Diabetes Blog – Happy-Medium.net

I was not given anything, or promised anything, in exchange for writing this post or others on this subject. I was given an invite, and I was happy to pay may way to be there. Really, it was only a 3 1/2 hour drive from home.

I’m a blogger, not a journalist. But I try to get the facts as accurate as possible. If I missed something somewhere, please let me know.

CHARLOTTESVILLE, VIRGINIA– In a small building in downtown Charlottesville, there’s a team of doctors, nurses, programmers, and mobile technology experts working on the Artificial Pancreas Project. I was able to meet some of these people last Thursday, and get a look into the work they’re doing, what kind of research has been done so far, and where things are heading for the artificial pancreas in the future.

There were about 20 visitors at the open house, including the first diabetes alert dog I’ve met (there’s a funny story there, but I don’t have time for it in this post). We were split into two groups… one group went to get up close and personal with the mobile device itself, and one group heard from a group of speakers about the project itself. I was in the second group.

Our first speaker was Boris Kovatchev, PhD. Among the long list of titles he holds is Director of the University of Virginia Center for Diabetes Technology. Dr. Kovatchev is the principal investigator of three large projects related to the design of the Artificial Pancreas. He gave us a brief history of diabetes technology over the decades, and then some great information about the Artificial Pancreas itself.

There are three parts to the technology that have been or will be developed. Kind of like three different platforms that will eventually live on the same device.

– One is a safety supervision mechanism. It’s there to keep your glucose level from going too high, and to keep it from going dangerously low. Have I mentioned that in all of the clinical trials in Europe and the USA, there have been zero nighttime lows?

– The second piece of the puzzle is designed to give post-meal corrections based on what you’re eating, where your glucose is trending, and how much insulin is on board already. Again, this is in conjunction with the safety supervision mechanism that’s already been developed.

– Finally, there’s a portion that’s yet to be tested. This platform deals with basal rate corrections and pre-meal bolus calculations. Once the development on this is complete and it’s fully tested along with the other two pieces, the device will hopefully be ready for FDA approval.

Our next speaker was Marc Breton, PhD. What makes Dr. Breton’s work interesting? Maybe it’s that he and Dr. Kovatchev participated in the design of the first (and to date only) simulation environment accepted by the FDA as replacement for animal studies in pre-clinical assessment of insulin treatment strategies. Dr. Breton is now in charge of its update and further development.

Let me break that down for you a bit. Part of why development and testing is progressing as quickly as it has is because Marc has developed a computer simulation of the human metabolic system. That means two things: first, it means that tests can be run on simulations instead of on animals; and second, it means that multiple testing can take place, at a very fast pace, before anything is tested on humans. How fast? One of the algorithms can be tested on a 24 hour computer simulation in about 1.5 seconds.

What kind of algorithms are being worked on? I’ve mentioned this before, but I’ll repeat it here. Algorithms based on young versus old and female versus male physiology. Everyone’s diabetes is different, and the staff there understands that. They’re working on bringing out something that will work for multiple individuals, rather than multiple individuals having to make something work for them.

Finally, we heard from Dr. Sue Brown. Dr. Brown is one of the endocrinologists working on inpatient studies and works closely with engineers and clinical researchers, helping to bridge the gap between technology and patient care and treatment. And she’s a bike rider too. Dr. Brown talked about clinical trials, how they’ve been conducted in the past, and what they’re like today.

There’s a three step approach in testing the device. There’s inpatient hospital testing, where everything is closely monitored in a special part of the UVA Medical Center set aside specifically for this testing. The second step, which has been taking place since last April, is testing in a hotel, where the patient spends a couple of nights in a hotel room with the device, leaving the room a couple of times per day. Again, always under close supervision, though not quite as close as in the hospital. In addition to the in-hotel testing, there have been a couple of other efforts, including testing just completed with kids at a diabetes camp in California. Finally, there will be (hopefully) at-home testing, where the patient will take the device home for a week or so and the team will remotely monitor the patient from Charlottesville (or closer– I didn’t catch every part of this description, so I might have gotten that wrong).

Dr. Brown also talked about the possible addition, in the future, of adding Amylin to the delivery system of this device. Right now, our pumps or syringes deliver insulin, to do what our pancreases don’t. But when our pancreases broke down, they also stopped producing Amylin, which helps with gastric emptying and helps us feel satiated, which could help us to prevent post-meal blood sugar spikes. I had to look it up before I wrote it. I’m glad to hear that someone is thinking about this. It may not come to pass, but we need to find out if it’s helpful, and doable, before we dismiss an idea like this completely.

After these presentations we were sent to another part of the center to see the mobile device itself and hold it in our hands.

More about that tomorrow.