The iLet Bionic Pancreas is billed as the first and only automated insulin-delivery system that determines 100 percent of all insulin doses. Credit: Beta Bionics
The FDA has cleared a bionic pancreas—a wearable, pocket-sized, automated insulin delivery device—that was first developed in a Boston University lab. The iLet Bionic Pancreas brings fresh hope to the almost 2 million Americans living with type 1 diabetes.
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 clipped on a bra strap or thrown in a pocket, 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 endeavor. The iLet 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 AID [automated insulin dosing] technology,” said Jeff Shuren, director of the FDA’s Center 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.”
The approval is a massive milestone in a two-decade—and deeply personal—journey. Invented 20 years ago in the lab of Ed Damiano, a BU College of Engineering professor of biomedical engineering, the bionic pancreas combines an insulin infusion pump with algorithm-controlled dosing decision software. Damiano was inspired to develop the system by his son, who was diagnosed with type 1 diabetes when he was just 11 months old.
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 numbers.
In 2015, Damiano cofounded Beta Bionics, a public benefit corporation, to advance the technology; four years later, the company raised $126 million to push the device through the final stages of its development. Given the iLet’s origins—and Damiano’s very personal motivation for ensuring its success—the FDA’s approval came on a fitting date.
“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,” says Damiano, founder and executive chairman at Beta Bionics.