FDA green-lights bionic pancreas studied at UT Health Science Center, University Health

Artificial intelligence insulin delivery and glucose monitoring system cleared for age 6 and older

While it won’t cure children of type 1 diabetes, the “bionic pancreas,” an artificial intelligence-powered system cleared Friday, May 19, by the U.S. Food and Drug Administration, will relieve youth and their parents of constant worries over estimating insulin doses and carb intake from food.

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

The pediatric endocrinology team at the University Health Texas Diabetes Institute was one of the first vanguard groups of researchers to study the bionic pancreas during a clinical trial reported in the New England Journal of Medicine in October 2022. This experience with the device’s implementation in patients allows 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 in the Long School of Medicine and at University Health. “This is a huge step forward for young people in the management of type 1 diabetes.”

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

In a press release, Jeff Shuren, MD, JD, director of 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 may help to broaden the reach of automated insulin dosing technology.”

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

“Instead of having preset insulin dosing, this device enables AI algorithms to learn a patient’s insulin requirements,” Lynch said. “It is unique and innovative.”

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

“At the Texas Diabetes Institute on Zarzamora Street, we care for predominantly Hispanic families, and we see the parents’ struggles to maintain their children’s sugars,” said Ruby Favela-Prezas, family nurse practitioner in the pediatric endocrinology practice. “Some youths adjust well, but others really struggle. For every young person with type 1 diabetes, the constant management that is required can be very stressful, so to have a system that is automatic in ensuring the children’s safety 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 provide insulin in response to continuous blood sugar patterns. The device is the size of a cell phone and is typically worn on the belt.

“The AI algorithm adjusts to the individual needs of each user,” Lynch said. “It is revolutionary, and our team is delighted to share this technology to reduce the daily burden of care for our patient who have type 1 diabetes here in our city and in South and Central Texas.”

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