Dexcom G6 Continuous Glucose Monitor Approved by FDA

Oct 10, 2019

New CGM eliminates fingersticks, introduces new data presentation.

Dexcom’s newest continuous glucose monitoring (CGM) system, the G6 Pro, has been approved by the FDA for healthcare professionals to use with patients 2 years of age and older. 

Noteworthy features of the newest installment in Dexcom’s single-use, disposable CGM sensor lineup include the elimination of finger sticks for calibration or diabetes treatment decisions, as well as new Blinded and Unblinded data presentation modes. 

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

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In Blinded Mode, healthcare providers can shield real-time glucose data from the patient and review retrospectively at the end of the session. Conversely, Unblinded Mode allows patients to observe their real-time glucose data-updated every five minutes-throughout their 10-day sensor period in order to gain fresh insights and make real-time treatment decisions. 

Other features promoted in Dexcom’s official release include: 

 

  • Easy sensor application-allows for one-touch, simple insertion

  • Auto-start transmitter-simplifies session initiation and cessation for both patients and providers 

  • Alerts and Alarms-warn users of dangerously high and low glucose levels (unblinded mode only)

  • Dexcom CLAIRTY-management software that allows providers to pull interactive reports and retroactively review glucose patterns, trends, and statistics with their patients

 

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