First human trials of artificial pancreas yields positive results

Singapore: The findings from the first feasibility study of an advanced first-generation artificial pancreas indicated that the system was able to automatically predict a rise and fall in blood glucose and correspondingly increase or decrease insulin delivery safely. The results were presented at the 72nd Annual American Diabetes Association Meeting in Philadelphia.

The Hypoglycemia-Hyperglycemia Minimizer (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 Juvenile Diabetes Research Foundation (JDRF) as part of an ongoing partnership to advance the development of a closed-loop artificial pancreas system for patients with type-1 diabetes.

In June 2011, Animas received investigational device exemption (IDE) approval from the US FDA to proceed with human clinical feasibility studies for the development of a closed-loop artificial pancreas system.

Dr Henry Anhalt, chief medical officer and medical director of the artificial pancreas program, Animas, said that, "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. 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."

Dr Aaron Kowalski, assistant VP, research, JDRF, said that, "We are encouraged by the results of the first human trials in this partnership with Animas. 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."