FDA Approves First Mobile App To Monitor Real-Time Glucose Levels
The FDA for the first time approved a set of mobile applications that will allow providers to monitor glucose levels in real-time for patients with diabetes, the Washington Post's "To Your Health" reports (Dennis, "To Your Health," Washington Post, 1/24).
In September 2013, FDA issued final guidance for mobile health apps. The guidance said FDA will focus oversight on apps that:
- Were developed to be used as accessories to regulated medical devices, such as apps that allow health care providers to make diagnoses by viewing medical images on smartphones or tablets; or
- Can transform mobile devices into regulated medical devices, such as apps that allow a smartphone to be used as an electrocardiography machine (iHealthBeat, 12/12/13).
According to "To Your Health," the approval marks the first of its kind since FDA started regulating certain medical apps as devices.
The app system, which was created by Dexcom, includes:
- A small sensor that is inserted under a patient's skin;
- An external monitor that the patient wears; and
- A smartphone app.
The sensor continuously sends data to the external monitor, which then sends the information to the app. The app transmits the data to a secure Internet-based storage center, which allows individuals who have been designated as "followers" by the patient to download the information ("To Your Health," Washington Post, 1/24). Followers use a different app to view the information.
The system currently works with Apple's iPhones (Slabodkin, Health Data Management, 1/26).
According to "To Your Health," the approval could make it easier for similar mobile apps to break into the market because FDA approved the app as a "low- to moderate-risk" medical device. As a result, manufacturers developing similar apps in the future will have to register their device with the agency, but they will not need to gain prior approval from FDA.
Alberto Gutierrez, director of FDA's Office of In Vitro Diagnostics and Radiological Health, in a statement said, "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" ("To Your Health," Washington Post, 1/24).
Emory University professor of epidemiology and medicine K.M. Venkat Narayan added that the app could be useful for patients with significant fluctuations in their glucose levels, but that it would likely not fundamentally change glucose monitoring for diabetes (Tavernise, New York Times, 1/23).
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