The FDA has permitted marketing of the Dexcom Share Direct Secondary Displays system — the first set of mobile medical apps that allow patients with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) in real-time using an Apple mobile device, according to an agency press release.
The Dexcom Share system allows caregivers to remotely monitor the blood sugar levels of a patient with diabetes using a system that is available on mobile devices, such as an iPhone. The system is the first of its kind to offer a legally marketed solution for real-time monitoring of CGM data.
The system displays data from the G4 Platinum CGM system using two apps — one installed on the patient’s mobile device and one installed on another person’s mobile device. The user designates people, or “followers,” with whom to share their CGM data. The app receives real-time CGM data directly from the G4 Platinum CGM receiver and transmits it to a Web-based storage location, and the follower’s app can then download the CGM data and display it in real time.
“This innovative technology has been eagerly awaited by the diabetes community, especially caregivers of children with diabetes who want to monitor their glucose levels remotely,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in the release. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
The agency reviewed data from the manufacturer demonstrating that the device functions as intended and transmits data accurately and securely, using the de novo classification process reserved for novel, low- to moderate-risk devices that have no legally marketed equivalents. The FDA has also classified the device as class II exempt from premarket submissions.
“Exempting devices from premarket review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers,” Dr. Gutierrez said.
In the release, the agency cautioned that the Dexcom Share system does not replace real-time CGM or standard home blood glucose monitoring and is not intended to be used by a patient in the place of a primary display device.