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FDA Allows First Medical Apps for Continuous Glucose Monitoring
The FDA has allowed marketing of the first set of mobile medical apps that allow people 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 data-sharing capability of the Dexcom Share Direct Secondary Displays system (Dexcom, Inc.) allows caregivers of a person with diabetes to monitor that individual’s blood sugar levels remotely through a legally marketed device that is available on mobile devices. Devices such as the Dexcom Share were previously available through open source efforts but were not in compliance with regulatory requirements. The Dexcom Share system is the first of its kind to offer a legally marketed method for real-time remote monitoring of a patient’s CGM data.
“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, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
A CGM is a device that includes a small, wire-like sensor inserted under the skin that provides a steady stream of information about glucose levels in interstitial fluid. CGMs are worn externally and continuously display an estimate of blood glucose levels, and the direction and rate of change of these estimates. When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels.
The Dexcom Share system displays data from the G4 Platinum CGM System using two apps: one installed on the patient’s mobile device and the other installed on the mobile device of another person. Using Dexcom Share’s mobile medical app, the user can designate people (“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.
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 the device maker showed that the device functions as intended and transmits data accurately and securely.
Because the device has a low to moderate risk, the FDA has classified it as class-II exempt from premarket submissions. In the future, manufacturers intending to market devices such as the Dexcom Share system will not need premarket clearance by the FDA prior to marketing, but they will still need to register and list their device with the agency, as well as follow other applicable laws and regulations.
The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring, the FDA points out. It is also not intended to be used by the patient in place of a primary display device. In addition, CGM values alone are not FDA-approved to determine the dosing of diabetes medications. 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.
An estimated 25.8 million people in the U.S. –– about 215,000 of them aged less than 20 years –– have diabetes. If left untreated, hyperglycemia can lead to serious long-term problems, such as stroke, heart disease, and damage to the eyes, kidneys, and nerves.
Source: FDA; January 23, 2015.