Final Clinical Trials for Artificial Pancreas Set to Begin

Participants are now being enrolled in clinical trials for the final tests on an artificial pancreas developed by the University of Virginia (UVA) to automatically monitor and regulate blood sugar levels in people with type 1 diabetes.

Participants in the trials will live at home and follow their regular routines to examine how well the device works in real-life settings. The studies will examine several factors, including safety, effectiveness, cost, and the physical and emotional health of trial participants. If the clinical trials produce favorable findings, the results could lead to applications to the U.S. Food and Drug Administration and other regulatory groups to approve the device for use by people with type 1 diabetes, whose bodies do not produce enough insulin. Long-term complications of the disease can include lower-limb amputations.

The goal of the artificial pancreas is to eliminate the need for people with type 1 diabetes to stick their fingers multiple times daily to check their blood sugar levels and to inject insulin manually.

The artificial pancreas, which uses a platform called InControl, is designed to oversee and adjust insulin delivery as needed. The platform features a reconfigured smartphone running advanced algorithms that is linked wirelessly to a blood sugar monitor, an insulin pump the patient wears, and a remote-monitoring site. Artificial pancreas users can also access assistance via telemedicine.

“Managing type 1 diabetes currently requires a constant juggling act between checking blood glucose levels frequently and delivering just the right amount of insulin while taking into account meals, physical activity, and other aspects of daily life, where a missed or wrong delivery could lead to potential complications,” said Andrew Bremer, MD. “Unifying the management of type 1 diabetes into a single, integrated system could lift so much of that burden.”

For more information, visit www.clinicaltrials.gov and search for NCT02985866 and NCT02844517. To watch a video about the artificial pancreas, visit www.youtube.com/watch?v=aH0-_BYHQtY.


This article was adapted from information provided by the University of Virginia Health System.

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