Ed Damiano, PhD, is working against the clock to produce a bionic pancreas that will help his son manage his Type 1 diabetes. The goal is to get FDA approval for the medical device before his son goes to college in 2017.
In our annual HealthLeaders 20, we profile individuals who are changing healthcare for the better. Some are longtime industry fixtures; others would clearly be considered outsiders. Some are revered; others would not win many popularity contests. They are making a difference in healthcare. This is the story of Ed Damiano, PhD.
This profile was published in the December, 2014 issue of HealthLeaders magazine.
"Diabetes is a relentless condition. … It's always there with you. It needs a tool that is as relentless as diabetes itself, and that's what we have built."
September 2017 is a date that is firmly planted in the mind of Ed Damiano, PhD. It's when his son will leave the nest and make his way to college.
While parents normally feel nervous about a child leaving home for higher education, Damiano's preoccupation with that date centers on an issue that has become the sole focus of his work. His son was diagnosed with Type 1 diabetes when he was 11 months old, and from that day Damiano has worked with his wife and son around the clock to manage the difficult disease.
The associate professor of biomedical engineering at Boston University is working on the bionic pancreas, a device that will not only help his son when he leaves for school, but countless others who have been diagnosed with Type 1 diabetes. "It gives him the independence that he deserves and needs to live a healthy young adult life," says Damiano. "While it's solving a huge problem for me and my son, it will also do so for hundreds of thousands of people with Type 1 diabetes across this country."
Possessing a background in applied mathematics and applied mechanics, Damiano never sought to cure the disease, but rather to develop a device that could automatically control glucose levels by integrating several technologies, some of which had not yet been invented at the time of his son's diagnosis in 2000.
This device, the bionic pancreas, is a mechanical management system designed to help those with Type 1 diabetes manage their glucose levels in a better, safer way than can be achieved with the tools available today. The version that Damiano and coworkers have developed is currently an investigational device, not the final commercial product. They are working on making it an integrated system, which would make it a medical device.
In its current form, the bionic pancreas is made of three components. The first piece is the continuous glucose monitor (CGM), a tool used today by Type 1 diabetes sufferers. The CGM has several smaller parts. Using an adhesive base to keep it in place, an introducer needle is used to insert a wire with a small sensor at its tip about a centimeter beneath the skin. A transmitter is clipped on the base of the sensor unit once the wire and sensor are inserted. The transmitter sends a wireless radio frequency signal to the receiver unit, which shows the user's glucose level every five minutes on a simple user interface.
The second component is novel and not currently seen in standard therapies. It is essentially a system of mathematical equations transcribed in software that makes automatic therapeutic decisions about how much insulin (to lower blood sugar levels) and how much Glucagon (to raise blood sugar levels) to deliver every five minutes.
Damiano and his team—a collaborative group from Boston University and Massachusetts General Hospital—along with their industrial collaborators, created a custom hardware interface that sends the data from a micro USB port on the receiver to an app that users can access on an iPhone. The CGM and iPhone app act as a team, with new glucose levels being sent to the app every time a new reading is measured.
Utilizing the Bluetooth radio on the iPhone, the app acts as a bridge to the third and final part of the bionic pancreas, which consists of two pumps delivering two different types of hormones independently. They look like typical insulin pumps, but only one delivers insulin; the other has been repurposed to deliver glucagon. Normal pumps only provide insulin, which makes Damiano's a unique tool.
Glucagon is absorbed through the skin faster than insulin, making it an effective hormone when combating hypoglycemia. After obtaining the data from the receiver, the iPhone app calculates how much of each hormone is needed. Through the phone's Bluetooth feature, a wireless signal is sent to the two pumps, and the hormones are injected into the user according to the app's calculations. Damiano's hope is to adapt the bionic pancreas so all the components are located on a single device, eliminating the need for the iPhone.
Through his unflagging efforts, Damiano has developed a tool that takes on the nature of diabetes. "Diabetes is a relentless condition," he says. "It does not take a vacation. It does not go to bed at night. It's always there with you. It needs a tool that is as relentless as diabetes itself, and that's what we have built."
It's been suggested, however, that the device might be too complicated to use. Damiano admits that it's a "nuisance" to keep up with maintaining it. The two hormones will need to be refilled every four to five days, the sensor will need to be changed every week, and the small catheters that deliver the hormones will need to be replaced every couple of days. However, while that might sound like a lot, it's no different than the standard maintenance that comes with insulin pumps and CGMs. Indeed, it's a small nuisance compared to the biggest benefit that the bionic pancreas has to offer: removing the stress of all the decision-making in diabetes care, including measuring blood sugar rates and determining appropriate doses of insulin.
"It's a device that makes diabetes management disappear," says Damiano. "That's the burden of diabetes. It's the management of all of those decisions and the fear of being harmed from severe hypoglycemia."
Getting the bionic pancreas ready for September 2017 will have its fair share of challenges, including convincing private payers and CMS to embrace the device and reimburse it at the appropriate level, and educating medical professionals on how the tool will change diabetes care. Currently, Damiano is in the midst of transition outpatient studies involving people wearing the device for one to two weeks continuously in various settings, along with several inpatient studies; all of these will hopefully be completed by the end of 2015.
Going forward, Damiano wants to start a massive trial using the device, involving hundreds of people over several months in the first quarter of 2016 and running through the year. The data accumulated throughout those trials would be used in the final application to the FDA in early 2017. Thanks to new guidance documents regarding Class III medical devices and his team's close relationship with the FDA, Damiano believes the organization can review the device in time for a release in the second half of 2017.
Damiano is cautiously optimistic that the bionic pancreas will be ready for his son's journey to college. While the giant goal of device approval stands at the end of the road, Damiano and his team see it as a million little milestones strewn over a long timeline.
Long, however, is relative. September 2017 may seem far away, but Damiano feels it will be here before he knows it. "What we're trying to do seems impossible, and yet we have to get it done," said Damiano. "We must strive for that date. As far as I'm concerned, it's tomorrow.