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Long-term artificial pancreas trial to begin in 2016

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A team of researchers led by the University of Virginia School of Medicine and the Harvard John A. Paulson School of Engineering and Applied Sciences will soon begin one of the largest long-term trials of the so-called artificial pancreas system in patients with type 1 diabetes.

The study, consisting of two trials set to begin in early 2016, is being funded with a $12.7 million grant from the NIH and will enroll 240 patients at nine sites in the United States and Europe. The University of Virginia and Harvard will conduct the study in collaboration with their partners in the International Diabetes Closed Loop Consortium: Mount Sinai Hospital, Mayo Clinic, Stanford University, the University of Colorado, the University of Padua in Italy, Regional University Hospital Center of Montpellier in France, the Academic Medical Center in Amsterdam, and William Sansum Diabetes Center in California, with coordination by the Jaeb Center for Health Research in Florida.

“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,” Boris Kovatchev, PhD, director of the University of Virginia Center for Diabetes Technology, said in a press release. “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."

In the first of the two trials, 240 patients with type 1 diabetes will test the safety and effectiveness of the artificial pancreas for 6 months while going about their normal daily routines. The control-to-range artificial pancreas system for this trial was developed at the University of Virginia and is now licensed to TypeZero Technologies. Researchers will compare the artificial pancreas system to a standard insulin pump to measure how well blood glucose levels are controlled and whether the risk for hypoglycemia is reduced.

The second trial will follow 180 patients who completed the first study for an additional 6 months to test the advanced adaptive control known as zone model-predictive control. The algorithm defines an acceptable zone for an individual’s glucose levels and controls variables to stay within that range.
— not a solution to diabetes, but a means to really extend the quality of their healthful living,” Francis J. Doyle III, PhD, dean and John A. & Elizabeth S. Armstrong professor of engineering and applied sciences at Harvard School of Engineering and Applied Sciences, said in a press release.

“This is the first trial where we’ll be looking at multi-month intervals of time with cohorts of subjects where we can actually see a long enough window to learn those patterns, to adapt and fine-tune the algorithms, and to improve the overall level of glucose control,” Doyle said.

The goal of the study is to acquire the data necessary to satisfy requirements for regulatory approval by the FDA and other international agencies, according to researchers.