(RxWiki News) An artificial pancreas meant to help type 1 diabetes patients is about to undergo its final testing. And favorable results could lead to the device's approval, researchers said.
The device, developed by University of Virginia (UVA) School of Medicine researchers, is designed to monitor and regulate blood sugar levels in patients with type 1 diabetes. Around 1.25 million US patients have this condition, according to the Centers for Disease Control and Prevention.
“To be ultimately successful as an optimal treatment for diabetes, the artificial pancreas needs to prove its safety and efficacy in long-term pivotal trials in the patient's natural environment,” said Boris Kovatchev, PhD, director of the UVA Center for Diabetes Technology, in a press release. “Our foremost goal is to establish a new diabetes treatment paradigm: the artificial pancreas is not a single-function device; it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem."
To reach that goal, Dr. Kovatchev and colleagues will test the artificial pancreas — with the help of a $12.6 million National Institute of Diabetes and Digestive and Kidney Diseases grant — at nine locations in Europe and the US.
The developers of this device said the goal is to change the way type 1 diabetes patients live. Instead of sticking their fingers and injecting insulin several times a day, patients would rely on the new device to monitor their blood sugar and release insulin as needed.
Insulin is a hormone that regulates blood sugar. In type 1 diabetes, the body does not produce enough insulin. Untreated diabetes can lead to heart and kidney disease, among other health problems.
The researchers behind this artificial pancreas said they will test the device in two clinical trials covering 420 patients total. Favorable results in these trials could set the device on the road to approval from the US Food and Drug Administration, these researchers said.