From Abby: Closed Loop Trial (Part II).
Hi again! Thanks for checking in with Abby's experience with the diabetes closed-loop study. Here's part two of Abby's feedback on the closed-loop study, including her questions and concerns about what happens next:
The great thing about this study, and the people running it, is that they are fully aware of the human component. The engineer I spoke with has a 12-year-old son with type 1, so he “gets” how this system needs to function, and under what circumstances. The nurse practitioner who runs the study also has type 1, and so did the night nurse) who watched me puke for two hours). These people know what its like, and why we need this system to function and help us.
While I'm not sure how much I can share publicly about what the engineer of this computer program told me, he did fill me in on where he sees this whole shindig ending up. His plan is to develop an iPhone application that would be controlling everything. The OmniPods would be replaced by a tubed pump (one that can hold glucagon and insulin in a very small pump; they have a contract with a company) and we, as patients, would wear two infusion sites about two inches apart, but connected to the same pump.
While this might seem like an excessive amount of stuff to wear, i don't actually think it would be, considering how tiny infusion sets have become. Also, he's really pushing to use the Navigator CGM system because of it's accuracy. Unfortunately that technology is no longer being made so he's trying to figure out a way for another company to make the same system - aka "reverse engineer" it. So patients would be wearing a Navigator (he's pushing for a smaller transmitter, since the current Navigator one is huge) a pump, and two infusion sets. The other problem is the lack of stability glucagon shows after 24 hours. So again, they're working with a company to develop a glucagon that is stable for three days at room temperature.
Assuming they get this pump generated, glucagon stabilized, and Navigators back on the market, the plan is to have an iPhone app that controls all three aspects. The algorithm would figure your body and habits out over the first few days, and then use a 10-day model to dose your insulin and glucagon. What this means is that your basals for the last ten days might not be the same as the next ten days, but the computer learns from what it's seen. The really coolest part to me, though, is how you bolus for meals. You would literally push a button that says either small meal, medium, or large meal. If you're eating less than 15g, for example, you don't bolus at all and let your computer react to your blood sugar.
At first I thought this was totally insane, but he said that during the trials they're finding this is actually an okay way to do it, and that your blood sugars won't skyrocket because you're being controlled so tightly. Also, the system learns what you consider a "medium" meal. So I may eat meal that is actually 60 grams of carb and guess it at 45 grams, so I call that medium - while you would see the same meal, guess it at 90g, and call it large. It won't matter after a few days, because the computer will just know what you consider small medium or large - as long as you're consistent with your guessing. How awesome is that!!
This team will build into this program things like sick days - the computer will adjust your basal rates if it is seeing consistent lows or highs for three hours. Also, it would shut off insulin for a while if you're dropping from something like exercise, but since it wouldn't be for over three hours it wouldn't totally change your basal pattern.
I have questions and concerns about this, as I'm sure you do. First of all this whole system, when available to us, will be SO expensive. Heck, I don't even have an iPhone now. [Editor's note: Neither do I.] Also, this is so complicated, you'd need to be in very close contact with your medical team. A large part of the population can't handle insulin pump therapy because of it's complexity - so how will people be able to grasp this concept? I suppose with time it'll become more readily covered by insurance, and easier to understand. I'm excited about the future of technology, especially after seeing it at this stage.
I think that future is coming soon.