Date Published: 23 January 2015
FDA allows marketing of first system of mobile medical apps for continuous glucose monitoring
The Food and Drug Administration (FDA) of the United States has permitted 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 a mobile device such as an Apple iPhone.
The Dexcom Share Direct Secondary Displays system's data-sharing capability enables people who look after a person with diabetes to monitor that individual's blood sugar levels remotely through a device that is available on mobile devices such as smart phones. Devices like 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 solution 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 Dr Alberto Gutierrez, 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 located just beneath the skin that provides a continuous flow of information about glucose levels in the fluid around the cells (interstitial fluid). When used together with a blood glucose meter, CGM information can alert people with diabetes 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 of the apps is installed on the patient's mobile device and the other app is 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 this system through the de novo classification process, which is 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 the device functions as intended and transmits data accurately and securely. As a result of this device being considered as having only a "low to moderate risk", the FDA classified it as class II exempt from premarket submissions. In the future, manufacturers wishing to market devices like 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. It is not intended to be used by the patient in place of a primary display device. It is also important to understand that CGM values alone are not approved to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters. Treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter.
Source: The U.S. Food and Drug Administration