In January the FDA approved Dexcom’s G4 Platinum Continuous Glucose Monitoring (CGM) System with ShareTM enabling diabetics as young as 2 years of age to automatically and securely share real-time CGM data from their Dexcom receiver and iPhone to a caregiver’s mobile app.
The Dexcom G4 PLATINUM Receiver with Share uses a secure wireless connection via Bluetooth Low Energy (BLE) between a patient’s receiver and an app on the patient’s iPhone® to transmit glucose information to apps on the mobile devices of up to five designated recipients, or “followers,” without the need for a dedicated docking cradle. These followers can remotely monitor a patient’s glucose information and receive alert notifications anywhere they have an internet connection, initially via their Apple® iPhone® or iPod touch®, giving them peace of mind and reassurance when they are apart.
The FDA counts the apps (on the patient’s and follower’s mobile devices) as mobile medical apps, the regulator’s term for smartphone apps that perform the same functions as traditional medical devices. However, the system was reviewed through the FDA’s regulatory pathway for low- to moderate-risk medical devices that are novel and not substantially equivalent to any legally marketed device. More info can be found here.