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Animas Makes Progress in Development of a First-Generation Closed-Loop Insulin Delivery System With Study Participants Maintaining Safe Glucose Levels for Over 90 Percent of the Overnight Period
Date:6/21/2013

t also helps ease worry throughout the night," said Ramakrishna Venugopalan, Director, Research & Development at Animas Corporation. "We are encouraged by the results of this overnight study, and we are excited to be one step closer to bringing this technology to patients."

Animas began collaborating with industry, academia and advocacy organizations, including the JDRF (formerly the Juvenile Diabetes Research Foundation), in 2010. After receiving Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) in 2011, researchers began the first human clinical feasibility studies for the development of a closed-loop insulin delivery system. Together with these key partners, Animas continues to work toward developing such an automated system to help people living with type 1 diabetes better control their disease. 

"We are encouraged by Animas' latest findings that indicate the System is able to control overnight blood glucose levels safely," said Aaron Kowalski, Ph.D., Vice President of Treatment Therapies Research at JDRF. "For children and their families living with diabetes, the fear of hypoglycemia during the night is very real, so any peace of mind we can provide, particularly in the overnight period, would be a tremendous benefit.

* The HHM System includes a continuous subcutaneous insulin infusion pump, a continuous glucose monitor (CGM) and a control algorithm used to predict changes in blood glucose.

About the Clinical Study
The study investigated an automatic control algorithm of a predictive glucose control system in development during the overnight period of 9 PM – 7 AM.  Glucose-related metrics calculated specifically for this overnight period were based on both continuous glucose monitor (CGM) readings and readings obtained from the YSI 2300 STAT Plus.  The results demonstrated that the System was capable
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