Upcoming artificial pancreas trial one of the largest ever conducted on the system

Kurt Wood
Tue, 05 Jan 2016
Upcoming artificial pancreas trial one of the largest ever conducted on the system
An upcoming clinical trial of the artificial pancreas system will be one of the largest long-term studies ever conducted on the subject. Should it perform well, the artificial pancreas could soon be commercially trialled, after which it may be regulated and approved.

The study, conducted by researchers from the University of Virginia School of Medicine and Harvard John A. Paulson School of Engineered and Applied Sciences (SEAS), will involve 240 patients across the US and Europe. The study will involve two separate six-month trials, to begin in early 2016. The system being trialled was developed using $12.7m (£8.65m) from the National Institutes of Health.

What is the artificial pancreas?

An artificial pancreas is a device that aims to mimic the function of a real human pancreas. Many models combine an insulin pump with a continuous glucose monitor (CGM). The CGM monitors rises and falls in blood glucose levels, and signals the release to the pump to release insulin when necessary.

Another promising artificial pancreas model uses an implantable insulin delivery device which uses a gel to monitor blood glucose levels; insulin is released as and when necessary.

The artificial pancreas system is aimed primarily at people with type 1 diabetes, but it is thought that people with insulin-dependent type 2 diabetes could also benefit from its use.

"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 study will consist of two six-month trials. The first will involve 240 participants, all of whom have type 1 diabetes. For six months, they will use the artificial pancreas, then go about their life as usual. The effectiveness and safety of the artificial pancreas will be compared to a standard insulin pump, with the researchers particularly interested in analysing blood glucose control and risk of hypoglycemia while using the artificial pancreas.

The second trial will involve 180 participants who completed the first study. They will use the artificial pancreas for another six months. The purpose of this trial is to test the blood glucose control algorithm developed by the Harvard team. The algorithm is based on zone model-predictive control (known as zone MPC). The idea behind MPC is that, rather than having a precise number for the artificial pancreas to aim for, it is better to have an "acceptable zone" for blood glucose levels to stay within.

"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 patterns, to adapt and fine-tune the algorithms, and to improve the overall level of glucose control."
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