The first and only real-time professional CGM, the Dexcom G4 PLATINUM Professional Continuous Glucose Monitoring System (CGM) Receives FDA Approval
Jun 03, 2014 12:00 AM PDT
The first and only real-time professional CGM, the Dexcom G4® PLATINUM Professional Continuous Glucose Monitoring System (CGM) Receives FDA Approval
Trusted patient CGM system now available in professional version enabling clinicians to gain valuable insight into their patients’ glycemic profiles leading to improved glucose control
San Diego, CA, June 3, 2014 – Dexcom, Inc., (NASDAQ:DXCM), a leader in continuous glucose monitoring (CGM), announced today that it has received U.S. Food and Drug Administration (FDA) approval for its Dexcom G4® PLATINUM Professional CGM. It 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. 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.
“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.”
Continuous glucose monitoring is considered the most significant breakthrough in diabetes management in the past 40 years.2 The traditional standard-of-care for glucose monitoring has been a finger stick meter. CGM augments the use of glucose meters for the management of diabetes. Meters are still required to calibrate CGMs and for making therapy and meal decisions. CGM is important because, in addition to providing the glucose level, it provides the direction and rate of glucose change with the push of a button and alerts users when glucose is too low or too high.
“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.”
Diabetes affects 25.8 million Americans and is the 7th leading cause of death in the United States.3 With diabetes, the body cannot produce or use the hormone insulin effectively, causing a buildup of glucose, or sugar, in the blood. It is estimated that approximately 79 million Americans over the age of 20 are at risk for developing diabetes, largely due to obesity, physical inactivity and poor diet.2 People with diabetes who take insulin must monitor their blood glucose levels frequently. Uncontrolled glucose can cause health complications and even death.4,5
About Dexcom, Inc.
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. For more information on the Dexcom CGM, visit www.dexcom.com.
Caren Begun, 201-396-8551
Steven Pacelli, 858-200-0200
1. Do not use the Dexcom G4® PLATINUM for treatment decisions
2. Clarke SF and Foster JR. A history of blood glucose meters and their role in self-monitoring of diabetes mellitus. Br J Biomed Sci. 2012;(3)2:83-93.
3. 2011 National Diabetes Fact Sheet. Centers for Disease Control and Prevention. http://www.cdc.gov/diabetes/pubs/factsheet11.htm. Updated October 25, 2013. Accessed December 3, 2013.
4. Hyperglycemia (High blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hyperglycemia.html. Updated August 5, 2013. Accessed December 3, 2013.
5. Hypoglycemia (Low blood glucose). American Diabetes Association Web site. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/hypoglycemia-low-blood.html. Updated July 16, 2013. Accessed December 3, 2013.