FDA Clears Way For Smartphone-Connected Continuous Glucose Monitors

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The FDA has cleared the way for a new continuous glucose monitor that will wirelessly connect to a smartphone, and then securely transmit glucose readings in real time to anyone involved in the patient’s care. Since 2013, the FDA has taken a hands-off approach to regulating mobile medical apps, but has maintained regulatory authority over apps that connected with a medical device. As a result, diabetics have been patiently waiting for technology that would allow them to remotely check glucose levels with their smartphones.

The newly approved app comes from Dexcom, a California-based medical device manufacturer. The technology, called Dexcom Share, wirelessly syncs data from an implanted continuous glucose monitor with a paired smartphone. That data is then shared with anyone that the patient provides access to. The Share app also includes an alert feature that will send an alarm to a designated caregiver if glucose levels trend out of range.

This functionality has a multitude of use cases. Seniors will be a key demographic for the new technology, providing caregivers the ability to remotely monitor glucose management. Remote glucose monitoring technology could also provide valuable data to local population health programs. Parents of diabetic children have been especially vocal in their calls for FDA-approved remote monitoring features.

The new technology has been in such high demand within the diabetes community that last year a team of engineers, and parents of a son with Type 1 diabetes, hacked their child’s glucose monitor and built a custom app so that they could monitor his glucose levels when he was at school or had a sleepover at a friend’s house. The parents then launched a social media campaign under the hashtag #WeAreNotWaiting, calling for expedited FDA approval for this seemingly straight-forward technology.

The FDA reviewed the app through its de novo classification process, which was designed to provide an approval pathway for low to moderate risk medical devices that are novel and not substantially equivalent to other approved devices. Now that approval has been granted, other CGM manufacturers should have a significantly faster route to FDA clearance and the technology should become more widely available to diabetics.


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