Waiting for a Cure (Continued)
Recently, there's been a lot of excitement about the FDA finally issuing some guidance regarding the Artificial Pancreas. Put your credit cards away, folks. Here's all that's happened: a draft guidance document has been issued to outline what the Feds would like to see in terms of research studies into the systems. It's an important first step.
But we've got a long way to go.
Once the guidance document gets out of the draft stage and becomes a real document, a process that might take a year, it will lay out the expectations for early feasibility studies, followed by the expectations for transitional studies, followed by the expectations for pivotal studies. By "expectations" the feds mean safety protocols, how study participants are to be recruited, the type of effectiveness the systems will have to demonstrate, and quite a bit more. If all of that sounds like it will take a long time, that's because it will.
To depress you even further: so far, research has shown that we're missing a few key ingredients that we need to make a true artificial pancreas—beyond CGMs that have more stable personalities. We need algorithms as smart as people. Nearly to the level of artificial intelligence. Oh, and we also need faster insulin to respond to fast rises in blood sugar. And we need stable glucagon to respond to rapid drops in blood sugar. And those two medications still need to be invented, developed, tested, approved, and manufactured before we even have the ingredients for a working Artificial Pancreas.
Ummm… we're trying to make an omelet without any eggs.
Worse than that.
The egg farmer doesn't even have any chickens yet.
People: this is going to take a long, long, long time.
Will we live to see a fully functioning, safe, effective, commercially available and practical Artificial Pancreas? That depends on how long you expect to live. Personally, I don't expect to live long enough to see it. But I do believe it will happen in the fullness of time. And I do believe that we should move forward with it. We've been trying to cure this disease for how many centuries now? Well that hasn't worked out so well, has it? Failing a cure, a cure-like treatment is well worth the time, energy, and money it will take. But it'll take a lot of all three of those things.
Consider all that stands in the way. We're missing technology. We're missing meds. We're missing regulatory leadership. And I haven't even talked about how much liability insurance would cost for an automated device that can give you a lethal injection if it fails.
You may accuse me of being a pessimist. That's OK, I've been called worse. But in this case I view my role as that of a realist. I worry that if you get your hopes up about the Artificial Pancreas you'll let your guard down. That instead of using the tools available to you today to the best of your ability, you'll slack off. That you'll let your control slip. That you'll figure it'll all work out in the long run ‘cause you'll have this perfect system in a few years.
That could be fatal.
I want you to focus on here and now, not on the pie in the sky. To use the tools available to you now.
Dare to dream, but don't bank on it—yet.
Wil Dubois is the author of four multi-award-winning books about diabetes. He is a PWD type 1, and is the diabetes coordinator for a rural non-profit clinic. Visit his blog, LifeAfterDX.
NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
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