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AMCR Institute Enrolls Initial Diabetes Patient for Clinical Trial of First-of-its-Kind Insulin Pump
Study’s New Insulin Pump Feature Aims to Reduce Hypoglycemia, a Critical Step Toward the Development of an Artificial Pancreas
AMCR Institute is recruiting additional volunteers to participate in a clinical trial of the MiniMed Paradigm® System featuring Low Glucose Suspend (LGS) automation, which has been developed by Medtronic, Inc. as an integral part of its Automation to Simulate Pancreatic Insulin Response or ASPIRE project. ASPIRE is being conducted at multiple investigational centers around the US to determine the safety and efficacy of LGS, an advanced feature for the MiniMed Paradigm insulin pump, which also integrates continuous glucose monitoring (CGM) technology to provide the continuous measurement of glucose levels.
The trial is being funded by Medtronic (http://wwwp.medtronic.com), the manufacturer of the MiniMed Paradigm insulin pump and a world leader in advanced diabetes management solutions.
“This study leads an industry-wide effort to tackle the important challenge of reducing the risk of hypoglycemia even when a person is asleep or unable to react,” said Timothy Bailey, MD, Director of the AMCR Institute and principal investigator of the ASPIRE study. “This is the world’s first and only insulin pump that can automatically shut off the supply of insulin if the patient’s glucose levels drop too low, reducing the duration and severity of hypoglycemia.”
The MiniMed Paradigm System featuring LGS is already available in 50 countries outside the US, but has not yet been approved by the US Food and Drug Administration. Previous generations of insulin pumps combined with CGM have been available in the US since 2003, but this next generation of Medtronic’s MiniMed Paradigm System, with the addition of LGS automation, is a first-of-its-
Hypoglycemia is a common occurrence and a real concern in diabetes management and can result in confusion, unresponsiveness and – in severe prolonged cases – even coma or death. Research has indicated that, on average, a person with diabetes will experience more than one hypoglycemic, or low blood glucose, event every two weeks. In addition, each year nearly one in 14 people with insulin-treated diabetes will experience one or more episodes of severe hypoglycemia.
AMCR Institute is seeking additional volunteers with type 1 or type 2 diabetes for this and other clinical research studies. With offices in Escondido and Temecula, AMCR Institute is a clinical research center focusing on Phase 1 to 3 trials in diabetes. AMCR Institute’s exceptional investigators and professional research coordinators are committed to bringing new treatments to patients. For more information contact AMCR Institute at 877-567-2627 or visit www.amcrinstitute.com.