Artificial pancreas system aimed at type 1 diabetes mellitus

Researchers will soon undertake one of the largest-ever long-term clinical trials of a system designed to help regulate blood sugar levels of individuals with type 1 diabetes mellitus.

If the scientists’ so-called artificial pancreas system performs in patients as they hope, it could lead to commercial trials and eventual regulatory approval in the United States and abroad.

With $12.7 million in support from the National Institutes of Health (NIH), the system developed by a team of researchers from the University of Virginia (UVA) School of Medicine and the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) will be tested in 240 patients at nine sites in the United States and Europe. The two six-month trials will begin early this year, in collaboration with other institutional partners.

Already one of the most common chronic disorders, the incidence of diabetes is increasing worldwide. According to the U.S. Centers for Disease Control and Prevention, 1.25 million Americans have type 1 diabetes. Diabetics must vigilantly monitor blood-glucose levels and, when necessary, administer doses of insulin via either needle injections or an infusion pump. Failure to maintain proper blood-glucose levels by managing insulin can cause life-threatening hypoglycemia, or low blood sugar, as well as other complications.

“To be ultimately successful as an optimal treatment for diabetes, the artificial pancreas needs to prove its safety and efficacy in long-term pivotal trials in the patient’s natural environment,” said principle investigator Boris Kovatchev, director of the UVA Center for Diabetes Technology. “Our foremost goal is to establish a new diabetes treatment paradigm: The artificial pancreas is not a single-function device; it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem.”