FDA Allows Marketing of Mobile Medical Apps for CGM

The U.S. Food and Drug Administration announced today that it will allow marketing of the first set of mobile medical applications 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 Dexcom Share Direct Secondary Displays system’s data-sharing capability allows caregivers to a person with diabetes to monitor that individual’s blood sugar level remotely through a legally marketed device available on mobile devices.

Devices similar to the Dexcom Share were previously available through open sources but lacked regulatory compliance. 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 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.”

What Is a CGM?

A CGM is a device that includes a small, wire-like sensor inserted just under the skin. This provides a steady stream of information about glucose levels in the fluid around the cells (otherwise known as interstitial fluid). CGM's 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 or dangerously low levels.

About Dexcom Share

The Dexcom Share system displays data from the G4 Platinum CGM System using two apps: one installed on the patient’s mobile device and one installed on the mobile device of another person. By using Dexcom Share’s mobile medical app, the user can choose people to share their CGM data with. The app receives real-time CGM data directly from the G4 Platinum System CGM receiver. It transmits the data to a Web-based storage location. The data can then be downloaded and displayed in real-time.

The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring, nor is it designed as a primary display device for patients.

Additionally, CGM values alone are not approved to determine dosing of diabetes medications. Treatment decisions like insulin dosing should always be based on readings from a blood glucose meter.

Source: Adapted from FDA press release

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