The U.S. Food and Drug Administration has cleared the first set of mobile medical apps that allow diabetics to automatically and securely share data from a continuous glucose monitor (CGM) with caregivers in real-time via an Apple mobile device.
According to the FDA, the Dexcom Share system manufactured by San Diego-based Dexcom, Inc., is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patients CGM data. CGMs are worn externally and are devices that include a small, wire-like sensor inserted just under the skin that provides a steady stream of information about glucose levels.
The Dexcom Share system displays data from the G4 Platinum CGM System using two apps: one installed on the patients mobile device and one installed on the mobile device of another person. Using Dexcom Shares mobile medical app, the user can designate 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. The app of the follower 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, said Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDAs Center for Devices and Radiological Health, in a written statement.
According to Gutierrez, the FDAs decision paves the way for similar technologies to be marketed in the United States. The regulatory agency has classified the device as class II exempt from premarket submissions. Going forward, manufacturers that want to market devices like the Dexcom Share system will not need premarket clearance by the FDA, but they will still need to register and list their device with the agency, as well as follow other applicable laws and regulations.
The FDA reviewed data for the Dexcom Share system through the de novo classification process, a regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. Data provided by Dexcom showed the device functions as intended and transmits data accurately and securely, states the agency.
However, at the same time, FDA warns that the Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring and that CGM values alone are not approved to determine dosing of diabetes medications and that CGMs must be calibrated by blood glucose meters, and treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter.
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