A University of Virginia-developed artificial pancreas that could potentially automate care for millions of Type 1 diabetes patients has received U.S. Food and Drug Administration (FDA) approval for a key testing phase.
The FDA recently approved the first U.S. outpatient clinical trials for the device, created by a UVA School of Medicine research team led by Patrick Keith-Hynes, PhD, and Boris Kovatchev, PhD. The hand-held device — created by reconfiguring a standard smart phone — automatically monitors blood sugar levels and provides insulin as needed, which may relieve patients from having to regularly check their blood sugar levels and administer insulin shots.
Earlier inpatient trials at UVA and Europe, as well as an ongoing outpatient trial that began last year in Italy and France, have shown promising results. In fact the first eight Type 1 diabetes patients participating in the outpatient trial in Europe were able to maintain safe blood sugar levels while spending a night outside of a hospital.
After years of research and testing this is a vital step in the development of the artificial pancreas and conducting the first U.S. tests is an important step toward evaluating its effectiveness and also the impact it may have when it comes to treating patients with Type 1 diabetes in the USA.
University of Virginia Health System (2012, March 19). Type 1 diabetes: Artificial pancreas approved for US outpatient testing