Editor’s note: This week’s WRAL TechWire Deep Dive article focuses on a possible means of improving the treatment of type 1 diabetes.
CHAPEL HILL – A device known as a bionic pancreas, which uses next-generation technology to deliver insulin automatically, was more effective at keeping blood glucose (sugar) levels within the normal range than standard treatment among people with type 1 diabetes, a new multicenter clinical trial study has found. The trial, conducted in part at UNC-Chapel Hill, 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 closed-loop monitoring systems, track a person’s blood glucose levels using a continuous glucose monitor and automatically deliver the hormone insulin when needed using an insulin pump. . These systems replace reliance on fingerstick glucose testing, continuous glucose monitoring with separate insulin delivery through multiple daily injections, or a non-automated pump.
Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because the device’s algorithms continually adjust insulin doses automatically 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 have to count carbohydrates or start insulin doses to correct high blood glucose. Additionally, healthcare providers do not need to make periodic adjustments to device settings.
The 13-week trial, conducted at UNC-Chapel Hill under the leadership of John Buse, MD, PhD, director of the UNC Diabetes Center, and 15 other clinical sites across the United States, enrolled 326 participants ages 6 to 79. who had type 1 diabetes and had been using insulin for at least a year. Participants were randomly assigned to a treatment group using the bionic pancreas device or a standard care control group using their personal pre-study insulin delivery method. All participants in the control group were provided with a continuous glucose monitor, and almost a third of the control group used commercially available artificial pancreas technology during the study.
In participants using the bionic pancreas, glycosylated hemoglobin, a measure of a person’s long-term blood glucose control, improved from 7.9% to 7.3%, but remained unchanged among the control group of standard care. Participants in the bionic pancreas group spent 11% more time, approximately 2.5 hours per day, within target blood glucose range compared to the control group. These results were similar in youth and adult participants, and improvements in blood glucose control were greater among participants who had higher blood glucose levels at the start of the study.
Hyperglycemia, or high blood glucose, caused by problems with the insulin pump equipment, was the most frequently reported adverse event in the bionic pancreas group. The number of events of mild hypoglycemia, or low blood glucose, was low and did not differ between groups. The frequency of severe hypoglycemia was not statistically different between the standard care and bionic pancreas groups.
Four companion articles were also published in Diabetes technology and therapeutics two of which provided more detailed results between adult and youth participants. The third article reported the results of an extension study in which participants in the standard care control group switched to the bionic pancreas for 13 weeks and experienced similar improvements in glucose control as the bionic pancreas group in the trial. randomized. In the fourth article, the results showed that use of the bionic pancreas with faster-acting insulin in 114 adult participants improved glucose control as effectively as use of the device with standard insulin.
The study is one of several NIDDK-funded pivotal trials to advance artificial pancreas technology and look at factors including safety, effectiveness, ease of use, participants’ physical and emotional health, and cost. To date, these trials have provided important safety and efficacy data needed for regulatory review and licensing of the technology to become commercially available. The Jaeb Center for Health Research in Tampa, Florida, acted as the coordinating center.
John Buse is the Verne S. Caviness Distinguished Professor of Medicine at UNC School of Medicine and director of the North Carolina Institute for Translational and Clinical Sciences (NC TraCS) located at UNC-Chapel Hill.