The bionic pancreas, which automatically delivers insulin, has been shown to be more effective in controlling blood glucose (sugar) levels within normal limits than standard treatment among people with type 1 diabetes. a multicenter clinical trial 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.
Compared to other available artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because its 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.
In addition, they do not have to titrate carbohydrates or start insulin doses to correct high blood glucose levels.
Its algorithms continuously adjust insulin doses automatically based on users’ needs
“Our study demonstrates that the advanced technology of the bionic pancreas controlled blood glucose better than currently available insulin delivery methods among participants of all ages, from adults to children as young as six years old,” he says. Nelly Mauras, from Nemours Children’s Health, Hospital (USA) and one of the principal investigators of the study. “This is a major advance in artificial pancreas technology as it requires minimal intervention from both providers and patients, making it very suitable for children and adolescents.” The 13-week trial , conducted at 16 centers in the United States, included 326 participants aged 6 to 79 years who had type 1 diabetes and had been using insulin for at least one year.
Participants were randomly assigned to a treatment group using the bionic pancreas device or a standard care control group using their personal method of insulin administration prior to the study. 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.
Following the trial, all study participants switched from open-loop pump devices, which required multiple daily insulin injections, to closed-loop hybrid pumps.
Hyperglycaemia, 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 mild hypoglycemias, or low blood glucose levels, 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.
Edward Damiano, principal investigator on the project, professor of biomedical engineering at Boston University, and founder and CEO of Beta Bionics, said, “The completion of this study represents an important milestone for the bionic pancreas initiative.”
This study is one of several pivotal trials aimed at advancing artificial pancreas technology and looking at factors such as safety, efficacy, ease of use, physical and emotional health of the participants, and cost. To date, these trials have provided the important safety and efficacy data needed for regulatory review and licensing for the technology to become commercially available.