Dexcom G5 Mobile CGM System Approved by FDA

Approval for the technology, which integrates with a smartphone, came sooner than company officials expected.

A fully mobile continuous glucose monitoring (CGM) system, which features wireless Bluetooth technology and can be used with a smartphone, received approval from FDA August 24, 2015. The technology was approved for adults and children as young as 2 years old with type 1 and type 2 diabetes mellitus.

The new technology from Dexcom, called the G5, will free users from needing a separate receiver to monitor their glucose data, giving insulin-dependent patients who use CGM to monitor blood glucose levels long-sought advances in privacy and convenience. The Dexcom G5 Mobile system is expected to start shipping in late September 2015, according to a statement from Dexcom.

According to the company, the FDA action came faster than expected, and Dexcom will offer programs for recent purchasers of its G4 Platinum and Share system and current users who have products still under warranty to receive low-cost or no-cost upgrades.

“Dexcom is rapidly advancing technology for continuous glucose monitoring devices to improve diabetes management. Since January, the company has introduced the G4 Platinum CGM with Share, apps to enable the first CGM on the Apple Watch, and now the Dexcom Mobile CGM,” said Kevin Sayer, president and chief executive officer of Dexcom. “These advances are making diabetes management more convenient and flexible than ever before.”

Dexcom’s Share technology allows users to designate up to 5 followers who can remotely monitor a patient’s glucose information and receive alerts if the patient is in danger of an episode of hypoglycemia or hyperglycemia. The technology is especially usefully for parents or spouses, as a person with diabetes who experiences a drop in blood sugar may be asleep or unaware of his or her status.

Reference

FDA approves Dexcom G5 mobile continuous glucose monitoring system [press release]. http://www.dexcom.com/news/1257506247-fda-approves-dexcom-g5%C2%AE-mobile-continuous-glucose-monitoring-system. San Diego, CA: Dexcom newsroom; August 24, 2015.