Artificial pancreas to undergo long-term clinical tests
04 January 2016
Researchers are to conduct one of the largest, long-term clinical trials of a system that can help regulate blood sugar levels of individuals with type 1 diabetes.
With $12.7 million in support from the US National Institutes of Health (NIH), the system developed by a team of researchers from the University of Virginia (UVA) School of Medicine and the Harvard School of Engineering and Applied Sciences (SEAS) will be tested in 240 patients at nine sites in the US and Europe. The two six-month trials will begin in early 2016, in collaboration with a half dozen other institutional partners.
The artificial pancreas system is designed to supply the appropriate levels of insulin by not only reacting to changes in the body, but accurately predicting blood glucose levels in advance. It is not a replica organ; rather it is an automated insulin delivery system designed to mimic a healthy person’s glucose regulating function.
The closed-loop system consists of an insulin pump, continuous glucose monitor placed under the user’s skin, and advanced control algorithm software embedded in a smart phone that provides the engineering brains, signalling how much insulin the pump should deliver to the patient based on a range of variables, including meals consumed, physical activity, sleep, stress, and metabolism.
In the first of the two trials planned as part of the new NIH-funded study, 240 patients with type 1 diabetes will test the safety and effectiveness of the artificial pancreas for six months while going about their normal daily routines. The control-to-range artificial pancreas system for this trial was developed at UVA and is now licensed to TypeZero Technologies. The artificial pancreas will be compared with a standard insulin pump on two key measures: how well blood-sugar levels are controlled and whether the risk of hypoglycaemia is reduced.
The second trial will follow 180 patients who completed the first study for an additional six months to test the advanced adaptive control algorithm developed by the Harvard team (led by Professor Francis Doyle - see video clip above). That system is based on zone model-predictive control (zone MPC), a strategy originally developed by Doyle and colleagues in 1996.
Rather than regulating glucose levels to a specific point in the same way that a home thermostat keeps the room temperature at a precise setting, zone-MPC defines an acceptable zone for an individual’s glucose levels and controls variables to stay within that range.
The UVA/Harvard award is the largest commitment by NIH under a $20 million programme the agency announced in 2014 to fund advanced clinical trials to test the safety and efficacy of artificial pancreas systems.