First mobile system of apps for continuous glucose monitoring approved by FDA
The first set of mobile medical apps that will allow diabetic patients to share data with others from a continuous glucose monitor (CGM) has received permission for marketing from FDA.
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By using Apple mobile devices, such as an iPhone, caregivers will be able to monitor their patient’s glucose levels remotely with the Dexcom Share Direct Secondary Displays system (Dexcom, Inc.). This is the first such legally marketed device, as previously these have been available but not in compliance with regulatory requirements.
The Share system displays data from Dexcom’s G4 Platinum CGM. Two apps are utilized with the system, the first app being downloaded by the diabetes patient and allowing the patient to designate “followers” who will receive their information, and the second app being downloaded by the caregiver to gather CGM data in real time.
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This technology will be especially valuable to the “caregivers of children with diabetes who want to monitor their glucose levels remotely,” explained Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health.
FDA reviewed data for the Share system by means of a regulatory pathway, the de novo classification process, for novel low- to moderate-risk medical devices that are not substantively equivalent to any legally marketed device. The manufacturer also provided FDA with data attesting to the system’s correct functioning and accurate and secure transmission of information.
This system has been classified as class II exempt from premarket submissions, which means that other manufacturers seeking to market devices like it in the future will not need premarket clearance by FDA. Such a device, however, will still have to be registered and listed with FDA, adhering to other applicable regulations and laws.
This system will not replace the use of fingerstick blood glucose monitoring for the accurate determination of insulin doses. Patients are also not to use it to replace a primary display device.
Approximately 25.8 million individuals have diabetes in the United States. Of this total, an estimated 215,000 are younger than aged 20 years.
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