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Artificial pancreas partly developed at UVa approved by FDA

The U.S. Food and Drug Administration has approved an artificial pancreas system that was based on research done at the University of Virginia.

The new artificial pancreas system is more effective at controlling blood sugar for those with Type 1 diabetes than are existing treatments and could mean an end to finger-pricking for Type 1 patients who use the device.

“With the FDA approval of Control-IQ, UVa physicians will be able to prescribe this system to people with diabetes who need insulin delivery, primarily those with Type 1 diabetes, and that’s the big change,” said Boris Kovatchev, director of UVa’s Center for Diabetes Technology.

The artificial pancreas system, manufactured by Tandem Diabetes Care, tracks blood glucose levels with a continuous glucose monitor and automatically delivers the hormone insulin as needed.

The system, also known as closed-loop control, is made up of an app and an implanted insulin pump; they calculate proper levels of blood sugar and deliver insulin automatically. The system means that people with Type 1 diabetes don’t have to prick their fingers to measure their blood sugar or inject themselves daily with insulin. Type 1 diabetes is a condition that means a person’s pancreas produces little to no insulin.

“With this clearance, we will be launching the most advanced automated insulin-dosing system commercially available in the world today,” John Sheridan, president and CEO of Tandem Diabetes Care, said in a statement. “This is a testament to our commitment to improving the lives of people with diabetes by offering simple-to-use products that deliver superior performance.”

Results from a clinical trial, published in the fall in the New England Journal of Medicine, found that the new artificial pancreas system was more effective than existing treatments at controlling blood glucose levels in people with Type 1 diabetes, and found the system worked effectively overnight.

Kovatchev said the team started this process back in 2005; at the time, many people said their idea would be impossible to develop.

“For me, it’s completion of a very long research process that continued for 14 years and ended up with a successful system that people now can use, and that doesn’t happen frequently to researchers, so I feel privileged in that sense,” he said.

He said the UVa Center for Diabetes Technology now is working on new generations of the device that aim to provide even better control and further automation of insulin delivery that takes conditional signals into account, such as physical activity. Researchers also are expanding the knowledge and the data that they have accumulated to cover more and more people, including those with Type 2 diabetes.

Kovatchev said he is thankful for those who helped throughout the research process, including Paul and Diane Manning, the Juvenile Diabetes Research Foundation, the UVa Strategic Investment Fund and the National Institutes of Health.

“All of these organizations and people supported our research throughout the years to the successful conclusion of phase one,” he said.


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