Medtronic, Inc. today announced FDA approval of the MiniMed Paradigm® REAL-Time Insulin Pump and Continuous Glucose Monitoring System, a progressive new therapy available for patients who use insulin to treat diabetes. For the first time in the history of diabetes management, an insulin pump integrates with REAL-Time continuous glucose monitoring (CGM). This new technology will 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.

The MiniMed Paradigm REAL-Time System is made up of two components, a REAL-Time Continuous Glucose Monitoring (CGM) 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,” said Robert Guezuraga, president, Medtronic Diabetes. “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.”

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. Medtronic is testing future systems that would employ advanced scientific algorithms to proactively recommend insulin dosages to patients. Through this process, Medtronic anticipates developing an external, closed-loop system designed to simplify and improve patient diabetes management.