Medtronic has presented Star 3 results which showed that the adult and pediatric patients using the MiniMed Paradigm REAL-Time System achieved better glucose control without an increase in hypoglycemia compared to multiple daily insulin injections (MDI).
The data of the longest and largest randomised, controlled study of sensor-augmented insulin pump therapy in type 1 diabetes also showed a 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.
The Sensor-Augmented Pump Therapy for A1C Reduction (STAR 3) trial showed patients 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% 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.
Medtronic said that the decrease in A1C observed in STAR 3 occurred without an increase in the rate of hypoglycemia, which is the most prevalent 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 one year.
The results also demonstrated a strong link between increased sensor use and increased benefit. Patients who used the sensor with the insulin pump more than 81% of the time reduced their A1C levels by 1.2%.
STAR 3 is the first study that confirms sensor-augmented insulin pump therapy provides superior glucose control for children and adolescents, an age group that is particularly challenging to treat due to the social and physiological changes due to growth and maturation.
In STAR 3, nearly 44% of pediatric patients using sensor-augmented insulin pump therapy achieved the American Diabetes Association’s age-specific glucose control targets, compared to only 20% of patients in the multiple daily injection group.
Francine Kaufman, vice president of global medical affairs of the Diabetes Business at Medtronic, said: “STAR 3 redefines what should be the standard of care for diabetes management. For the first time, with the sensor-augmented insulin pump, adults, children and teens had a sustained improvement in A1C levels, which can greatly reduce the risk of complications from diabetes.
“Furthermore, this study clinically validates our sensor-augmented pump system, the foundation upon which we are building a closed loop system or 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.”