Bionic pancreas simplifies type 1 diabetes management

An experimental device known as a bionic pancreas, which uses next-generation technology to automatically deliver insulin, has proved more effective at maintaining blood glucose (sugar) levels within normal range than standard-of-care management among people with type 1 diabetes.

That’s according to a multicentre clinical trial that was primarily funded by the US 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.

Less than 20% of patients in the US living with type 1 diabetes — a disease characterised by the gradual loss of cells in the pancreas that produce insulin — meet the goal of less than 7% glycated haemoglobin, a long-term measure of blood sugar control. Automated and semi-automated insulin delivery systems, also called artificial pancreas or closed-loop control systems, have the potential to increase the number of people able to achieve this metric, by tracking 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 testing glucose level by finger stick, a continuous glucose monitor with separate insulin delivery through multiple daily injections or a pump without automation. They do, however, still require considerable user input, which can be onerous and prone to error: various parameters need to be entered when setting up the device and may need periodic updating by a healthcare provider; at meal times, the user may have to enter the amount of carbohydrates consumed to determine the proper insulin dose; and insulin doses may need to be manually adjusted in order to manage episodes of high (hyperglycaemia) or low (hypoglycaemia) blood glucose.

Compared to other available artificial pancreas technologies, the bionic pancreas is designed to require less user input and provides more automation because the device’s algorithms continually adjust insulin doses automatically based on the user’s needs. The device only needs the user’s body weight upon set-up and, while the user still needs to enter meals, they only need to include an estimate of carbohydrate amount (more, less or the same as typical). All other aspects of insulin delivery are completely automated.

The 13-week trial, conducted at 16 clinical sites across the United States, enrolled 326 participants aged six to 79 years who had type 1 diabetes and had been using insulin for at least one year. Participants were randomly assigned to either a treatment group using the bionic pancreas device or a standard-of-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 nearly one-third of the control group were using commercially available artificial pancreas technology during the study.

In participants using the bionic pancreas, glycated haemoglobin improved from 7.9% to 7.3%, while remaining unchanged among the standard-of-care control group. The bionic pancreas group participants spent 11% more time, approximately 2.5 hours per day, within the targeted blood glucose range compared to the control group. These results were similar in youth and adult participants, and improvements in blood glucose control were greatest among participants who had higher blood glucose levels at the beginning of the study.

“Among the children, teens and parents participating in this study, youth showed statistically and clinically meaningful improvements in their time spent in target blood glucose range, even though there was no need to count carbohydrates, calculate basal insulin dosing or correct high glucose levels,” said study co-author Jill Weissberg-Benchell, paediatric psychologist at Ann & Robert H. Lurie Children’s Hospital of Chicago and Professor of Psychiatry and Behavioral Sciences at Northwestern University. “This novel insulin delivery system likely decreases both the emotional and cognitive burden of diabetes management for both youth and parents living with type 1 diabetes.”

Hyperglycaemia caused by problems with insulin pump equipment was the most frequently reported adverse event in the bionic pancreas group. The number of mild hypoglycaemia events was low and was not different between the groups, while the frequency of severe hypoglycaemia was not statistically different between the standard-of-care and bionic pancreas groups.

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

“While we continue to search for a cure for type 1 diabetes, devices like the bionic pancreas can allow people to worry less about their blood glucose levels and focus more on living their fullest, healthiest lives,” concluded NIDDK Director Dr Griffin Rogers.

Images credit: Beta Bionics.

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