Star 3 Clinical Trial
STAR 3 validates Medtronic's integrated system (MiniMed Paradigm® insulin pump, CGM and CareLink® therapy management software), the technology platform upon which an artificial pancreas is being built. Medtronic therapies were the only products used in the trial.
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STAR 3 trial clinically validates the Medtronic integrated system
STAR 3 is a multicenter, randomized controlled trial that compared Medtronic's sensor-augmented insulin pump (an integrated system using an insulin pump, continuous glucose monitoring (CGM) and therapy management software) to multiple daily injections (MDI). The data showed a statistically significant improvement in A1C across the age spectrum (adults, teens, and children) without increasing severe hypoglycemia. The reduction was seen early (at three months) and was sustained over the course of one year. Equally as exciting, in this study, Medtronic's integrated system provided superior glucose control for teens and children compared to MDI therapy.
The results from STAR 3 have been published by the prestigious New England Journal of Medicine and are currently available online (slated to appear in print in July 2010).
As the longest and largest study of its kind, we believe STAR 3 results will help establish a new standard of care for diabetes patients who use insulin. Medtronic's integrated system can provide superior glucose control so that people with diabetes can reduce their risk of long-term complications from diabetes.
Key Results
- Patients using Medtronic's integrated system demonstrated a reduction in mean A1C that was four times greater than the MDI group (0.8% for the integrated system vs. 0.2% for MDI) (p<0.001). This occurred without an increase in severe hypoglycemia.
- A1C decreased from 8.3% to 7.5% in the group using Medtronic's integrated system, compared to a decrease from 8.3 % to 8.1% in the MDI group.
- Adult patients using an integrated system experienced a 1.0% A1C reduction (mean). Near normal blood glucose control has been shown to greatly reduce long-term complications of diabetes including kidney, nerve and retinal eye disease.1
- Patients who wore their sensor ≥81% of the time reduced their mean A1C by 1.2% (reduction from baseline to 1 year).
- The benefit of an integrated system was gained early (three months) and was sustained over the course of one year.
- Medtronic's integrated system provided a significant improvement in A1C levels for teens and children.
- Nearly half (44%) of the children and teens using an integrated system achieved the blood glucose target recommended by the ADA2, compared to only 20% in the multiple daily injection arm (p=0.005). (This is more than two times the number in the MDI group.)
STAR 3 clinically validates Medtronic's integrated system, the foundation upon which we are building an artificial pancreas. Following on the landmark STAR 3 results, Medtronic will continue to partner with investigators from the best institutions around the world to build a clinical body of evidence that guides diabetes therapy.