The U.S. Food and Drug Administration (FDA) has approved a key testing phase for an artificial pancreas developed by researchers of the University of Virginia, which could potentially automate care for millions of type-1 diabetics.
The FDA's recently approved first U.S. outpatient clinical trials for the hand-held device that was developed by reconfiguring a standard smart phone, was led by Patrick Keith-Hynes, PhD and Boris Kovatchev, PhD, and automatically monitors blood sugar levels, providing insulin as needed. This means patients' do not have to check their blood sugar levels at regular intervals and inject themselves with insulin.
Previous inpatient trials at UVA and in Europe, and an ongoing outpatient trial that started in Italy and France last year, have displayed promising results, with the first eight Type 1 diabetes European participants in the outpatient trial being able to maintain safe blood sugar levels whilst spending a night outside of a hospital.
Kovatchev is eagerly anticipating this crucial step in the development of the device after years of research and testing, saying:
"Conducting the first U.S. tests of a portable artificial pancreas running on a cell phone in a real-world setting is an important step toward evaluating its effectiveness and how it may impact treatment for Type 1 diabetes patients in the United States."
He anticipates the U.S. outpatient trial to begin within about six weeks.
The Artificial Pancreas Project is a collaboration of researchers from UVA, the University of California, Santa Barbara, Montpellier University Hospital in France and the Universities of Padova and Pavia in Italy.
Written by Petra Rattue