An artificial pancreas is being tested in a clinical trial

Researchers are testing an artificial pancreas as part of the last step before seeking regulatory approval to use it. Success in the clinical trials could be a life-changing breakthrough for people living with type 1 diabetes.

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The artificial pancreas is being tested by a team from Yale and colleagues from around the US and the world. It focuses on an integrated system which automatically monitors blood glucose levels and provides either just insulin or a mix of insulin and another hormone. The system could replace the need for diabetes sufferers to have to rely on finger-stick testing or continuous glucose monitoring and separate insulin delivery devices.

Range of trials

Four separate trials involving a range of experts, including clinical trial assistants, are currently being carried out and Yale is involved in two.

There has been ongoing development of the artificial pancreas for over ten years. In 2015, devices were tested on teenagers as part of a study at Yale and involved the wearing of a sensor under clothing to transmit blood glucose data at five-minute intervals to a smartphone. The phone then informed an insulin pump how much insulin to deliver and when.

Clinical trials, which typically involve a large group of team members including clinical trials assistants sourced by companies such as http://www.gandlscientific.com/clinical-trial-assistants/, will run from 2017 to 2018. Participants in the four projects will live at home, monitoring themselves and being monitored remotely by study staff.

Global research

The studies are taking place around the world, including in the US, UK, France, Holland, Germany, Italy, Israel and Slovenia. The Jaeb Center for Health Research, situated in Tampa, Florida, is to serve as a coordinating centre. More information on the centre can be found at https://www.jaeb.org/.

The trials include the testing of an automated system to deliver insulin, known as inControl, at the University of Virginia, and a year-long trial of a youth-focus artificial pancreas. The latter study at England’s University of Cambridge will involve young people aged between six and 18.

The hybrid artificial pancreas already approved by the FDA, meanwhile, will be compared to a newer system by researchers in Minneapolis and Israel, and next year, a study involving researchers from Boston University and Boston’s Massachusetts General Hospital will look at a bihormonal system to deliver insulin and counteracting hormone glucagon.