Artificial Pancreas for Diabetics Set for 2 More Clinical Trials
An artificial pancreas is currently in development, set for two stages of testing before getting approval for public use. If eventually approved, this technological advancement could mean those with Type 1 diabetes no longer need to be subjected to needles every day.
According to a report from IBTimes UK, the device in the works acts as an artificial pancreas by self-regulating the hormone insulin in the body of diabetics. Boris Kovatchev, who leads the research of the artificial pancreas in the University of Virginia, explained the necessity of the trials as well as the nature of the device the team is currently developing.
"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," Kovatchev said. "The artificial pancreas is not a single-function device; it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem."
Algorithms found in smartphones also power this new device and it's even wirelessly connected to a blood-sugar monitor and insulin pump.
It's bound to take a while before the work in progress gets approved for use by the US Food and Drug Administration. The process includes two long-term clinical trials, which will take place in nine different locations.
The first test is dubbed the International Diabetes Closed-Loop trial. It will test the safety of the device and compare it to an insulin pump in 240 patients by monitoring blood sugar levels and hypoglycaemia risks for six months.
Next up is the second test, which simply follows 180 patients from the first stage for another six months. It will check if blood sugar levels increase with an equation developed by Harvard University, who is working with the University of Virginia on the artificial pancreas.
According to a report from US News, co-principal investigator Francis Doyle III elaborated on the team's goals in an official statement saying, "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."
Doyle added, "The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body. 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."
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