MAY 30, 2023 6:00 AM PDT

iLet Bionic Pancreas Clears FDA Hurdle, Now Commercially Available for Type 1 Diabetes Patients

It’s been 20 years since Dr. Ed Damiano, who is a professor of biomedical engineering at Boston University, used his lab to invent the iLet Bionic Pancreas, which is an automated, wearable, and pocket-sized insulin delivery device. After years of trials, it finally received approval from the Food and Drug Administration (FDA) for use by individuals ages six and up with type 1 diabetes.

The iLet Bionic Pancreas from Beta Bionics is hailed as the “first and only automated insulin-delivery system that determines 100 percent of all insulin doses.” (Credit: Beta Bionics)

“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 Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, in an official FDA statement. “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.”

While iLet was invented 20 years ago, this endeavor began a few years earlier as Dr. Damiano’s son suffers from type 1 diabetes, and the professor recalls him and his partner having to wake up every few hours throughout the night during the early years of their son’s life to check on his blood sugar levels, followed by either insulin or juice to help manage it.

Video report on a 2022 study about the bionic pancreas. (Credit: YouTube)

This gave Dr. Damiano both personal and professional motivation to develop iLet, leading to him eventually co-founding Beta Bionics in 2015, followed by raising $126 million in 2019 to help fund iLet in the last stages of product development.

Since iLet is automated, Beta Bionics says the user is only required to enter their weight and the device does the rest, including the regulation of blood sugar levels with minimal input from the user afterwards.

“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,” said Dr. Damiano, who is also the executive chairman at Beta Bionics.

Despite his type 1 diabetes, David has lived a full life, eventually graduating summa cum laude from Boston University in 2021, where he double majored in international relations and history, and is now a successful researcher for a feature film and documentary production company.

“The bionic pancreas project has its origins with David, but the experimental research got started in my lab at Boston University almost 20 years ago,” says Damiano. “My appreciation and affection for Boston University runs deep. I will always be grateful to the multitudes of people from across the institution who came together to support my research team’s efforts over the years.”

Additional video report on a 2022 study about the bionic pancreas. (Credit: YouTube)

Credit for iLet also goes to Dr. Kenneth R. Lutchen, who is a professor and Dean at the Boston University College of Engineering. In the early stages of iLet’s development by Dr. Damiano, Dr. Lutchen was instrumental in gaining initial funding for the project, including a grant from the Wallace H. Coulter Foundation, along with the procurement of internal translational resources, as well.

“I am so proud of Boston University and Ed Damiano working together to spawn what has now become a product that will transform the quality of life for so many human beings suffering from type 1 diabetes, and in a way never before imaginable,” said Dr. Lutchen. “I watched Ed Damiano’s inexhaustible energy and brilliance sustain development of the iLet from concept to the early studies on animals to the clinical trials and now to a product.

Across the world, approximately 8.7 million people live with type 1 diabetes, which includes 1.45 million in the United States, 370,000 in the United Kingdom, and over 300,000 in Canada, to name a few countries. By 2040, the number of Americans living with type 1 diabetes is expected to rise to 2.1 million, and the number of diagnosed cases of type 1 diabetes has surpasses the global population growth by as much as four times over.

How will iLet help improve the lives of people living with type 1 diabetes throughout the world? Only time will tell, and this is why we science!

Sources: Food and Drug Administration, Beta Bionics, EurekAlert!,Beyond Type 1

As always, keep doing science & keep looking up!

About the Author
Master's (MA/MS/Other)
Laurence Tognetti is a six-year USAF Veteran who earned both a BSc and MSc from the School of Earth and Space Exploration at Arizona State University. Laurence is extremely passionate about outer space and science communication, and is the author of “Outer Solar System Moons: Your Personal 3D Journey”.
You May Also Like
Loading Comments...
  • See More