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 U.S. 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.

“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.”

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