FDA Approves in Silico Model of the Artificial Pancreas

The FDA recently approved an in silico model of diabetes—a computer simulator—as a pre-clinical testing tool for closed-loop research at the seven Artificial Pancreas Consortium sites. The simulator, which allows consortium researchers to “plug-and-run” their algorithms in a controlled virtual environment, will facilitate the development of new algorithms by enabling the 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, saving time and considerable expense. Construction of the simulator represents the collaborative work of Dr. Claudio Cobelli of the University of Padova in Italy, a pioneer in the mathematical modeling of glucose metabolism, who laid the foundation for building the in silico platform; and Dr. Boris Kovatchev, principal consortium investigator at the University of Virginia in Charlottesville, who took the lead for the consortium in developing and obtaining approval for the device.