It was Ed Damiano's worst nightmare. At 11-months-old, his son David began showing odd symptoms beyond a simple cold or virus. The symptoms prompted the family to take David in for testing.

"My wife [a pediatrician], wanted to rule out three very scary things," Damiano, an associate professor of at Boston University, told Medical Device Daily. "One was leukemia, one was a brain tumor, and another was diabetes. One of the first things [physicians] did was draw blood labs. In an hour or so came a phone call with the results. His blood [glucose] level was about eight times the normal range, and really there's only one thing that can cause that in an 11-month old baby and that's Type 1 diabetes. I remember thinking to myself, the main difference between a nightmare and reality is that reality lasts longer."

What happened next was Damiano took his expertise in mathematics coupled with his love for his son and developed the Bionic Pancreas. The system, which was developed with the help of other researchers at Boston University and Massachusetts General Hospital (Boston) is an application that in its current iteration runs off the iPhone platform.

"The role that we play would be in the algorithm that makes the decisions about how to dose insulin and glucagon," he said.

With the use of the Bionic Pancreas, a sensor is implanted just beneath the skin and keeps an eye on blood sugar levels. The sensor then sends that information to an iPhone application. Nearly every five minutes the application then determines how much insulin or glucagon is needed by the wearer and sends a command to the device to deliver the hormones via one of two pumps.

Damiano points out that the Bionic Pancreas differs from traditional insulin pumps. He noted that an insulin pump only delivers insulin into the blood – not glucagon. He also noted that people who wear the insulin pumps have to manually program them to dispense the dispense the proper amount of insulin by inputting the exact amount of carbohydrates they eat at each snack or mealtime.

Although the system is currently being used on the iPhone, it's not limited to the IOS platform.

"Certainly, and conceptually it would work on an Android platform as well as an iPhone [platform]," he said. "The device that we built is actually an investigational device and we shouldn't think of it as a system that's going to be the final commercial embodiment of the Bionic Pancreas. It's one we're using in these carefully monitored clinical trials."

He added, "the device that we'd ultimately make available to large numbers of people out there wouldn't run on a smart phone at all. All the stuff that's running on the application, that's running on the iPhone right now will be coded into firmware on a dedicated pumping platform."

Damiano noted that he and his team were working with industrial collaborators to build a fully integrated system with both pumps built into it and a continuous glucose monitor built on to it.

Researchers behind the project have not yet set up a company to get the product out on the market. But that will change.

"We're still getting a little more yardage out of the academic setting that we're currently in," he said. "There's still a few more clinical trials to do in the remainder of this year and through 2015, before we do the final pivotal trial in 2016, and that'll take most of the year to complete. It isn't until those pivotal trials begin that we would have the need for a corporate structure."

But the project still needs funding – and while venture capitalists haven't played a role in that regard, grants from the National Institutes of Health, philanthropic giving, and funding from foundations have netted the project about $12 million. The project will still need additional funding to finish the clinical work.

Damiano said that the goal is to have this device completed prior to his son going to college. One of the main concerns is that even though David, who is now 15-years-old, has a pretty strong handle on monitoring himself during the day, he will still require monitoring while he's sleeping – something the family does now.

"He sleeps soundly and he doesn't wake up to low blood sugar," Damiano said. "That's a wonderful thing when you have someone looking over your shoulder all the time, but when he goes to college that won't be the case and that's our greatest concern, and always has been for me. When he goes to college he doesn't have me in the next room in the middle of the night checking his blood sugar."

Damiano said the Bionic Pancreas could make a tremendous difference for patients sleeping at night.

"It's there. It's constant surveillance, it's constant control – day and night," he said. That was the real impetus behind this."

Published: July 22, 2014