Bionic pancreas helps maintain blood sugar levels in people with type 1 diabetes

Bionic pancreas helps maintain blood sugar levels in people with type 1 diabetes

A device known as a bionic pancreas that uses next-generation technology to automatically deliver insulin was more effective than standard treatment in maintaining blood glucose (sugar) levels within the normal range in people with type 1 diabetes, a new multicenter clinical trial has found. The study was funded primarily by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, and published in the New England Journal of Medicine.

Automated insulin delivery systems, also called artificial pancreases or control systems, monitor a person's blood sugar levels using a continuous glucose monitor and automatically release the hormone insulin when needed using an insulin pump. These systems replace the reliance on fingerstick glucose measurement, a continuous glucose monitor with separate insulin delivery with multiple daily injections, or a pump without automation.

Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and offers more automation as the device's algorithms continually automatically adjust insulin doses based on users' needs. Users initialize the bionic pancreas by entering their body weight into the device's dosing software at the time of first use.

Users of the bionic pancreas also do not need to count carbohydrates or administer insulin doses to correct high blood sugar levels. Additionally, healthcare providers do not need to regularly adjust the device's settings.

Among children, adolescents, and parents participating in this study, adolescents demonstrated statistically and clinically meaningful improvements in the time spent in target blood glucose range, despite there being no need to count carbohydrates, calculate basal insulin dosage, or correct for high glucose levels. This novel insulin delivery system is likely to reduce both the emotional and cognitive burden of diabetes management for both adolescents and parents living with type 1 diabetes.”

Jill Weissberg-Benchell, PhD, CDCES, study co-author, child psychologist, Ann & Robert H. Lurie Children's Hospital of Chicago and professor of psychiatry and behavioral sciences at Northwestern University Feinberg School of Medicine

The 13-week study, conducted at 16 clinical sites across the United States, included 326 participants ages 6 to 79 who had type 1 diabetes and had used insulin for at least a year. Participants were randomly assigned to either a treatment group using the bionic pancreas device or a standard control group using their personal insulin administration method before the study. All participants in the control group received a continuous glucose monitor and nearly a third of the control group used commercially available artificial pancreas technology during the study.

In participants who used the bionic pancreas, glycated hemoglobin, a measure of a person's long-term blood sugar control, improved from 7.9 percent to 7.3 percent, but remained unchanged in the standard control group. Participants in the bionic pancreas group spent 11 percent more time, about 2.5 hours per day, within the target blood sugar range compared to the control group. These results were similar in adolescent and adult participants, and improvements in blood sugar control were greatest in participants who had higher blood sugar levels at the start of the study.

Hyperglycemia, or high blood sugar, caused by problems with insulin pump equipment, was the most commonly reported adverse event in the bionic pancreas group. The number of mild hypoglycemia, or low blood sugar levels, was low and did not differ between groups. The incidence of severe hypoglycemia was not statistically different between the standard treatment group and the bionic pancreas group.

Four accompanying papers were also published in Diabetes Technology and Therapeutics, two of which provided more detailed results in adult and adolescent participants. The third article reported results from an extension study in which participants in the standard control group switched to using the bionic pancreas for 13 weeks and experienced similar improvements in glucose control to those in the bionic pancreas group in the randomized trial. In the fourth paper, results showed that using the bionic pancreas with a faster-acting insulin improved glucose control as effectively as using the device with standard insulin in 114 adult participants.

Source:

Ann & Robert H. Lurie Children's Hospital of Chicago

Reference:

Russell, S.J., et al. (2022) Multicenter, randomized study of a bionic pancreas in type 1 diabetes. New England Journal of Medicine. doi.org/10.1056/NEJMoa2205225.

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