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Artificial Pancreas Clinical Trial Enabled by NIH Grant

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Artificial Pancreas Clinical Trial Enabled by NIH Grant
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artificial pancreasAn artificial pancreas, the ultimate cure for type 1 diabetes, will be tested in clinical trials as a result of a $1 million National Institutes of Health Grant awarded to Dr. B. Wayne Bequette of Rensselaer Polytechnic Institute to fund research concerning his closed-loop artificial pancreas developed along with colleagues at Stanford University, the University of Colorado, and the University of Virginia. Frequent insulin injections and blood samples may be a thing of the past for recipients of the device.

“An artificial pancreas that automatically compensates for exercise and meals while maintaining desirable blood glucose concentrations, without the need for patient intervention, would greatly change the treatment of diabetes,” said Dr. Bequette, in a news release from RPI. “Better, more precise control of blood sugar levels would lead to significant lifestyle improvements and a reduced chance of medical complications for most people with diabetes.”

The trial will begin with 12 patients with type 1 diabetes and will be conducted in a hospital setting. Eventually, the trial will progress to 18 patients who will be treated with the system at home for two weeks. “These clinical trials will be critical for building upon our initial results, and collecting data that will enable us to improve and optimize the artificial pancreas system,” said Dr. Bequette.

Dr. Bequette’s artificial pancreas is deemed as “closed-loop” because there is continuous feedback between a glucose monitor and an insulin pump. The receiving diabetic patient would wear the device at all times, requiring a needle inserted under the skin. This would be considered an improvement to many diabetics who must test their blood sugar with a finger stick several times a day and administer insulin shots.

The pump mechanics and system controller first detect blood glucose levels. Upon a high reading of blood glucose, the pump automatically administers insulin. Upon a low reading, the pump shuts off insulin supply to avoid hypoglycemia.

Uniquely, the system is designed to include a smart phone app the patient interacts with to input the time of meals and the amount of carbohydrate intake. In the future, an accelerometer will be included to measure increased or decreased physical activity to adjust insulin accordingly.

By maintaining blood glucose through monitoring and insulin delivery, Dr. Bequette’s closed-loop artificial pancreas nearly replicates the function of a normal pancreas and may greatly enhance quality of life for the nearly 20,000 young patients diagnosed with type 1 diabetes in the United States each year. Similar work is being conducted in the field by Nuvilex, Inc., but their system revolves around insulin-producing cells rather than a device.

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