Smartphone-based artificial pancreas to enter large-scale clinical trials

Researchers are preparing an artificial pancreas for two international, multi-site, large scale clinical trials beginning in early 2016. The goal is to make the artificial pancreas the optimal treatment for people with type 1 diabetes, according to researchers at University of Virginia (UVA) School of Medicine, in Charlottesville, VA, where it was developed.

The artificial pancreas system uses smartphone technology to monitor and stabilize blood-glucose levels in people with type 1 diabetes. (Photo: UVA)

The artificial pancreas is a closed-loop system that uses smartphone technology linked wirelessly to an insulin pump and continuous blood glucose monitor to automatically monitor and control blood-glucose levels in patients with type 1 diabetes.

“Our foremost goal is to establish a new diabetes treatment paradigm,” said lead investigator Boris Kovatchev, PhD, Director of the UVA Center for Diabetes Technology. “The artificial pancreas is not a single-function device—it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem.”

Preliminary trials, in which patients used the system through the night at home, showed encouraging results in maintaining target blood-glucose levels.

“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,” Dr. Kovatchev noted.

The two clinical trials will be conducted at 9 sites in the US and Europe. The first study, the International Diabetes Closed-Loop trial, will include 240 type 1 diabetes patients who will test the safety and effectiveness of the artificial pancreas for 6 months while going about their regular daily routines. The artificial pancreas will be compared with a standard insulin pump on two key measures: how well blood-sugar levels are controlled, and whether subjects’ risk of hypoglycemia is reduced.

The second trial will also examine a new control algorithm—developed by the team of Francis Doyle III, PhD, Dean of the Harvard Paulson School of Engineering and Applied Sciences at Harvard University, in Cambridge, MA—to test whether it further improves glycemic control.

“The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body,” Dr. Doyle said. “Day to day, hour to hour, the various stresses that impact the human body change the way it responds to insulin-controlling glucose … This is the first trial where we’ll be looking at multi-month intervals of time with cohorts of subjects 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.”

Along with UVA and Harvard, the artificial pancreas will be tested at Mount Sinai School of Medicine, Mayo Clinic, University of Colorado, Stanford University, University of Montpellier in France, University of Padova in Italy, and Academic Medical Center at the University of Amsterdam in The Netherlands.