A device known as a bionic pancreas, which uses next-generation technology to automatically deliver insulin, was more effective at maintaining blood glucose (sugar) levels within normal range than standard-of-care management among people with type 1 diabetes, a new multicenter clinical trial has found.
The trial, conducted partly at CHOC, was primarily funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), part of the National Institutes of Health, and recently published in the New England Journal of Medicine.
The bionic pancreas device results in a new level of ease for day-to-day management of type 1 diabetes.
Automated insulin delivery systems, also called artificial pancreas or closed-loop control 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 can replace the multi-step process of testing glucose levels by fingerstick or continuous glucose monitor then manually determining and administering the dose of required insulin by injection or non-automated insulin 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 initiate doses of insulin to correct for high blood glucose. In addition, health care providers do not need to make periodic adjustments to the settings of the device.
“The ease of use of this system, combined with the improvement in overall glucose control shown in this study, is truly very exciting,” said Dr. Mark Daniels, principal investigator at CHOC for the clinical trial and division chief, endocrinology and diabetes. “I believe that this type of system will take much of the stress and effort out of the unending work required for parents and children dealing with diabetes, while offering a lower risk of diabetes complications.”
‘Really exciting study’
The 13-week trial, conducted at CHOC and 15 other clinical sites across the United States, enrolled 326 participants ages 6 to 79 years who had type 1 diabetes and had been using insulin for at least one year.
At CHOC, 23 patients with type 1 diabetes, ages 6 to 18 years old, completed the clinical trial, which came after five years of pilot studies and concluded in October 2021, said Heather Speer, MPH CCRC CDE, senior clinical research coordinator supervisor.
“This was a really exciting study for us,” she said. “The participants did so well, and it really gave them some peace of mind knowing that they didn’t have to be so tied to their insulin pump.”
CHOC treats over 1,700 children and adolescents with type 1 diabetes.
The bionic pancreas device is similar in size to a pager and clips onto a belt or clothing.
A continuous glucose sensor worn by the user communicates with the pump that then learns via algorithms how the body reacts to food and insulin, and delivers variable amounts of insulin into the body via a tube.
Users simply have to tap on a touchscreen to indicate whether they will have a small, normal-sized, or large meal.
The device has a cartridge for insulin, which lowers blood sugar, and users have to change the infusion site every three days.
In addition to Dr. Daniels and Speer, several CHOC associates served as sub-investigators on the diabetes/endocrine bionic pancreas study team.
They were: Dr. Nikta Forghani, medical director, pediatric diabetes program at the Mary and Dick Allen Diabetes Center; Dr. Amrit Bhangoo, director of research, division of pediatric endocrinology; Himala Kashmiri, DO, program director, pediatric endocrinology and diabetes fellowship program; Dr. Christina Reh, pediatric endocrinologist specialist and assistant director of the CHOC diabetes program; Francoise Sutton, FNP, pediatric nurse practitioner-endocrinology; Samantha Thompson, RD CDE (certified diabetes educator), diabetes center program coordinator; Allyson McDaniel, BSN CDE, supervisor, certified diabetes education team; Marissa Erickson, MPH CRC, clinical research coordinator II; and Hunter Vallejo BS, clinical research coordinator assistant.
Results of clinical trial
Participants in the multi-center clinical trial 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 hemoglobin, a measure of a person’s long-term blood glucose control, improved from 7.9% to 7.3%, yet remained 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.
“Our observation that this system can safely improve glucose control to the degree we found, and do so despite requiring much less input from users and their health care providers, 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 staff physician at the Massachusetts General Hospital in Boston.
Four companion papers published
Hyperglycemia, or high blood glucose, caused by problems with insulin pump equipment, was the most frequently reported adverse event in the bionic pancreas group. The number of mild hypoglycemia events, or low blood glucose, was low and was not different between the groups. The frequency of severe hypoglycemia was not statistically different between the standard of care and bionic pancreas groups.
Four companion papers were also published in Diabetes Technology and 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 randomized trial.
In the fourth paper, results showed that using the bionic pancreas with a faster-acting insulin in 114 adult participants improved glucose control as effectively as using the device with standard insulin.
“NIDDK’s decades-long investment in developing advanced technologies for diabetes management has reached another promising milestone and continues to provide significant return,” said NIDDK Director Dr. Griffin P. Rodgers. “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.”
Dr. Edward Damiano, project principal investigator, professor of biomedical engineering at Boston University, and founder and executive chair of Irvine-based Beta Bionics, Inc., manufacturer of the experimental device, iLet, concurs.
“The completion of this study represents a major milestone for the bionic pancreas initiative, which simply would not have been possible had it not been for the support provided by the NIDDK over the years,” he said.
Goal is commercial availability
The study is one of several pivotal trials funded by NIDDK to advance artificial pancreas technology and look at factors including safety, efficacy, user-friendliness, physical and emotional health of participants, and cost.
To date, the trials have provided the important safety and efficacy data needed for regulatory review and licensure to make the technology commercially available.
The Jaeb Center for Health Research in Tampa, Fla., served as coordinating center for the study. Funding was provided by NIDDK grant 1UC4DK108612 to Boston University, by an Investigator-Initiated Study award from Novo Nordisk, and by Beta Bionics.
Insulin and some supplies were donated by Novo Nordisk, Eli Lilly, Dexcom, and Ascensia Diabetes Care.
Partial support for the development of the experimental bionic pancreas device was provided by NIDDK 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 kidney, urologic, and hematologic diseases. Spanning the full spectrum of medicine and afflicting people of all ages and ethnic groups, these diseases encompass some of the most common, severe and disabling conditions affecting Americans.