FDA OKs Unblinded Professional Continuous Glucose Monitor

Miriam E. Tucker


June 04, 2014

The US Food and Drug Administration (FDA) has approved the first unblinded continuous glucose monitoring system for professional use.

The Dexcom G4 Platinum Professional Continuous Glucose Monitoring System (CGM) consists of a medical practice–owned professional CGM system and sensors. Patients are placed on the device for up to 7 days, during which they can view their glucose profiles. The physician then reviews the data retrospectively with the patient at the next office visit and makes treatment recommendations on the basis of the patterns.

"Clinicians can use the insights gained from a professional CGM session to adjust therapy and to educate and motivate patients to modify their behavior after viewing the effects that specific foods, exercise, stress, and medications have on their glucose levels," according to a Dexcom statement.

The new system, which also offers the physician the option of blinding the patient to the data if desired, is intended to assist in the management of patients who have difficulty meeting glycemic goals, experience frequent hypoglycemia, or have excessive glycemic variability.

Current professional-version CGMs only allow for retrospective review of downloaded blinded glucose data.

The new Dexcom system provides readings on the rate and direction of glucose change as often as every 5 minutes. Patients calibrate the system at least twice a day, using the results of fingerstick glucose measurements from conventional blood glucose meters.

The new system also allows for customized glucose targets and alerts and includes an alarm feature to alert the user if glucose levels rise or fall beyond preset thresholds.

More information is available on the Dexcom Web site.


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