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

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%.

STAR 3 is the 1st study that confirms sensor‐augmented insulin pump therapy provides better 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, M.D., 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.

The MiniMed Paradigm® REAL‐Time Revel™ System is the latest generation of Medtronic’s sensor‐augmented insulin pump therapy. The MiniMed Paradigm Revel System is comprised of three key components: a “smart” insulin pump, a continuous glucose monitoring system and therapy management software. The system incorporates new innovative CGM features including predictive alerts that can give early warning to people with diabetes so they can take action to prevent dangerous high or low glucose events.

Source: Medtronic

Written by Christian Nordqvist