I first wanted to share a couple of things from the trials that have already been done. The thing that stands out the most to me, more than the change in average blood sugars and highs, is the dramatic change in time spent with blood sugars below 60. That is a huge deal that I don't think most people think about. In the outpatient trial from 2013, in 20 adults over 21, the mean blood glucose of participants went 159 to 133. In the control arm participants had blood glucose below 60 3.7% of the time and over 180 34% of the time. Those on the bionic pancreas dropped to 1.5% of the time below 60 and 16% over 180. In the next trial in 2014 the control arm showed a mean blood glucose average of 162 with 1.9% of the time spent under 60 and 20% over 180. While those using the bionic pancreas had a mean blood glucose average of 141 with .6% of the time being under 60 and 20% over 180. While the average blood glucose averages don't show a huge drop, the control that participants saw, with time spent between 60 and 180, was pretty outstanding. A1c's on the bionic pancreas averaged below 7, the goal for people with Type 1.
The information was great, but the most exciting part was seeing the prototype of the iLet! While we didn't get to see a live model or anything like that, getting to see what it was all about was enough.
Introducing the iLet!
I was furiously trying to write down notes all the way through the presentation but had troubles keeping up at times so some of my info may incomplete but here is what I've got. The previous trials for Go Bionic have consisted of 4 parts. A Dexcom CGM receiver to track blood glucose levels, 2 Tandem pumps to supply insulin and glucagon, and an iPhone to put numbers through the algorithm. Not exactly ideal for real world application. The new prototype is one standalone unit to do all of these things. It takes two pen cartridges, one with insulin and one with glucagon, receives data from a Dexcom CGM transmitter and has all the information to run the algorithm on board. The touchscreen interface can display bg levels, insulin micro boluses, and glucagon micro boluses. There are screens to show the life of the Dexcom sensor, infusion sets, battery life, and cartridge levels. Users have the option of pre-bolusing for meals. The iLet will give 75% of the amount of needed insulin up front and then monitor and adjust from there. The system is always using previous information to determine needs based on meal, time of day, carb counts, etc. The more information that goes into the algorithm, the more it can learn and adjust. The system learns over time and adapts to the user. All that is needed to start is the users body weight. The iLet will also come with a bluetooth enabled meter that communicates with the receiver for calibrating the CGM as well as entering blood sugars if the sensor is not active, for example during the two hour warm up period. This eliminates the chance of incorrectly entering a blood glucose value. The system can still be used without a sensor, it just tends to let averages run a little higher and will not administer glucagon. During those times the user can use the carb count entry menu and the bluetooth meter. Another new feature is the G-Burst. This allows a burst of glucagon to raise blood sugars before disconnecting from the iLet.
Of course the iLet is only as good as the accuracy and performance of its individual parts. We are still waiting on a more stable form of glucagon, CGM and meter accuracy can always be better, and currently insulin with a fast acting time would be ideal. The Go Bionic team is working with three companies who are developing new glucagon formulas, one of which is a liquid glucagon stable at room temperature for 2 years. They are entering animal trials and are hoping to start human trials in about 6 months. If this is not ready at the time the iLet is released to consumers, the system can be ran as an insulin only artificial pancreas and ready for dual hormone use later. And as the numbers show, even using the current insulin available use of the bionic pancreas can lead to much better control. I don't know about you, but I'd sign up for that in a heartbeat.
Disclosure: I was in no way compensated for this post. I attended DTreat 2015 in Boise as a facilitator where this information was presented. I'm just ridiculously excited about it.