One of the largest ever clinical trials of the artificial pancreas system is to be conducted in early 2016. If the trials are successful, the system will be commercially trialled, after which it may well be approved.

The study, which is being conducted by researchers at the University of Virginia School of Medicine, and Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS), will involve two separate six-month trials, both of which will begin in early 2016. The artificial pancreas system being trialled cost $12.7m to produce, most of which was provided by the National Institutes of Health.

What is the artificial pancreas?

The artificial pancreas is designed to mimic the function of a human pancreas by judging when insulin dosage needs to be increased and providing insulin as necessary. Many models combine an insulin pump and a continuous glucose monitor; others use a gel to monitor blood glucose levels.

The artificial pancreas is designed mainly for use in people with type 1 diabetes, but it is thought that people with insulin-dependent type 2 diabetes might also find it useful.

“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, director of the UVA Center for Diabetes Technology, and principle investigator of the study. “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.”

“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,” said Francis J. Doyle III, John A. & Elizabeth S. Armstrong Professor of Engineering and Applied Sciences at Harvard School of Engineering and Applied Sciences, and co-principal investigator in the study.

How will the trials be conducted?

The two trials will have quite different purposes. The first trial, which will involve 240 participants, is designed to test the safety and efficacy of the artificial pancreas in people with type 1 diabetes, with a particular focus on blood glucose control and incidence of hypoglycemia.

The second trial will involve 180 of the same participants from the first trial. Its purpose is to test an algorithm designed by the Harvard team. The purpose of the algorithm is to provide an “acceptable zone” for blood glucose levels, rather than having an ideal number. So rather than the system constantly injecting tiny amounts of insulin to reach a certain number, the system will understand that there is a range of blood glucose readings that are safe, and don’t require insulin.

“The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body,” said Doyle. “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. This is the first trial where […] we can actually see a long enough window to learn those patients, to adapt and fine-tune the algorithms, and to improve the overall level of glucose control.”