Seminar Series
“The Dawn of a New Era in Fully Automated Insulin Titration in Type 1 Diabetes: Pivotal Trial and Real-world Results of the Ilet Bionic Pancreas”
Edward R Damiano, PhD
Research Professor of Biomedical Engineering
Boston University
Monday, April 28, 2025
GP1002
12:00pm – 12:50pm
Abstract: Twenty-five years ago, when my infant son was diagnosed with type 1 diabetes, I set my sights on building and integrating autonomous, intelligent systems into a purpose-built, wearable medical device that I referred to as a bionic pancreas. In 2021, a 13-week pivotal clinical trial was conducted that tested the iLet Bionic Pancreas in 440 adults and children with type 1 diabetes. The clinical data from that pivotal trial was published in the New England Journal of Medicine in 2022. Based in part on that data, the iLet Bionic Pancreas received clearance by the US Food and Drug Administration in May 2023. Since June 2023, the iLet has been commercially available for people six years and older with type 1 diabetes through commercial and government insurance across the US. Results from the pivotal clinical trial will be presented and compared with real-world results of the iLet during the first 18 months of commercial usage.
Biography: Edward Damiano is Research Professor of Biomedical Engineering at Boston University. He was the founder-CEO of Beta Bionics, Inc.\ and Chairman of the Board beginning in 2015. His academic research has been in the areas of mathematical biology and glycemic control. His basic scientific research combined aspects of fluid dynamics, solid mechanics, and intravital microscopy to study the biomechanics of the inner ear and blood flow in the microcirculation. Ever since his 25-year-old son, David, was diagnosed with type 1 diabetes at 11 months old, he set his sights on building and integrating autonomous, intelligent systems into a purpose-built, wearable medical device that he referred to as a bionic pancreas. In 2021, a 13-week pivotal clinical trial was conducted that tested the iLet Bionic Pancreas in 440 adults and children with type 1 diabetes. The clinical data from that pivotal trial was published in the New England Journal of Medicine in 2022. Based in part on that data, the iLet Bionic Pancreas received clearance by the US Food and Drug Administration on David’s 24th birthday in May 2023. Since June 2023, the iLet has been commercially available for people six years and older with type 1 diabetes through commercial and government insurance across the US.
For a zoom link please contact Kate Harrison at kharrison@wpi.edu