FDA Approves DexCom G4 Platinum Professional Continuous Glucose Monitoring System

San Diego, Calif.-based DexCom Inc. has earned approval from the U.S. Food and Drug Administration for its DexCom G4 Platinum Professional Continuous Glucose Monitoring (CGM) system.

The Professional CGM system is an analytical tool designed to allow healthcare experts to treat patients who suffer from frequent hypoglycemia (low blood sugar), struggle to meet glycemic goals, or have wide fluctuations in glycemic variability. It provides unblinded feedback, thus allowing patients to experience the benefits of real-time glucose monitoring.

The system consists of a medical practice-owned professional CGM system and sensors. Patients are placed on a professional CGM for a period of seven days, which according to DexCom involves minimal training and setup time. During this period, dynamic and comprehensive data is collected that can be shared with the patients. Such information helps patients to understand the impact of their behavior on their glucose levels. It thus provides the doctor with an opportunity to review glucose data retrospectively with the patients to make therapeutic treatment recommendations.

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.

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.

Continuous glucose monitoring is extremely important for diabetes management. It helps regulate the glucose level by providing information on the direction and rate of glucose change and also alerts users in case of major fluctuations in the glucose level.

Through real-time visibility of dynamic glucose changes, clinicians can coach their patients to better outcomes. The professional CGM system allows clinicians to retrospectively alter treatment after viewing the effects that specific foods, exercise, stress and medications have on their patients’ glucose level, the company reports.