COMMENTARY

'Bionic Pancreas' Will Simplify Diabetes Management -- for Clinicians, Too

Edward R. Damiano, PhD; Steven V. Edelman, MD; Jeremy Hodson Pettus, MD

Disclosures

July 01, 2016

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Hello. Today we are going to talk about the artificial pancreas—the biggest advance in [management of] type 1 diabetes. My name is Steve Edelman. I work at the University of California, San Diego, as does my colleague, Jeremy Pettus. We were both diagnosed with type 1 diabetes when we were 15 years old, and we both have a huge interest in type 1 diabetes.

This is our good friend and colleague, Ed Damiano, who is definitely one of the leaders in the development of the artificial pancreas. Ed calls his project "the bionic pancreas." We are going to talk about what is going on at the 76th Scientific Sessions of the American Diabetes Association (ADA) [and] bring you up to snuff, and then talk a little about the bionic pancreas, which is something that Jeremy and I are very excited about.

Let's talk about the artificial pancreas and briefly let our viewers know what it is [and] where we are; then we will get into more specifics.

Edward R. Damiano, PhD: I'll tell you a little bit about my background. I am a dad of a child with type 1 diabetes. My son was diagnosed by my wife, who had been a pediatrician at the time for just a year. He was 11 months old. He is now 17 years old and will be going to college in a mere 15 months (not that I'm counting).

Dr Edelman: Thank you for reminding me. When Ed started this whole project, he said he was going to do it before his kid goes to college. We had an idea, Jeremy and I, that if your kid could flunk out of high school for a couple of years, you might be able to reach that goal.

Dr Damiano: I just need 12 more months. That's why they have the gap year.

Dr Edelman: The bottom line is that you can talk about all the immunotherapies, islet cell transplantation, and encapsulated islet cells (which Jeremy is working on), but this is here and now, and I think it is the most exciting thing.

What Is the Bionic Pancreas?

Dr Damiano: We use the term "bionic pancreas" mainly because we think that it is a more descriptive term. "Artificial pancreas" tells you what it is not; it is not a real pancreas. But a bionic pancreas tells you literally what it is. It is a device that imitates pancreatic function—in this case, the endocrine pancreas—through electronic devices and electromechanical means. That is exactly what it does. It is a body-worn device.

This is the one that we built [shows device]. It is a technology that infuses both insulin analogues and glucagon analogues. It has a built-in continuous glucose monitor.

I am wearing a sensor right now, a body-worn sensor. I do that just for demonstration purposes. The sensor sends data by way of Bluetooth® communication right to the Bluetooth radio in our device. We have all these mathematical algorithms that we have developed over the years that take that glucose information every 5 minutes and make automated dosing decisions, therapeutic dosing decisions, on a 5-minute schedule to determine precisely how much insulin or glucagon to administer through subcutaneous infusion sites. On the surface, it looks like an insulin pump, but it offers so much more because it adds a new technology.

Dr Edelman: It looks like an iPhone®, actually.

Dr Damiano: This one does. In fact, I like to carry the old iPhone, the original iPhone from 2007. We actually call this device the iLet, in homage to the islets of Langerhans. It is about the size of the original iPhone—a little bit thicker, at 17 mm thick vs 11 mm.

Basically, it is a device and not a cure. What it does is achieve glycemic control that is near-normal levels. You are achieving near normal glycemia in people with type 1 diabetes, but it does so across the board. It's very effective in people with high blood sugar levels and people who have good control; it is a leveler. It asks very little information about you—just your body weight—and it adapts insulin and glucagon dosing every 5 minutes.

Jeremy Hodson Pettus, MD: A lot of data are out there on lowering A1c and reducing hypoglycemia, but as someone living with the disease, I am curious about some of your anecdotal experiences and what people say when they are using the bionic pancreas. I remember you saying that for one of your studies, you were trying to recruit patients and you had everybody you needed in 24 hours. It's like selling out a concert in 20 seconds. What are you hearing?

Dr Damiano: We do have a long waiting list; recruitment has not been a problem. The challenge has been turning people away, which is a good sign and a bad sign. The support that we've gotten from our volunteers is unbelievable. We simply could not be here with 12 years of research—animal studies first and then 8 years of clinical trials, inpatient setting first and then outpatient setting—without this extremely passionate desire to help move the needle on diabetes care. This is a tremendous community to do that.

Competition Stokes Innovation

Dr Edelman: The reason you do not have any trouble recruiting is because staying between 80 mg/dL and 180 mg/dL is almost impossible. It is such an unmet need, staying in the zone.

I thought you might talk a little about what is going on in the field of the artificial pancreas, because as most people do not know, you are one of the few folks who are using glucagon to help prevent lows and insulin to prevent highs, using a special algorithm. Other folks just use insulin alone. Don't forget the hormone amylin. Of course, a trihormonal pump might be a little too aggressive to try right now. What is going on in that area?

Dr Damiano: All of these technologies have a spectrum of capabilities, all of which are going to improve the standard of care. These things are not in tension with one another; they are complementary. We will see these technologies being rolled out over the next 24-48 months. One will be better than the next, with the ultimate goal being to bring a fully bihormonal system that is fully automated to people with type 1 diabetes as a bridge to a cure. It is a device that will take care of people for as long as is necessary until there is a biological cure, which is what we are looking for. We don't want to be connected to contraptions and having to change insulin and glucagon cartridges.

Some other devices that we are expecting to see will come out within the next year. Medtronic has a technology coming out that will modulate the basal infusion rate, increasing or decreasing it as the sensor dictates, up to a certain extent. It is not a fully autonomous system. The user will still have to know their nominal basal rates, and they will have to program the pump with that information, carb-to-insulin ratios, and correction factors. It will look very much like an insulin pump, but it will have this new functionality that will give much better control.

Dr Edelman: Baby steps.

Dr Damiano: Baby steps, but they are close together. Baby steps that take 10 years in between are not something that we embrace.

Dr Edelman: You mentioned Medtronic, but Animas is also in the game and Tandem is in the game, partnering with Dexcom. That is good news.

Dr Damiano: It is. Competition is good for people with type 1 diabetes; it is good for the ecosystem. Each of these various companies, some of which grew from parents of kids with type 1 diabetes and some of which grew out of academic curiosity, all have different takes on this.

The reality is that when it comes to things like glucose, it is quite a personal matter. How you wear devices, whether you want a tubeless pump or a tube pump, the kind of sensor you wear, the kind that is indwelling for many months vs one that you change out frequently—these are personal decisions, and you need to have lots of different choices.

We are building a platform technology that we hope will allow you to use all the different insulins that you need—potentially different glucagons, but certainly different sensors. We want to make sure that this is a device that appeals to as many people as possible.

Emotional and Mental Benefits

Dr Pettus: I'm excited about it just from the mental burden side of it. The calculations that Steve and I are constantly doing—

Dr Edelman: —and miscalculations.

Dr Pettus: Yes, a lot of time you are high [or] you are low, [and these devices take] away some of that burden. Seeing the glucose control reported in the publications is impressive, but I am just thinking about the mental energy that we can free up.

Dr Damiano: Which is a huge part of it. It goes back to your original question about the subjects' response to the trials and their experience with the device. Before having this fully integrated device, the system that predates it ran on an iPhone. It talked to two Tandem t:slim® pumps, it had Dexcom G4, it had many parts, and it was a cumbersome thing, but it took away the emotional burden of the day-to-day management of type 1 diabetes. People said they would hook up to this thing in a heartbeat and wear all this garbage to be free of the emotional burden.

This will be a much more appealing, much more palatable device. I would say that many people did not want to give the device back. That was a common reaction.

Changing Clinical Practice

Dr Pettus: Let's fast-forward 10 years from now. Your product is out there, people are doing well with it, and maybe there are other products on the market. What other type of occupation do you think Steve and I should look for after you put us out of a job?

Dr Damiano: Now wait a minute.

Dr Edelman: Think about it. If people are staying in the zone all the time and my practice is primarily type 1 diabetics, do you think I should look for a job at Starbucks? Jeremy is thinking about working at Supercuts. Not as a hair stylist, but as someone sweeping up the floor.

Dr Damiano: I have to say that it will certainly change the patient encounter, all in positive ways. You will not be focusing on the frustrating part of type 1 diabetes management, which is not a matter of the patient complying with therapy. It is a matter of therapy being able to adjust itself to constant physiologic change, which is really what we are talking about.

Maintaining a teaspoon of sugar in your blood all the time is an absurd and impossible task. Nevertheless, we are tasked with it, the three of us at the table. I help my son manage his diabetes and I have been doing that since infancy (not my infancy), and you guys [have] managed your diabetes for all these years.

Dr Edelman: We share our blood sugars on the share app. He gives me so much crap.

Dr Damiano: It's like a Fitbit fight.

Dr Edelman: It's a competition. What you mentioned about the emotional and the physical issues are really the unpredictable nature of type 1 diabetes.

Eliminating Emotional Dosing

Dr Edelman: I want to ask about safety. With your system, you just put in your weight and that's it; it learns on its own and adjusts over time. Are you concerned about that? People ask whether you're really going to trust Tesla and take your hands off the steering wheel when you're on the freeway. How trustworthy is it, and how safe is it?

Dr Damiano: The best I can do to answer that question is to report on our clinical trial results. We have never had any severe hypoglycemic events. The types of adverse events we've had were usually associated with the infusion set failing. The most concerning one would be a sensor telling you that your blood sugar is higher than it actually is. That is always a concern, and it's my greatest concern.

The infusion set failing scenario is just like with a pump—you would replace it. The difference is that you don't have to figure out how to bring yourself down from a blood sugar of 400 mg/dL. You change the infusion set, and the device does that autonomously.

Dr Edelman: We call that a "rage bolus."

Dr Damiano: This device is mathematically objective, has no opinion about the matter, and makes no judgements about you.

Dr Pettus: That is key. Like Steve said, it is hard not to be emotional when you see that 300.

Dr Damiano: It's a very patient device.

Dr Edelman: Our current technology, if you wear a pump, allows you to put in your blood sugar and it suggests a dose for your correction, but it has no clue about what direction your blood sugar is going or how fast it is going. That is where the algorithm comes into play.

Dr Damiano: That is correct. I was talking about the incremental steps from insulin-only to bihormonal. This device is really three devices in one. It is a bihormonal bionic pancreas, and all of the mathematical algorithms and the cartridge detection system that we built into it are always looking to see whether both cartridges are installed.

If you only have the insulin cartridge in, the device behaves fundamentally differently. It sees that there is no glucagon cartridge and behaves a bit more conservatively as an insulin-only system.

Dr Edelman: I did not know that.

Dr Damiano: This device will come out initially, hopefully within about 24 months, as an insulin-only system. A year later, the glucagon cartridge will become available. You load that in, and it will see it. Every 5 minutes, it is looking for the glucagon cartridge. It is infinitely patient. It is a device.

Dr Edelman: Will it tell you what time of the day it is, too?

Dr Damiano: It does do that. We thought it was a little over-the-top in sophistication, but we did add a clock.

Finally, it's also a glucagon-only device for postbariatric surgery. There will be populations that benefit from this outside of type 1 diabetes, and of course, type 2 is immediately on everyone's mind. They probably won't need the second hormone, but as an insulin-only system, it could work quite well in that population. There's a lot of low-hanging fruit that can suddenly be tested with a device like this.

Dr Edelman: We have an appointment to apply for a job at a car wash down the street.

Thanks so much. We could talk all day about this. We will be waiting. It's an exciting area, especially for us.

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