Diabetes controlled with ‘bionic pancreas’

First clinical trial at UT Health San Antonio published in the New England Journal of Medicine

A device known as a bionic pancreas was more effective at maintaining sugar levels within normal range than standard-of-care management among people with Type 1 diabetes, a new multicenter clinical trial has found.

SAN ANTONIO – It may not be a total cure for diabetes, but the largest, randomized clinical trial for a “bionic pancreas” in San Antonio resulted in what may be the best effortless control of the disease ever invented.

The trial pitted the technology, which involves a cellphone and an implant, against every available FDA-cleared diabetes control product on the market.

Dr. Rabab Jafri, a pediatric endocrinologist at University Health’s Texas Diabetes Institute said the results were so successful it will likely be FDA-approved as well sometime next year.

The huge trial got rave reviews from those facing a lifetime of finger-prick blood sugar tests and insulin injections like Bella and Kat Hickman. They participated in the clinical trial that commenced in 2020 and were sad to see it come to an end.

“I did the study for that one. I didn’t want to leave. Like when even when I was halfway through, I was like, ‘No!” said 8-year-old Kat, who has suffered from diabetes since she was 3 years old.

Her older sister was diagnosed at 10 years old, and was only able to experience her first sleepover because of the bionic pancreas trial. Bella shows off the tubing from her current monitoring system that is similar to the one she wore during the study.

“The little balloon thing up here, that’s my insulin, that’s my battery,” she pointed out. Until the bionic pancreas is FDA approved, she and her sister are making do with a version that does not offer as many options or features.

Their mother, Angelique Keys, was waking up every two hours through the night to take a blood sugar reading on both girls prior to the trial. Now she said there are audible alerts when things are going off track.

“There’s less trial and error, there’s less chance of having those really severe lows where you can go into a diabetic coma, when you’re by yourself. It’s just a way to kind of alert to say, ‘Hey, you know, maybe you’re not doing so good. Let’s go get some juice. Let’s get something to get you back up,” Keys said.

The bionic pancreas called the iLet from Beta Bionics features a pancreatic implant that connects to Bluetooth devices and an insulin infusion set up. It sounds alarms, monitors, gives insulin treatments, and even sends patients specific food needs or choices depending on the numbers it is calculating.

“Things like carbohydrate counting, calculating doses of insulin, giving yourself multiple doses to bring down high blood sugars are not needed at all with the bionic pancreas,” Jafri said. Blood sugars are checked five times a day and continuously transmitting the data to the insulin pump.

“The pump is making autonomous decisions to deliver small doses of insulin every five minutes, depending on where the blood sugars are, and so a lot of the work of diabetes control is taken away from the wearer,” Jafri said.

She and Angelique Keys agree that quality of life is improved for everyone involved, from a parent whose responsibility it has been for medical monitoring, as well as the elderly diabetes patient who is not technically savvy and lives alone.

The UT Health San Antonio study is being published in the New England Journal of Medicine as well as a number of other medical journals. The results showed there was an improvement in blood sugars, an improvement in A1C, which is usually used as a target for blood sugar control, and an increase in the amount of time spent in the target blood sugar range in both children and adults.

It’s also important to note that the18 participants were from the ages of 6 to 17 years and had diabetes for at least one year. They also came from a variety of backgrounds, but 40% were of Hispanic origin, which is reflective of the diversity of San Antonio.

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About the Author:

Ursula Pari has been a staple of television news in Texas at KSAT 12 News since 1996 and a veteran of broadcast journalism for more than 30 years.