An Artificial Pancreas Clinical Trial - On Candid Camera!
An Artificial Pancreas Clinical Trial - On Candid Camera!
Written by Allison Blass
| Published on March 24, 2011
In January, I met with Dr. Ed Damiano, one of the co-investigators at Boston University studying the artificial pancreas trials in humans. At the end of our conversation, he invited me to come up to Boston to check out one of the experiments. The artificial pancreas project has always been something I've been a little skeptical of, especially since I haven't had the best experience with the continuous glucose monitor. However, the more I hear about it, the more I'm looking forward to when it finally comes onto market.
What actually goes into putting together an artificial pancreas and where are they now? Dr. Steve Russell, another investigator, walks us through the mechanics with the volunteer-of-the-week, Jim Stage.
(Here's hoping that all this bulky technology one day looks as antiquated to us as the first insulin pump does now)
So, what do you all think of the evolution of the "artificial pancreas"?
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Great video, it takes this fuzzy concept of how an artificial pancreas would really work and makes it much more comprehensible. Although it also makes me think an AP is still years and years away, but then we've been through this each round with meters and pumps and CGMs. My only questions is where in the world would I wear all those pods and sensors?!
@riva: The idea is to eventually wear just one sensor and 2 pods, or possibly a dual chamber pod if a company ever created one. Hopefully you wouldn't have to wear quite as much stuff as Jim is wearing! It's definitely a process and will change how it appears in the various stages.
Thanks for sharing that with us! Fascinating! Of course, I've already had bad luck with Pods (skin sensivity to adhesive, malfunctioning pods. site absorption issues) and obviously the super-duper Navigator is no longer available, so this seems to me to be a pipe dream. Unless the delivery of insulin and glucagon can be guaranteed, I can't believe that most Type I's will benefit (at least maybe not for another 10 years - if ObamaCare doesn't make sensors and pumps unavailable due to their exorbitant cost.) It is nice to know that researchers really want to help us, however!
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Great info .. Thanks for sharing Its unfortunate to hear more evidence that the market was unable to support the best/most accurate product on the market, in the Navigator... If the note in this video is accurate, when a company the size of Abbott give up on this technology, what does that mean for the future ? Maybe they have a new version in the pipe line. Its clear that for ANY of these APs to work the sensor technology is key Thanks again Doug
@June ... this is no pipe dream. Dexcom sensors are already much more accurate than they were five years ago. Both Dexcom and Medtronic are in trials to introduce new versions of their sensors. Everyone would like to see the Navigator come back but this solution is not dependant on that system.Also, "Obamacare" has no effect on my employer's insurance. It's really more about the benefits your employer offers than any government program.
@DavidHaving used both the Navigator and the DexcomThere is NO comparison in accuracy or the feature set. Not even close ...Maybe Dexcoms next version will be better but this one cant carry the Navigators suitcase.Sorry to Hijack Doug
Sounds like stable form glucagon will be very important. Has anyone done that yet?It's a shame wiring these pieces together isn't easier. Open interfaces. Allison, it sounds like you're saying that the Navigator has less lag time than the Dexcom. Is that true?
Also, I tried to sign up for those trials but there was a requirement to take aspirin. As I'm allergic it was a no-go. Is that still needed? I'm surprised that even small doses of glucagon caused nausea.Thanks Jim for sharing your experience and Allison for getting all this onto video, it's excellent.
All in all, I gotta say that this is pretty neat stuff indeed! :)I certainly understand & agree w/ the not wanting to get locked in bit (from the doctor in the video) too.BTW, I still do my T1D the old fashioned way because that's all I can afford to do. Thus, I've never used a CGM or a pump.Thanks again to everyone involved.Cheers,Jeff
@Bernard: Dr. Russell asked me to post these comments in response to your questions: "It is really unfortunate that the volunteer had nausea and a headache. We haven't had other volunteers report these symptoms in the previous experiments we've done, about 40 experiments in all, although some of them received more glucagon than was given in this experiment. Even at the high end, the amounts of glucagon we give are very low relative to the typical doses. This particular volunteer got a total of 1 mg of glucagon spread out over 48 hours (no more than 0.02 mg at a time) compared to the 1 mg that is given in a single injection for severe hypoglycemia. There is undoubtedly a range of sensitivities to these symptoms, and the symptoms the volunteer experienced are the most common side effects in people given large doses of glucagon. Perhaps he is more sensitive to these effects than the other volunteers so far. The other possibility is that the symptoms were not due to glucagon. He's doing another experiment (he's a really good sport!), so we'll find out.I agree that we really need a stabilized glucagon. There is a small company called Biodel that has produced one. Unfortunately, Biodel is focusing most of their energy on their rapid-acting insulin, Linjeta, and don't have much effort to spare for glucagon at the moment. We're trying to find a way to do some of the testing that is needed on their stabilized glucagon ourselves - this is something we're proposing as a project to the JDRF. Lilly has also acquired rights to a glucagon analog that is stable. Hopefully they will aggressively develop it - they certainly have the resources to do so.We haven't specifically analyzed the lag times of the sensors, so I can't answer that question yet. We will do that analysis before we submit the comparative results for publication (sometime in the next few months), and we'll post the final paper on our website (www.artificialpancreas.org). At this point we know that the Navigator is more accurate than the Seven+, which is more accurate than the Guardian RT. The Seven+ is a lot better than the older Seven, but still not up to the Navigator standard, and there are more missing values than for the other two devices. There are new versions from all of the companies in the works and we'll test them as soon as we can.Taking an aspirin is still a requirement, because it helps to keep open the IVs we use for monitoring (not part of the closed-loop system, but still important for the experiment)."
I'm pleased that they're working on it, and I hope they continue to get the funding they will need, because this is just the first step of a long journey!
All nice and dandy.. my quesiton is? And who's going to pay for this?Another Toy for the Rich or those with Rich Health Insurance ..We can't even provide enough Test strips, Insulins to T1's now as it is..and the Test meters are so off kitler still.. But it does sound like a big $ maker...as all the new toys they come out with.. Instead of using that Reserach Grant $ for how to make a Item that will still only treat the diesease, and Make $, why not just focus on the cure instead..?at the least? Lets get Every T1 a Insulin pump and plenty of test strips 1st.. That would save alot more lives I think.. than a AP for a select few..and how about getting Medicare to up the Amt. of Strips allowed from 3-10 for T1's... They are treating T1's like T2's... as usual.
The whole notion of an artificial pancreas is quite interesting, but like Dennis stated, "'why not just focus on the cure instead..?" I watched all 3 parts of Dr. Kowalski's presentation at the JDRF that are included with this video. Was Jim's 2 day trial a JDRF deal?The JDRF really angers me because they won't provide any support to Dr. Faustman, who really may have a cure - she is just beginning phase 2 of her clinical trial, but needs more money, and the JDRF won't give her a cent. It makes me nuts. I went to a JDRF function in Boston where Dr. Kowalski made his presentation, and I asked him why the JDRF won't support Dr. Faustman. He just kinda shrugged and said "Well....there's only so much money to go around." Yet the JDRF is dumping umpteen millions into the artificial pancreas. Sometimes, it really makes me question their motives. I apologize for the rant - it is just a very touchy subject for me, since I am enrolled in Dr. Faustman's trial - I'm very hopeful (but skeptical at the same time).
@Tom: This trial is partially funded by JDRF. The sponsors involved in this trial are listed on the clinical trial database website: http://clinicaltrials.gov/ct2/show/NCT01161862?term=NCT01161862&rank=1.
Hi Allison,The link you provided is to the artificial pancreas trial - not Dr. Faustman's which I *think* is this one: http://clinicaltrials.gov/ct2/show/NCT00607230?term=bcg&cond=diabetes&rank=1Again, I'm terribly upset with the JDRF that they won't do anything to help Dr. Faustman - when they spend umpteen millions on an artificial pancreas. With my MM 522 & CGM, I have the closest thing I need to an artificial pancreas. I want to be CURED! And sometimes, it truly seems as though the JDRF is not really interested in a cure - I know that's more cynical than I really am, but I just get so derned bummed. She nees over $25 million to complete phase II.
@Tom: You asked in your comment "Was Jim's 2 day trial a JDRF deal?" So I wanted to answer it by saying yes, and providing some additional information if you were curious. I interviewed Dr. Faustman in January and you can watch the video on DiabetesMine's YouTube channel, but I don't have any additional information as to JDRF's decision to not fund her research. Sorry!
Hi Allison,Thanks for telling me about the interview. I had seen the one that Bernard did with her a year or so ago, but I'd not seen this. I got all excited again listening to her. I met with her for about an hour or so, and she just impressed the heck out of me. I go back to Boston in October to get a shot - I don't know whether I will get the BCG or a placebo, but I've got a strong feeling I'll be able to tell the difference. It's really weird - I've had Type 1 for 26 years now, and what's strange is that although I produce no insulin (C-peptide < .1), I show no evidence of GAD antibodies. So I really don't know what the heck is up with that. I've asked a few endos, and generally they just shrug their shoulders. Evidently, after so many years, the antibodies don't show up, but if that's the case, and Dr. Faustman is right, why don't I just begin regenerating beta cells and begin producing insulin?!?I truly apologize for thaking this subject so far off topic, but if anyone want's to see Allison's interview with Dr. Faustman, here http://www.youtube.com/user/DiabetesMine#p/u/3/utlcaP52YGc is the link.
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