FDA clears Dexcom to integrate glucose monitor and insulin dosing devices, streamlines path for future products

The next company to seek approval for an integrated CGM will encounter a simpler path to market. (Image: FDA)

Dexcom has received FDA approval for a continuous glucose monitor (CGM) that integrates with insulin pumps and other diabetes devices. The regulatory clearance marks the first time the FDA has signed off on such an integrated system—and creates a simpler path to market for future CGMs.

The G6, like its predecessor, is a wearable patch that takes glucose readings and wirelessly transmits the data to a connected device. Dexcom has made typical iterative improvements in size and lifespan but it is what happens to the data after it leaves the patch that is the big change. 

For the first time, a CGM can integrate with a range of dosing devices, providing a stream of data that enables automatic insulin deliveries in response to rises in blood glucose. Other CGMs are on the market as part of closed loop systems that handle both monitoring and dosing with minimal active input from the patient. But the G6 is the first CGM indicated for integration more broadly with compatible medical devices.

In approving the G6, the FDA left the door open for future integrated CGMs. The approval categorizes the G6 as a class II device and establishes certain special controls. The upshot is the next company to seek approval for an integrated CGM will encounter a simpler path to market.

“The FDA has taken steps to expedite the review process for similar, integrated CGMs and make these types of systems available to patients as quickly as possible while also helping to ensure their safety and reliability,” Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health at the FDA, said in a statement.

The device also closes a technological gap that had opened up between Dexcom and its rival Abbott.  Dexcom G5 required users to take finger pricks to calibrate the device. Abbott’s FreeStyle Libre freed users from this task, contributing to the device supplanting the G5 as the CGM connected to Bigfoot Biomedical’s experimental insulin delivery device.  

RELATED: Bigfoot picks Abbott glucose sensor for insulin delivery tech

Dexcom G6 eliminates Abbott’s edge by coming factory-calibrated, ending the need for users to take finger pricks. That is one of the headline technological advances but is far from the only thing to change between the G5 and G6.

“You all should be cognizant of the fact that this isn't just a new algorithm or it isn't just a new sensor. This is a new everything. The sensor is new, the membranes are new, the applicator is new, the manufacturing processes are different, the algorithm is different, the calibration scheme is different, everything across the board is different than anything we've ever done before,” Dexcom CEO Kevin Sayer said on a conference call last month.

Dexcom has a lot resting on the G6 and is hoping to hit the ground running in multiple markets. That will result in a big advertising campaign as Dexcom pushes messages targeted at kids, parents, adults and seniors in a bid to ensure a successful liftoff for G6.

“That's going to be a very big dollar spend for us, and we'll attack every single avenue that we have when we get that product out there because we really believe it's a home run,” Sayer said. 

With the G6 approval in the bag, the attention of Dexcom’s regulatory and R&D teams will turn to the next iteration of the device. Dexcom is working on a version that lasts for 14 days, rather than the current 10, that will feed into a fully-disposable CGM device it is developing with Alphabet’s Verily.