FDA OKs Marketing for Glucose Monitoring App
The FDA announced today that it will permit the marketing of a mobile medical app that will help patients with diabetes share data from a continuous glucose monitor with other individuals.
The FDA announced today that it will permit the marketing of a mobile medical app that will help patients with diabetes share data from a continuous glucose monitor (CGM) with other individuals.
With the Dexcom Share Direct Secondary Displays, caregivers can keep an eye on their patient’s glucose levels remotely using Apple mobile devices, such as an iPhone.
Systems such as Dexcom Share existed previously, but this app will be the first of its kind with a legally marketed solution for monitoring patient’s blood sugar levels in real time, according to the FDA.
The Dexcom Share involves 2 apps. The patient with diabetes will download 1 app, which will allow the patient to set up “followers” for their information. The caregiver can download the second app, which will gather the CGM data in real time.
CGMs help patients with diabetes examine the direction and rate of their blood glucose levels, so they know when their levels are getting too high or low.
“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,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a press release. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”