In January, 2015 permitted the marketing of mobile apps for continuous glucose monitoring. That release was specific to Apple iOS supported applications. As mentioned above, Dexcom Share Direct Secondary Displays system is first of its kind to offer a legally marketed solution for continuous monitoring. This device has a small wire like sensor that is inserted under the skin. The actual device is worn externally and has a continuous display of glucose for patients who have acute diabetes.

The FDA reviewed the Dexcom Share system under 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 device maker showed the device functions as intended and transmits data accurately and securely.” Since the risk is low to moderate, FDA has classified it as a Class II. Due to this, if there are other systems in the future like Dexcom, then they will be exempt from pre market clearance from FDA. But they will have to register their device to FDA.

There is also a device approved by FDA known as the Medtronic’s MiniMed 670G hybrid closed looped system. This is “intended to automatically monitor glucose (sugar) and provide appropriate basal insulin doses in people 14 years of age and older with type 1 diabetes.” However, this contains a sensor under the skin and a catheter attached to the device. It has a display on the device but not through a phone app.