Study Supports Final Pivotal Trial of Bionic Pancreas

Damiano Nets $12M in Supplemental NIH Funding to Move Forward with Trial

By Sara Cody

Ed Damiano (BME)

On the heels of winning $12 million in supplemental funding from the National Institutes of Health (NIH) to conduct a major, multi-center, national clinical trial of his iLetTM bionic pancreas, Professor Edward Damiano (BME) has co-authored 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 FDA for regulatory approval, which will pave the way for us to bring the bionic pancreas to market,” says Damiano.

The study was conducted with Damiano’s long-time clinical partner Steven Russell, MD, PhD, at Massachusetts General Hospital (MGH), along with clinical partners Bruce Buckingham, MD, at Stanford University, John Buse, MD, PhD, at the University of North Carolina, and David Harlan, MD, at the 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 funding from the NIH, 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.

Above: Ed Damiano, BU Professor of Biomedical Engineering and pioneering creator of the first bionic pancreas, discusses the revolutionary breakthrough of the bionic pancreas and its ability to manage diabetes. Damiano has spent 16 years developing algorithm strategies for blood glucose and insulin control, and conducted multiple clinical trials in an effort to help his son and others living with diabetes.

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 he 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,” says Damiano. “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 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 will begin his freshman year at BU in the fall of 2017, and while Damiano had long hoped that David would head off to college with a bionic pancreas, he now knows that he will fall short of achieving that goal by about a year.

“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 making – so if it takes an extra year or two to get it right on balance, I think it will be worth it.”