Mia Campos finds freedom and happiness in spending the day at Six Flags with her friends or shopping at La Cantera. For 15-year-old Campos, these everyday activities wouldn’t be possible without her “bionic pancreas.”
Campos has Type 1 diabetes, meaning her pancreas doesn’t produce enough insulin to regulate her glucose levels. Her new “bionic pancreas” is a wearable, electronic device that replaces the role of her pancreas and adapts to the needs of her endocrine system over time.
Campos was one of 17 San Antonio children who played a role in the development of the iLet Insulin Bionic Pancreas system, which was approved in May by the U.S. Food and Drug Administration for Type 1 patients ages 6 to 79. Medicaid, Medicare and private insurances approved coverage for the system in September.
“I didn’t want to return to my pump,” Campos said about when the study ended. “I felt like a normal girl. I could do anything, I didn’t have to poke myself or anything. I felt more freedom.”
The approval comes more than two years after the UT Health Science Center San Antonio and University Health led a 13-week, randomized clinical trial. In its entirety, the study started in January 2020 and ended November 2021.
The wait was long, but worth it for Campos’ new sense of freedom.
The iLet Insulin system was developed by Massachusetts-based Beta Bionics and is one of many new advances in diabetes management technology which are improving ways to automate insulin delivery.
The system uses input from the continuous glucose monitor and nutrition data to automate the insulin pump, adapting to the patient’s insulin needs and working as a pancreas to manage a patient’s glucose levels.
It stands out from other insulin pump systems through three levels of automation by using three artificial intelligence-based algorithms: One for background insulin, correction for high blood sugar and meal announcements.
“It has its own memory it improves on overtime to adjust to your body,” said Dr. Jane Lynch, pediatric endocrinologist at the Texas Diabetes Institute. “The iLet remembers from day to day what your needs were.”
Campos, a patient at the University Health Texas Diabetes Institute on Zarzamora Street, used a continuous glucose monitor and administered insulin manually using an insulin pen injector before participating in the study for six months.
The clinical trials in San Antonio included local children ages 6 to 17. The study recruited children for their racial and ethnic backgrounds and for their use of technology: Researchers wanted to learn how adaptable the system was going from shots and older pumps to the new technology.
Like Campos, most children in the study previously used insulin pens or wore pumps that required them to calculate or log how many carbohydrates they consumed — for some, that meant doing math every time they ate.
Campos administered one unit of insulin per five grams of carbs consumed.
But the bionic organ eliminates that need, administering insulin based on a qualitative estimate of carbohydrates by logging “meal announcements” that ask the patient how much they ate: “usual for me,” “more” or “less.”
The system automatically pumps however much insulin the patient needs through a thin tube connected to the vial of insulin when a continuous glucose monitor notifies that glucose levels are high or low.
Though the bionic pancreas isn’t monitoring continuously, it checks the patient’s blood glucose levels every five minutes.
“Other systems adjust the background in the moment for what your needs are, but they don’t have a longitudinal memory for your body’s rhythm,” Lynch said. “They adjust in the moment to give more or less background based on how your blood sugars look.”
The insulin infusion set in the bionic pancreas can hold about 200 units of insulin and must be changed every three days. Lynch said it takes about five minutes to refill the insulin. Mia Campos said she does it on her own.
When the study finished, Campos was forced to return the bionic pancreas system, because it had not been FDA-approved yet.
Though Campos upgraded to another pump system, she still had to count carbs and didn’t have the independence she wanted. Every three to six months, she would ask about the bionic pancreas at check-ups.
Then one day, Campos’ mother, Ruby Campos, learned that the bionic pancreas had been FDA-approved.
“I told Mia and she got very excited. The nurse called and told us it had been approved and that she was a candidate to get it,” said Ruby Campos, her eyes shimmering with tears of joy remembering the moment.
The system costs $3,500 and requires purchasing an infusion set, also covered by insurance. Mia Campos’s Children’s Health Insurance Program (CHIP) covered the costs and most of the price tag for her insulin.
Researchers said clinical trials in San Antonio helped them learn not to override what the system does, because it will backfire. Users should allow the system to administer insulin on its own instead of forcing more or less insulin at different times.
“So you say I’m having more, usual or less food for a meal, and it remembers, ‘Oh okay. You need this much insulin in the morning and in the afternoon and in the evening.’ So it has it’s own memory that improves overtime to adjust to your body,” Lynch said.
A second phase of the study in San Antonio starting early 2024 will incorporate small doses of a second hormone called glucagon into the system, a rescue medication that raises blood sugars for people living with Type 1 diabetes.
“It’s novel, it has not ever been done before in a pump,” Lynch said.
Lynch said the Texas Diabetes Institute is also studying the safety of newer drug therapies like Ozempic, which is approved for adults, in insulin-resistant children living withType 2 diabetes.
For the future of diabetes management, Mia Campos said she hopes insulin becomes more affordable and for more development of new technology like the bionic pancreas that makes patients’ lives easier.
There are a lot of stereotypes that come with a diabetes diagnosis, she said, especially at school, “because they don’t know.”
In the meantime, Campos said she’ll do her part in spreading awareness about diabetes management and embracing her diagnosis.
“I’m going to tell them about it,” she said. “One day, a little girl asked me [about my system]. I explained it to her.”
UT Health San Antonio and University Health are financial supporters of the San Antonio Report. For a full list of business members, click here.
