Dexcom Share, a smartphone-connected CGM charging cradle, gets FDA clearance

By Jonah Comstock
12:40 pm

Dexcom-SHAREDexcom Share, a cradle device that will allow users to send data from a Dexcom continuous glucose monitor to multiple smartphones, has received 510(k) clearance from the FDA. The system is designed to help parents and caregivers remotely track the glucose of a child, elderly parent, or spouse when the diabetes patient is at home or stationary.

“Dexcom Share represents a significant advance in diabetes care by allowing people with diabetes to share important glucose information with their loved ones from afar,” Terrance H. Gregg, Chief Executive Office of Dexcom, said in a statement. “With Dexcom Share, users, parents and personal caregivers now have a new tool to dramatically improve how they communicate about their diabetes.”

The Dexcom G4 CGM system consists of a sensor with a needle that rests under the skin and can be worn for seven days at a time and a pocket-sized receiver device that displays the near real-time blood glucose data from the sensor. The Share is a docking cradle for that receiver. It has to plug into a wall, so it supports a use case where the user is at home, in a hotel room, or in a classroom, rather than out and about. However, with an operational distance of 20 feet, the receiver can charge its battery while still collecting data from the sensor -- and forwarding it to up to five smartphones at any distance away.

When the device was first announced last year in a Dexcom investor call, DiabetesMine reported that "the data could be sent to the parent of a CWD who’s sleeping over at a friend’s house, to a spouse of a traveling adult [person with diabetes] from a hotel room in another state, or even to a health care provider if desired." The device uses Bluetooth to transmit the data to a nearby host smartphone, which then uploads it to a secure server to share with up to five other smartphones. It's cleared to work with Apple devices.

Dexcom Share is a first step in smartphone-connected continuous glucose monitoring, but it's not portable when a patient is on the move. Gregg has said he hopes eventually the cradle will connect to a lithium battery. In addition, a patent filing from January shows Dexcom may be working on a system that connects the smartphone and the G4 directly.

Dexcom may have an incentive to work fast on such a system: At Health 2.0 in September, competitor Medtronic showed off a prototype of its not-yet-FDA-cleared Guardian Mobile system. Guardian Mobile connects Medtronic's Guardian CGM directly with the user's smartphone via Bluetooth and is set to begin a clinical trial soon.


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