Real-time Professional CGM a Reality as FDA Gives Nod to Dexcom G4 PLATINUM System

Continuous Glucose Monitoring (CGM) device company Dexcom, Inc., has received U.S. FDA approval for its Dexcom G4® PLATINUM Professional CGM.

Background

Diabetes affects 25.8 million Americans and is the 7th leading cause of death in the United States. People with diabetes who take insulin must monitor their blood glucose levels frequently as uncontrolled glucose can cause health complications and even death. 

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.

Dexcom, Inc., headquartered in San Diego, California, develops and markets continuous glucose monitoring systems for use by diabetes patients, as well as blood glucose monitoring systems used by healthcare providers in hospital critical care settings.

The company claims its newly approved Dexcom G4® PLATINUM Professional system 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.

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. 1 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.

Physician comments 

“Professional CGM provides healthcare practitioners and patients the necessary data to plan treatment and lifestyle decisions to keep glucose at safe levels, in the reference range found in persons without diabetes,” said Lori Laffel, MD, M.P.H., Chief of the Pediatric, Adolescent and Young Adult Section, Joslin Diabetes Center, in Boston, MA. “The ability to rapidly deploy and translate this data for the better of patients is a valuable instrument in the management of diabetes.”

Company comments

“Dexcom’s mission is to provide doctors, patients and caregivers new medical technology to improve their understanding and management of diabetes,” said Terrance H. Gregg, CEO, Dexcom. “The G4® PLATINUM Professional is Dexcom’s latest answer for healthcare professionals and patients seeking novel and insightful tools to optimize therapeutic decisions.”

Source: Dexcom, Inc., Business Wire

 

 

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