- Dexcom said Thursday it received a CE mark for its G6 continuous glucose monitor (CGM) for use during pregnancy, a step in expanding the patient population for its signature device.
The company has never run a pregnancy-specific study itself, but a body of real-world evidence and other research out of Europe and the U.S. helped the company secure a CE mark, CEO Kevin Sayer told MedTech Dive on Thursday. "We look at this as a first step toward a very big market for us," he said.
- Pregnancy is one of the key indications Dexcom is after as it looks to new populations beyond Type 1 and Type 2 insulin users. The company is also targeting non-insulin-dependent Type 2 individuals and people with diabetes who are in the hospital.
FDA authorizations of Dexcom's G6 and Abbott's FreeStyle Libre 14 Day system in 2018 say the devices are not intended for pregnant women. Similarly, user information for Senseonics' implantable Eversense CGM and Medtronic's 670G insulin delivery system, which incorporates its Guardian sensor, note the systems have not been studied in pregnant women.
Whereas some women are already active CGM users prior to getting pregnant, the company aims to convert and maintain new customers during pregnancy.
"We're hoping what this does is it will take somebody who's not on CGM but is on insulin, and because we have this specific indication, a physician will say, 'Hey, we need to put you on this to manage your pregnancy,'" Sayer said. "As the patient gets through the pregnancy obviously the next course of events will be, 'Hey, this was so good I want to keep using it.'"
In addition to reducing the need for many fingersticks, Dexcom highlighted how its 'Follow' app can allow healthcare providers, family and others to more easily track a woman's health during pregnancy, if desired.
That feature landed the company in hot water in November when a systems outage disabled the ability to track loved ones via the app, unbeknownst to many users. Sayer eventually issued a public apology following customer backlash.
Earlier this month, the company established a real-time status webpage to keep users informed of any disruptions to the feature's availability. Additionally, Sayer told investors last week that Dexcom is "in the final stages" of rolling out an in-app messaging system that will similarly aim to more efficiently keep customers in the loop. Sayer further clarified Thursday that the company committed to having that product completed during the first half 2020, aiming for June at the latest.
The pregnancy labeling change is expected to be rolled out starting in the U.K. this spring. The next steps are to grow awareness among physicians and work on reimbursement for the indication.
"We eventually want to get our labeling ... to whereby anybody who has a glucose risk in pregnancy can use this and that is our long-term goal," Sayer said.
Pregnancy-friendly labeling in the U.S. may still be a ways out. Dexcom is working with FDA to figure out what it would need to have a label change approved, Sayer said.
Historically, there hasn't been much company-driven research on the utility of diabetes technologies in the pregnant population, resulting in Dexcom and others not being able to market the devices to pregnant women specifically. But several studies on outcomes among pregnant women using the devices were on display at the Advanced Technologies & Treatments for Diabetes (ATTD) meeting in Madrid this week.
Earlier this week at ATTD, both Dexcom and Abbott laid out plans to integrate their CGMs with a forthcoming automated insulin delivery system from Insulet. On Thursday, Abbott highlighted new real world data on Libre's reduction of HbA1c levels in people with Type 1 and Type 2.