FDA Green-lights First System of Apps for Continuous Glucose Monitoring

(Dexcom G4 Platinum Continuous Glucose Monitoring System with Share, courtesy of Dexcom)

On January 23, the U.S. Food and Drug Administration (FDA) permitted marketing of the Dexcom G4 Platinum Continuous Glucose Monitoring system (CGM) with Share, a device that allows users as young as two years old to automatically share blood glucose data with designated followers using a system of apps.


The Dexcom G4 Platinum is composed of a sensor, a transmitter, and a monitor. The sensor, which is approximately the diameter of a human hair, is inserted under the skin of the abdomen, where it continuously monitors the glucose level of the interstitial fluid (the fluid between cells). These values are sent to the monitor via the transmitter every five minutes for up to seven consecutive days.

The original Dexcom Share accessory, approved in October 2014, included a physical cradle into which the CGM was place to transmit the data. The new technology uses a secure wireless network via Bluetooth Low Energy (BLE) to transmit the glucose levels measured by the Dexcom G4 Platinum from the CGM receiver to an app on the user’s smartphone. From this app, the data is then transmitted to the smartphones of up to five designated recipients, or “followers,” such as parents or other caregivers of people with diabetes. Using their iPhone or iPod touch (and, in the future, Android devices), these followers can remotely monitor the glucose data and receive alert notifications from almost anywhere.

The “Share” and “Follower” apps will be available at no charge in the Apple App Store.

The Share receiver is expected to ship to new customers in early March 2015. Those who purchased a Share cradle, as well as those who purchase a G4 Platinum receiver from January 1, 2015, until the Share receiver is shipped, will receive a free upgrade to the Share receiver. Those who are still under warranty with their existing receiver will have the option of a low-cost cash upgrade to the Share receiver.

For more information, see the press releases on the BusinessWire and FDA websites.