Positive Results from First Human Clinical Trials of a First-Generation Artificial Pancreas System

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The FINANCIAL — Results from the first feasibility study of an advanced first-generation artificial pancreas system were presented today at the 72nd Annual American Diabetes Association Meeting in Philadelphia.

 

Findings from the study indicated that the Hypoglycemia-Hyperglycemia Minimizer System was able to automatically predict a rise and fall in blood glucose and correspondingly increase and/or decrease insulin delivery safely.  The HHM System included a continuous, subcutaneous insulin pump, a continuous glucose monitor (CGM) and special software used to predict changes in blood glucose.  The study was conducted by Animas Corporation in collaboration with JDRF as part of an ongoing partnership to advance the development of a closed-loop artificial pancreas system for patients with Type 1 diabetes.

“The successful completion of this study using the HHM System in a human clinical trial setting is a significant step forward in the development of an advanced first-generation artificial pancreas system,” said Dr. Henry Anhalt, Animas Chief Medical Officer and Medical Director of the Artificial Pancreas Program. “It lays the foundation for subsequent clinical trials, bringing us one step closer to making the dream of an artificial pancreas a reality for millions of people living with Type 1 diabetes.”

According to Johnson & Johnson, in June 2011, Animas received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to proceed with human clinical feasibility studies for the development of a closed-loop artificial pancreas system. The company partnered with the JDRF in January 2010 to begin developing such an automated system to help people living with Type 1 diabetes better control their disease.

“We are encouraged by the results of the first human trials in this partnership with Animas,” said Aaron Kowalski, Ph.D., Assistant Vice President of Research at JDRF.  “An artificial pancreas system that can not only detect, but can predict high and low blood sugar levels and make automatic adjustments to insulin delivery would be a major advance for people with Type 1 diabetes.  Such a system could alleviate a huge burden of managing this disease.”

 

 

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