System to undergo longterm clinical testing.

Harvard University School of Engineering & Applied Sciences Cambridge, MA

A team of scientists from the University of Virginia (UVA) School of Medicine and the Harvard John A. Paulson School of Engineering and Applied Sciences developed a project to turn an ordinary smartphone into an artificial pancreas that has since received a $3.4 million grant from the National Institutes of Health. Now, researchers are beginning one of the largest-ever long-term clinical trials of a system designed to help regulate blood sugar levels of individuals with type 1 diabetes mellitus. The “artificial pancreas” system will be tested in 240 patients at nine sites in the US and Europe. Two six-month trials are beginning in early 2016, in collaboration with a half dozen other institutional partners.

Fig.1 - Researchers will soon undertake one of the largest-ever long-term clinical trials of a system designed to help regulate blood sugar levels of individuals with type 1 diabetes mellitus. (Credit: Peter Allen, Harvard University)
If the system performs in patients as well as the researchers hope, it could lead to commercial trials and eventual regulatory approval in the United States and abroad.

According to the U.S. Centers for Disease Control and Prevention, 1.25 million Americans have type 1 diabetes. Diabetics must monitor their blood glucose levels scrupulously, and administer doses of insulin when needed either via needle injections or infusion pump.

“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,” explains principal investigator Boris Kovatchev, Director of the UVA’s Center for Diabetes Technology. “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 artificial pancreas system is designed to supply appropriate levels of insulin by accurately predicting blood glucose levels in advance; not merely reacting to changes in the body. It acts as an automated insulin delivery system designed to mimic a healthy person’s glucose regulating function. The closed-loop system consists of an insulin pump, a continuous glucose monitor placed under the user’s skin, and advanced control algorithm software embedded in a smartphone that signals 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. (See Figure 1)

In the first of the two trials planned as part of the new 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-torange artificial pancreas system for this trial was developed at UVA and is now licensed to TypeZero Technologies LLC, Charlottesville, VA. 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 hypoglycemia 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. That system is based on zone model-predictive control (zone MPC), a strategy originally developed by Harvard researchers 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.

In addition to UVA and Harvard, other institutions in the International Diabetes Closed Loop Consortium who will participate in the clinical trials include: Mount Sinai Hospital, New York; the Mayo Clinic; Stanford University; the University of Colorado; the University of Padua, Italy; Regional University Hospital Center of Montpellier, France; the Academic Medical Center, Amsterdam; William Sansum Diabetes Center, Santa Barbara; with coordination by the JAEB Center for Health Research in Florida.

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