The Bionic Pancreas (Continued)
The fine print: There are a lot of things that have to go well in order for this to be commercially available by 2017. That is the year that Dr. Damiano's son will go to college and the year that Dr. Damiano hopes to see a commercial system approved by the FDA. Here's what has to happen:
- The rest of the current trial has to go well so that the researchers can move onto the next phase — testing the system at diabetes camps this summer (they will be followed by one nurse per four kids).
- After that, Drs. Damiano and Russell's team will test the bionic pancreas in healthcare providers who have diabetes themselves. The two-week study will be more ambitious, as the participants will sleep in their own homes and go to work as they normally would. (This is pretty smart right — they still have healthcare providers around, to ensure safety, but they are themselves!)
- If all goes well, the research group plans to conduct pivotal studies, at least one of which will last six-months, that will test the final version of the system in 2015 and 2016.
- For these longer-term trials, a new pump will need to be built and approved that can carry both insulin and glucagon. Tandem Diabetes Care is currently working on developing such a pump.
- A stabilized liquid glucagon must be developed that can last for a few days in a pump. In this study, the researchers used the current glucagon "kit," which requires mixing glucagon powder with water. Unfortunately, it had to be replaced every day in the glucagon t:slim pump I was wearing. While this was acceptable in a research setting, it's not a viable real-world solution because it is too expensive (it's also a pain, though I would do it in a heartbeat). We believe that this is the biggest obstacle to overcome in the next few years. Fortunately, companies such as Xeris Pharmaceuticals, Biodel, and others are working hard on addressing this problem. The timeline will be tight to make the goal, though I'm optimistic.
- Before it can be sold, the FDA has to approve the bionic pancreas — certainly no easy task considering the ongoing three-plus-year delay in approving Medtronic's MiniMed 530G. Known as the Veo outside the US, this is the most basic version of an automated insulin delivery system — it suspends insulin delivery for up to two hours when the CGM crosses a low threshold and the user does not respond to an alarm. We understand that Dr. Damiano and colleagues' interactions with the FDA have been quite constructive, so we are hopeful here as well, though it may be a complex journey. Indeed, given last year's artificial pancreas guidance from the FDA, there does seem to be a clear approval path forward.
I had been warned that I wouldn't want to give my bionic pancreas back to the researchers at the end of my five days with it. They said I might become depressed. I laughed — who could possibly become depressed after being so lucky to be chosen for this trial?
Well, they were right — I definitely did not want to give it back. And I certainly miss it.
1The BU/MGH team believes the term "bionic pancreas" is more descriptive than "artificial pancreas" — 1) "bionic" literally means "Having anatomical structures or physiological processes that are replaced or enhanced by electronic or mechanical components," which describes exactly what the system is trying to do; and 2) the term "artificial" lacks specificity, as it only describes what the system is NOT. Going into the trial, I wondered if this was semantics but coming out of it, I absolutely felt I had a bionic pancreas rather than an artificial one.
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