FDA-Approved Diabetes Simulator Commercially Available

A computer-based diabetes simulation tool developed by University of Virginia researchers is now commercially available, thanks to a partnership with the Charlottesville-based medical research firm The Epsilon Group. The simulator is the only protocol that has been accepted by the U.S. Food and Drug Administration as an alternative to animal testing of Type 1 diabetes control strategies.

Boris P. Kovatchev and Marc D. Breton of the U.Va. Center for Diabetes Technology developed the simulator in collaboration with Claudio Cobelli and Chiara Dalla Man at the University of Padova, Italy. The U.Va. Patent Foundation granted Epsilon, a division of Medical Automation Systems Inc., an exclusive license to the technology in April.

“It takes a tremendous amount of time and resources to conduct animal testing for clinical trials, often only to find that a treatment doesn’t work,” said Miette H. Michie, interim executive director and CEO of the U.Va. Patent Foundation. “Through their innovative diabetes simulator, Drs. Kovatchev and Breton and their collaborators have provided an FDA-accepted substitute for animal trials, allowing effective treatments to reach the market - and start impacting patients - much sooner.”

The simulator uses a software algorithm to model the human metabolic system. Based on patient data from 300 children, adolescents and adults with Type 1 diabetes, the algorithm uses 26 different parameters to mimic human metabolism at the individual level, through several distinct patient profiles. Within these individual profiles, variables such as diet, exercise behavior and insulin intake can be manipulated to test the accuracy or effectiveness of a new product under varying conditions - or to compare it to existing products.

According to the researchers, this technology is an improvement over other simulators, which provide only average or group-level results.

“This simulator allows ‘in silico’ pre-clinical experiments to be conducted at the level of an individual, revealing inter-personal differences due to treatment,” said Kovatchev, director of the diabetes technology center at U.Va. and an internationally renowned diabetes technology scientist.

Kovatchev and Breton are researchers in the U.Va. School of Medicine’s Department of Psychiatry and Neurobehavioral Sciences. Kovatchev holds a joint appointment in the School of Engineering and Applied Science’s Department of Systems and Information Engineering and was named U.Va. Patent Foundation’s 2011 Edlich-Henderson Inventor of the Year for the development of novel computational methods that have advanced the state of diabetes research.

Approximately 60 academic and industrial sites are already using a test version of the simulator for research purposes.

Kurt Wassenaar, Epsilon CEO, said that computational modeling can help improve and accelerate new products for diabetes care. “We are very enthusiastic about the opportunity to build and provide a robust commercial version of the model technology to the diabetes research and disease management community,” he said.

The simulator project has been funded by the Juvenile Diabetes Research Foundation and the National Institute of Diabetes and Digestive and Kidney Diseases. A patent on the simulator is pending.

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Source: University of Virginia