Published on: October 07, 2022
Study partly conducted at UT Southwestern shows promise of experimental device
DALLAS – Oct. 7, 2022 – An experimental device known as a bionic pancreas kept blood sugar levels within normal ranges more effectively than standard-of-care glucose management among patients with Type 1 diabetes in a multicenter trial conducted partly at UT Southwestern. The findings, published in the New England Journal of Medicine, show the promise of this new device, which uses next-generation technology to automatically deliver insulin.
“Our study shows that the advanced insulin pump managed blood glucose as well as or better than currently available insulin delivery methods among participants of all ages, from adults to children as young as 6 years old,” said Perrin C. White, M.D., Professor of Pediatrics at UTSW and Chief of the Division of Pediatric Endocrinology at Children’s Health, and Philip Raskin, M.D., Professor of Internal Medicine at UTSW. Drs. White and Raskin served as lead investigators of the trial at UTSW.
“Because this system requires much less input from the user and their health care providers than other insulin pumps, it can safely improve glucose control for many more people living with diabetes,” they said.
Fewer than 20% of patients in the U.S. living with Type 1 diabetes – a disease characterized by the gradual loss of cells in the pancreas that produce insulin – meet the goal of less than 7% glycated hemoglobin, a long-term measure of blood sugar control. Automated and semiautomated insulin delivery systems have the potential to increase the number of people able to achieve this metric. Commercially available hybrid closed-loop systems, which partially automate insulin delivery, require significant input from users – including a basal rate of background insulin delivery, insulin sensitivity factors, and carbohydrate grams at each meal – an onerous obligation that can harmfully sway glucose control due to user error.
In contrast, the device tested in this study uses algorithms that determine glucose delivery based on only body weight at initial use and a rough estimate of carbohydrate content at meals.
To determine the effectiveness of the bionic pancreas, researchers at 16 U.S. medical centers, including UT Southwestern and Children’s Health, worked with 306 patients with Type 1 diabetes ranging from 6 to 79 years old, with 165 under age 18. About two-thirds used the bionic pancreas to control their blood sugar for 13 weeks; the other third used their usual standard of care, along with a continuous glucose monitor.
Results showed that patients using the bionic pancreas improved their glycated hemoglobin measurements to 7.3% from 7.9% on average, while this measurement remained unchanged for those using standard-of-care management. In addition, the bionic pancreas group participants spent 11% more time, about 2.5 hours per day, within the targeted blood sugar range compared to the control group. These results were similar among youths and adults, and improvement in blood sugar control was greatest among participants who had higher blood glucose levels at the beginning of the study.
The researchers say these results suggest this new technology could significantly improve blood sugar control among those with Type 1 diabetes, helping them avoid complications frequently associated with this disease, including heart attack, stroke, nerve damage, and blindness.
Dr. Raskin holds the Clifton and Betsy Robinson Chair in Biomedical Research. Dr. White holds the Audre Newman Rapoport Distinguished Chair in Pediatric Endocrinology.
Other UTSW researchers who contributed to this study include Abha Choudhary and Jimmy Penn.
This research was funded by the National Institute of Diabetes and Digestive and Kidney Diseases (1UC4DK108612-01), an investigator-initiated study award from Novo Nordisk, and Beta Bionics Inc., which also provided the experimental bionic pancreas devices used in the study.
About UT Southwestern Medical Center
UT Southwestern, one of the nation’s premier academic medical centers, integrates pioneering biomedical research with exceptional clinical care and education. The institution’s faculty has received six Nobel Prizes, and includes 26 members of the National Academy of Sciences, 17 members of the National Academy of Medicine, and 14 Howard Hughes Medical Institute Investigators. The full-time faculty of more than 2,900 is responsible for groundbreaking medical advances and is committed to translating science-driven research quickly to new clinical treatments. UT Southwestern physicians provide care in more than 80 specialties to more than 100,000 hospitalized patients, more than 360,000 emergency room cases, and oversee nearly 4 million outpatient visits a year.
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