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The iLet-Bionic Pancreas uses next-generation technology to automatically deliver insulin
to people with type 1 diabetes.
In a multicenter trial conducted at the University of Texas Southwest, an experimental device called the bionic pancreas was more effective at keeping blood sugar levels in people with type 1 diabetes within the normal range
than standard blood glucose management.
The findings, published in the New England Journal of Medicine, show the promise of this new device, which uses next-generation technology to automatically deliver insulin
.
"Our study shows that advanced insulin pumps are as good or even better at controlling blood sugar in participants of all ages as the currently available insulin delivery methods, from adults to children under 6 years of age," said
Perrin C.
White, M.
D.
Dr.
Philip Raskin
Because the system puts much less input into users and their healthcare providers than other insulin pumps, it can safely improve blood sugar control
in more people with diabetes.
In the United States, less than 20 percent of people with type 1 diabetes have met the goal of less than 7 percent glycosylated hemoglobin, a long-term indicator
of glycemic control.
Type 1 diabetes is characterized by a gradual decrease
in the number of insulin-producing cells in the pancreas.
Automated and semi-automated insulin delivery systems have the potential to increase the number of people
who can achieve this target.
Hybrid closed-loop systems on the market partially automate insulin delivery and require a lot of input from the user — including basal insulin delivery rates, insulin sensitivity factors, and grams of carbohydrates per meal — a onerous obligation that can have a detrimental effect
on blood sugar control due to user error.
In contrast, the device tested in this study used an algorithm that determined glucose delivery
based only on a rough estimate of the weight at the time of initial use and the carbohydrate content at mealtimes.
A wearable sensor sends glucose levels to the iLet-bionic pancreas
via Bluetooth every 5 minutes.
The algorithm on iLet's calculates the insulin dose, and the iLet's pumping mechanism manages the insulin dose
through a catheter and infusion device (right side of the navel).
The infusion set contains a small catheter inserted under the skin, through which insulin is injected into the subcutaneous tissue (not intravenously
).
This closed-loop sequence is repeated every 5 min and 288 times
a day.
To determine the effectiveness of the bionic pancreas, researchers at 16 medical centers in the United States, including the University of Texas at Southwestern and the Children's Health Center, studied 306 people with type 1 diabetes between the ages of 6 and 79, 165 of whom were under the age of
18.
About two-thirds of people use the bionic pancreas to control blood sugar within 13 weeks; Another third use their usual standard of care while using a constant blood glucose monitor
.
The results showed that glycosylated hemoglobin measurements in patients using bionic pancreas increased from an average of 7.
9% to 7.
3%, while glycosylated hemoglobin measurements remained unchanged
in patients using standard care management.
In addition, participants in the bionic pancreas group spent 11% more time within the target blood glucose range compared to the control group, about 2.
5 hours
per day.
These results were similar in young people and adults, with the greatest
improvement in blood sugar control among participants with higher blood glucose levels at the start of the study.
The researchers say the results suggest that the new technique could significantly improve blood sugar control in people with type 1 diabetes, helping them avoid common complications associated with the disease, including heart attacks, strokes, nerve damage and blindness
.