FDA approves first single-use continuous glucose monitoring system

The Dexcom G6 Pro Continuous Glucose Monitoring (CGM) System was approved by the FDA October 8 for use by physicians to help monitor patient data in real time.

The G6 Pro is the first and only single-use CGM that gathers glucose data in real time over a 10-day period in both a blinded and unblinded mode, according to a news release from Dexcom.

Glucose data is hidden from the patient and reviewed retrospectively with their doctor in blinded mode, while unblinded mode allows the patient to see the data throughout the 10-day sensor wear granting them the ability to learn from the data and make treatment decisions in real time, the release said.

Whatever mode the system is used in, the glucose data gathered enables physicians to adjust their patient’s diabetes therapy with precision and customization, while that data can also be used to allow patients to modify their behavior while observing the effects that variables like food, exercise, stress, and medication have on their glucose levels.

“Dexcom G6 Pro will enable healthcare providers to set up their patients with CGM in minutes,” says Davida Kruger, MSN, a diabetes specialist with the 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.”

Some of the features and benefits of the Dexcom G6 Pro include:

• An easy sensor applicator which allows for one-touch, simple insertion

• Single-use disposable sensor which simplifies the start and end of sessions for both patients and providers

• Blinded and unblinded modes

• Continuous glucose readings automatically every five minutes

• Alerts and alarms which warn users of dangerously high or low glucose levels in unblinded mode

• Eliminates the need for fingersticks in calibration or diabetes treatment decisions

• Dexcom CLARITY which allows physicians to pull interactive reports on glucose patterns, trends, and statistics

“At Dexcom, we are continuing to drive innovation in wearable health technology,” says Kevin Sayer, president, CEO and chairman of Dexcom. “Using the power of Dexcom G6 Pro, clinicians can use the insights gained from a 10-day professional CGM session to adjust treatment plans and empower their patients to live healthier lives.”

The Dexcom G6 Pro is expected to begin shipping in early 2020.