Researchers are preparing to undertake what may be the largest ever long-term clinical trials in the fight against diabetes. They are using an artificial pancreas system that helps regulate blood sugar levels for those with type 1 diabetes. Should it be successful, these will likely lead to commercial trials.
The dual six-month trials will involve 240 patients in nine different locations in the United States and Europe, and it is set to begin this year.
Diabetes is now one of the most common chronic disorders, with the U.S. Center for Disease Control and Prevention reporting that 1.25 million Americans already have type 1 diabetes. Diabetics need to monitor their blood-glucose levels and administer doses of insulin when necessary, and sadly, this is something that becomes increasingly difficult with age.
Principal investigator and director of the UVA Center for Diabetes Technology Boris Kovatchev says that “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.”
“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,” adds Kovatchev.
The artificial pancreas system is designed to be able to supply the appropriate levels of insulin to the body by reacting to changes in glucose levels and even accurately predict those levels in the future.
Co-principal investigator and engineering lead on the project Francis J. Doyle III says: “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.”
The program has received support from the National Institute of Health (NIH) in the form of $12.7 million. The artificial pancreas system was developed by researchers from both the University of Virginia School of Medicine and the Harvard John A. Paulson School of Engineering and Applied Sciences.