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Dexcom G5 Mobile CGM System Approved by FDA
Mary K. Caffrey

Dexcom G5 Mobile CGM System Approved by FDA

Mary K. Caffrey
A fully mobile continuous glucose monitoring (CGM) system, which features wireless Bluetooth technology and can be used with a smart-phone, received approval from the FDA on August 24, 2015. The technol-ogy was approved for adults and children as young as 2 years who have either type 1 diabetes or type 2 diabetes.

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 a 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 the company.

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

“Dexcom is rapidly advancing technology for CGM 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 CEO 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. EBDM
Reference

FDA approves Dexcom G5 mobile continuous glucose monitoring system [press release]. San Diego, CA: Dexcom, Inc newsroom; August 24, 2015. www.dexcom.com/news/1257506247-fda-approves-dexcom-g5%C2%AE-mobile-continuous-glucose-monitor-ing-system. Accessed August 31, 2015.
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