NEJM: Bionic pancreas improves the management of type 1 diabetes compared to standard insulin delivery methods

A new multicenter clinical trial found that in patients with type 1 diabetes, a device known as bionic pancreas uses next-generation technology to automatically deliver insulin more effectively
than standard care management in keeping blood glucose levels within the normal range.
The trial, conducted in part at the Nemoor Children's Health Center in Jacksonville, was largely funded by the National Institute of Diabetes, Digestive and Kidney Disease (NIDDK), a division 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, use continuous blood glucose monitors to track the body's blood sugar levels and automatically deliver insulin hormones
using insulin pumps when needed.
These systems replace continuous blood glucose monitors that rely on finger sticks to detect blood sugar levels, deliver insulin through multiple injections per day, or do not have automated pumps
.

Compared to other existing artificial pancreas technologies, the bionic pancreas requires less user input and provides more automation because its algorithms constantly automatically adjust insulin doses
based on the user's needs.
By entering their weight into the device's administration software on the first use, users can start the bionic pancreas
.

Users of the bionic pancreas do not need to count carbohydrates and do not need to initiate insulin doses to correct hyperglycemia
.
In addition, healthcare providers do not need to adjust device settings
regularly.

The Nemoor Children's Health Center in Jacksonville was one
of 16 U.
S.
institutions involved in the study.
It is an American Diabetes Association-accredited center of excellence that brings world-class medical, academic and research collaboration
to Northeast Florida.
One of the study's lead investigators, Nelly Mauras, MD, is a career clinical research scientist in pediatric endocrinology and diabetes, director of research and associate director of pediatrics at the Nemoor Children's Health Center in Jacksonville, and professor of pediatrics at
the Mayo Clinical School of Medicine.

"Our study shows that advanced bionic pancreas technology manages blood sugar better than currently available insulin delivery methods and is suitable for participants of all ages, from adults to children under 6 years of age," said
Dr.
Mauras.
"This is a big leap forward in artificial pancreas technology because it requires minimal input from providers and patients, making it ideal for children and adolescents
.
"

The 13-week trial, conducted at the Nemore Children's Health Center in Jacksonville and 15 other clinical sites in the United States, enrolled 326 people with type 1 diabetes between the ages of 6 and 79 and used insulin for at least a year
.
Participants were randomly assigned to a treatment group using a bionic pancreatic device or a standard nursing control group
using an individual pre-studied insulin delivery method.
All participants in the control group were equipped with continuous blood glucose monitors, and nearly one-third of the control group used commercially available artificial pancreas technology
during the study period.

Among participants who used bionic pancreas, glycosylated hemoglobin — a measure of a person's long-term blood glucose control — increased from 7.
9 percent to 7.
3 percent, but remained unchanged
in the standard care control group.
Participants in the biomimetic pancreas group spent 11% more time within the target blood glucose range, about 2.
5 hours
per day, compared to the control group.
These results were similar in both young and adult participants, with the greatest
improvement in blood glucose control among participants with higher blood glucose levels at the start of the study.

The lead research coordinator at the Nemoor Children's Center in Jacksonville has seen first-hand how advanced technology can improve the day-to-day diabetes management
of study participants and their families.
"Our team found that blood sugar fluctuated much less, and patients were grateful to be able to stop counting carbohydrates while eating," said
Keisha Bird of DNP, APRN.

After the trial, all study participants transitioned from open-loop pump devices that required multiple injections of insulin per day to hybrid closed-loop pumps
.

Hyperglycemia caused by problems with insulin pump equipment was the most commonly reported adverse event
in the bionic pancreas group.
The number of mild hypoglycemic events or hypoglycemia was low, and there was no difference
between the two groups.
The frequency of occurrence of severe hypoglycemia was not statistically different
between the standard care group and the bionic pancreas group.

Four companion papers were published in the journal Diabetes Technology and Treatment, two of which provided more detailed results
in adult and adolescent participants.
One paper focused on 165 children (ages 6-17) who participated in the study, and the results showed that mean glycosylated hemoglobin (HbA1c) decreased from 8.
1% at baseline to 7.
5% at 13 weeks, compared with 7.
8%
at baseline and 13 weeks under standard care.
Notably, the average HbA1c ≥ 9.
0% of children with minimal diabetes control at baseline decreased from 9.
7% to 7.
9% after 13 weeks of blood pressure control, compared with 9.
7% to 9.
8%
in the standard treatment group.
The third paper reports the results of an extended study in which participants in the standard care control group switched to using the bionic pancreas for 13 weeks and experienced similar glucose control improvements
as in the bionic pancreas group in the randomized trial.
In the fourth paper, the findings suggest that the use of bionic pancreas with rapid-acting insulin in 114 adult participants was as effective in improving glucose control
as using a device with standard insulin.

Dr.
Edward Damiano, the project's principal investigator, professor of biomedical engineering at Boston University, founder and executive chairman of Beta Bionics, agrees
.
"The completion of this study is an important milestone in the Bionic Pancreas Program, which would not have been possible without the support provided by NIDDK over the years
.
"

The study, one of several key trials funded by NIDDK, aims to advance artificial pancreas technology and focuses on factors
including safety, efficacy, user-friendliness, participants' physical and emotional well-being, and cost.
So far, these trials have provided important safety and effectiveness data
for regulatory review and commercialization of licensed technologies.
The Jeb Health Research Center in Tampa, Florida serves as the focal point
.

Funding for the study was provided by Boston University's NIDDK grant 1UC4DK108612, the Novo Nordisk Investigator Initiated Research Award, and Beta Bionics, which also provided experimental bionic pancreatic devices
used in the study.
Insulin and some supplies were donated by Novo Nordisk, Eli Lilly, Dexcom and Ascensia Diabetes Care
.
Beta Bionics, Inc.
received NIDDK SBIR grant 1R44DK120234 to provide partial support
for the development of experimental biomimetic pancreatic devices.

About NIDDK: NIDDK is an integral part of the NIH that conducts and supports research into diabetes and other endocrine and metabolic diseases; Digestive disorders, nutrition and obesity; There are also kidney and urinary system and blood diseases, which cover the entire field of medicine, afflicting people of all ages and racial groups, including some of the most common, most serious, and most disabling diseases
that affect Americans.
For more information about NIDDK and its programs, see the National Institutes of Health (NIH): The NIH is a medical research institution in the United States, comprising 27 institutes and centers, and is an integral part
of the U.
S.
Department of Health and Human Services.
The NIH, the leading federal agency that conducts and supports basic, clinical, and translational research, is investigating causes, treatments, and cures for common and rare diseases
.
To learn more about the NIH and its programs, visit the Nemore Children's Health Center: The Nemore Children's Health Center is one of the largest multistate pediatric health systems in the United States, including two separate children's hospitals and a network of more than 70 primary and specialty care clinics
.
Nemoirs Children's Hospital seeks to transform children's health by adopting an integrated health model that leverages innovative, safe and high-quality care, while caring for the health of the entire child outside of medicine
.
Nemours Children's also powers Nemours KidsHealth.
org, the world's most visited website for child and adolescent health information
.

The Nemoor Foundation was established through the legacy and philanthropy of Alfred i.
DuPont to provide pediatric clinical care, research, education, advocacy and prevention programs
for the children, families and communities it serves.
For more information, visit the Nemours.
org
.