Issue: April 2012
February 29, 2012
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ASPIRE: Low Glucose Suspend feature moves researchers closer to artificial pancreas

Issue: April 2012
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Medtronic today announced that recent study results have brought researchers one step closer to developing an artificial pancreas. According to a press release, data from an in-clinic study demonstrated that patients using the company’s MiniMed Paradigm System with Low Glucose Suspend automation experienced a 19% reduction in time spent below the low glucose threshold compared with those using conventional pump therapy.

The Automation to Simulate Pancreatic Insulin Response (ASPIRE) study showed that patients with diabetes using the MiniMed Paradigm System with Low Glucose Suspend automation spent less time below 70 mg/dL and their average drop in blood glucose values remained higher vs. those using conventional insulin pumps. The Low Glucose Suspend feature also did not result in rebound hyperglycemia. Additionally, more than half of the glucose values with Low Glucose Suspend were within normal range (70 mg/dL to 180 mg/dL) and none were within hyperglycemic range (higher than 250 mg/dL) at the end of observation.

The results of ASPIRE have been published online in the March edition of Diabetes Technology & Therapeutics.

“Until now, we have never had a therapy designed to automatically intervene when blood glucose becomes dangerously low, which is the greatest fear and biggest challenge in achieving better glucose control in patients with diabetes,” Satish K. Garg, MD, professor of medicine and pediatrics at Barbara Davis Center for Childhood Diabetes, said in the release. “Therapies that help people with diabetes stay within normal range are important and we look forward to continued advancements in this area. It makes sense to stop insulin delivery when a low glucose threshold is met and that is how Low Glucose Suspend is designed.”

The Low Glucose Suspend feature of the integrated insulin pump and continuous glucose monitor works by automatically suspending insulin delivery if the sensor glucose value is equal to or below the low threshold value. Although commercially available outside of the US, the Paradigm System is restricted to investigational use in the US.

“Achieving the endpoints of the in-clinic ASPIRE study is an important milestone toward FDA approval and bringing Low Glucose Suspend technology to the US market,” said Francine Kaufman, MD, chief medical officer and vice president of global clinical affairs for the diabetes business of Medtronic. “We are excited about this first step and are committed to advancing the insulin delivery, sensor technology and closed loop algorithms to commercialize and artificial pancreas.”

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