The U.S. Food and Drug Administration in January allowed marketing of the first set of mobile medical apps that allow people with diabetes to automatically and securely share data from a continuous glucose monitor (CGM) with other people in real-time using an Apple mobile device such as an iPhone. The technology may find special use among caregivers of children with diabetes who want to monitor their glucose levels remotely according to the FDA.
The Dexcom Share Direct Secondary Displays system’s data-sharing capability is said to allow caregivers to a person with diabetes to monitor that individual’s blood sugar levels remotely through a device available on mobile devices. Devices such as the Dexcom Share were previously available through open source efforts, but were not in compliance with regulatory requirements, according to the FDA. 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. Using Dexcom Share’s mobile medical app, the user can designate people (“followers”) with whom to share their CGM data.
A CGM is a device that includes a small, wire-like sensor inserted just under the skin, which provides a steady stream of information about glucose levels in the fluid around the cells (interstitial fluid), according to the FDA. 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.
The Dexcom Share system is not intended to replace real-time continuous glucose monitoring or standard home blood glucose monitoring, according to 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; treatment decisions, such as insulin dosing, should be based on readings from a blood glucose meter.