alignment with the FDA.”
He noted that Dexcom maintains “good alignment” with the FDA and plans to roll out the feature as soon as it can.
The collaborative effort with the FDA, even if it resulted in a slightly delayed timeline
“We’re set up really well for some of our future products based on all the learning on both sides, FDA’s and ours,” Leach explained. “G7 was such a large submission with all the changed components. It’s one of many. We’re going to keep doing new generations of products and keep enhancing features.
Transitioning users to next-gen technologies
Leach said Dexcom expects a “much faster transition” from G6 to G7 compared to the move from G5 to G6.
“One of the things that really limited us with G6 was our manufacturing capacity,” said Leach. “We just underestimated what the market demand was going to be. So with G7, we have that experience. We have better market intelligence now, and we know what the demand is going to look like. And we’ve got plenty to ensure that we’ve got that covered now.”
Issues may arise here and there, Leach said. The supply chain can always cause problems, while adjusting to a new product can, too. So far, though, he said Dexcom experienced no issues around availability.
The next step in the transition between products involves the company’s insulin pump partners. In the U.S., Dexcom partners with Insulet and Tandem Diabetes Care, offering its CGM to help measure glucose levels for their automated insulin delivery platforms.
Those platforms won’t be compatible when G7 launches at the start of the new year, but it won’t be too long a wait, Leach said.
“They’re working quickly to upgrade those,” Leach said. “Once we have those systems compatible, there’s no reason for anybody to not jump on the G7.”
CMS ruling set to benefit Dexcom
In October, the Centers for Medicare and Medicaid Services (CMS) published a new proposed local coverage determination (LCD). The LCD modifies coverage criteria for continuous glucose monitors (CGMs). That 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 wrote that 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 aimed for 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.
Leach stressed that Dexcom is “really excited” by the potential expanded coverage.
“We see that as just another validation of how CGM can really benefit people with diabetes,” he said. “This is a whole new group of folks that haven’t had access to it before. I think we’re going to really see some great outcomes as that population starts to use CGM more regularly. We’re really excited about G7 servicing that population when it becomes available.”
He expects to see that coverage come through in the second half of 2023. However, if it comes earlier, “we’ll be ready,” Leach declared.
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.
Plus, with lessons learned from the G6 launch, both around demand and limited launches, Leach said Dexcom feels good about its manufacturing capacity. Plants in San Diego and Mesa, Arizona, are on the job, while Dexcom is finishing construction on another plant in Malaysia.
“We’ve got quite a bit of inventory already and we’re continuing to build more,” he said. “That’s the one benefit of the delay to the approval. [It] just gave us more time to get ready for it. We’re feeling really good about being ready to go.”
Another transition for G7 comes with the Dexcom One platform. Dexcom designed the Dexcom One system as an easy-to-use, real-time CGM (rt-CGM). It aims to make CGM more affordable and accessible for people with diabetes in a number of countries overseas, including the UK. Dexcom One uses the G6 as part of its overall offering.
“We do want to transition to the G7 hardware platform over time for all the products because it is more scalable and it’s built. The capacity is there,” Leach said.
Finally, what about the next one?
Leach said the company is always keeping an eye on the next generation of its technology. He explained that G7 “was well under development” when Dexcom launched G6, and that remains true for future iterations.
“We’ve been innovating in the space for a long time,” Leach said. “We still have plenty more to do.”