First Mobile Apps Approved By FDA For Blood Glucose Monitoring

Caregivers of people with diabetes can now monitor patients' blood sugar levels through the first FDA-approved mobile medical technology.

A set of apps called the Dexcom Share system allows one app to be installed on a patient's smart phone and the other on the device of the caretaker. The patient wears a small sensor inserted under the skin which provides feedback about blood glucose levels. The data is then transmitted to the apps, alerting the patient and caretaker when blood sugar levels are dangerously low or high.

“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 Dr. Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at 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.”

Technology Transmits Data Securely and Accurately

The FDA's approval of the Dexom Share system means the technology transmits data accurately and securely.

A person using the "follower" app can download information about the patient's blood glucose levels and view it in real-time.

The system is not intended for stand-alone use or in place of home blood sugar monitoring, but it may provide caretakers another helpful tool while setting a standard for similar technologies to be brought into future markets.

Source: FDA.gov

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