Boris Kovatchev, PhD, Director Center for Diabetes Technology at the University of Virginia talks about the artificial pancreas.
Interview conducted by Ivanhoe Broadcast News in October 2019.
Tell me a little bit about this project, Boris. when you say the term artificial pancreas, can you describe it for me? What are you talking about?
KOVATCHEV: Yes, so there are people who have diabetes, there are many of them. Approximately 10% of the U.S. population has diagnosed diabetes. And it’s a global pandemic, as well. Some of these people who have diabetes need insulin injections to keep their blood sugar levels in check. So this is a device that has been in development for close to 14 years now that replaces the insulin injections people need. It’s an automated system that delivers insulin without the person having to do anything essentially.
If I’m correct, just for the type 1.
KOVATCHEV: Not necessarily, no. There are people with type 2 diabetes who do need insulin. And it hasn’t been tested in people with type 2 diabetes who need insulin as much as it has been tested in type 1 diabetes. Basically for type 1 everybody needs insulin. For type 2 diabetes only some people. But for anyone who needs insulin that would be a system to look at.
Can you describe the system for me how it looks and how it works?
KOVATCHEV: So the system has two major components. One is a little sensor the size of a quarter that sits somewhere on the skin. And that sensor has a little needle that sits under the skin. And that needle measure of blood sugar levels and sends the blood sugar levels out to a cell phone or to a different device every five minutes. So that is the source of the data, a sensor that measures the blood sugar levels very frequently. The other component is an insulin pump, which contains a reservoir with insulin. The pump receives the signal from the sensor and delivers insulin. And what the artificial pancreas really is, is the mathematical formula, the algorithm that determines how much insulin to be delivered every five minutes. And that’s what we’ve done.
That was my next question. How do you guarantee or how do you know that the diabetic is getting just that right amount that they need to bring their levels into each branch?
KOVATCHEV: Yes, it did take a while to get to that realization how exactly to use insulin so it’s both safe and effective. But I think we’re there now with many years of clinical trials behind us. And we think that the current system is both user friendly and effective.
Is that dosage different for every person depending and could it be different from hour to hour depending on where?
KOVATCHEV: Yes, it’s very closely monitored and tailored to the person and to the person’s state at the moment because it’s recalculated every five minutes.
You mentioned that, a sensor. Where does a person put that on?
KOVATCHEV: Typical place would be the back of the arm or on the abdomen somewhere. The current versions need to be replaced every 10-14 days. This is something people do at home. There is no medical procedure involved. Just take one and put the other – there is an applicator. And it’s very easy procedure.
If you could describe it.
KOVATCHEV: It is waterproof. People can use it in wet situations, of course. It’s designed to be waterproof, to be on continuously for 10 days and then wears off, replacement and move on.
Can you tell me a little bit about what your role was with the development? Did you help with the algorithm part of it or was there another portion of this project?
KOVATCHEV: Yeah, so we here at UVA did develop it from scratch. It’s entirely a UVA development. And we started some time ago. The first portable system that was out there to be worn by people in their normal life. It was developed at UVA. It was called DiAs, the Diabetes Assistant for short, it did appear in 2012. We did the first clinical trials in 2012. At the time Charlottesville became the first city where people with diabetes type 1 diabetes in this case walked downtown on artificial pancreas that hasn’t happened before in the United States. And since then, there was a sequence of various clinical trials as it should be that culminated in a very large study that was completed in April, May this year. The results were reported that the Scientific Session of the American Diabetes Association in San Francisco in June and are now published in the New England Journal of Medicine, showing that the system was safe and effective. In this large study, people wore a system, which is sort of commercial grade because the technology was exported to industry from UVA in 2015. And there were more than a hundred people wearing this system for six months in their normal life. So it did prove safe and effective. The results were reported out there. We think we’ve got the first generation of artificial pancreas come out.
You talk about the sensor that you wear in the second part. How did this change a little bit? Can you describe for me what it what it is like now? It’s no longer the size of the cell phone. Or is it the size of a cell phone?
KOVATCHEV: No, it’s about one third of the size of a cell phone. So the initial experiment that we did with that DiAs system that I mentioned we’re running this mathematical algorithm on a smartphone. And they were communicating, receiving information from the sensor, processing the information on a smartphone and then telling an insulin pump what to do. So we did experiment with that for years with this type of system. And during these experiments, UVA licensed out the algorithm technology to industry. And in 2017 that algorithm was built directly in the insulin pump. So the phone became unnecessary at this time. And the current system has just a sensor and a pump, which is about one-third of the size of a smartphone.
Where does the pump stand in the person essentially?
KOVATCHEV: Again, it’s somewhere on the outer. It has a short or longer catheter depending on the choice of the person that has the needle to deliver insulin. And then the pump is on the other end of that catheter.
Talking about the trials, is this in Phase 3?
KOVATCHEV: Yes.
What is the next step? How much are you able to tell me about the next step because usually there’s FDA approval?
KOVATCHEV: It is at FDA for approval.
This is not an academic process at this time – we are not responsible for this process anymore. When a publication comes out with the results of the paper, the academic work is complete. And that is now done. And then the FDA is considering the system for approval. This process is not controlled by us. It’s not in our hands. We don’t know how long it’s going to take and we hope for the best. But we don’t know when they will say sure.
What’s the impact for people with Type 1 diabetes? This is a very unpredictable condition of what I understand. Blood sugar can just go all over the place. What’s the impact of having a device like this?
KOVATCHEV: My guess as an engineer, and Dr. Brown will talk more about the human side of it, but it’s my knowledge that the blood sugar control of a person improves very significantly on that system. And their engagement with their diabetes goes down because people don’t have to do all this calculation every time on their own. So the interactions with the person are limited to meals. But that’s about it. The rest of it is automated.
From your perspective, watching the different versions, this latest version that you have or it’s gone directly into the pump, how much of an improvement is that? And how much easier would it be for a user the way you designed it now?
KOVATCHEV: I personally think that in the future they will be running on both smartphones and pumps – both types of systems will co-exist in the future. People will have a choice to choose one or another, whatever they prefer. Right now, the version build directly in an insulin pump could be considered more reliable because you have one device less and the signal goes directly from a sensor to a pump without an intermediate device, which should be more reliable and less prone to errors, as shown in these trials. But I can easily envision giving people a choice. If you want it on your phone, that’s fine. If you want the pump, that’s fine, too. And if you on both, that’s fine, as well.
So anything that I didn’t ask you so that you would want to make sure people know about this project.
KOVATCHEV: Well, the project was supported by NIH, by the National Institutes of Health. So we have to give them full acknowledgement because they invested heavily in this project and so did in the first stages of the project JDRF, the Juvenile Diabetes Research Foundation invested in that, as well. And last but not least, the University of Virginia made a very significant strategic investment, specifically in type 1 diabetes in 2017. It’s called PriMeD project – precision individualized medicine for diabetes. And that includes not only technology development and the artificial pancreas project but also genomics and immunotherapies. And we are trying collectively in an interdisciplinary fashion to cover as many aspects of type 1 diabetes as we can.
END OF INTERVIEW
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