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Adults and children with diabetes who used the Medtronic MiniMed Paradigm® REAL-Time System achieved better glucose control without hypoglycemia increase compared to patients using multiple daily insulin injections, in the longest and largest randomized, controlled study of sensor‐augmented insulin pump therapy in type 1 diabetes.

According to the data, there was a statistically significant drop in glycated hemoglobin (A1c) levels - a reduction which was sustained over a prolonged 12-month period for patients enrolled in the sensor‐augmented insulin pump therapy arm of the trial.

Study results were concurrently 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.

  • The Sensor‐Augmented Pump Therapy for A1C Reduction (STAR 3) trial showed adult, teen and pediatric patients on sensor‐augmented insulin pump therapy demonstrated a reduction in mean A1C levels that was 4 times greater than the multiple daily injection group (0.8% study vs. 0.2% control (p<.001).
  • The mean A1C decrease was from a baseline of 8.3% to 7.5% in the sensor‐augmented pump therapy group, compared to only 8.3% to 8.1% in the MDI group.
  • In addition, for the adult participants in the sensor‐augmented insulin pump therapy arm, there was a full 1% 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 and156 pediatric subjects).

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, said:

Sensor‐augmented insulin pump therapy is a major advancement in the treatment of many people across the age spectrum with type 1 diabetes. This data is very important because it provides strong evidence that sensor‐augmented insulin pump therapy results in good glucose control with minimal hypoglycemia.

Diabetes association guidelines recommend that most people with diabetes maintain A1C levels of 7% maximum in order to live healthier and more productive lives. Every percentage point drop in A1c blood test results (e.g., from 8.0% to 7.0%) can reduce the risk of microvascular complications (eye, kidney, and nerve diseases) by 40%.

The considerable decrease in A1C found in STAR 3 occurred without an increase in hypoglycemia rates, which is the most common clinical risk with intensive insulin management. The benefit of the sensor‐augmented insulin pump therapy was gained early (i.e., at three months) and sustained during the course of 12 months. Notably, the results showed a strong link between increased sensor use and greater benefit. Patients who used the sensor with the insulin pump more than 81% of the time reduced their A1C levels by 1.2%.