FDA gives green light to bionic pancreas being studied at UT Health Science Center, University Health

Artificial Intelligence Insulin Delivery and Blood Glucose Monitoring System Authorized for Ages 6 and Up

Contact: Will Sansom, UT Health Sciences Center, 210-567-2579, [email protected]

Academic Health Communications, 210-358-2335

SAN ANTONIO (May 25, 2023) — Although it won’t cure children with type 1 diabetes, the “bionic pancreas,” an artificial intelligence-powered system cleared Friday, May 19, by the United States Food and Drug Administration United States, will relieve young people and their parents of constant worries about estimating insulin doses and carbohydrate intake from food.

“We don’t want to call it a pump. It is more. It’s AI for insulin delivery,” said Jane Lynch, MD, professor of pediatric endocrinology and diabetes at the University of Texas Health Sciences Center at San Antonio. Lynch, a professor at the Joe R. and Teresa Lozano Long School of Medicine at the Health Sciences Center, treats children with type 1 diabetes at the Texas Diabetes Institute at University Health on the West Side of San Antonio.

The pediatric endocrinology team at the University Health Texas Diabetes Institute was one of the first groups of pioneering researchers to study the bionic pancreas in a clinical trial reported in the New England Journal of Medicine in October 2022. This experience with implementing the device in patients enables the team to be the first in South and Central Texas to offer it to more children.

“We are absolutely thrilled to have the opportunity to launch the bionic pancreas in San Antonio,” said Rabab Jafri, MD, pediatric endocrinology and diabetes specialist at the Long School of Medicine and University Health. “This is a huge step forward for young people in managing type 1 diabetes.”

The FDA reviewed the bionic pancreas and associated AI software through the 510(k) premarket clearance pathway. The system is licensed for people 6 years and older with type 1 diabetes.

In a press release, Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, said the May 19 clearance “will provide the type 1 diabetes community with additional options and flexibilities. for diabetes management and could help expand the reach of automated insulin dosing technology.

The system, made by a Massachusetts medical technology company, only requires entry of the wearer’s body weight to get started. The automated insulin delivery system is associated with a continuous blood glucose monitoring system. At mealtimes, users estimate their carb intake simply as small, medium, or large.

“Instead of having a preset insulin dosage, this device allows AI algorithms to learn a patient’s insulin needs,” Lynch said. “It’s unique and innovative.”

In people with type 1 diabetes, the pancreas does not make insulin, the hormone that regulates blood sugar. The result is a lifestyle of monitoring glucose levels every day and taking insulin through injections or via an insulin pen or pump. A healthy diet and exercise are also necessary to control blood sugar.

“At the Texas Diabetes Institute on Zarzamora Street, we care for predominantly Hispanic families and we see the difficulties parents have in maintaining their children’s blood sugar levels,” said Ruby Favela-Prezas, Family Nurse Practitioner at the Pediatric Endocrinology Practice. . “Some young people adapt well, but others really struggle. For every young person with type 1 diabetes, the constant management that is required can be very stressful, so having a system that automatically keeps children safe and well-being through regulated glucose levels is truly a dream. come true.

The device uses an attached plastic infusion set that communicates with a sensor to deliver insulin in response to continuous blood glucose patterns. The device is the size of a mobile phone and is usually worn on a belt.

“The AI ​​algorithm adapts to each user’s individual needs,” Lynch said. “It’s revolutionary, and our team is excited to share this technology to reduce the daily burden of care for our type 1 diabetes patients here in our city and in South and Central Texas.”

The University of Texas San Antonio Health Sciences Center (UT Health San Antonio) is one of the nation’s leading health sciences universities and is designated as a Hispanic-Serving Institution by the U.S. Department education. With teaching, research, patient care and community engagement missions, its graduate schools of medicine, nursing, dentistry, health professions and biomedical sciences have graduated more than 41,100 graduates who lead change, advance their fields and bring hope to patients and their families. throughout South Texas and around the world. To learn more about the many ways We Make Life Better®, visit

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About University Health

University Health is San Antonio’s only local health system and South Texas’ only academic medical center. Its teaching hospital serves as the region’s Tier I trauma center for adults and children, and is the only hospital in the region to be state-designated at the highest level for its maternity center and neonatal intensive care unit. . Ambulatory care is provided by a comprehensive network of urgent, primary and specialist care centres. For more than 100 years, University Health has been committed to providing compassionate, culturally competent, and high-quality health care, based on a solid foundation of results-oriented research and innovative teaching. Learn more at Follow us on Twitter and Facebook.

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