In the longest and largest randomized, controlled study of sensor-augmented insulin pump therapy in type 1 diabetes, adult and pediatric patients using the Medtronic MiniMed Paradigm® REAL-Time System achieved better glucose control without an increase in hypoglycemia compared to multiple daily insulin injections (MDI), the most common approach to care today. The data also showed a statistically significant reduction in glycated hemoglobin (A1c) levels, which was sustained over a prolonged one-year period for patients enrolled in the sensor-augmented insulin pump therapy arm of the trial. Study results were simultaneously published online in The New England Journal of Medicine (NEJM) and presented at a late-breaking clinical study symposium at the American Diabetes Association (ADA) 70th Scientific Sessions in Orlando.
“Sensor-augmented insulin pump therapy is a major advancement in the treatment of many people across the age spectrum with type 1 diabetes”
The Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) trial showed patients (adults, teens and children) on sensor-augmented insulin pump therapy demonstrated a reduction in mean A1C levels that was four times greater than the multiple daily injection group (0.8 percent study vs. 0.2 percent control (p<.001). The mean A1C decrease was from a baseline of 8.3 percent to 7.5 percent in the sensor-augmented pump therapy group, compared to only 8.3 percent to 8.1 percent in the MDI group. In addition, for the adult participants in the sensor-augmented insulin pump therapy arm, there was a full one percent reduction in their A1C levels. The study was sponsored by Medtronic (NYSE: MDT) and conducted at 30 sites in the United States and Canada with participation from 485 patients, ranging in age from seven to 70 years (329 adult and 156 pediatric subjects).
"Sensor-augmented insulin pump therapy is a major advancement in the treatment of many people across the age spectrum with type 1 diabetes," said Richard M. Bergenstal, M.D., executive director of the International Diabetes Center at Park Nicollet Health Services in Minneapolis and Clinical Professor for the Department of Medicine at the University of Minnesota. "This data is very important because it provides strong evidence that sensor-augmented insulin pump therapy results in good glucose control with minimal hypoglycemia."