The Artificial Pancreas has the potential to become a huge leap forward in diabetes care. As anxious as all of us are to push the boundaries in diabetes technology, we can't forget the importance of clinical trials; nothing will move forward without real patients ready and willing to strap on the gear and let researchers observe them for hours on end, most of the time in a clinical setting.
That might not seem like the most appealing prospect, but Tom Brobson, a 52-year-old PWD from Virginia who was diagnosed 8 years ago, was up for the challenge. He's been participating in diabetes clinical trials for the past five years. Specifically, he was a subject in studies for the Artificial Pancreas Project at the University of Virginia in 2007 and 2009. Plus, he's participated in other research, like a study on insulin kinetics last September.
Tom joined the staff of JDRF as Director of Major Donor Relations in 2005 — after just one year of adjusting to his new life with diabetes. But his interest in health, science and technology started long before his diagnosis. Previously, he worked for 16 years at his alma mater, Virginia Tech, in development work for the university's science and applied science programs, and he also worked for the Office of the Secretary of the Department of Health and Human Services as a policy analyst.
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Each research center typically has its own approach to research trials, so Tom took some time to discuss his experience with us: how they do things at UVA, what a "hybrid-control" model for the APP looks like, and what it feels like to abdicate total control over your diabetes to a machine.
"It was a life-changing moment, because you find yourself realizing that you don't need to think about your diabetes.'"
— Tom Brobson, on being part of the Artificial Pancreas clinical trial
DM) How did you get involved with the Artificial Pancreas trial?
TB) My endocrinologist, Stacey Anderson, is one of the researchers for the clinical trial at the University of Virginia. I was at a JDRF research symposium in 2007, right when decisions at FDA were going on about moving forward with the first round of trials. Stacey pulled me aside and said, "You should do this trial." And I said, "Yeah, that makes a lot of sense." I was already her patient and had the necessary paperwork done. They were trying to do a quick enrollment.
Were you nervous at all about starting the clinical trial?
Not particularly. I had a moment of hesitation, but that was more associated with the fact that I work hard to be a tightly controlled diabetic. I was curious if the artificial pancreas could do what I was doing for myself.
You've taken part in two APP trials so far. What was your first experience like?
The way the protocol was designed, there is a "control period," as well as a time when you wear the system and it takes over and runs things for you. Each time I've done this, it has been slightly different in what was being tested.
The first time, the clinical trial was a full-control, fully closed-loop system. I went in for the control time, where all the devices are put on you. Two sensors plus the insulin pump, but you're actually managing things yourself. In fact, you're blind to the data feed from the sensors. It felt a little bit like I'd taken a step backwards, because I couldn't rely on sensors. I was testing my blood sugar and looking at the meal, and guess-timating on what to bolus.
When the engineer told me, "We got you. The system is running the show," there was moment of "Wow. What does that mean?" I always feel like there is a subroutine running in the back of my mind: do I need to eat more, how're my blood sugars? It's the first thing I do in the morning, and the last thing I do in at night. It was a life-changing moment, because you find yourself realizing that you don't need to think about your diabetes. There's usually never a moment of the day that I don't think about my diabetes.
After a couple of hours, I was just eating and living and thinking, the system really does have me. I was allowed to see the data-feed of blood sugars, but I didn't need to do anything with it. That was pretty mind-blowing and pretty emotional for me.
Did anything interesting or unexpected happen while you were hooked up to the system?
Later in the evening, at about 11pm, my endo and the engineers were talking to each other and clearly having a confab over something. I was like, "What's up?" Apparently the system wanted to suspend all insulin. The way the algorithm works at UVA is that it dials the basal all the way down, and then uses small boluses to keep you "in the zone." In my case, the system was looking at the data, and it didn't think I needed any basal or boluses. I asked, "So what are we going to do about that?" Like I had any say in the matter. My endo said, "That's the whole point of the system, so we're going to do that. For right now, we're going to let it do what it's supposed to do." For the next hour or so, I was waiting for something to happen — waiting for the computer to make a new decision or the blood sugar to change or the doctor override the system. And after an hour, my BG was perfectly fine and I was perfectly steady. At this point, it's after midnight, and I found my energy going up over the excitement over the reality that the system was working and working well. I started texting and telling people that this is awesome!
Finally the doctor said that I needed to go to sleep so they could view the dawn phenomenon.
So I said OK and I shut everything down and rolled over and went to sleep. When I woke up, just before 6 am, I looked at my doctor and asked what happened. My endo said the microboluses started again right when the dawn phenomenon began in the morning. I had started drifting up and it kindly and gently brought me back down. I had really good control in the overnight.
What was your experience in the second clinical trial like? Had anything changed?
For the second trial, it was a hybrid-control clinical trial, but the system was capable. This trial also tested exercise, whereas the first one was just about eating. The second time, we used DexCom sensors and the OmniPod pump. All the equipment was put into a fanny pack so I became far more mobile. You could already begin to see an evolution toward making a system that's easy to use.
In this clinical trial, they had you eat just a salad at 11 a.m. Then you didn't do anything more until 4pm, when you had to get on an exercise bike and exercise for 30 minutes. Then you get off and you don't eat dinner until 7pm. It purposefully attempted to trigger a low blood sugar. When I ran the show myself, I went low almost immediately after getting on the bike. When the system ran the show, I went 5, 10, 20 minutes, and the system was fine. They were pulling the blood from me using an IV while exercising and I was fine. But right at the 26th minute, I nicked the threshold. Instead of dropping like a rock, I was just shallowly falling. The safety protocols and the brains of this system had started dialing back in anticipation of a low long before I would have, and almost succeeded in pulling it off.
What exactly does "hybrid-control" mean?
The control-to-range hybrid system is a combination of you and the system. It literally says OK, I'm going to keep you under 200 mg/dl automatically, but if you are under 200 mg/dl, I'm going to default back to your settings. I'm going to do my best to help you avoid going below 100 mg/dl. If you are below that target, I'll alert you to that. There's a lot of reasons for that path, mainly so that people can have confidence in the system. The person will still have a significant role.
Last September, I was in an insulin kinetics evaluation for the algorithm for the Artificial Pancreas Project, and I got to hold and play with the cell phone platform that is now being used in clinical trials in Italy and France as the next step in this technology. I see this as a very clear migration from being clunky to being put in a fanny pack to the user interface on a cell phone. I didn't want to give it back!
This system looks like it's color-coded.
If the device shifts to yellow, algorithm is projecting that you will have a blood sugar that you don't want in the next 45 minutes. If it goes to red, the safety system is coming on. The system is saying, "I've done everything I can do to prevent you going low, so you need to do something."
Parts of the time it's asking you to be involved, and parts of the time it's doing things automatically. If your blood sugar goes high, it will go from yellow to red, suggest a 3.15 unit bolus, and then ask "Yes or No?" It's giving you a chance to be part of the process. But if I know I'm going to exercise, I can ignore it. If you don't do anything, the system kicks in and delivers the bolus and manages you back into range.
How trusting are you of this technology?
This is an interesting question. Am I comfortable turning things over? Yeah, and I can't wait to do it. I already turn my care over to a machine on some level. I'm trusting the pump to do what it does. If my Omnipod becomes occluded, then it's going to alarm and I can put a new one on, or it'll deactivate itself. This system is the same thing. It's a machine, it's technology. If something doesn't work properly, I'll notice it or the system will identify it for me. I can intervene and do what I need to do. The particular advantage is that this is a smart system. If you've got a problem, like impaired delivery, it can flag things far sooner than I'd ever notice. You're adding some brains to the system.
Am I worried it will make a mistake and deliver too much insulin? Not at all. Because of the safety failure protocol, the system has done more to help me avoid lows than I do for myself. Clearly a massive step forward over shat we have today. In the first clinical trial, during the control section, when I ran the show, I had hypoglycemia six times and I had hyperglycemia once. When the system ran the show, I went low only once and I went high only once, and the high was comparable to my own high. It was a post-prandial spike just after breakfast.
You have a lot of good things to say about the Artificial Pancreas. Is there anything you don't like about it?
I wasn't allowed to leave the hospital and experience the real world conditions! I guess all this is with the realization that we have type 1 diabetes, there are times I get tired of wearing a pump, so I suppose at some point that would be the same with APP. There's really no negative, because it's not a finished product. I can't really say I like this feature versus this one.
It felt like there was a coach in my pocket. A personal GPS system. It's a great help.
You're also in charge of Major Donor Relations at JDRF. What do you tell potential or current donors about the Artificial Pancreas? How do you describe it?
I've worn a lot of different hats at JDRF and I've also worked as motivational speaker, connecting JDRF audiences to the reality of the research. Not everybody is gung-ho about the Artificial Pancreas Project. Some people would rather see autoimmune intervention or beta cell intervention. I try to be clued-in to where people's interests are at.
For people not familiar with the Artificial Pancreas Project, I try to quickly explain to them that there are three essential pieces to it: a sensor, a pump and portable computer that allows the two to speak to each other. We all tend to carry cell phones, and in fact, that's where we'd like to see this technology go. That tends to get people's interests.
What do you tell donors — and interested patients — about participating in clinical trials?
I had not fully realized the importance of clinical trials before, how challenging they are. They are exhausting, but they are essential to the translational conversation. I definitely use that as a point of reference. We all need to be willing to participate in trials. There are trials going on, and this demonstrates forward momentum and forward movement.
We're definitely excited about where APP technology is going. Thanks, Tom, for sharing your story!