In healthy children and adults, the pancreas is constantly working to produce enough insulin to keep the body’s blood sugar levels in check.
In people with Type 1 diabetes, however, the pancreas fails to deliver, instead leaving these patients to work around the clock to manage their blood glucose levels.

Even with the advent of diabetes management tools such as insulin pumps and continuous glucose monitors, “You are still the driving force behind the diabetes management,” said Elliott Mendes, a Type 1 diabetic, in a video interview for the Juvenile Diabetes Research Foundation’s Artificial Pancreas Project.

By developing “an automated system to disperse insulin based on real-time changes in blood sugar levels,” the project seeks to free Type1 diabetics of the onus of diabetes management and reduce the incidence of severe diabetes-related outcomes, such as ulcers, nerve damage, vascular diseases, blindness and kidney failure.

“We have to keep working for a cure, absolutely, but until we get to that point, we need an artificial pancreas,” Mendes said.

At the core of the artificial pancreas is a “smart” algorithm developed by University of Virginia diabetes technology scientist Boris P. Kovatchev, Ph.D., and collaborators. Using existing diabetes management technology and information unique to each patient, the algorithm recommends and delivers a custom insulin dose every 15 minutes. The system is thus able to automatically regulate a patient’s insulin levels, with no action required on behalf of the user — or, in Mendes’ words, taking that burden off my shoulders and helping me go and enjoy the other aspects of my life.”

The algorithm is currently being tested in clinical trials at the U.Va. Health System and 10 other centers spanning seven countries.

For his work on the artificial pancreas and other leading diabetes management technologies, the U.Va. Patent Foundation selected Kovatchev as the 2011 Edlich-Henderson Inventor of the Year. Awarded annually, the honor recognizes a U.Va. inventor or team of inventors whose research discoveries have proven to be of notable value to society. Kovatchev was honored at the Patent Foundation’s annual awards reception April 19 at the Rotunda.

“Dr. Kovatchev’s novel computational methods have significantly advanced the field of diabetes research worldwide,” said Patent Foundation assistant director and senior licensing manager Miette H. Michie, who formerly served as interim director. “For his achievements in Type 1 and Type 2 diabetes control, the U.Va. Patent Foundation is pleased to recognize him as the 2011 Edlich-Henderson Inventor of the Year.”

Director of the U.Va. Center for Diabetes Technology, Kovatchev is among the University’s most prolific inventors, with 38 issued U.S. and international patents and an additional 74 patents currently pending. Through agreements brokered by the Patent Foundation, industry partners are working to bring several of these patented technologies to market.

“Diabetes technology, and particularly the artificial pancreas, is an area of very rapid academic and industrial development,” said Kovatchev, a professor in the School of Medicine’s Department of Psychiatry and Neurobehavioral Sciences with a joint appointment in the School of Engineering and Applied Science’s Department of Systems and Information Engineering.

“I am thankful to my colleagues, collaborators and supporters for their help with positioning U.Va. as a leader in this new and promising field of medical science,” he added.

In addition to his work on the artificial pancreas, Kovatchev has developed several pioneering tools that have advanced the state of diabetes research, including a computer-based diabetes simulator that is the only protocol to have been accepted by the U.S. Food and Drug Administration as an alternative to animal testing of Type 1 diabetes control strategies. Developed in collaboration with U.Va. colleague Marc
D. Breton, Ph.D., along with Claudio Cobelli, Ph.D., and Chiara Dalla Man, Ph.D., of the University of Padova, Italy, 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.

Offering an improvement over other simulators, “This simulator allows in silico preclinical experiments to be conducted at the level of an individual,
revealing interpersonal differences due to treatment,” Kovatchev said.

The Patent Foundation granted Charlottesville-based medical research firm The Epsilon Group, a division of Medical Automation Systems Inc., an exclusive license to the simulator technology in April 2011.

“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,” Michie said. “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.”

Approximately 60 academic and industrial sites are already using the simulator for research purposes. Patents on the simulator are pending.

Among Kovatchev’s other diabetes technology projects are methods for predicting the short- and long-term risks of severe hypoglycemia, a serious condition arising from patients’ blood sugar dipping below safe levels; computational tools for assessing behavioral irregularity associated with Type 1 diabetes and for assessing long-term diabetes control; and a method for evaluating the accuracy of continuous glucose sensors. He has also developed computational methods useful in the study of conditions such as substance addiction and attention-deficit/hyperactivity disorder.

Kovatchev has received funding from the Juvenile Diabetes Research Foundation, the National Institute of Diabetes and Digestive and Kidney Diseases, the Wallace H. Coulter Translational Research Partnership, Paul and Diane Manning, and industry sources.