The first set of mobile medical apps that permit secure, real-time data sharing by people who have diabetes and use a continuous glucose monitor were approved today by the Food and Drug Administration.
The Dexcom Share Direct Secondary Displays system allows caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely through an Apple mobile device such as an iPhone. 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 legally marketed solution for real-time remote monitoring of a patient’s CGM data, according to a press release from the FDA.
“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, Ph.D., 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.”
The CGM is worn externally and includes a small, wire-like sensor inserted just under the wearer’s skin. The device monitors and continuously displays an estimate of blood glucose levels as well as the direction and rate of change of these estimates.
The app transmits real-time CGM data 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 has classified the device as low to moderate in risk and 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. They will still need to register and list their device with the agency, as well as follow other applicable laws and regulations.
“Exempting devices from premarket review is part of the FDA’s effort to ensure these products provide accurate and reliable results while still encouraging the development of devices that meet the needs of people living with diabetes and their caregivers,” said Dr. Gutierrez.
The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring. CGM values alone are not approved to determine 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.The Dexcom Share system is manufactured by Dexcom, Inc., located in San Diego, Calif.
