Beta Bionics founder Ed Damiano, a longtime BU engineering professor, with his son, David Damiano (CAS’21, Pardee’21), who has type 1 diabetes and helped inspire the development of the iLet Bionic Pancreas. Photos courtesy of Ed Damiano (left), by Joshi Radin (top), and by Cydney Scott (bottom)

Diabetes

His Son Inspired Him to Invent a Bionic Pancreas

And now this BU engineering professor’s breakthrough automated insulin delivery device, the iLet, could transform life for people with type 1 diabetes

Is there anything I should be doing right now to keep myself alive?

That’s a question Stacey Cunnington (COM’17, SPH’22) has asked herself countless times a day since receiving a type 1 diabetes diagnosis at age 16.

For people living with type 1 diabetes, every day is a never-ending series of mental calculations and adjustments: If I go out for after-work drinks, how much insulin will I need to adjust my blood sugar levels? What about if we order appetizers, too? Do I feel stable enough right now to add an extra mile to this hike? How many carbohydrates will I need to eat if my blood sugar crashes? They may need to check their glucose (blood sugar) levels upwards of a dozen times a day in order to maintain stability.

The consequences of not monitoring glucose levels are dire. If blood sugar remains too high for too long (hyperglycemia), people can experience blurred vision and exhaustion, and even diabetic ketoacidosis, a condition where the body starts breaking down fat to use as an energy source, which can lead to a coma or death. If blood sugar drops too low (hypoglycemia), they can experience confusion, seizures, or loss of consciousness; it too can be fatal.

For patients like Cunnington, a program and communications manager at Boston University School of Public Health, her mental math—performed with the help of a continuous glucose monitor and an insulin pump—is second nature at this point. 

But, as one BU professor wondered, what if it didn’t have to be so mentally taxing? When Ed Damiano’s son, David, was diagnosed with type 1 diabetes as an infant, the BU College of Engineering professor of biomedical engineering began to consider how he could use his expertise to spare his son, and others like him, a life of constant calculations—and worry. Almost 25 years later, he’s achieved that goal, and the fully automated bionic pancreas he coinvented has the potential to revolutionize type 1 diabetes management—and transform the lives of millions around the world.

“Our Lives Have Changed Forever”

David Damiano (CAS’21, Pardee’21) was born in spring 1999. As he neared his first birthday, it was clear something was wrong. He was suddenly quiet and lethargic, and kept staring off into space. Most worryingly, he dropped two pounds—10 percent of his body mass. His mother, pediatrician Toby Milgrome, had three hypotheses: type 1 diabetes, leukemia, or a brain tumor.

She took him to her office. Her colleagues ran tests. Within a matter of hours, they had news: David’s blood sugar was almost 10 times the normal range. Her 11-month-old had type 1 diabetes. 

“Toby rushed out the door saying, ‘David has type 1 diabetes. Our lives have changed forever,’” recalls Damiano. 

Type 1 diabetes is an autoimmune condition where the pancreas produces little to no insulin, the hormone that the body relies on to allow sugar into cells to use as energy. Insulin lowers blood sugar levels; without it, sugar builds up in the bloodstream, leading to high glucose levels. If untreated, diabetes can lead to death. When undertreated, it can result in serious long-term health problems, including nerve damage, blindness, and kidney and heart disease, among a host of other complications; overtreating with too much insulin leads to hypoglycemia. According to the Centers for Disease Control and Prevention, an estimated 1.6 million adults have type 1 diabetes in the United States.

There is no cure for type 1 diabetes. Day-to-day treatment involves intensive insulin therapy—monitoring blood sugar levels throughout the day and adjusting insulin accordingly. Many people with diabetes opt to wear a continuous glucose monitor (CGM) that attaches to the body and regularly checks their blood sugar levels via a small sensor placed just under the skin. Or, there’s the manual method of pricking a finger with a lancet, then placing a drop of blood on a test strip. 

The learning curve was steep for David’s family. “Truthfully, even the doctors didn’t know what to do for someone that small,” Damiano says. “It was rare to find type 1 in a child that young.”

Insulin has to be injected—either manually or via a wearable insulin pump—for it to enter the bloodstream. The syringes the doctors used for David weren’t designed for users who weighed less than 20 pounds. As a result, they struggled to settle on the right insulin doses for an 11-month-old. 

Much of David’s early treatment came down to trial and error. For two months, Milgrome and Damiano used a blood sugar monitor to check their son’s glucose levels 15 times a day. They quickly learned how to correct his fluctuations and injected him with insulin diluted with water another 10 times a day. At night, they woke up every few hours to continue the routine. They documented everything meticulously in a notebook. 

Eventually, they were able to get him an insulin pump. “Pumps weren’t even FDA-cleared for someone his age,” Damiano says. “But nevertheless we were able to convince the insurance company to buy him one. We put him on a pump at 13 months of age; he’s been on one ever since.” 

But the round-the-clock glucose checks were endless, and a constant source of anxiety. Nighttime was particularly fraught, as David’s blood sugar often rose and dipped dramatically. The dips were especially concerning: suffering severe hypoglycemia while sleeping can be especially dangerous for people with diabetes. Some never wake up. The phenomenon is known as dead in bed syndrome and is believed to account for 6 percent of deaths in people under 40 with type 1 diabetes. Damiano knew that his son—and others like him—needed a better safety net, and soon. 

After years of studying and teaching biomedical engineering, with a focus on applying fluid dynamics and solid mechanics to physiological systems, Damiano had a new mission: create a fully automated, wearable device that administers all insulin doses without the user having to ever calculate or worry about them.

FDA Clears Bionic Pancreas, “A Fully Self-Driving Car”

In 2002, Damiano began work on what would become the iLet Bionic Pancreas, a high-tech insulin delivery system. In May of this year—after almost 20 years of research, trials, and cutting-edge innovation—it finally received FDA clearance for people with type 1 diabetes who are six years and older.

“The analogy I like to make with the iLet is going from a manual to a fully self-driving car,” says Damiano, who in 2015 cofounded a public benefit corporation, Beta Bionics, to advance the iLet, and now serves as its executive chair. His coinventor and cofounder, Firas El-Khatib, was formerly a senior research scientist at BU and is now Beta Bionics’ vice president of research and innovation.

The iLet eliminates two main things: First, the need for a diabetes specialist to create and regularly reevaluate a tailored insulin regimen for a patient. And, second, the need for a patient to make constant calculations throughout the day and night to correct glucose fluctuations. Plus, the device, which can slip in a pocket or clip to clothing, collects data on the patient’s blood sugar levels and insulin needs the entire time it’s worn. 

To get started, all a user needs to do is input their body weight. When paired with a CGM, the iLet delivers insulin doses (through a tiny cannula inserted just under the skin) every five minutes based on calculations of current and past glucose levels, as well as the body’s reaction to past insulin doses.

“That’s 288 decisions a day that you no longer have to make,” Damiano says. “There’s no overriding a dose of insulin; there’s no weighing in on a dose [the iLet will give you]—the device just does it. We call it ‘diabetes without numbers.’” 

Beta Bionics has already launched the iLet in the United States and is talking to healthcare providers and payers about reaching as many patients as possible. Also in the works is a bihormonal version of the iLet that delivers both insulin and glucagon (a hormone that raises blood sugar levels), which would allow users even better overall glycemic control.

Looking back at the history of diabetes technology, device systems have been “far from plug and play,” says Howard Wolpert, a BU Chobanian & Avedisian School of Medicine clinical professor of endocrinology and director of diabetes care delivery innovation at Boston Medical Center, BU’s primary teaching hospital. 

Historically, even hybrid closed loop systems—a paired monitor and pump—“really require a person who has the time and wherewithal to commit to using the technology and troubleshooting it and all the rest,” says Wolpert, a former Joslin Diabetes Center researcher and a leading endocrinology expert. Not to mention the fact that diabetes is a notoriously expensive disease due to insulin and supply costs, among other expenditures. All in all, that often means patients with means, resources, and support systems are best able to manage their diabetes.

“Type 1 diabetes is 24/7/365: there’s no vacation from the demands of the disease,” Wolpert says. “When you add in competing demands and challenges that people have to deal with—especially in populations where people are just struggling to survive [day-to-day]—there is much to detract from managing one’s diabetes.”

That’s just another reason the iLet system is a game changer, according to Wolpert and Damiano. 

“The data is clear: the iLet most helps the people who need the most help,” Damiano says. “The poorer your glucose control is at baseline, the more your glucose control will be improved relative to those who already have good control.

“That’s a testament to the egalitarian nature of the system.”

No More Worry

Is there anything I should be doing right now to keep myself alive?

For Cunnington, it’s a question that’s never far from her mind. But it’s not always the burning, urgent question it used to be.

People with type 1 diabetes can still live regular lives packed with all of the joys and minutiae that everyone without a chronic condition experiences. It just takes a little more planning. 

At 28, Cunnington has lived with type 1 for just over a decade. She’s used to calling her insurance company and doctor’s office to push through approvals for her prescriptions. She always has backup insulin and syringes on hand just in case her pump malfunctions. And when she needs a quick boost to get her glucose back up to normal, she has her go-to: Welch’s fruit snacks.

It’s a long way from the early days of her diagnosis, she says, where her world was “completely flipped upside down.”

“I remember what those first six months were like, when you’re learning everything about how your new body works, and you’re thinking about it 24/7,” she recalls. “I remember having conversations with my family where I’d wonder if I would ever get to the point where I could go an hour without thinking about my diabetes. But you get into a routine, and eventually you get used to your new normal.” 

She stays connected to the diabetes community as much as possible. She recently managed the social media for Pay or Die, a documentary on the insulin pricing crisis in the United States. As an undergrad, Cunnington interned for the Joslin Diabetes Center and the nonprofit College Diabetes Network. (She took a full-time job with the organization after graduation.) She also worked as a clinical trial monitor for an earlier version of the iLet system. A couple of years later, Beta Bionics invited her back to test the system as a trial participant. 

“It was really cool to be able to test the bionic pancreas after being on the back end for so long, and seeing how awesome it was,” she says, especially for people just coming to terms with a diagnosis. 

The potentially life-changing impact of the system was celebrated by The Brink readers when we broke the news of the iLet’s FDA approval:

At 24, David Damiano, the inspiration behind the iLet, has lived with diabetes almost his entire life. He says he’s “oddly blessed” to have been diagnosed so young, despite a procedure-filled childhood of monitoring and managing his glucose levels.

“I can’t recall life without [diabetes],” says David, now a researcher at a local production company. 

When you’re diagnosed later in life, particularly as a teen or young adult, you know what it’s like to sit down and eat lunch—and just think about lunch, he says. But with diabetes, “You have to think about, ‘How many carbs am I eating? How much insulin should I give myself?’ And if you forget about it, you have to deal with the consequences later. You’re always furious with yourself when that happens, because you’re like, ‘How can I be so stupid as to forget about something like that?’ But of course you do—you’re a human being.”

That’s why automation is so crucial for type 1 management, he stresses: “Human beings mess up, to no fault of their own.”

For now, he’ll be sticking with his insulin pump and CGM—“I’m so familiar with the rigors of management, and I’m not as comfortable giving up control,” he says. But that’s the whole point of living with type 1 diabetes, he adds: finding a management system that works for you and your lifestyle.

In a world that doesn’t always grasp the complexities or severities of diabetes management, both he and Cunnington cite the need for greater awareness of diabetes as an invisible disability. Employers, teachers, coaches—it’s crucial to provide accommodations for people with diabetes to check their glucose, inject their insulin, or even just take a break when their blood sugar drops. The consequences of not accommodating are dire, Cunnington says: “If we’re asking for something, we’re asking for a reason.”

But again: type 1 doesn’t have to be a life-ending diagnosis—especially with the help of innovations like the iLet. 

“What I want people to know and understand is that if you have type 1, you’re still a normal person. You don’t have to change every facet of your life to deal with your diabetes; you can still live your life,” David says. “You just adjust to whatever BS you have to deal with.”

This research was supported at BU by a number of organizations, including the National Institutes of Health, the Helmsley Charitable Trust, the Juvenile Diabetes Research Foundation, the Bantling Foundation, and the Wallace H. Coulter Foundation, as well as the University and private gifts.