FDA Approves Dexcom's Fully Mobile G5 CGM System
G5 is Dexcom's first continuous glucose monitor released since its partnership with Google Life Sciences, as well as the first-ever CGM to send reports directly to the user's phone.
Five months after the launch of Dexcom’s G4 Mobile Continuous Glucose Monitoring (CGM) System, the FDA has approved Dexcom’s newest model, the G5, which boasts a transmitter with wireless Bluetooth technology and can communicate with iOS-enabled devices without an additional receiver. Dexcom announced that patients who had received the G4 model after the beginning of August would be eligible for a free upgrade to the new model.
CGM systems allow diabetes patients to track their glucose levels continuously, without having to stop their daily activities to perform a finger stick, an advance that experts say is one of the biggest game-changers diabetes management has ever seen. New systems come equipped with apps that help patients plan meals and alert them to potentially dangerous spikes or dips in their glucose levels.
Dexcom’s G4 PLATINUM, as well as the G5, come with Share, an app and communication system that gives diabetes patients the option to share their data and alerts with up to five individuals remotely. In April, Dexcom announced that this technology would be compatible with the Apple Watch.
The biggest difference between the G4 and the G5 is that the G5 no longer requires an external receiver to communicate with the sensors attached to the body; the transmitter that hooks onto the sensor is equipped with Bluetooth technology that can communicate directly with the iOS systems. In a press release, Dexcom announced that Android-compatible apps will be available early next year.
Kevin Sayer, president and CEO of Dexcom, commented in the release that FDA approval of the G5 came sooner than everyone expected, and he reported that patients who invested in the G4 system since the beginning of August will be able to upgrade their systems for free. Those patients whose earlier models are still under warranty can upgrade their systems for a low fee.
“Obviously there are a lot of moving parts to our commercial launch plans given this sooner-than-expected approval, and the financial ramifications, such as inventory adjustments and revenue recognition policies are being evaluated,” said Sayer, who added that further details will be available in early November.
Last month, Dexcom announced a new partnership with Google’s Life Sciences Group, whose expertise will influence Dexcom CGM’s size and explore new ways of harnessing the healthcare potential of big data in all Dexcom models, starting with the G5.
Steve Pacelli, Dexcom’s VP, told Forbes that Google was the first to approach with an offer, and Dexcom was enthusiastic about the opportunity to incorporate Google’s data platform into its CGM products.
“I don’t think anyone could argue who has the best data platform,” Pacelli told Forbes. “Diabetes management is largely predicated on having data to make better decisions.”
The G5 CGM systems will begin shipping in late September.