Researchers at the University of Virginia will head a $12.7 million project studying so-called “artificial pancreas” technology, in this case a smartphone application that wirelessly reads a sensor measuring a person’s glucose level and that tells an insulin pump to deliver the correct dose of insulin.
Such technology, under development by several companies, is referred to as an artificial pancreas because it does the work of the pancreas, the organ in the body that normally releases insulin to control the body’s blood sugar levels. In people with diabetes, the pancreas doesn’t work like it’s supposed to.
“Essentially the person … will carry that smartphone in addition to their current equipment,” said Boris Kovatchev, director of the U.Va. Center for Diabetes Technology and the principal investigator on the grant, which was won through a competitive process.
“The smartphone talks wirelessly to a little sensor that scans glucose, blood sugar level, every five minutes and controls an insulin pump, also wirelessly.
“Our development is the most mature and the most tested in the world,” Kovatchev said. “We have close to 200,000 hours of human testing of this system in several countries and in several U.S. states.”
Type 1 diabetes used to be called juvenile-onset diabetes because it is most often diagnosed in children and adolescents, though it can occur at any age. It results when the body’s immune system for some unknown reason attacks the cells in the pancreas that make insulin.
(Type 2 diabetes, on the other hand, typically develops gradually and in older people. Obesity is a factor and, with lifestyle changes such as losing weight, changing eating habits and adding more physical activity, people can often control glucose levels without medication.)
About 5 percent of the people in the U.S. with diabetes have Type 1 diabetes, while 90 to 95 percent have Type 2.
The grant from the National Institutes of Health will fund two trials in which people will use the technology. The first will enroll 240 people at nine study sites — U.Va., Harvard University, the Mount Sinai School of Medicine, the Mayo Clinic, the University of Colorado, Stanford University, the University of Montpellier in France, the University of Padova in Italy and the Academic Medical Center at the University of Amsterdam in the Netherlands.
People in the first study will be followed for six months as they go about their regular lives.
A second trial will follow 180 of the original participants and use a different algorithm or mathematical formula to determine how much insulin to deliver and when.
“The biggest challenge in the design of the artificial pancreas is the inherent uncertainty in the human body,” said Francis Doyle III of Harvard, co-principal investigator on the study, in a Harvard news release on the grant.
“Day to day, hour to hour, the various stresses that impact the human body change the way it responds to insulin-controlling glucose. Physical stresses, anxiety, hormonal swings will all change that balance. To be able to control for those factors, we need to see longer intervals of data. This is the first trial where we’ll be looking at multi-month intervals of time.”
The technology has been decades in the making.
“Ten years ago, nobody really believed that this was even possible,” Kovatchev said. He said the JDRF, formerly known as the Juvenile Diabetes Research Foundation, funded much of the early research.
“It’s been a huge project, over $100 million that we’ve spent to try to move this field forward, and the team at U.Va. led by Dr. Kovatchev has been kind of a linchpin of this project,” said Aaron J. Kowalski, JDRF chief mission officer.
“The goal is helping people with diabetes do better. While we have insulin, people with Type 1 diabetes still have significant challenges in managing their glucose levels. We believe artificial pancreas systems will do two very important things: They will help them be healthier … and they will make life with diabetes easier,” Kowalski said.
Other companies developing artificial pancreas technology include Medtronic and Johnson & Johnson.
Molly McElwee-Malloy was in one of the earlier trials of the U.Va. technology in 2006 and later changed careers — pursuing a nursing degree — so she could help in the device’s development. She was diagnosed with Type 1 diabetes at age 20 in 1998.
“It was that different from my regular treatment and that much easier that I decided that anything I was doing at that time was unimportant,” said McElwee-Malloy, head of patient engagement and director of marketing for TypeZero Technologies.
Even now with a glucose monitor and insulin pump, she checks her blood sugar at least 12 times a day, she said.
“It’s all-consuming. I tell people all the time once this gets on the market and I can wear this device, I will have time to have a hobby. It will be liberating.”