Medtronic reveals positive results from hybrid closed loop system trial

Jack Woodfield
Tue, 20 Sep 2016
Medtronic reveals positive results from hybrid closed loop system trial
New data from a study evaluating a closed-loop hybrid artificial pancreas shows the device maintains normal blood sugar levels in young people with type 1 diabetes.

Medtronic says this data, which was taken from its hybrid closed-loop system, demonstrated that patients had less glycemic variability and spent more time in the target blood sugar range compared to those using sensor augmented pumps.

The findings were presented at the 52nd annual meeting of the European Association for the Study of Diabetes (EASD) in Munich, Germany.

The hybrid closed-loop system is designed to use the Medtronic MiniMed 670G insulin pump, fourth-generation sensors and a control algorithm to determine basal insulin delivery.

The three-month trial involved 124 patients all of whom had type 1 diabetes and were aged 14 and older. The results comprised over 12,000 patient-days in the evaluation, making it the largest and longest at-home closed-loop study in the US.

Researchers monitored the differences between open- and closed-loop systems and effects on several health markers, such as HbA1c, insulin requirements and body weight.

"This large at-home study demonstrated that participants with the Hybrid Closed Loop system experienced improved glucose control and did not demonstrate any safety issues; during the study phase, there were no episodes of severe hypoglycemia or ketoacidosis in patients with type 1 diabetes on the therapy," said lead investigator Dr Richard M. Bergenstal, International Diabetes Centre.

Those who used the device also had reduced HbA1c levels, and researchers are buoyed by the findings. Medtronic has already sent a pre-market approval application for the system to the FDA.

"The data is compelling and shows that the system's ability to automate insulin dosing 24 hours a day has the potential to impact patients' lives in a very meaningful way - particularly at night when it's most challenging to maintain target blood glucose levels," added Bergenstal.

Alejandro Galindo, president of the Intensive Insulin Management Diabetes business at Medtronic, said: "We are pleased with the progress we have made in automating basal insulin delivery and that each new advancement in our phased approach delivers increased automation and greater peace of mind by helping to simplify diabetes management."

The study findings were published online in The Journal of the American Medical Association (JAMA).
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