A long-term clinical trial of an artificial pancreas designed to control blood sugar levels in people with type 1 diabetes will begin early this year.
The artificial pancreas will be tested for six months in 240 people with type 1 diabetes at nine sites in the United States and Europe. Researchers will compare this system to current diabetes management with an insulin pump. Then, 180 of those patients will be followed for another six months, the researchers said.
The wearable system — developed by University of Virginia and Harvard University researchers with almost $13 million in funding from the U.S. National Institutes of Health — supplies appropriate amounts of insulin by detecting changes in the body and predicting blood sugar levels in advance.
“The idea is that this can lead to an improved quality of life for individuals with this disease — not a solution to diabetes, but a means to really extend the quality of their healthful living,” co-principal investigator Francis Doyle III said in a joint news release from Harvard University and the University of Virginia School of Medicine. Doyle is dean of Harvard’s School of Engineering and Applied Sciences.
About 1.25 million Americans have type 1 diabetes, according to the U.S. Centers for Disease Control and Prevention.
In type 1 diabetes, the body’s immune system mistakenly destroys insulin-producing cells in the pancreas. Insulin is a hormone that plays a key role in regulating blood sugar levels in the body. People with type 1 diabetes must replace that lost insulin, either through multiple daily injections or via a thin tube inserted under the skin that’s then attached to an insulin pump.
The artificial pancreas is not a replica of a human pancreas. Instead, it consists of an insulin pump with tubing inserted under the skin, a blood sugar monitor with a wire sensor placed under the skin, and a smart phone loaded with software that determines how much insulin is required based on factors such as food intake, physical activity, stress, metabolism and sleep.
“The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body,” Doyle said. “Day to day, hour to hour, the various stresses that impact the human body change the way it responds to insulin-controlling glucose. Physical stresses, anxiety, hormonal swings will all change that balance. To be able to control for those factors, we need to see longer intervals of data.”
Doyle said this is the first trial that will give the researchers multiple months of information. That much data will give the researchers a long enough window to learn patterns, adapt and fine-tune the algorithms for the system, and to improve the overall level of glucose control, he explained.
“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,” principal investigator Boris Kovatchev, director of the Center for Diabetes Technology at the University of Virginia, said in the news 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,” he added.
Learn more about artificial pancreas systems from the U.S. Food and Drug Administration.
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