Thirteen years ago, Edward Damiano, PhD, associate professor of biomedical engineering at Boston University, found out his infant son had type 1 diabetes. Since he did not think he had the expertise to develop a cure, he figured he could contribute in another way to the quality of his son’s life. “My skill set seemed to lend itself more toward developing devices, technology, gadgets that could help improve blood glucose control rather than finding an actual cure for type 1, so I set my sights on that,” he explained.
Damiano’s expertise is in applied mathematics, specifically pertaining to physiological systems. He reasoned that a smart algorithm could be used to interpret a glucose signal and dose hormones accordingly, which would take the burden of finger pricks and insulin estimates off patients. He began collaborating with one of his PhD students at the time, Firas El-Khatib, to test mathematical algorithms in diabetic pigs. From the very beginning, Damiano felt it was essential that the artificial pancreas, or the bionic pancreas as he likes to call it, could infuse both insulin and glucagon. The goal was to keep patients’ blood glucose as even as possible throughout all daily activities: from big meals to big workouts.
The task of finding an accurate and reliable sensor created a major obstacle for the device in the initial stages. “That was actually a tougher nut to crack than any other part of this,” Damiano said. The resources needed to develop such medical technology were beyond the scope of his work, so he and his team had to wait for innovations from the medical device industry. Fortunately, they came through. “We now are in a position where we have two sensors out there that are accurate enough to drive the system.” Ultimately the DexCom G4 became a part of the bionic pancreas and resolved past concerns – allowing the project to move forward.
There’s an App for That
As an academic, the United States Food and Drug Administration (FDA) approval process for clinical trials was alien to Damiano. He was the first academic to obtain an investigational device exemption (IDE) for an artificial pancreas system and has since obtained several others as the bionic pancreas has evolved. Th e current prototype consists of a mobile system with two tandem pumps – one for insulin and one for glucagon – and a third device that merges an iPhone and a DexCom receiver into a handheld unit that wirelessly controls the pumps.
Damiano claims that the bionic pancreas would not be possible in its current form without the help of a smartphone. “It’s amazing what that technology has brought us in five years,” he said. Rather than develop a whole new platform, Damiano and his team collaborated with engineers at SweetSpot Diabetes and Egret Technologies to build an app that runs the algorithm and communicates wirelessly with the Bluetooth-enabled pumps and sensor. Th e rest of the phone is inaccessible to the subject once the app is open, so “subjects can’t get into it to play Angry Birds,” he explained.
The bionic pancreas reads blood glucose every five minutes and distributes drugs accordingly. It is worn in a similar manner to a traditional insulin pump, but is significantly more effective at controlling diabetes. The fully automated system requires only the patient’s weight to get started. The algorithm learns and adjusts to the specific individual’s glucagon and insulin needs within hours of first use. Damiano has tested the artificial pancreas in both adults and children over multiple-day periods with both in-patient and out-patient settings and has seen great success. His team is planning to test the performance of the system in 32 children at a diabetes camp in central Massachusetts over a four-week period this summer. In April the FDA approved the device’s IDE for this specific purpose.
The Road Ahead
Th e last big hurdle for the bionic pancreas is the development of a stable, pumpable glucagon. There is no commercial pathway forward using reconstituted glucagon from rescue kits because current formulations are not chemically stable in solution. Damiano is collaborating with device and pharmaceutical companies to test more stable formulations in animal and human studies, and is so far encouraged by the results.
Naturally, Damiano’s team is not the only group developing an artificial pancreas. Several different versions of a closed-loop system are undergoing testing around the United States and the world. Th e Artificial Pancreas Project was started in 2005 to motivate the creation of algorithms for diabetes care, and the FDA listed the artificial pancreas as a major priority shortly thereafter. Grant funding began to fl ow in the millions and pancreas projects sprouted up across the globe, according to the May 2012 issue of Nature.
However, most of these studies have limited patients to a hospital setting and required hookups to a laptop computer. They also have often involved only insulin. Damiano’s version allows full mobility, thanks to the iPhone, and glucagon control, making it an appealing contender to patients. Damiano hopes to bring the bionic pancreas to market by the time his son leaves for college. That milestone is four short years away, but his team just might achieve it.
Providers interested in learning more about the bionic pancreas, including those with a patient that may like to participate in a future trial, can find more information at artificialpancreas.org
—Mapes is a freelance writer in Washington, D.C., and a regular contributor to Endocrine News.