Parents and caregivers of people with diabetes can now download a mobile app to their Apple device to help monitor their loved ones blood sugar levels remotely.
The new app is called the Dexcom Share Direct Secondary Displays system. It is designed to allow remote monitoring of an individual’s blood sugar levels through secure mobile devices.
According to the Food and Drug Administration (FDA), "devices like the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements. The Dexcom Share system is the first of its kind to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data."
“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. “Today’s marketing permission paves the way for similar technologies to be marketed in the United States.”
The app is designed to be used with a continuous glucose monitor (CGM), which provides a steady stream of information about glucose levels. CGMs are worn externally and continuously display an estimate of blood glucose levels, and the direction and rate of change of these estimates.
"When used along with a blood glucose meter, CGM information can help people with diabetes detect when blood glucose values are approaching dangerously high and dangerously low levels," noted the agency.
The Dexcom Share system displays data from the G4 Platinum CGM System using two apps: one installed on the patient’s mobile device and one installed on the mobile device of another person. Using Dexcom Share’s mobile medical app, the user can designate people (“followers”) with whom to share their CGM data. The app receives real-time CGM data directly from the G4 Platinum System CGM receiver and transmits it to a Web-based storage location. The app of the “follower” can then download the CGM data and display it in real-time.
The Dexcom Share system does not replace real-time continuous glucose monitoring or standard home blood glucose monitoring, noted the FDA. It is also not intended to be used by the patient in place of a primary display device. Additionally, CGM values alone are not approved to determine dosing of diabetes medications. CGMs must be calibrated by blood glucose meters, and treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter.
The Dexcom Share system is manufactured by Dexcom, Inc., located in San Diego, California.