Dexcom Chair, President & CEO Kevin Sayer, presenting clinical study results for the G7 at the 40th Annual J.P. Morgan Healthcare Conference, has previously lauded the expected impact of the wearable glucose monitor, and the new data shared today has only raised his excitement.
“The performance of this product is something I never really thought I would see in nearly 30 years in this business,” Sayer said during his J.P. Morgan presentation.
G7 features a 60% size reduction from the G6, a 30-minute warmup period, more information in one place with personalized insights, extended-wear design and more.
Data presented by Sayer and Dexcom highlighted strong performance to accompany the new and improved features of the next-generation technology. G7 outperformed ICGM standards established by the FDA across the board with its time-in-range performance, including overall time-in-range (measured by percentage within 20%) with a tally of 93.3% compared to the FDA standard of 87%.
Mean absolute relative difference (MARD) for G7 registered at 8.1% in pediatric patients and 8.2% in adult patients, highlighting consistency to accompany performance.
“G7 very comfortably meets high CGM standards,” Sayer said. “This dataset is three times larger than our G6 data set and much larger than any data set anybody else has ever produced in the industry. With a sample size this large, there’s absolutely no doubt as to how the system will perform. … The results are much superior to G6 and any competitive product in the market.”
Dexcom earmarked the fourth quarter for FDA submission and has stuck to that, Sayer noted, with the data from the trial used in the submission.
Sayer said the FDA’s initial feedback has been as expected, and he doesn’t want Dexcom to throw the agency any surprises, with the company using the data to “leave no doubt” about how the G7 performs. He won’t predict a timeline for approval because of external factors in the world.
Meanwhile, outside the U.S., the expectation was to have CE mark this quarter, but that approval hasn’t come. Sayer said they “would have liked to have launched G7” in Europe by today, but the company is going through the EU MDR process and is communicating with the regulatory authorities.
Sayer joked that the urgency of the approving bodies “probably doesn’t match mine.” Still, he’s not concerned about approvals as Dexcom has maintained cooperative, interactive discussions and hopes for the nods to come in the near term.
“We think it’s going to be a fabulous product across the board,” Sayer said. “It was very rewarding when we launched G6 to see how that changed the world. This product is going to do it again.”
