New automated insulin device helps children and adults manage diabetes

October 20, 2022

Researchers have developed a bionic pancreas capable of delivering insulin on its own, helping diabetic patients better manage their blood sugar levels.

In the New England Journal of Medicine study, researchers found the wearable device was better at managing blood glucose levels than existing standard care methods.

Your pancreas is like a little digestive engine, working hard to keep your body fueled and running. Just six inches long, it’s responsible for turning lunch into energy to get you through the afternoon and ensuring your blood sugar levels stay balanced.

But in people with type 1 diabetes, the pancreas fails in the second job. The organ – tucked away behind the stomach – doesn’t produce enough insulin, a hormone needed to convert and store sugars. Without it, these sugary carbs can’t enter cells, leaving sugars stuck in the blood and people with type 1 diabetes feeling thirsty, hungry and tired.

In the long term, diabetes can cause heart disease and damage the eyes, kidneys, feet and skin. Patients must constantly monitor their blood sugar levels and inject themselves with insulin in an attempt – often unsuccessfully – to control them.

“Significant” results
In a 13-week clinical trial at 16 sites across the United States, iLet improved levels of glycated hemoglobin (A1C) – a measure of blood sugar control – reducing them by an average of 7.9% to 7.3%.

In contrast, A1C levels did not, on average, change in the control group, where participants continued with their existing care regimens and ongoing glucose monitoring. Although the American Diabetes Association suggests people with type 1 diabetes try to keep their A1C levels below 7% – noting that higher levels lead to an increased risk of complications – only one in five people in the United States with type 1 diabetes achieves this goal.

“It sounds so modest, you lose the entire cohort on average by half a percent, but it’s actually quite significant,” says Ed Damiano, executive chairman of Beta Bionics.

He says regulators and industry consider this to be a clinically meaningful reduction. “Each percentage point reduction in A1C has been shown to confer significant reductions in long-term health complications for people with type 1. In a population, this can be huge.”

Those using the bionic pancreas spent, on average, an additional 2.6 hours per day with their glucose levels in the target range of 70 to 180 milligrams per deciliter. The trial included 326 children and adults, aged 6 to 79, all with type 1 diabetes; 219 participants were randomly assigned to bionic pancreas, the rest to standard care. The researchers found a mean reduction in A1C in the iLet adult and child cohorts.

How does the bionic pancreas work?
The 15mm thick iLet is about the length and width of a credit card. Worn on a belt clip – or even in a bra strap or pushed into a pocket – the device communicates with a separate Bluetooth monitor to continuously track a subject’s glucose levels.

Through a thin tube connected to the body, the iLet automatically delivers a tailored dose of insulin every five minutes, which it calculates based on current and past glucose levels; it can also learn and adapt to changing needs based on the body’s response to past insulin deliveries.

In contrast, other methods of managing type 1 diabetes require the patient to prick their finger or use a monitor to measure their blood sugar, then administer insulin by injection or by injection. using a pump: it is up to him, with the help of his doctor, to calculate the correct dosage.

“Some systems have partial automation of insulin dosing,” says Damiano. “However, the bionic pancreas autonomously determines the size of each insulin dose.”

For most people with type 1 diabetes, maintaining optimal blood sugar levels is a 24/7 effort – Damiano says the disease is relentless.

“Basically, you’re constantly measuring the dosage of a very dangerous drug,” Damiano says of many existing approaches. “Insulin is a vital hormone, a vital hormone, but it is very, very sensitive.

“Tiny drops of insulin can cause big changes in blood sugar, so even the slightest overdose can have serious consequences. And consistent underdosing, in response to fear of acute hypoglycemia, low blood sugar, can lead to long-term complications.
Easier diabetes control
When the researchers broke down the trial results, they found differences between demographic groups. The study showed that iLet had a much greater impact on participants who were non-white, earned less than $100,000, or did not have a bachelor’s degree. These groups started with higher baseline A1C levels, but experienced greater reductions – by more than one percent in some cases.

“The iLet is designed to demand next to nothing from you,” says Damiano. “As much as possible, it’s designed to look like a self-driving car, instead of holding the wheel and making all the decisions about insulin dosing. It’s a decidedly different experience.

“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,” says Guillermo Arreaza-Rubín, director of the National Institute of diabetes and the digestive system. and diabetes technology program for kidney disease.

“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.”

In 2014, Damiano and colleagues at Massachusetts General Hospital successfully tested an early version of the bionic pancreas in two five-day trials; by 2019, Beta Bionics had secured over $137 million in funding.

Earlier this year, Beta Bionics submitted iLet to the US Food and Drug Administration for commercial clearance. Damiano says the latest trial was crucial: “it is more important than any other trial done to test an automated insulin delivery system.” The company hopes to soon obtain federal approval to market the bionic pancreas in the United States.

For now, the device only infuses insulin, but Damiano and his team have also been working on a version that prevents sugar levels from getting too low by automatically delivering another hormone: glucagon.

“Even for people who get really good blood sugar control through great effort,” says Damiano, “when they go on the ilet, they may feel a huge relief in letting go of control and that constant diligence.”