The artificial
pancreas system, developed at UVA, uses smartphone technology
to monitor and
stabilize insulin levels.
(January 5, 2016) A
device developed by University of Virginia School of Medicine researchers to
automatically monitor and regulate blood-sugar levels in people with type 1
diabetes will undergo final testing in two clinical trials beginning early this
year.
Favorable results from these long-term clinical trials
examining how the artificial pancreas works in real-life settings could lead
the U.S. Food and Drug Administration and other international regulatory groups
to approve the device for use by people with type 1 diabetes, whose bodies do
not produce enough insulin. Approximately 1.25 million Americans have type 1
diabetes, according to the U.S. Centers for Disease Control and Prevention.
The trials will be conducted at nine locations in the U.S.
and Europe, supported by a grant of more than $12.6 million from the National
Institute of Diabetes and Digestive and Kidney Diseases of the National
Institutes of Health. The first study – the International Diabetes Closed-Loop
trial – will test technology developed at UVA by a research team led by Boris
Kovatchev, director of the UVA Center for Diabetes Technology. That technology
has been further refined for clinical use by TypeZero Technologies, a startup
company in Charlottesville that has licensed the UVA system.
Boris Kovatchev
has worked with researchers at UVA and elsewhere
to develop and
refine the artificial pancreas, which will soon undergo human trials.
The second trial will also examine a new control algorithm
developed by the team of Dr. Francis Doyle III at the Harvard John A. Paulson
School of Engineering and Applied Sciences to test whether it further improves
control of blood-sugar levels. “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,”
Kovatchev said. “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.”
Instead, the artificial pancreas is designed to oversee and
adjust insulin delivery as needed. At the center of the artificial pancreas
platform – known as InControl – is a reconfigured smartphone running advanced
algorithms that is linked wirelessly to a blood-sugar monitor and an insulin
pump that the patient wears, as well as a remote-monitoring site. People with
the artificial pancreas can also access assistance via telemedicine.