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Artificial Pancreas Device Undergoes Clinical Trials, Supported By $12.7 Mill. NIH Grant

artificial-pancreasStacey Anderson, MD, and Boris Kovatchev, PhD, co-directors of the Center for Diabetes Technology in the Division of Endocrinology, have been awarded a $12.7 million grant from the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct clinical trials for an artificial pancreas device developed at UVA.

The device, which automatically monitors and regulates blood-sugar levels in people with type 1 diabetes, will undergo final testing in two clinical trials beginning in early 2016. The first – the International Diabetes Closed-Loop Trial – will test technology developed at UVA and further refined for clinical use by TypeZero Technologies, a Charlottesville startup company that has licensed the UVA system. The second trial will examine a new control algorithm developed by a Harvard co-investigator, testing whether it further improves control of blood glucose in patients with type 1 diabetes. Trials will be conducted at nine locations in the U.S. and Europe, including UVA.

Stacey-Anderson-vid

In this nbc29.com video, Dr. Anderson and Dr. Kovatchev discuss the artificial pancreas clinical trials.

According to Anderson, “These are some of the largest-ever long-term clinical trials of the artificial pancreas in the patient’s natural environment. The ultimate goal is to establish the safety and efficacy of the system for regulatory approval and commercialization.”

Kovatchev adds that the artificial pancreas establishes a “new paradigm” for diabetes treatment: “It is not a single-function device; it is an adaptable, wearable network surrounding the patient in a digital treatment ecosystem.”

Favorable results could lead the U.S. Food and Drug Administration and other international regulatory groups to approve the device for use by people with type 1 diabetes, whose bodies do not produce enough insulin. Approximately 1.25 million Americans have type 1 diabetes, according to the U.S. Centers for Disease Control and Prevention.

How the Artificial Pancreas Works

The goal of the artificial pancreas is to eliminate the need for people with type 1 diabetes to stick their fingers multiple times daily to check their blood-sugar levels and to inject insulin manually.

Anderson says, “Individuals with diabetes constantly have to think about the food they eat, their activity level and other factors like illness and stress when making insulin-dosing decisions. Even with meticulous care, the occurrence of high and low blood sugars is often inevitable. By automating much of the insulin decision-making and reacting to predicted changes in blood sugar, the artificial pancreas can improve the quality of life for diabetics while reducing extreme blood sugar fluctuations.”

At the center of the artificial pancreas platform – known as “InControl” – is a reconfigured smartphone that runs advanced algorithms and is linked wirelessly to a blood-sugar monitor and an insulin pump, as well as a remote-monitoring site. People with the artificial pancreas can also access assistance via telemedicine.

International Clinical Trials

Two trials are planned as part of the NIH-funded study. In the first study, 240 patients with type 1 diabetes will test the safety and effectiveness of the artificial pancreas for six 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 the risk of hypoglycemia, or low blood sugar, is reduced.

A second trial will follow 180 patients who completed the first study for an additional six months to test the Harvard University-developed algorithm and determine whether it further enhances blood sugar control.

Along with UVA, the artificial pancreas will be tested at eight other sites: Harvard University, 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.

Co-investigators on the grant include Francis J. Doyle III, PhD (Dean, Harvard School of Engineering and Applied Sciences); Yogish C. Kudva, MBBS (Professor of Medicine, Mayo Clinic), and Carol Levy, MD (Associate Professor of Medicine, Division of Endocrinology, Mt. Sinai Hospital). The NIH/NIDDK grant is No. UC4DK108483.


–  From UVA Health System news release by Eric Swensen, 1/4/16

 

 

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