An artificial pancreas will integrate two currently available technologies -- continuous glucose monitors and insulin pumps -- with a software that provides the right amount of insulin at the right time. It will enable people with diabetes to achieve tight blood glucose control avoiding both highs and dangerous lows, thereby significantly reducing the risk of the disease's devastating complications.
JDRF has established a consortium of top diabetes scientists, doctors, and engineers at 8 research institutions to develop and test sophisticated software that can automatically control glucose levels in a variety of circumstances and types of people. This research builds on work already funded by JDRF at Yale University, which showed people with type 1 diabetes using closed-loop systems in the hospital spent more time in normal glucose range. The consortium is now funding multiple sites to test the safety and effectivenes of various versions of a closed-loop system. While the initial research will take place in hospital-based clinical settings, the goal of the initiative is to eventually test artificial pancreas systems in everyday settings such as home, work or school.
In early January 2008, the FDA approved an in silico model of diabetes developed by the JDRF funded consortium as a pre-clinical testing tool for closed loop research. The simulator will facilitate the development of new control algorithms -- the computer programs that interpret continuous glucose sensor data and instruct the pump to dose the proper amount of insulin -- by enabling consortium researchers to test and refine artificial pancreas algorithms quickly; it will allow for computer-based algorithm comparisons; and it will eliminate the need for animal testing, allowing investigators to focus instead on in-hospital human clinical trials, which will save significant investments of time and money. Because the simulator is now FDA-approved, the process of receiving regulatory approval for human trials of closed-loop systems will also be faster and more clearly defined. On a broader scale, because the simulator is equipped with a wide array of tools for precise fine-tuning, it should help to bring promising software closer to perfection in a shorter time frame.