Bionic pancreas improves type 1 diabetes management over standard insulin delivery methods

Bionic pancreas improves type 1 diabetes management over standard insulin delivery methods

Press release

Wednesday, September 28, 2022

Next-generation technology maintains blood glucose levels by automatically delivering insulin.

A device known as the bionic pancreas, which uses next-generation technology to automatically deliver insulin, was more effective at keeping blood glucose (sugar) levels within the normal range than standard care management in patients. people with type 1 diabetes, a new multicenter clinical trial has found. The trial was primarily funded 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 known as artificial pancreas or closed-loop control systems, monitor a person’s blood sugar levels using a continuous blood glucose monitor and automatically deliver the hormone insulin when needed. necessary using an insulin pump. These systems replace reliance on fingertip glucose testing, a continuous glucose monitor with separate insulin delivery with multiple daily injections or a pump without automation.

Compared to other artificial pancreas technologies available, the bionic pancreas requires less user intervention and offers more automation as the device’s algorithms continuously 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 initiate doses of insulin to correct high blood sugar. Additionally, healthcare providers do not need to make periodic adjustments to device settings.

“Keeping tight blood sugar control is important in the management of diabetes and is the best way to prevent complications such as eye, nerve, kidney and cardiovascular disease,” said Dr. Guillermo Arreaza-Rubín, program director of NIDDK Diabetes Technology. “Bionic pancreas technology introduces a new level of ease in the day-to-day management of type 1 diabetes, which may help improve quality of life.”

The 13-week trial, conducted at 16 clinical sites across the United States, recruited 326 participants aged 6 to 79 who had type 1 diabetes and had been using insulin for at least a year. Participants were randomly assigned to either a treatment group using the bionic pancreatic device or a standard-of-care control group using their personal pre-study insulin delivery method. 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 using the bionic pancreas, glycated hemoglobin, a measure of a person’s long-term blood sugar control, improved from 7.9% to 7.3%, but remained unchanged in the group reference witness. Participants in the bionic pancreas group spent 11% longer, about 2.5 hours per day, in the targeted blood glucose range compared to the control group. These results were similar in young and adult participants, and improvements in blood sugar control were greatest in participants with higher blood sugar levels at the start of the study.

“Our observation that this system can safely improve blood sugar control to the extent we have found, despite requiring significantly less intervention by users and their providers healthcare, has important implications for children and adults living with diabetes,” said Dr Steven Russell. , study chair, associate professor of medicine at Harvard Medical School, and physician at Massachusetts General Hospital in Boston.

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

Four complementary articles were also published in Diabetes Technology and Therapeutics, two of which provided more detailed results among 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 using the bionic pancreas for 13 weeks and experienced improvements in blood sugar control similar to those of the bionic pancreas group in the randomized trial. In the fourth paper, results showed that using the bionic pancreas with faster-acting insulin in 114 adult participants improved blood sugar control as effectively as using the device with standard insulin.

“NIDDK’s decades-long investment in the development of advanced technologies for diabetes management has reached another promising milestone and continues to deliver significant returns,” said NIDDK Director Dr. Griffin P. Rodgers. “As we continue to search for a cure for type 1 diabetes, devices like the bionic pancreas may allow people to worry less about their blood sugar and focus more on living a healthier, fuller life.”

Dr. Edward Damiano, the project’s principal investigator, professor of biomedical engineering at Boston University and founder and executive chairman of Beta Bionics, Inc., agrees. “The completion of this study represents a major milestone for the Bionic Pancreas Initiative, which simply would not have been possible without the support provided by the NIDDK over the years.”

The study is one of several pivotal trials funded by the NIDDK to advance artificial pancreas technology and examine factors such as safety, efficacy, user-friendliness, participants’ physical and emotional health, and cost. To date, these trials have provided the important safety and efficacy data needed for regulatory review and registration to make the technology commercially available. The Jaeb Center for Health Research in Tampa, Florida served as the coordinating center.

Funding for the study was provided by NIDDK grant 1UC4DK108612 to Boston University, a Novo Nordisk Investigator Initiated Scholarship, and Beta Bionics, Inc., which also provided the experimental devices for bionic pancreases used in the study. Insulin and some supplies were donated by Novo Nordisk, Eli Lilly, Dexcom and Ascensia Diabetes Care. Partial support for the development of the bionic pancreas experimental device was provided by NIDDK Small Business Innovation Research (SBIR) grant 1R44DK120234 to Beta Bionics, Inc.

The NIDDK, a component of the NIH, conducts and supports research on diabetes and other endocrine and metabolic diseases; digestive diseases, nutrition and obesity; and renal, urological and hematological diseases. Spanning the full spectrum of medicine and affecting people of all ages and ethnicities, these diseases encompass some of the most common, serious, and disabling conditions affecting Americans. For more information about the NIDDK and its programs, see https://www.niddk.nih.gov/.

About the National Institutes of Health (NIH):
The NIH, the country’s medical research agency, comprises 27 institutes and centers and is part of the US Department of Health and Human Services. The NIH is the primary federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about the NIH and its programs, visit www.nih.gov.

NIH…Transforming Discovery into Health®

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