When his son was diagnosed with type 1 diabetes as an infant, engineer Edward Damiano, PhD, set himself the task of working to produce a bionic pancreas that would help his son manage his diabetes. The goal is to get FDA approval for the device before his son goes to college in 2017.
“The challenge is how to automatically regulate insulin and glucagon levels in type 1 diabetes patients in real time, said Dr. Damiano, Associate Professor of Biomedical Engineering at Boston University, who spoke on “Outpatient Studies of the Bionic Pancreas in Adults, Adolescents and Pre-adolescents” at Thursday’s Plenary Session.
Dr. Damiano is part of a collaborative group from Boston University and Massachusetts General Hospital that’s working to make automated blood glucose control a reality. Engineers from Boston University have developed a bionic pancreas system that uses continuous glucose monitoring along with subcutaneous delivery of both rapid-acting insulin and glucagon as directed by a computer algorithm in a closed-loop system.
“The bionic pancreas automatically makes a new decision about insulin and glucagon dosing every five minutes; that’s 288 decisions per day,” Dr. Damiano explained. “The device adapts automatically to the insulin needs of that person as insulin needs change, and it adapts without input by the user. We are developing and testing technology to reduce the impact of diabetes on those who live with it every day.”
The system works via a sensor that captures an individual’s blood sugar and sends that data to a smartphone. The control algorithm runs on the smartphone and uses the data it’s just received to determine the patient’s insulin and glucagon needs. The smartphone uses a Bluetooth signal to send this information to two pumps worn by the patient, one pump for insulin and one for glucagon. The pumps then administer the needed amounts of each.
“The work began with design and development work on mathematical algorithm strategies for blood-glucose control, which we began testing in a swine model of type 1 diabetes. Working closely with the FDA, we conducted the necessary animal experiments and performed the required software and hardware validation studies in order to qualify our system for clinical testing. Our first-generation device became the first academically sponsored investigational device exemption ever to receive FDA approval for human testing,” Dr. Damiano said.
Research proceeded through four clinical trials involving patients in different age categories, with a control group and a bionic pancreas group in each study.
In 2008, the first clinical trial of the device involved 24-hour experiments in adults with type 1 diabetes. It was conducted at the Clinical Research Center at Massachusetts General Hospital. “All of the device subjects came in under goal for therapy,” Dr. Damiano said.
Results were similar in the next clinical trial in 2013, a five-day summer camp study for teens. The 12 to 20 year olds were able to participate in typical outdoor camp activities without having to think about managing their diabetes. The same was true at a 2014 five-day summer camp trial with preteen subjects aged 6 to 11 years, Dr. Damiano noted.
The next clinical trial involved adult subjects in a multi-center study from 2014 to early 2015. “In that trial, the device almost eradicated the subjects’ incidence of hypoglycemia,” Dr. Damiano said.
The trials were conducted using algorithms the team developed with a device that was cobbled together using different technologies, he noted.
“What’s needed is a fully integrated Class III medical device. For the next step, we have proposed a bionic pancreas pivotal trial and mapped out a trial design for FDA approval,” he said. “The goal is to create a device that eliminates management challenges and keeps people safe until a cure is found.”