First Apps Approved for Sharing Glucose Monitoring Data
The Food and Drug Administration (FDA) has granted marketing of the Dexcom Share system, the first set of mobile medical applications (apps) that allow patients with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone.
The Dexcom Share system displays data from the G4 Platinum CGM System using an app installed on the patient's Apple mobile device and one installed on the Apple mobile device of another person; the patient can designate individuals (“followers”) with whom to share their CGM data. The app receives real-time CGM data directly from the G4 Platinum System CGM receiver and transmits it to a Web-based storage location. Then, the app of the “follower” can download the CGM data and display it in real-time. The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring and is not intended to be used by the patient in place of a primary display device.
The FDA reviewed data from the manufacturer through the de novo classification process for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. This data showed that the device functions as intended and transmits data accurately and securely.
For more information visit FDA.gov.