FDA www.fda.gov has approved the marketing of the first set of mobile medical apps so that diabetics can 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 Dexcom SHARE www.dexcom.com system is the first system to offer a legally marketed solution for real-time remote monitoring of a patient’s CGM data. Devices like the Dexcom SHARE were previously available through open source efforts, but were not in compliance with regulatory requirements.
A CGM device includes a small, wire-like sensor inserted just under the skin to provide a steady stream of information about glucose levels in the fluid around the cells. GCMs 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 or dangerously low levels.
The Dexcom SHARE system displays data from the G4 Platinum CGM System using two apps. One app is installed on the patient’s mobile device and the other app is installed on the mobile device of another person. Using the mobile medical app, the user can designate people or followers to share their CGM data. The app of the follower can then download the CGM data and display it in real-time.
FDA reviewed the data for the system through the de novo classification process, a regulatory pathway for low to moderate risk medical devices that are novel and not substantially equivalent to any legally marketed device. Data provided by the maker of the device showed that the device functions as intended and transmits data accurately and securely.
Since the device is low to moderate risk, FDA has classified the device as class II exempt from premarket submissions. In the future, manufacturers wishing to market devices like the Dexcom SHARE system will not need premarket clearance by FDA prior to marketing, but they will still have to register and list their device with FDA, as well as follow other applicable laws and regulations.