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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

 
PRLog - Dec. 13, 2011 - ESCONDIDO, Calif. -- One of the most frightening aspects of living with type 1 diabetes is the risk of hypoglycemia, or low blood sugar, while a person sleeps. AMCR Institute has announced that it has enrolled its first patient in a clinical trial of a first-of-its-kind insulin pump for the US market that addresses nocturnal hypoglycemia and is another step toward the eventual development of an artificial pancreas for type 1 diabetes management.
   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-kind insulin pump that works by automatically suspending basal insulin delivery temporarily if glucose levels become too low as defined by the patient’s healthcare provider. The CGM-integrated system and LGS automation are critical first steps toward the creation of an artificial pancreas.
   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.

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Contact Email:
***@amcrinstitute.com Email Verified
Source:AMCR Institute
Phone:760-466-1534
City/Town:Escondido - California - United States
Industry:Health, Biotech
Tags:amcr institute, medtronic, insulin pump, nocturnal hypoglycemia, type 1 diabetes, aspire, LGS automation, CGM technology
Shortcut:prlog.org/11748671
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