New Artificial Pancreas System to be Tested in Two Clinical Trials

Scientists at the University of Virginia School of Medicine have developed a device that can automatically monitor and regulate blood-sugar levels in individuals with type 1 diabetes. The device will undergo final testing in early 2016.

According to scientists, promising results from these clinical trials 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.

‘A new artificial pancreas system can help automatically monitor and regulate blood-sugar levels in individuals with type 1 diabetes.’

The trials will be carried out at nine locations in the U.S. and Europe. The trials will receive around $12.6 million from the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health.

The first study will test technology developed at UVA by a expert team led by Boris Kovatchev, PhD, director of the UVA Center for Diabetes Technology.

The second trial will also analyze 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 examine whether it further improves control of 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."



Source: Medindia