FDA clears practice-owned diabetes management tool

The Food and Drug Administration has given clearance to the Dexcom G6 Pro single-use continuous glucose monitoring system to enable healthcare providers to tailor treatment plans for diabetic patients.

Patients wear a single-use, disposable sensor for 10 days and then Dexcom’s CLARITY software enables providers to put together reports on glucose patterns, trends and statistics that can be retrospectively reviewed with patients when they return to their physician’s office.

According to Dexcom, the G6 Pro is the first and only single-use, professional CGM that gathers patients’ real-time glucose data over a 10-day period and operates in both blinded and unblinded modes.

“In blinded mode, real-time glucose data is hidden from the patient and reviewed retrospectively with their healthcare professional at the end of the session,” according to the vendor’s announcement. “In unblinded mode, patients can see their glucose data throughout the 10-day sensor wear to gain insights and make treatment decisions in real time.”

The Dexcom G6 Pro, which is slated to begin shipping in early 2020, is indicated for management of diabetes in persons two years of age and older. The system is FDA-permitted to make diabetes treatment decisions without confirmatory fingersticks or calibration.

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The G6 Pro automatically provides glucose values every five minutes and—in unblinded mode only—alerts users of dangerous high and low glucose levels on their smart device. In addition, the glucose data can be shared with up to 10 followers.

“Dexcom G6 Pro will enable healthcare providers to set up their patients with CGM in minutes,” said Davida Kruger, a diabetes specialist in the Division of Endocrinology, Diabetes, Bone and Mineral Disorders at the Henry Ford Health System in Detroit. “This new professional system will serve as a simple way to obtain data from CGM naïve patients who need glucose insight, but don’t need or want to be monitored around the clock. It will give all my patients a chance to try the Dexcom G6 Pro under a healthcare provider’s supervision before they commit to a personal system.”

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