The technology was patented through the UVA Licensing & Ventures Group and was limited to ages 6 and up. But now, even her two-year-old child with type 1 diabetes can use the system.
The Licensing & Ventures Group's Office of Communications spoke with Breton, a professor in UVA's School of Medicine and College of Engineering and Applied Sciences.
Q. How does this system make life easier for infants with type 1 diabetes and their parents?
A. Well, just like with older patients, the system takes over most of the insulin dosing decisions, freeing the family from the worries and daily hurdles of managing a 2-year-old's blood sugar. Eating or not eating, definitely not planning physical activity, and responding to much smaller changes in dosage. The biggest difference we keep hearing is parents being able to sleep through the night, but we're also hearing stories of families who were able to return to work because of this system.
Q. Will FDA approval be required for neonates in the future? If so, what is the rough timeline for approval?
A. I am not aware of any data that has been generated to show that this system works in children under 2 years of age. Approval typically takes about a year from the completion of a major study and is contingent on the data being convincing in nature.
It is important to note here that the pediatric endocrinologist also has the opportunity to work with the family to decide to use the system “off-label” if they feel it would be in the best interest of the child. is. This has happened to children between the ages of 2 and 6 before this approval, and it could happen again if it makes clinical sense.
Q. How have the device algorithms evolved since you first created the device, and what are you and your team currently working on?
A. The algorithm has not changed since December 2015, but of course there have been many iterations between the first version in 2008 and the current Control-IQ. Since 2017, his team at UVA has been hard at work designing a next-generation device, a system that doesn't require patients or parents to announce meals or count what they're eating. We are well along that path and are currently conducting our first home trials with teenagers and adults.
Q. How has UVA's Diabetes Technology Center grown since its founding, and how much progress has it made toward one of the center's goals of helping people with type 2 diabetes?
A. Well, when I joined in 2004, there were four of us. PI Boris Kovachev. Stacey Anderson, Endocrinologist. Nancy Kirshner as clinical research coordinator; And me as a postdoctoral researcher. Currently, the company employs 60 people, with more than a dozen researchers conducting at least 10 studies a year, and a team of about 20 engineers and quantitative scientists discovering new algorithmic solutions every month. doing. In other words, her growth over the past 20 years has been amazing.
And so it is. We have made a concerted effort over the past few years to extend our research to more patients with type 2 diabetes. Four clinical trials are currently underway to provide solutions tailored to the specific needs of these patients.
Q. Overall, how gratifying is it to know that your invention is helping more than 500,000 people around the world?
A. I feel very lucky as a scientist to be able to have a visible impact on the world with the results of my research. It is truly incredible that its impact is contributing to freer and safer lives for people around the world. When we started, we had no idea that our discoveries could have such a far-reaching impact. I am proud and humbled by what we have accomplished.