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Trial Testing Artificial Pancreas for Type 1 Diabetes

Diabetes Assistant screen

Diabetes Assistant screen (University of Virginia)

7 February 2017. A clinical trial testing day-to-day use of a smartphone-controlled artificial pancreas for people with type 1 diabetes began enrolling participants. The late-stage trial is led by endocrinologist Stacey Anderson and biomedical mathematician Boris Kovatchev at University of Virginia medical school in Charlottesville.

The NIH-funded trial is testing a system that measures and analyzes blood sugar levels in people with type 1 diabetes, then infuses a personalized dose of insulin from an insulin pump. The system is managed by software made by TypeZero Technologies LLC in Charlottesville. Kovatchev is a co-founder of TypeZero Technologies and serves as the company’s chief mathematician. If the trial results return favorable findings, the university and TypeZero are expected to apply for marketing approval from regulatory authorities.

Type 1 diabetes is an inherited autoimmune disorder where the body does not produce insulin, and is diagnosed primarily in children or young adults. Autoimmune disorders are conditions where the immune system is tricked into attacking healthy cells and tissue as if they were foreign invaders, in this case, insulin-producing beta cells in the pancreas. About 1.25 million people in the U.S. have type 1 diabetes, about 5 percent of people with diabetes of any kind.

The system combines an insulin pump, made by Tandem Diabetes Care in San Diego, with a glucose monitoring sensor by Dexcom, also in San Diego. The system is managed with TypeZero software called Diabetes Assistant that runs on a dedicated, reconfigured smartphone. The software is based on algorithms developed by Kovatchev and colleagues at Virginia’s Center for Diabetes Technology, where Kovatchev is the center’s director.

The algorithms analyze data sent wirelessly from the glucose monitoring sensor, then send instructions to the pump to dispense insulin in a dose personalized for the individual. TypeZero’s software also has modules for meals, exercise, and diabetes management decisions. The software connects as well to the cloud where physicians, caregivers, or family members can be notified if necessary.

The clinical trial is testing the system among individuals age 14 and older with type 1 diabetes. Participants will be randomly assigned to receive the artificial pancreas system or continue using their current glucose monitoring and insulin pump devices for 6 months. The trial is recruiting participants at 10 sites in the U.S. and Europe.

The study is looking primarily at the ability of participants to keep their blood glucose levels between specified safe limits over the 6-month period as they go about their daily lives. The study team led by Anderson is also evaluating safety and cost, as well as the overall physical and emotional health of the participants. A second, similar trial is also planned, but testing the artificial pancreas with a different control algorithm written by Francis Doyle at Harvard University.

In the following video, Anderson, Kovatchev, and a participant from an earlier clinical trial tell more about the Diabetes Assistant system.

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