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Bionic Pancreas Passes Critical Science Hurdle

$12M from NIH moves ENG prof’s device forward

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On the heels of winning $12 million in supplemental funding from the National Institutes of Health (NIH) to conduct a major, multicenter, national clinical trial of his iLet™ bionic pancreas, Edward Damiano, a College of Engineering professor of biomedical engineering, has coauthored a study in The Lancet that affirms the technology’s effectiveness in managing type 1 diabetes (T1D) better than current conventional methods.

“This award provides us with significant resources to collect the final clinical data required by the US Food and Drug Administration for regulatory approval,” says Damiano, “which will pave the way for us to bring the bionic pancreas to market.”

The study was conducted with Damiano’s longtime clinical partner Steven J. Russell, a Harvard Medical School assistant professor of medicine and an endocrinologist at Massachusetts General Hospital (MGH), along with clinical partners Bruce Buckingham (Stanford University), John Buse (University of North Carolina), and David Harlan (University of Massachusetts). It tracked adult T1D patients over two 11-day periods, one using the bihormonal bionic pancreas (which dispenses the hormones insulin and glucagon as needed) and the other using the conventional insulin pump therapy for diabetes management. On days when patients were on the bionic pancreas, their average blood glucose levels were significantly lower compared to their standard treatment, and they reported fewer episodes of hypoglycemia (low blood sugar). The bionic pancreas performed even better overnight, which is a period of particular concern for people with T1D.

“Patients with type 1 diabetes worry about developing hypoglycemia when they are sleeping and tend to let their blood sugar run high at night to reduce that risk,” says Russell. “Our study showed that the bionic pancreas reduced the risk of overnight hypoglycemia to almost nothing without raising the average glucose level. In fact, the improvement in average overnight glucose was greater than the improvement in average glucose over the full 24-hour period.”

The results of The Lancet study are promising, especially as Damiano and his colleagues move forward with conducting the final pivotal clinical trials under the $12 million NIH funding, supplementing a previous $1.5 million award he received in 2015. The nine-month trial will test the safety and efficacy of the bihormonal bionic pancreas in adults with T1D, a crucial step in the medical device approval process. Additional funding is being sought to extend this study to the pediatric population and to fund a separate final pivotal trial to test the safety and efficacy of the insulin-only configuration of the iLet™ bionic pancreas in adults and children with T1D. The researchers are also seeking funding to conduct separate studies to test the safety and efficacy of the insulin-only and glucagon-only configurations of the iLet™ bionic pancreas in people with other glycemic control disorders, such as type 2 diabetes, hyperinsulinism, insulinoma, and many others.

Soon after his son, David, developed T1D as an infant almost 17 years ago, Damiano began working with his team on the bionic pancreas. The technology that they have developed optimizes blood sugar levels by using their mathematical dosing algorithms to automatically calculate and precisely dispense two hormones every five minutes: insulin, when blood sugar levels are high, and glucagon, when they are low.

When Damiano and his clinical collaborators at MGH began human trials nearly nine years ago, the tests were done in a hospital setting using a laptop-based system. They switched to their iPhone-based system nearly four years ago, and began trials outside of the hospital in diabetes summer camps in children and in the home-use setting in adults.

Over the past three years, they have been developing their iLet™ bionic pancreas platform, which integrates all of the components of their iPhone-based platform into a single, compact, handheld device, which is about the size of the original iPhone. The two chambers within the iLet house one vial of insulin and one of glucagon, or just one or the other, depending on how the iLet is configured.

“The iLet really is three devices in one and is flexible enough to treat different chronic conditions of glycemic dysregulation,” Damiano says. “But obtaining the appropriate approvals for those other uses will require additional trials, so we will continue to work on securing funding for those indications.”

Damiano’s goal of providing an easy-to-use, safe, and effective system to help his son and others with T1D now seems within reach. Whereas the final pivotal trial for the bihormonal configuration of the iLet won’t begin recruiting participants for another 18 months or so, Damiano hopes to begin recruiting participants for the final pivotal trial for the insulin-only configuration of the iLet in about a year. David enters BU as a freshman in fall 2017, and while his father has long hoped that he would head off to college with a bionic pancreas, he now knows that that goal will be about a year later.

“The reality is, David probably won’t get the iLet until his sophomore year at BU, and even then, he’ll have to start with the insulin-only configuration because the bihormonal configuration won’t be ready until his junior or senior year,” says Damiano. “However, whenever I reflect upon this, I also remind myself that practically every aspect of our endeavor is truly unprecedented—it’s an experiment in the makingso if it takes an extra year or two to get it right on balance, I think it will be worth it.”

32 Comments

32 Comments on Bionic Pancreas Passes Critical Science Hurdle

  • Andrea on 02.07.2017 at 9:16 am

    Wow. Hope for millions.

  • Jill on 02.07.2017 at 10:52 am

    LOVE this!!

  • Dan DiLeo on 02.07.2017 at 12:38 pm

    It’s great. But the T1 diabetic’s life still depends on the supply of insulin. I hope research into the transplantation and protection of insulin-producing cells continues.

    • Chris Cunier on 05.04.2017 at 10:54 am

      I found what you are looking for, look at: Defymed – Mailpan, Dr. Severine Sigrist, France. – No problem, it’s available in French and English :)
      Dec 2016: collaboration with “Semma Therapeutics” an American biotechnology compan specialising in the development of cell therapies.
      Love from Switzerland chris

  • Sharon Bailey on 02.07.2017 at 1:03 pm

    As someone who has had their pancreas totally removed, this is my future & at this time the closest to a cure I’ll get. Wish I could be a test subject for it. So very THRILLED!!

  • Mary cissel on 02.07.2017 at 1:05 pm

    Great news!

  • Kevin Melady on 02.07.2017 at 4:33 pm

    As the Father of 4 Kids – 3 of whom have T1D, this can not come soon enough !! Thank you Mr. Damiano for doing this work .

  • Susan Cleaver on 02.07.2017 at 4:49 pm

    Congratulations on moving beyond another of many critical hurdles with such dedication and persistence – so encouraging!

  • Cari Mortensen on 02.07.2017 at 5:41 pm

    There are over 2000 families from all over the world who have little ones with T1 and your work is beyond a miracle. Thank you for all that you do from the bottom of my heart. My sister died from T1 at the age of 27 and now my son has T1 as well. If he could see this device before he becomes a teenager it would be amazing.

    • Lisa Santuccio on 02.08.2017 at 1:00 pm

      Hi Cari- I’m so sorry to hear about your sister. That’s so sad. I have a 3 year old with T1D that was diagnosed a year ago. May I ask how your sistetr died from the disease? 27 is very young. Lisa

  • Christopher Wright on 02.07.2017 at 6:10 pm

    Truly amazing, having witnessed the hardships and complications of living with T1D and how technology has evolved over the last few years gives encouragement for those who are personally affected by this disease. Dr. Damiano’s mission may have started as a personal motivation but what he and his team have done for this community is nothing short of a miracle. Keep up the good work, the goal line is in sight!

  • Denis on 02.08.2017 at 12:39 am

    My elder brother died a year ago from T1D at 42yo, while my youngest brother also has the same condition. They wereally both diagnosed at about the same time 4+ years ago. They live in Africa.
    I’m keeping my fingers crossed that all works out well for the trial soon.

  • Becky on 02.08.2017 at 7:04 am

    Can’t wait! My T1D son is going through puberty right now and his blood sugars are so out of control. This would be a dream if we would be able to use it soon.

  • Nikki on 02.08.2017 at 10:54 am

    Thank you so very much for your continued commitment and perseverance in bringing your device to the people who need it, Dr Damiano.

    My son is 8 with Type 1. I know the goal was to get it to your son before he left for college (I’ve seen the TED Talk – terrific!), but thank you for giving us with younger kids hope that this may be our reality.

    What an amazing show of love to your son – he will wear his device with such pride – soon!

  • Susan on 02.08.2017 at 11:30 am

    Thank you to BU, Mr. Damiano, Russell, Buckingham, Buse and Harlan. Your drive to succeed with the iLet was watched by a lot of hopeful families at CWD and now we are seeing it come to fruition! I am so thankful for all of you. Thank you, thank you, thank you!

  • Dennis Karbach on 02.08.2017 at 2:10 pm

    Being a father of a T1D son, I am overjoyed with the progress of this device & its studies. My son has accomplished much in life. Successful NYC Businessman, College Graduate, Academic All America Swimmer, Trained at Colorado Springs Olympic Center, Pennsylvania JDRF Congressional Representative, Countdown Cover Person, MTMoore Film Person & I could go on but he has always had major problems with nighttime hypoglycemia. This devise would literally be a life saver for him. Thank you.

  • Ashley on 02.08.2017 at 3:20 pm

    As a T1D for over 35 years, I think this is just amazing! I’ve been bloodsugars over 1000 & lows in the single digits. Something like this would help make managing this unpredictable disease so much easier. I’d sign up to be in the trials in a heart beat.

  • Janet Burns on 02.08.2017 at 4:28 pm

    My husband developed type 1 diabetes 25 years ago. It has been a roller coaster ride chasing his sugar levels. I sent funding when I first heard of this project. I thank Dr. Damiano for creating this breakthrough. Type 1 can strike at any time–in childhood and even in adulthood, as happened to my husband. I am grateful every day that we have survived the many hospitalizations and crises when his sugar went wrong in the night. I hope the love of my life gets a chance to experience life on your mechanical pancreas.

  • Karen Cavallo on 02.08.2017 at 7:53 pm

    Dr. Damiano and the rest of the incredible team-thank you does not begin to express my gratitude for your endeavors. My son with Type 1 went of to college this fall, and although I am thankful to have “Share”
    for now, we look forward to him entering the next stage of adulthood with all the benefits of this technology. You know, when he was diagnosed 4 1/2 years ago, those generally in the know in the Type 1 community were saying it would be decades before
    we saw this type of advancement. I agree, get it right
    and we will all be grateful when it’s ready to help
    ease the burden. Your work is truely extraordinary.

  • Leah on 02.08.2017 at 8:05 pm

    There are no words to describe how grateful I am for your work. Our 11 year old daughter was diagnosed this past year, and it has been so hard on all of us. We are just getting over the stomach flu, and I couldn’t help but think of your work with the iLet. It is like walking a tightrope at times, especially when you throw in illness, or hormones, or activity, or, or, or… I am a pediatric nurse, but until you are in this side of Type 1, it is impossible for someone to understand the horror of this disease. Thank you for your dedication and perseverance. This can’t come soon enough.

  • Polina on 02.08.2017 at 8:41 pm

    Such a wonderful news for T1D community :)
    Very much hopeful that bionic pancreas will be available to all people in need.
    My grandson and I have T1D.
    Very excited about bionic pancreas! Many thanks to our talented scientific researchers! Looking forward to our future…

  • Erin on 02.09.2017 at 10:40 am

    Could this possibly be used to facilitate treatment of pancreatic cancer? By replacing the pancreas.

  • Kit on 02.09.2017 at 8:42 pm

    The importance of this research is beyond words. My son turns 21 tomorrow and was diagnosed T1 when he was 14. Even if the science aspect is under control which frequently it is not, I can’t stress with the stars emotionally to my boy and the family. We lost my brother when he was only 37 to diabetes and I can’t bear to think of this going any further I’m crushing anyone else. Keep up the good work

  • A on 02.10.2017 at 4:37 pm

    I have been a T1D for 37 years and have struggled through 2 difficult pregnancies but now have a son and daughter due to finish uni this year thanks to the endless help from GP and hospital staff. Monitoring sugars is a constant challange with exercise, weather and hormones all having to be taken into consideration. Thank you to all concerned in the creating the bionic pancreas. I can’t wait until these are available and have made a donation to help a little along the way. Thank you all.

  • Sharon on 02.24.2017 at 4:53 pm

    My 24-year-old daughter has had T1D for nearly 15 years. She also has epilepsy and is on the autism spectrum. She uses an insulin pump, but despite being pretty high functioning and working at a job, she can’t live alone and can’t make estimations of carbs or other discretionary decisions about treating the diabetes because of the autism. On top of that, low blood sugars combined with seizure meds at a trough level can trigger seizures. She lives with us; we manage the diabetes via regular cell phone contact with her, but if this research is successful it will be a life-changing development for her! And for us, it would take away much of the worry we have about what becomes of her when we’re no longer able or around to provide her care. I pray the upcoming trials are hugely successful!

  • mary saylor on 03.31.2017 at 11:18 am

    Do you think with the new fed gov they will lower the regulations that might let this device be released earlier??
    My wifes sugars are low all the time <20 , this would be great to live again after 20 years.

    mark

  • Selma de Oliveira on 04.04.2017 at 2:34 pm

    I was diagnosed with T1D in 1984. I’m taking the maximum of 14 units of insulin daily just to avoid lows. I cannot stand them. Please put me on the list to get this device. I have suffered long enough.

  • James G. Marker on 04.18.2017 at 12:58 pm

    Thanks and Blessings to you and your team, in your continued progress. I stopped using the Medtronic 530G Pump and CGM over 15 months ago, in order to stay alive until your device is commonly available. I was having 5 to 10 severe low BS in any given week, despite 24 years experience having T1D, and pleading with Medtronic and my endocrinologist for help. Their goal was to lower my A1C. Medtronic’s CGM simply failed to detect falling BS rapidly enough to be in any way effective. I now have Dexcom 5G, great at predicting onset of lows, so I know it is possible. I am well educated and very fortunate, at 54 y.o., to have no long-term damage yet, so I am hopeful that the Ilet availability becomes quickly widespread when marketability occurs. I realize that children with T1D are more desperately in need of this grand improvement in T1D care. I wonder whether availability will have to be affected by level of need?? I would love to work with the training and distribution of this product, but I am not a health-care professional. Best in the years ahead. Jim

  • Lori milledge on 07.08.2017 at 11:25 pm

    I was so excited to come across this information I’ve been diabetic for 39 years and use the Medtronic 630g. I simply cannot wait to be able to use the bionic pancreas! I’ve been searching for a new pump AZ I too am having problems with the CGM detecting low blood sugars. I’m what they used to call a brittle diabetic. Thank you so much to you and your team for your hard work and dedication on creating that bionic pancreas. This is the very closest thing we have to a normal life. it brings me to tears just thinking that I may actually live to have this❤️
    Blessings, Lori

  • Nikitas on 10.09.2017 at 4:03 pm

    Hope it comes on the market soon. Been a T1D for 32yrs. I’m afraid that one day my hypoglycemia at night will not let me wake up. All the power to you.

    Nikitas

  • Mickey on 11.05.2017 at 8:28 pm

    Thanks for the great work, I’m 60 years old, diagnosed t1 in 94, always thought if they could only combine a glucose meter and insulin pump, and add glucagon pump, it would be great, now you have done it.
    Anytime you need a test subject, please contact me.
    Hope you can get approval soon, my highest level with DKA was 1600, should be dead, my low’s run in low 20’s. have a pump and CGM now

  • Prakash Kumar on 12.03.2017 at 9:05 am

    This is great news…Thank you Dr. Damiano..My daughter will be 18 in april and was diagnosed with t1d. She will be going to college next yeay and this invention will help her..

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