Artificial Pancreas Approved
Artificial Pancreas Approved for US Outpatient Testing. UVA’s Hand-held Device First to Receive FDA Approval for Outpatient Clinical Trials
CHARLOTTESVILLE, Va., March 16, 2012 – 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.
Device Based on a Cell Phone
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 in Europe, as well as an ongoing outpatient trial that began last year in Italy and France, have shown promising results. 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, Kovatchev is looking forward to this vital step in the development of the artificial pancreas. “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.”
Collaboration Supports Artificial Pancreas Development
The device’s development was supported by Paul and Diane Manning of Charlottesville, the Frederick Banting Foundation of Richmond and the JDRF’s Artificial Pancreas Project. The Artificial Pancreas Project brings together researchers from UVA, the University of California, Santa Barbara, Montpellier University Hospital in France and the Universities of Padova and Pavia in Italy.
Kovatchev hopes the U.S. outpatient trials will begin within approximately six weeks.