Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System Receives FDA Approval


Dexcom logoThe  U.S. Food and Drug Administration (FDA) has given its approval for the Dexcom G4 PLATINUM Professional continuous glucose monitoring system (CGM). The Dexcom G4 PLATINUM Professional is the only professional-version CGM that offers real-time, unblinded feedback allowing the patient to experience the full benefits of real-time CGM, while providing the doctor with an opportunity to review glucose data retrospectively with the patient to make therapeutic treatment recommendations. 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. Current professional CGMs offer only retrospective, blinded information but with the Dexcom G4 PLATINUM Professional system, physicians can help coach their patients to better outcomes through real-time visibility of dynamic glucose changes as they occur.

Professional CGM is a powerful, analytical tool for healthcare professionals to help their patients who:

·       Struggle to meet glycemic goals;

·       Suffer from frequent hypoglycemia; or

·       Have wide fluctuations in glycemic variability

The Dexcom G4 PLATINUM Professional CGM consists of a medical practice-owned professional CGM system and sensors. With minimal training and setup time, patients are placed on a professional CGM for a period lasting seven days. During that time, dynamic and comprehensive data is collected and can be shared with the patient, which aids in their understanding of the impact between behavior and glucose activity. By taking at least two calibrations from a blood glucose meter daily, the Dexcom G4® PLATINUM Professional CGM provides continuous readings on the rate and direction of glucose change up to every five minutes; and supports therapy adjustments and treatment recommendations made by their healthcare practitioner.  The system can also be customized for personalized glucose targets and alerts, and has an alarm feature to alert the user if glucose levels rise or fall to dangerous levels.

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