Dexcom Receives FDA Clearance for Dexcom G6 Pro Continuous Glucose Monitor

Dexcom G6 Pro
Image: Dexcom

Dexcom, a maker of continuous glucose monitoring systems for diabetes management, received FDA clearance of its Dexcom G6 Pro Continuous Glucose Monitoring (CGM) System for healthcare professionals to use with their patients, ages two years and up.

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“Dexcom G6 Pro will enable healthcare providers to set up their patients with CGM in minutes,” said Davida Kruger, MSN, APN-BC, BC-ADM, diabetes specialist, Division of Endocrinology, Diabetes, Bone and Mineral Disorders at 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.”

Dexcom G6 Pro can gather real-time glucose data over a period of 10 days and has the ability to be switched to blinded mode or unblinded mode. 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. 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, reports Business Wire.

Dexcom G6 Pro
Image: Dexcom

Regardless of mode, glucose data gathered by the Dexcom G6 Pro enables providers to adjust a patient’s diabetes therapy plan with precision and customization. Providers can also use the data to help patients modify their daily behavior after seeing the effects that variables such as food, exercise, stress and medication have on glucose levels.

The system includes a single-use, disposable sensor; auto-start transmitter, continuous glucose readings, alerts and alarms, and the Dexcom Clarity platform, which gives reports and patterns about glucose. There is no need of fingersticks for calibration or diabetes treatment decisions.

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“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,” Davida Kruger, a diabetes specialist, said in a Dexcom press release. “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.”