The US FDA has approved MiniMed Paradigm REAL-Time Insulin Pump and Continuous Glucose Monitoring (CGM) System of Medtronic, Inc., a progressive new therapy available for patients who use insulin to treat diabetes. This new technology is expected to help patients take immediate corrective or preventive action to maintain healthy glucose levels and delay or prevent diabetes-related complications, including coma, blindness, kidney failure, amputation, impotence, and heart disease, said a release.
The MiniMed Paradigm REAL-Time System is made up of two components, a REAL-Time Continuous Glucose Monitoring System, and a MiniMed Paradigm insulin pump. The REAL-Time CGM System relays glucose readings every five minutes from a glucose sensor to the insulin pump, which displays to 288 readings a day - nearly 100 times more information than three daily fingersticks. REAL-Time glucose information displayed on the insulin pump allows patients to take immediate action to improve their glucose control after taking a confirmatory fingerstick. The REAL-Time CGM System component is indicated for any patient 18 years of age or older, and insulin pump therapy for all patients requiring insulin.
"The approval of the MiniMed Paradigm REAL-Time System opens the door to the next generation of diabetes management," Robert Guezuraga, president, Medtronic Diabetes said adding, "As this is the first integrated insulin pump and continuous glucose monitoring system ever approved, we feel this new therapy will revolutionize the way patients manage their diabetes and will improve their lives."
According to the company release, integrating an insulin pump with REAL-Time CGM is a major step toward the development of a "closed-loop" insulin delivery system that may one day mimic some functions of the human pancreas. Through this process, Medtronic anticipates developing an external, closed-loop system designed to simplify and improve patient diabetes management.