News ID: 134386
Published: 0144 GMT January 05, 2016

Artificial pancreas to undergo long-term clinical tests

Artificial pancreas to undergo long-term clinical tests

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

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 US and Europe. The two six-month trials will begin in early 2016, in collaboration with a half dozen other institutional partners, EurekAlert‎ said.

"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."

Through a marriage of control engineering with medical practice and behavioral science, the artificial pancreas system is designed to supply the appropriate levels of insulin by not only reacting to changes in the body, but accurately predicting blood glucose levels in advance.

The artificial pancreas is not a replica organ; it is an automated insulin delivery system designed to mimic a healthy person's glucose regulating function. The closed-loop system consists of an insulin pump, continuous glucose monitor placed under the user's skin, and advanced control algorithm software embedded in a smart phone that provides the engineering brains, signaling how much insulin the pump should deliver to the patient based on a range of variables including meals consumed, physical activity, sleep, stress, and metabolism.

"The idea is that this can lead to an improved quality of life for individuals with this disease — not a solution to diabetes, but a means to really extend the quality of their healthful living," said co-principal investigator and engineering lead on the project Francis J. Doyle III, dean and John A. and Elizabeth S. Armstrong Professor of Engineering and Applied Sciences at Harvard SEAS.

 

   
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