Diabetes and Technology

Diabetes and Technology

I’m Steven Russell. I’m a Physician at the Massachusetts General Hospital Diabetes Research Center.

The Bionic Pancreas

The Bionic Pancreas is a combination of several different diabetes technologies that have been combined to produce something that is greater than some of its parts.

How Does the Bionic Pancreas Work

The first part of the Bionic Pancreas is a continuous glucose monitor. And these are available for sale for people with diabetes now. Essentially, they use a tiny little sensor, like a tiny wire, that goes about half a centimeter into the skin where it contacts the fluid between the cells of the skin. And it measures the glucose in that fluid. And the fluid is in equilibrium with the blood. So, this is an indirect way for us to measure the blood glucose. That glucose information is measured by the continuous glucose monitor every five minutes. And then its sent, by radio frequency, to the bionic pancreas device. Where its interpreted and acted on by a combination of several different mathematical algorithms. And those algorithms determine, on the basis of those blood glucose measurements, how much insulin to give, to lower the blood glucose, if that’s necessary. Or how much glucagon to give to raise the blood glucose.

Insulin and Glucagon

So, insulin and glucagon are two hormones that the normal pancreas produces. Insulin to lower the blood glucose, and the insulin producing capability, the pancreas, is destroyed in people with type 1 diabetes.

What Does Glucagon Do?

The glucagon is also produced by cells of the pancreatic islets. And it has the opposite role. It raises blood glucose. Those cells aren’t destroyed in people with type 1 diabetes, but they don’t work properly anymore, and no longer respond to low blood sugars. So, the whole mechanism, for regulating blood glucose is essentially absent with people with type 1 diabetes. Most diabetes therapies replace just the insulin part of the function, and they don’t do it in a, automated way that takes advantage of all this information from the continuous glucose monitor. So, ours does that. It takes those glucose measurements every 5 minutes, 288 times a day, to constantly adjust the insulin. But, it does something in addition to that, which is to replace this glucagon function of the pancreas as well.

Bionic Pancreas Components

The Bionic Pancreas is an externally worn device that looks a lot like an insulin pump. But it has two chambers. Instead of an insulin chamber, it has an insulin chamber and a glucagon chamber. And you fill them using pen cartridges. Many people with diabetes are familiar with the pen cartridges that go in the pens. Well, this pump will take those pen cartridges and then connect them to tubing that will go to an infusion set. And so that infusion set will have two catheters as a part of it and it will go to an infusion set that will, it can be inserted anywhere in the skin. That infusion set will be about this big around, a little patch that is adhesive to the skin. And it has two steel cannulas that come out of it, like two little insulin needles, about half a centimeter long, very, very tin, and insulin goes through one of them and glucagon goes through the other. So, that is adhesive to the skin, and is connected with tubing to this, Bionic Pancreas device that you would drop in your pocket or clip on your belt or something.

And then the continuous glucose monitor has a little sensor that goes under the skin. And it has a transmitter that’s about this long, this wide and this thick. And it sends information about the glucose to the Bionic Pancreas device by radio frequency communication. So, you have two attachment sites to your skin, one for the continuous glucose monitor, one for the drug infusions and then this little device that, if you remember the size of an iPhone 4, its going to be about the size of an iPhone 4 and about 1.7 centimeters thick. So, about this thick. And it will be something that you can drop in a pocket or tuck into a waistband, or something like that.

Bionic Pancreas Trial

So, this isn’t something that’s implanted. It doesn’t require any surgery. Recently, we’ve been doing out patient trials where we train people to use the device and then we send them home, to live their lives. Going to school, or work, their own recreational activities. We’ve made no restrictions on them, in terms of their diet or how much exercise they get. So, recently we’ve been able to test the system in a very realistic environment. The same kind of environment that it will ultimately be in, once its approved for sale. And what we’ve shown in those trials, is that, we’re able to lower the average blood glucose of people using the device, below what their able to do on their own, when they’re controlling their own blood glucose. One of the main problems that we have, when we try and intensify somebody’s insulin therapy, to bring their blood glucose under tighter control, is that as you get more aggressive lowering the blood glucose, you increase the risk of hypoglycemia. And what’s really, very, very encouraging about the Bionic Pancreas is, we lower the average blood glucose and at the same time we actually reduce the risk of hypoglycemia. Those are two things, lowering the average blood glucose and also lowering hypoglycemia, that almost never go together.

Even more exciting though, is the fact that patients, subjects in the trial, had to do very little to achieve that. What the system does, is that it dramatically reduces the amount of thought and effort that the patient has, to expend to try and maintain this hypoglycemic control. They had to calibrate the continuous glucose monitor twice a day and they had the option to tell the device, when they were going to eat, but they didn’t even have to do that. So, we’re able to achieve these much better results but with much, much less work on the part of the patients. And that’s a big deal, because diabetes is really a lot of work.

When Will the Bionic Pancreas Be Available

We have worked with the FDA, to plan, what’s called a pivotal trial. A phase 3 pivotal trial, which is required to get approval of the device, to sell to the general public. And that pivotal trial is going to be quite a large trial because it has two components. One is to get, approval to sell the Bionic Pancreas, to show that the Bionic Pancreas itself, is safe and effective to regulate blood glucose. But the other part of it is, that we need to have a glucagon formulation that is stable. And currently the form of glucagon that we’re using has to be reconstituted, from a freezed dried pellet every day. So that’s not going to be something that’s not gonna work in the ultimate commercialization of this device. Fortunately, there are a number of pharmaceutical companies that have developed very stable glucagon formulations, but they are not yet approved for this use. So, the trial will have to serve two purposes, it will have to get approval of the new glucagon formulation, as well as, the Bionic Pancreas itself. So, we plan to start those studies in the beginning of 2017, and to complete them by the middle of 2018. We could have approval by as early as the end of 2018, but more likely in 2019.

How to Get the Bionic Pancreas

So, if people want to help, if they have diabetes, they can volunteer to participate in our trials, and they can raise money or donate money if they have it, to help us move the commercialization of the fully integrated device forward.

The Future of the Bionic Pancreas

Once you go beyond the Bionic Pancreas, or an artificial pancreas technology, I think all of us are looking forward to technologies that will reduce the need for those sorts of devices. I think we’re looking at a long way in the future, but, I’m excited about the possibility of cell replacement therapies, that take stem cells, differentiate them into beta cells that produce insulin, alpha cells that produce glucagon, and capsulate them in a way that they no longer vulnerable to autoimmune attack. Because of course, that’s the cause of type 1 diabetes, destruction of the beta cells by the immune system. If we can, we now know that we can create lots of alpha and beta cells in the laboratory, the problem has been how to implant them in a way that they won’t be destroyed. And there is a lot of progress being made on that line of investigation, and I’m hopeful that, that will eventually reduce the need for these diabetes treatment technologies. But I think that’s probably years away, so, in the meantime, we’re working as fast as we can to make the Bionic Pancreas technology available to people. I’ll be able to see patients a lot less often, and they’re going to get to spend a lot less time in doctors’ offices. Yet, get better glucose control than they get now. Its going to be really big.