FDA Approves First Fully Mobile Continuous Glucose Monitor

Miriam E. Tucker


August 25, 2015

The US Food and Drug Administration (FDA) has approved the first continuous glucose monitoring (CGM) system that sends data directly to a smartphone and does not require a separate receiver, according to a company release.

The Dexcom G5 Mobile CGM System was approved on August 25 for adults and children as young as 2 years of age. Using wireless Bluetooth technology built into the transmitter, the device sends real-time glucose information directly to an app on iOS-enabled devices, such as the iPhone. Android applications are expected early next year, according to the company release.

As with its predecessor, the G4 system, the G5 allows for up to five "followers," such as parents or other caregivers, to remotely monitor the patient's glucose levels and receive notifications about readings of concern.

Similar to other CGMs, the G5 system provides glucose trend information and issues alerts, but fingerstick blood glucose testing is still required for determining insulin doses and for system calibrations.

Dexcom aims to begin shipping the G5 system in late September 2015. Individuals who purchased the G4 system after August 1, 2015, will be eligible for a no-cost upgrade to the G5, and low-cost upgrades will be available for those who are still under warranty with existing Dexcom systems.


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