The US Food and Drug Administration (FDA) has approved the first-ever system of mobile medical apps that allow real-time data to be shared between a continuous glucose monitor and mobile devices such as an Apple iPhone.
The Dexcom Share Direct Secondary Displays system is the first wireless device that allows caregivers or other designated “followers” to remotely monitor glucose levels of a person with diabetes.
“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, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in an FDA statement.
In October 2014, the FDA approved a Dexcom accessory cradle for a monitoring device, primarily for night time use. The new system that the FDA just cleared can communicate all the time wirelessly, and does not have to be in close proximity to the patient.
The Share system displays data from Dexcom’s G4 Platinum Continuous Glucose Monitor (CGM) using apps installed on the patient’s mobile device and on the mobile device of another person. Through the user’s app, “followers” are designated who can receive the glucose data. The app receives the data from the CGM and transmits it to a Web-based storage location from which the app of the “follower” can download and display the data in real time.
As with other CGMs, the Dexcom Share system is not intended to replace fingerstick blood glucose monitoring for determining insulin doses, and fingerstick testing is still needed for system calibrations. It is also not intended to be used by the patient in place of a primary display device.
The FDA classifies the Share system as a novel but low-to-moderate risk device, exempt from the requirement for premarket submissions.
According to Dr Gutierrez, “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…. Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
Miriam E. Tucker