FDA Approves First Diabetes-Related App

By Megan Williams, contributing writer

Diabetes apps just got a lot more useful on a clinical level. The FDA has announced that it is allowing marketing of the first set of medical apps that shares information from a continuous glucose monitor to people with diabetes.

Premiered by Dexcom, their Share Direct Secondary system allows diabetes caregivers to remotely monitor patient blood sugar levels through a device that’s available on mobile platforms. While the device isn’t new, prior to the FDA announcement, they were not compliant with regulatory requirements.

According to 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, “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. Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”

The Device
The CGM includes a wire-like sensor that’s inserted directly under the skin. The sensor provides a continuous stream of information about glucose levels in the interstitial fluid it’s in contact with. The devices, worn externally, display a continuous estimate of blood glucose levels, along with the direction and rate of change of the levels recorded. The purpose of the device is to help notify patients with diabetes when their blood glucose values are approaching dangerously high or low levels.

Two apps are used in the device: one on the patient’s mobile device, and another on the device of a different person, or “follower.” Followers are then able to download CGM data, and display it in real-time.

Device Classification
The FDA has determined that the device is moderate to low risk, qualifying it as class II exempt from premarket submissions. Future manufacturers producing devices similar to the Dexcom Share system will not need to qualify for FDA premarket clearance prior to marketing. They will, however, still need to contact the agency to register and list their device, and are still subject to other laws and regulations. Gutierrez added,

“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.”

Go Deeper
Read more about some of the benefits mobile apps can bring your clients.