What exactly is the
Artificial Pancreas that JDRF is working on? How would it operate?
For many years, the concept of an artificial pancreas has been an attractive one - both to scientists and obviously to people with diabetes. Simply, an artificial pancreas will consist of a device to sense glucose levels, a separate device to give insulin and a computer program to control how much and when that insulin is given. In the 1970's a version actually existed. It was called the Biostator but for many reasons, for example its size (about that of a refrigerator) and complexity, it was limited to use in the hospital. Devices to give insulin, as we know, exist - they are insulin pumps and many people with diabetes wear them. What has been lacking has been the continuous glucose sensor. Now we have such a sensor. Recently the FDA approved continuous sensors from both Medtronic and DexCom. I believe the first generation of an artificial pancreas will combine insulin pumps - like those that are worn today - and continuous sensors - like those that are worn today - and instead of setting basal rates and bolusing at meals, a computer program will do this automatically. The JDRF has actually funded some very exciting clinical trials in people (kids) at Yale University that have shown this is possible right now in a controlled setting. The JDRF Artificial Pancreas Project aims to speed these technologies to people with diabetes and the first generation of a closed-loop.
What does the JDRF
Artificial Pancreas Project entail?
We are focused on two main objectives. The first is to get people with diabetes access to promising technologies that will help them control their blood sugars better. For example, right now I am wearing a continuous glucose sensor and it's helped me tremendously, but I have to pay out of pocket because my insurance does not cover it. Many people can not afford such an expense. This part of the JDRF Artificial Pancreas Project will focus upon clinical trials that show that people with diabetes do better on CGM devices - lower A1c and less lows for example - and we will use these data to demonstrate to insurance companies that these better outcomes will actually save them money in the long run.
The second focus of the Project is to close the loop. As I mentioned above, JDRF-funded research has shown that you can take a current insulin pump and a CGM and run the pump automatically - closed-loop "autopilot" - in kids in a controlled setting. Now we want to bring this to the "real world". We will fund many of the best researchers in the world to make this a reality as soon as possible.
What progress has
been made so far?
New continuous glucose sensors are already showing themselves to be extremely helpful to people with diabetes as they manage their blood sugar levels. Research has shown that with a CGM people spend significantly more time in "target," that is less time low, less time high and more time in the normal range. And recent studies have shown that people using a CGM can lower their A1c levels considerably with less low blood sugar. This is very exciting for a first generation of these technologies. My A1c dropped from 7.2 to 6.5 after less than two months on a CGM!!
The closed-loop studies at Yale and others in California have generated much excitement in the scientific community. What these studies have shown is that patients can get very good control - often tremendously better then before the study - with a completely closed-loop system.
What have been the
major setbacks?
There have not been any major setback per se, but there are many challenges ahead. The development of a continuous glucose sensor was a long and costly process. It took many years of research before these recently approved sensors were ready to be used by people with diabetes. Now we need more experience with patients using the sensor to determine how to maximize their benefits.
Why has it taken so
long for a closed loop system to get this much funding and support?
The main reason has been the lack of a reliable continuous sensor to this point. Now, with this piece of the puzzle in place, I think we'll see considerably more investment in this line of research. People with diabetes stand to benefit tremendously when we first see automated insulin delivery.
How long do you
think it will take before the Project is completed?
Ah - this is a tough question!! I've been around diabetes long enough to know that it's frustrating when the science doesn't fit the expectations. We want to see the first generation of an artificial pancreas by 2011 - less than five years from now. I do not think we will go directly from continuous monitoring to a completely closed-loop, but I think that there are important steps along the way that we could realistically see. For example, pumps that turn off when someone is low and not responding. This could be first. Next, we may see automated basal control - overnight for example, which could get people much more in target. A great diabetes doctor and JDRF Artificial Pancreas Project researcher, Dr. Bruce Buckingham from Stanford, told me - "Don't let perfection be the enemy of the good" and this really stuck with me. What he meant was the first generation of the artificial pancreas will not be just like the non-diabetes pancreas, but it will be a large step forward compared with where we are today. If we could lower average A1c's from 8 to 6.5 (which is not perfect, but pretty darn good), the impact will be immense. We could eliminate most diabetic complications while easing some of the daily burden that we all know is the hardest part of diabetes.
The artificial
pancreas is essentially a combination of a pump and a continuous
glucose monitor, both of which exist today. What are the advantages
of having the artificial pancreas?
I can attest to the fact that even with a continuous sensor, it's still tough to get into the target range and stay there. There are so many variables to factor into the calculations for determining insulin dosing, like variety of foods, exercise, time of day, etc., that go into maintaining good control. And, you sleep. And it's pretty tough to monitor a CGM, other than the alarms, while catching your zzz's!! The Artificial Pancreas will take most of these things out of the mind of the person with diabetes and do it for you. Imagine sitting down for lunch and just eating! Or going to bed after a day of exercising and not worrying about getting low. Or going to bed and being confident you would wake up with blood glucose at 100, for example. This is the difference and I'm super excited about it.
What is your role in
the JDRF Artificial Pancreas Project?
I'm a scientist at the JDRF and I lead the research portion of the project. This means that I help coordinate the research that we fund. In this role, I work closely with the researchers in academia, in industry and with other funding agencies, such as the NIH, to ensure that the money that we spend on research is spent wisely and will have the biggest impact possible. I also work with a great team in our Washington D.C. office. The JDRF Artificial Pancreas Project involves research, but it will also involve advocacy and our Washington office coordinates the many other areas of the project. We will need all people with diabetes to help and I urge your readers to go to visit our JDRF Artificial Pancreas Project website where you can find much more information about the Project as well as sign up for our new APP electronic newsletter and to be an advocate for type 1 diabetes.
As I mentioned above, I live with type 1diabetes and have for over 20 years. My brother Steve has had type 1 since age 3 - nearly thirty years now. Like your readers, I anxiously await the day we can all walk away from diabetes. Working at the JDRF, I am more confident than ever at the progress that we're making. Next year we'll spend more than $130 million aimed at finding a biological cure to diabetes and its complications. But, as you can appreciate, while we work towards the ultimate goal, we need new tools now to help us do better. I'm very confident that in the near term continuous sensors and then the artificial pancreas will make a tremendous difference for you, for your readers and for me. In the JDRF Countdown magazine I've called the artificial pancreas a bridge to a cure. The JDRF has made this a top priority and I'm confident we're going to get there.
