The U.S. Food and Drug Administration on Friday approved the first set of medical apps that automatically and securely share data from a continuous glucose monitor in real time. The apps are part of a data-sharing system developed by San Diego-based Dexcom, Inc.
A small, wire-like sensor inserted under the skin continuously transmits glucose level data to a monitor worn externally. The app on the patient’s smartphone then receives and transmits the data to a web-based storage location.
A patient can designate “followers” with whom to share the data. Followers can then download and display the data in real time using another app.
“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, Ph.D., director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement.
The FDA noted that the Dexcom system does not replace fingerstick glucose monitoring and should not be used to determine dosing of diabetes medications. It is also not intended for use in place of a primary display device, the agency said.
Gutierrez said that Friday’s marketing approval paves the way for similar technologies because the device was classified as “low to moderate risk.”
That means other companies that want to market a similar product will not need prior approval from the FDA and will only need to register their device with the agency, a policy set forth in the FDA’s 2013 guidance that noted most mobile medical apps pose little risk to consumers.
Rather the agency, which by 2013 had already cleared about 100 apps, said it would regulate health-related mobile apps that “present a greater risk to patients if they do not work as intended.”