Hope for the Battle Against Type 1 Diabetes

A company is founded by parents of children with the disease

Ed Damiano (middle) in his lab with members of his new medical device company, Beta Bionics; (left to right) Raj Setty and Rob LeBourdais, design engineers; Firas El-Khatib, senior engineer; Ed Raskin, vice president for benefit development and corporate strategy; Serafina Raskin, vice president and general counsel; Gibb Clarke, chief operating officer. Beta Bionics’ mission is to improve the health of people with type 1 diabetes. Photo by Michael D. Spencer

Ed Damiano, a Boston University professor of biomedical engineering and the father of a 16-year-old boy with type 1 diabetes, has been racing for nearly 13 years to develop an artificial, or bionic, pancreas that could transform the lives of millions of people who have the same disease as his son, freeing them from the round-the-clock burden of managing a potentially life-threatening disorder themselves. Damiano’s device, which regulates blood sugar levels by automatically delivering precisely calibrated doses of insulin and glucagon, will start the final round of Food and Drug Administration-approved human clinical trials in the first half of 2017.

Most academics would have long since turned their invention over to industry to push it through the cumbersome regulatory and commercialization maze. Instead, Damiano and BU senior research scientist Firas El-Khatib have started an unorthodox, socially minded medical device company to bring their bionic pancreas through final clinical trials and regulatory approval and into the hands of the people with type 1 diabetes who have been eagerly awaiting this kind of breakthrough tool. Damiano says his team moves faster, more efficiently, and more aggressively than has been seen in the medical device industry.

Eli Lilly and Company, the pharmaceutical giant that in 1923 first commercialized the lifesaving insulin hormone for patients with diabetes, is betting on Damiano. Lilly invested $5 million in the new company, Beta Bionics, Inc., at the end of 2015 and Deirdre Ibsen, Lilly Diabetes’ global brand development leader, holds a seat on the Beta Bionics’ board.

“I’m so impressed with Ed’s passion, but also with his pragmatism, his creativity in moving this forward,” says Enrique A. Conterno, president of Lilly Diabetes. “We thought for us it was a great investment.”

Damiano’s lab is one of a half dozen teams working on various kinds of artificial pancreases or closed-loop, automated insulin delivery systems, which are expected to become commercially available over the next few years. While most other systems automate only the delivery of insulin, Damiano’s device, which has moved through nearly eight years of successful clinical trials, has a bihormonal pump that supplies both insulin and glucagon. “We are a huge believer that glucagon will be a very important part of the artificial pancreas,” says Conterno. “That’s how, physiologically, the human body works.” Describing Damiano’s device as “the most advanced,” Conterno adds, “he had incredible data. It’s pretty clear that his algorithms and his systems are delivering better outcomes.”

Beta Bionics is a public benefit corporation. If you’ve heard of Patagonia and Kickstarter, you know something about this new kind of company. Unlike traditional companies, which are all about maximizing profits, these new corporations are for-profit entities that are also dedicated to social responsibility and a public benefit mission. The first public benefit corporation was launched in 2010 and Massachusetts is now among 30 states that allow this business model. In its corporate charter, Beta Bionics defines its broad public benefit as improving human health.

“Our mission is to act always in the best possible interest of the type 1 diabetes community,” says Damiano, who is president of Beta Bionics and holds a seat on the board, but will remain at BU as a professor and researcher. “We have no desire to flip the company for a quick return on investment. In fact, I think that would be the surest way to undermine the mission of Beta Bionics. I believe that if Beta Bionics remains faithful to our convictions and to our core values, it will lead to the best possible products—products that will thrive in the marketplace and change the paradigm of type 1 diabetes management.”

Beta Bionics appears to be the first medical device company to enter the public benefit realm.

Mike Pratt
Mike Pratt, interim managing director of BU’s Technology Development office, has been a supporter of Ed Damiano and Firas El-Khatib’s quest to build a bionic pancreas since the beginning, when, Pratt recalls, “it was Ed and Firas and an idea and a few pig experiments.” Photo by Jackie Ricciardi

“Traditional corporations may make decisions based on a short-term horizon,” says Mike Pratt, interim managing director of BU’s Technology Development office, whose team helped Damiano navigate the mountain of licensing and intellectual property agreements required to start the company (BU holds a 5 percent equity stake in Beta Bionics and owns the patents). “Venture capitalists want to see returns on their investments fast. Ed recognizes that he has to generate some profit in order to be sustainable, but the public benefit corporation structure gives Beta Bionics some flexibility that other companies don’t have—to put the people who need the device first. Bottom line: Ed wants to put extra focus on a really safe, effective product.”

Damiano gives a hypothetical example of how the public benefit model could protect the bionic pancreas: A large medical device company makes a lucrative offer to acquire Beta Bionics. If Damiano and his board conclude that the company will shelve their potentially disruptive device in order to keep drawing revenue on their existing products, Beta Bionics can—and it will, Damiano says—legally turn down the offer because it’s not in the best interest of the type 1 diabetes community. A traditional corporation would be required to accept the offer.

Type 1 diabetes, which affects about two million people in the United States, is an autoimmune disease that destroys the pancreatic beta cells that normally produce insulin, which allows the body to convert carbohydrates to energy. If treated poorly over the years, the disease can damage organs such as the kidneys and eyes, as well as blood vessels and nerves. The bionic pancreas mimics the efficiency of the natural pancreas, which fine-tunes the body’s glucose level both by lowering it (with minute amounts of insulin) and by raising it (with tiny doses of glucagon).

In keeping with his public benefit mission, Damiano founded Beta Bionics with a group of parents of children with type 1 diabetes—Orange County, Calif., attorneys Edward B. and Serafina Raskin, whose 10-year-old son Max was diagnosed with type 1 diabetes at age 7; and Jeff Hitchcock, whose 28-year-old daughter was diagnosed at 24 months and who founded the non-profit Children with Diabetes, an online community that promotes understanding of the care and treatment of the disease. These corporate founders have bonded over the round-the-clock management required to keep their children healthy—monitoring blood sugar levels, calculating insulin doses, counting carbohydrate grams—and the constant worrying about long-term complications. They all know the fear of “dead-in-bed” syndrome, which can occur if blood sugar levels go too low while a person with type 1 diabetes is sleeping.

“My daughter is perfectly healthy, but to get there has been an extraordinary amount of work,” says Hitchcock, who is the Beta Bionics public benefit director and holds a seat on the board.

Hitchcock met Damiano at a diabetes technology conference in 2006. “I heard for the first time someone talking about a technological solution that I knew would work,” says Hitchcock. “He spoke with passion and with the conviction of a scientist—not that touchy-feely hope kind of thing, but with ‘I know how to do this and I’m not going to stop until I solve it.’”

“When we ask our families ‘How often do you think about type 1 diabetes,’ the answer for some is ‘about every five minutes,’” Hitchcock says. As Hitchcock explains, about 10 percent of people in the US who have the disease—including David Damiano and Max Raskin—wear continuous glucose monitors, which are tiny sensors that give blood sugar readings every five minutes. David and Max also wear insulin pumps, which deliver relatively precise injections of insulin under the skin.

With its patented algorithms, Damiano’s bionic pancreas, which is called the iLet and is about the size of an iPhone 3, does all the calculating, adjusting, and dosing autonomously and automatically. The only information that users have to enter is their weight.

“All that constant worry goes away,” says Hitchcock. “The bionic pancreas never gets tired. It’s always there.

iLet, in homage to the pancreatic islets of Langerhans. The device automatically delivers both insulin and glucagon, and manages type 1 diabetes for the user
The fully autonomous, dual-chamber bionic pancreas is called the iLet, in homage to the pancreatic islets of Langerhans. The device automatically delivers both insulin and glucagon, and manages type 1 diabetes for the user, instead of the other way around, says Damiano.

With parents following his progress on the bionic pancreas for more than a decade now, Damiano has attained rock star status in the type 1 diabetes community. Two years ago, a few months after his son had been diagnosed, Ed Raskin connected online with Damiano. It was 2 a.m. in Orange County, 11 p.m. in Boston. Parents of children with type 1 diabetes don’t get much sleep; they stay up to monitor blood sugar levels.

“When I was in the hospital with Max when he was being diagnosed, that’s when I understood—you mean no one’s invented a way to tell me how much insulin to give my kid?” Raskin recalls. “A machine doesn’t do this? I have an amazing iPhone in my pocket and I have to do all this manually?”

The two fathers ended up talking by phone for a couple of hours that night. Damiano gave Raskin a crash course on the bionic pancreas. Raskin pledged that he and his wife, who are founding partners in a small law firm that handles a lot of health care-related work, would help in any way they could.

Now, in addition to his day job, Ed Raskin is vice president for public benefit development and corporate strategy at Beta Bionics and holds a seat on the board. Serafina Raskin is a vice president, secretary, and general counsel for Beta Bionics. The company’s chief operating officer, Gibb Clarke, is a social entrepreneur who has launched several successful, small medical device companies. Clarke is a longtime friend of the Raskins and the couple says he has watched them grapple with the non-stop management of their son’s disease and wanted to help. Steven J. Russell, an assistant professor of medicine at Harvard Medical School and endocrinologist at the Massachusetts General Hospital (MGH), and Roy Beck, executive director of the nonprofit Jaeb Center for Health Research, serve on Beta Bionics’ scientific advisory board.

After Damiano’s son, David, was diagnosed with type 1 diabetes at 11 months, he set himself a deadline: To get the bionic pancreas on David by the time he heads off to college. David is now a high school junior.

The National Institutes of Health has awarded Damiano $1.5 million for the Bionic Pancreas Bridging Study, which will begin later this year and will be the first home-use trial to test the iLet in adults and children with type 1 diabetes. The final Bionic Pancreas Pivotal Trial is scheduled to begin in 2017.

“It’s a horrible disease,” says Pratt. “Ed is passionate about it. His mission, his vision, is what’s driving him. Why would you not want to help him?”

In 2008, Damiano needed healthy adult volunteers to participate as control subjects at MGH in the first human clinical trials of the bionic pancreas. Pratt volunteered. “I spent 27 hours in bed with IVs in both arms,” he says.

“As an administrator at a university, when you come across a person who’s passionate about something and it’s for a humanitarian purpose—in Ed’s case, something that improves people’s health—that inspires you,” says Pratt. “Sometimes in my group’s meetings, I’ll play Ed’s TEDx talk. I say, ‘Let’s remember why we’re doing this.’ I like to think of the University as a problem solver and Ed’s a perfect example of that.”



  1. My son Max was diagnosed at age 11 and just turned 17. Wears a pump and cgm but plays a lot of soccer and risk of hypoglycemia weighs on all of us. I am so excited about this technology and am a big fan and supporter of Ed for his love and care of his son and his passion and drive to develop this technology and Beta Bonics.

    1. My daughter was diagnosed at the age of 11. In the beginning they said it was Type II, shortly after a Type 2. She is now 23. We have had so much trouble with her sugars, I could sit and cry. Dr. after Dr. have prescribed more long term dosages and carb counts with sliding scales, I can’t begin to repeat. Last fall, the Dr. that was the best and cared more about her, followed her crazy sugars for months. After seeing them, he said they looked like a Type I. Blood work basically proved wrong. There’s too much for me to ever tell you in this comment. My daughter desperately wanted a pump, unfortunately the price was totally out of our reach. I am a critical care RN and have taken care of several severe DKA’s, and even with my knowledge and reading material and talking to Dr’s I deal with, everyone remains baffled.
      If there is any possible way I could speak to Ed Damiano so I could explain everything I can’t here, I would be forever in your debt. If there is anything I can possibly do, I’m your’s. I’m on disability due to cancer and multiple complications, so I’m here.

      1. By the way, I forgot to tell you. I Dr. that my daughter and I were seeing passed away at the age of 54 in April. He was not only a fantastic physician he was a dear friend. I had the most wonderful experience working beside him in a CCU.

  2. My son was just diagnosed. He’s just 11. I am praying this comes to all of the us quickly. I am so thankful it has stayed out of the hands of those who profit from our children’s illness. we are waiting!!

    1. My son is 11; diagnosed at 7. He is living an awesome life and we are so proud of him everyday. This would be a game changer. We have been watching Dr Damiano’s work for four years anxiously awaiting the bionic pancreas. He really is a rock star to parents of type 1s and deservedly so. As parents we all wish we could do something to take away the burden of this disease and he is actually doing it. When this is approved, he and his team deserve a Nobel prize.

    2. I am pleased as you are about the project being in the hands of people who know how devastating this disease is and having to watch your child grow up with little to no progress in the field until these wonderful and totally amazing people came along. God bless all of you and your child that fight this horrendous disease.

  3. My son Wyatt is 4 he was diagnosed 5 months ago. Thank you Ed and all involved. I worry night and day like most parents who live with this. It gives me hope and peace of mind knowing great things are coming out of Beta Bionics. May God bless your families and work. Thank you from the Whitten family

  4. Hope this works …im 52 and have been diabetic for 30 yrs type 1 …would love the benefit of this …please keep us informed

  5. My son has done amazing with his t1d for ten years. He is 19. My boyfriend for 36 years is very healthy. He is 49. Please keep working and know we pray for your success everyday. We need a cure. God bless you all

  6. I have been type 1 diabetic since June of 1962 , at which time I was only 22 months old . This technology needs as much help as we can afford to treat this horrible health issue .

  7. My 7 year old daughter was diagnosed almost 2 years ago and to say it turned our lives upside down is an understatement. The general public does not realize just how consuming and life threatening this disease is. I pray this technology becomes available to us soon and to those of us fighting this disease in Canada.

    1. Hi Maritta, just 2 days back my nephew who is just three and half year old is diagnosed with diabetes. Though I’m a Type 1 (last 18 years and now 33) but we don’t know how to manage such a young child who refuses to let us inject and do the testing. He resists strongly, starts crying and gets angry. Could you please guide us how you managed and managing your daughter?

  8. My son was diagnosed at 3, he is now 15. Between the ages of 11 and 14 he grew so quickly and so much that we had little control over his numbers. Things have gotten better but diabetes has led to so much worry and tension in our home. This device sounds amazing. I cried while reading this. Thank you so much to the brilliant, determined people working on this. I will get a second mortgage on our home if that’s what it takes to get my son on this when it eventually comes on the market.


  10. Our son was diagnosed 3 months ago and I like all Type 1 parents have read so much and watch a lot of research going on. To me this is the most promising project that will give us all hope for an amazing device to give our kids and everyone suffering this horrible disease a light at the end of a very long, dark tunnel. Thank you to everyone involved and I can’t wait to see where this goes in the near future. I also hope we get the opportunity to see it in Australia when publicly available.

  11. This could also be very beneficial for people who have an inoperable tumour in their pancreas. The device could be used after the pancreas is removed……VERY EXCITING!! My brother is fighting for his life because of a tumour in the body of the pancreas.

  12. Next month, it will be 50 years since I was diagnosed. I was 9 years old and in the 5th grade. No one in the family had it. I do now have a nephew who has type 1, also. The technological changes over 50 years is fantastic. I’ve been on pump therapy for 7 1/2 years. Sure is nice!

  13. I was diagnosed with type 1 diabetes at the age of 13 in 1964. I am now 65 years old and have been on the insulin pump for 15 years. I am so grateful for all the research and changes that have taken place over these many years regarding diabetes and am excited about this research also. This disease can be very complicated to manage but I have found that accepting my condition and doing the best I can while managing a good attitude has helped me along the way. I have a very supportive husband and he has walked beside me all the way with managing my diabetes.

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