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STUDY: ‘BIONIC PANCREAS’ IMPROVES TYPE 1 DIABETES CONTROL


NEWS RELEASE


September 28, 2022
For immediate release


STUDY: ‘BIONIC PANCREAS’ IMPROVES TYPE 1 DIABETES CONTROL

Users of the investigational device spent 11% more time in the target
blood-glucose range than control-group members.

Media Contact: 

Brian Donohue - 206-543-7856, bdonohue@uw.edu

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In a study, an investigational device was found to outperform commercially
available insulin pumps.

A pocket-size wearable 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.

Results were published today in the New England Journal of Medicine. 

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; they automatically deliver the hormone insulin via
pump as needed. These systems replace reliance on fingerstick tests of glucose
levels, glucose monitoring that still requires multiple daily insulin
injections, and non-automated pumps.

“This pump uses more artificial intelligence than the other pumps on the market.
It identifies trends of the continuous glucose monitor to give insulin that
keeps blood glucose in the normal range — without patients having to count
carbohydrates,” said Dr. Irl Hirsch. He is a diabetes expert at the University
of Washington School of Medicine, one of 16 U.S. trial sites and the only one in
the Pacific Northwest.

Compared with other artificial pancreas technologies, the bionic pancreas
requires less user input because the device’s algorithms continually adjust
insulin doses 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.

“Many patients closely manage their type 1 diabetes, and do extremely well,”
Hirsch said. “But there’s another, very large group of patients who don’t pay as
much attention, for a variety of reasons. Our findings could be informative for
those patients, in terms of keeping their blood sugar under better control.”

The 13-week trial enrolled 326 participants ages 6 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.

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 with the control group. These results
were similar in youth and adult participants.

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.

The trial was primarily funded by the National Institute of Diabetes and
Digestive and Kidney Diseases (NIDDK), part of the National Institutes of
Health. Funding for the study was provided by NIDDK grant 1UC4DK108612 to Boston
University, by an investigator-initiated study award from Novo Nordisk, and by
Beta Bionics, which also provided the experimental bionic pancreas devices 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
experimental bionic pancreas device was provided by NIDDK SBIR grant
1R44DK120234 to Beta Bionics.

Category: 
Research
Tags: 
insulin
diabetes
blood sugar
health technology

###

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