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Wearable bionic pancreas approved for use in US

Professional Engineering

The iLet Bionic Pancreas combines an insulin infusion pump with algorithm-controlled dosing decision software (Credit: Beta Bionics)
The iLet Bionic Pancreas combines an insulin infusion pump with algorithm-controlled dosing decision software (Credit: Beta Bionics)

A wearable bionic pancreas that automates insulin delivery to manage type 1 diabetes has been cleared for use by the US Food and Drug Administration (FDA).

The iLet Bionic Pancreas, which combines an insulin infusion pump with algorithm-controlled dosing decision software, is now commercially available.

The pocket-sized device was first invented by biomedical engineering professor Ed Damiano at Boston University (BU), Massachusetts. Damiano was inspired to develop the system by his son, who was diagnosed with type 1 diabetes when he was just 11-months-old.

When paired with a Bluetooth-enabled glucose monitor, the iLet can deliver tailored insulin doses every five minutes, based on calculations of current and past glucose levels and the body’s reaction to past insulin deliveries.

Small enough to be placed in a pocket or clipped on to a bra strap, the iLet “means patients will no longer have to constantly measure their glucose levels and calculate, with help from their doctor, their correct insulin dose – a 24/7 endeavour,” a BU announcement said.

The device was cleared for people aged six years and older with type 1 diabetes.

“Today’s action will provide the type 1 diabetes community with additional options and flexibilities for diabetes management, and may help to broaden the reach of automated insulin dosing technology,” said Jeff Shuren, director of the FDA’s Centre for Devices and Radiological Health, in a statement announcing the decision.

“The FDA is committed to advancing new device innovation that can improve the health and quality of life for people living with chronic diseases that require day-to-day maintenance, like diabetes, through precision medicine approaches.”

Damiano’s co-inventor was Firas El-Khatib, formerly a senior research scientist at BU and now vice-president of research and innovation at developer Beta Bionics. Last autumn, the two inventors were co-authors on a study that found the iLet helped adults and children maintain healthier blood glucose levels, outperforming existing standard-of-care methods – a significant step towards FDA clearance.

In people with type 1 diabetes, the pancreas does not produce enough insulin, an essential hormone for converting and storing sugars. The chronic condition can cause a host of complications, from heart disease to eye damage, and there is no cure.

According to Beta Bionics, users of the iLet just need to enter their weight to get started – the system will then use ‘continuous learning’ to do the rest, regulating blood glucose levels with minimal input.

For most of his son’s early life, Damiano and his partner would wake every few hours in the night, checking their son’s blood sugar levels, giving him insulin or juice to control the levels.

In 2013, nearly a decade into development, Damiano talked to BU alumni magazine Bostonia about the fear and panic of those night time checks, which often started with making sure his son was still warm and breathing.

“Sleeping is the scariest part of all this,” he told Bostonia. “It’s what put this project on a high-speed rail. It’s a very scary prospect that blood sugars could go low at night. When you’re sleeping, you’re checked out – you don’t want to check out permanently.”

Speaking in the announcement this week, he said: “This milestone is particularly poignant to me as the news of FDA clearance coincided with the 24th birthday of my son, David, who developed type 1 diabetes as an infant, just over 23 years ago.”

The story also had another positive note in 2021, when David graduated with the highest distinction from BU, double majoring in history and international relations.

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Content published by Professional Engineering does not necessarily represent the views of the Institution of Mechanical Engineers.


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