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. 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,” he says.
Kovatchev hopes the U.S. outpatient trials will begin within approximately six weeks.
Health-e-Solutions comment: There is no doubt that the artificial pancreas, once perfected, should be a great improvement in blood glucose control for many people with type 1 diabetes who require insulin injections. We applaud its development. This does not, however, change the need for people with diabetes – all types of diabetes – to change their lifestyles toward healthier eating habits, regular sleep and exercise, and healthier mental and emotional practices. These are all components of living in a way that improves health. Blood glucose control is vital to avoiding complications, but it is not the only thing that matters for long term health.