Scientific innovations can come from our most personal experiences. For Ed Damiano, PhD, the co-founder of Beta Bionics, his transformative invention began with his son’s diagnosis of type 1 diabetes and an unwavering determination to find a better way to manage the condition. After more than 20 years of research, the FDA approved - on the 24th birthday of Damiano's son - the iLet Bionic Pancreas, a revolutionary device that autonomously regulates blood glucose levels for people with type 1 diabetes.
The Diagnosis
When Damiano’s son David was 11 months old, his wife Toby, a pediatrician, started noticing that something was off. David was irritable, frequently wetting his diapers, and he often became glassy-eyed, staring off into space. Worried it might be a brain tumor, she took David for a blood test that came back showing his blood sugar was eight times the normal range, and immediately rushed him to the pediatric intensive care unit to start insulin therapy. “It's all to [Toby’s] credit that she caught him so early,” Damiano said.
There is no cure for type 1 diabetes, an autoimmune condition where the pancreas produces little to no insulin. Insulin is the hormone we rely on for sugar to enter our cells for use as energy. Without insulin, sugar builds up in the bloodstream, leading to high glucose levels. When undertreated, diabetes can cause nerve damage, blindness, and heart and kidney disease. If left untreated, diabetes can cause death. “Before the discovery and purification of insulin a century ago, it was a death sentence,” Damiano said.
Immediately after the diagnosis, Damiano and his wife started David on insulin therapy. Back then, there was no such thing as continuous glucose monitoring. “He was so small, even the smallest amount of carbohydrates, the glucose that he'd eaten, could cause his blood sugar to spike,” Damiano explained. They would have to guess the timing and doses of up to eight shots daily with diluted insulin and tiny syringes. It meant waking three times a night to test his blood. “There was nothing quantitative about it even though we pretended we were being very quantitative,” he said. “There were just too many variables.”
The Big Idea
It became clear that David needed an insulin pump, which made Damiano think about the future. “Is David going to be able to do what we can do for him?” Damiano worried. “Whose going to have his back at night?”
As an engineering professor, he began to imagine how to build a real-time continuous glucose monitor that people with diabetes could wear all the time. The idea was to program algorithms that could communicate with a sensor that monitors blood levels to know when to give a dose of insulin - a single-hormone bionic pancreas. And it had to be scalable for anyone to use. “You have to have a system like a self-driving car,” Damiano said. “It took two decades. Whoa… 20 years ago, it was a hobby.”
Getting to a clinical trial in the middle of a pandemic
Research began in pigs with diabetes, and then, in collaboration with Steven Russell, MD, PhD, at Massachusetts General Hospital, human trials began in 2008. Twelve years later, they raised $30 million through grants to fund clinical trials to improve and refine the algorithms. In 2020, they launched a 440-person randomized study of the device. A pivotal trial followed in 2021 to begin the FDA approval process. ”I was stunned by just how closely those data sets aligned,” Damiano said. “It produced in the adult population where we had the most experience.”
Fourteen months later, the touch-screen device that displays glucose levels and the amount of insulin in a cartridge cleared the FDA. The device holds up to three days of insulin.
“It makes 288 decisions a day that you no longer need to make,” Damiano said. “To some degree, you can exhale and not wake up three or four times trying to make all these mathematical calculations to see how much insulin to give your child.”
Next, Beta Bionic will focus on recruiting patients for a larger trial for a two-hormone device that monitors both insulin and glucagon.