Dexcom G5 Mobile CGM system gets CE mark

Dexcom G5 Mobile CGM

After getting a nod from the FDA, the Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System has received CE Mark (Conformite Europeenne) and will be available in several European countries in the coming weeks.

Once launched, the system will be the first mobile-connected CGM in the EU and is indicated for adults and children as young as two years of age. The device offers wireless Bluetooth technology that allows glucose information to be displayed directly onto a smartphone, freeing users from the need to carry a separate receiver. Users can still use the System Receiver as an alternate display if they so choose.

Dexcom G5 Mobile CGM also features Share technology that lets users select up to five designated recipients, or “followers” who can remotely monitor the patient’s glucose information and receive alert notifications from almost anywhere for an added circle of support. In addition, the new Dexcom G5 Mobile CGM system does not require confirmatory finger sticks when making treatment decisions, except to calibrate the device.

Dexcom G5 Mobile offers wireless Bluetooth technology that allows glucose information to be displayed directly onto a smartphone.“With an enhanced interface and fully mobile design, the device is changing the landscape of diabetes management, offering users greater convenience, flexibility and discretion than ever before,” said Kevin Sayer, President and CEO of Dexcom.

The Dexcom G5 Mobile comes with a 7-day sensor and offers customizable alerts and a built-in low glucose alarm to provide patients with advanced warning to help them avoid dangerous high and low glucose events. Data from the Dexcom G5 Mobile can be integrated with DIASEND, a communications platform that transfers and integrates CGM data and provides retrospective reports that help patients and caregivers with overall diabetes management.

Diabetes affects about 60 million people in Europe and is on the rise, according to the World Health Organization. As part of the wider goal to fight diabetes, Dexcom is working with Google to develop low-cost CGM products.