A device developed at the University of Virginia School of Medicine which automatically monitors and regulates blood-sugar level in type 1 diabetes patients is slated to undergo 2 final clinical trials beginning early this year.
UVA said it was hopeful that the long-term clinical trials would pave the way for FDA clearance of the ‘artificial pancreas’ devices for type 1 diabetes sufferers.
“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. 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,” research team lead Boris Kovatchev of the UVA Center for Diabetes Technology said in a press release.
Trials are slated to be run at 9 locations across the U.S. and Europe, and are being supported by more than $12.6 million in grant money from the National Institute of Health’s National Institute of Diabetes and Digestive and Kidney Diseases, according to the university.
The 1st study, the International Diabetes Closed-Loop trial, is set to test UVA developed technology. The university’s technology has been ‘further refined for clinical use’ by Charlottesville, Va.-based startup TypeZero Technologies, who licensed the technologies.
A 2nd trial will examine a control algorithm developed by Dr. Francis Doyle III at Harvard to test its ability to improve control of blood-sugar levels.