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FDA approves first continuous glucose monitoring app

Clears remote blood sugar monitor Dexcom Share

Dexcomm_Share_CGM_copyUS regulators have for the first time cleared mobile apps that allow diabetes patients to automatically and securely share blood glucose data collected using their iPhone or iPod Touch.

The approval for the Dexcom Share apps from San Diego-based Dexcom is the first time the FDA has approved apps for real-time data sharing from a continuous glucose monitor (CGM).

Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, 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.

“[This] marketing permission paves the way for similar technologies to be marketed in the United States.”

Devices like the Dexcom Share were previously available through open source efforts, but did not comply with regulatory requirements, so Dexcom becomes the first firm to be able to offer a product that could be legally marketed for real-time remote monitoring of a patient's CGM data.

CGMs are devices that include a small, wire-like sensor inserted just under a patient's skin to provide a steady stream of information about glucose levels in the fluid around the cells (interstitial fluid).

In the case of the Dexcom Share system two free apps are used, one installed on the patient's mobile device (the 'Share' app) and one installed on the mobile device of up to five other people (the 'Follower' app). Users can designate people with whom to share their CGM data, which is transmitted via a receiver device and the $299 Dexcom Share Cradle to a cloud-based storage service.

The FDA counts the apps as mobile medical apps, the regulator's term for smartphone apps that perform the same functions as traditional medical devices.

However, the system was reviewed through the FDA's regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device.

Manufacturers of similar devices will not need premarket regulatory clearance prior to marketing but, the FDA said, will still need to register and list their device with the agency.

The regulator also cautioned that systems like the Dexcom Share do not replace real-time continuous glucose monitoring or standard home blood glucose monitoring.

Article by
Dominic Tyer

5th February 2015

From: Regulatory



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