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JDRF, Animas & Dexcom Artificial Pancreas development Pact

Discussion in 'Parents of Children with Type 1' started by badshoe, Jan 13, 2010.

  1. Darryl

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    This is correct - Closed loop control is not viable with the currently available sensor and pump technology. Current technology fails to meet all three of the non-negotiable requirements of stability of closed loop control systems, especially 99%+ reliability. Anyone who has seen what happens when a kid rolls over and sleeps on a sensor knows that "cutting off insulin when BG goes low" will likely result in DKA in cases like that. One could imagine that software could make up for these shortfalls, but it can not.

    It proves little that patients hospitalized for a 24 hour period had better BG control. Those patients were no doubt monitored by doctors or nurses 24 hours a day while on the closed loop system, because the sensors are not reliable enough to trust in a clinical setting under closed loop control. Perhaps for one or two days you could be lucky, but not for much longer than that.


    Even if the "Artificial Pancreas", which it is not, went on sale tomorrow, here's what life would look like for those who want to use it:
    • First, you have to get a CGM and a pump.
    • Second, you have to tell the pump when you eat, so it will compute boluses (due to insulin action time, meals can not be corrected after the fact under closed loop control - anyone who uses a CGM now and would wait to bolus until after the CGM detects the rise knows what the outcome would be).
    • Third, you have to do BG tests every 8-12 hours and calibrate your "AP"
    • Fourth, when BG goes low, carbs must be given (the "glucagon" approach talked about by the AP people is nothing but a concept at this point).
    • Finally, you have to double check every decision the "AP" makes, because sensors are not reliable enough to be trusted under closed loop control. When BG drops overnight, you still need to roll your kid over and test their BG before deciding to "stop insulin delivery for 2 hours or until BG reaches a higher concentration".
    In other words, of the "Artificial Pancreas" went on sale tomorrow, nothing would change from what pump/CGM users already do today.
     
  2. Jordansmom

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    I agree 100% with Darryl on the subject of a closed loop system. My first thought after reading the announcement was that I would be the last parent on the planet to buy into an Animas/dexcom artificial pancreas. We love our Animas pump and we'd never give up our Dexcom cgms, but I would never trust the dexcom sensor we currently use to tell the pump when to shut off insulin. My DDs biggest basal needs are at night. Her bg could be 300+ in her sleep and roll onto the sensor and the Dex would give us an under 55 alarm. Missing 1.5 units an hr with automatic shutoff could put my Dd in dka overnight. They would have to make Incredible advancements in cgms to be even remotely safe. Even if they could claim that level of advancement of the technology, I'm still not sure I'd want a pump that could make those calls.
     
  3. buggle

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    I think that the 4 year claim is way off too. Dr. Chase at Barbara Davis said a year ago that they were in clinical studies just for the nighttime pump suspension and said that this piece alone would take a while to get approved. He thought that any system that allowed the CGM to control any other part of the pump was many years in the future.
     
  4. sooz

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    I guess I am just am grateful that product development has been done and is continuing to be done. Product development has made the life of my granddaughter so much better than it would have been had she been born even 25 years ago. We resisted using the pump. We thought who can trust something like that? Our brains are way better than a pump. And of course we are right. And we still have to do BG checks..But is it better, yes. Is her life better today than my friend who is 60 and who's mother had to boil and file his syringe to sharpen it before he got his one type of insulin? Yes! Do rich people sit on nonprofit boards? Yes. Do people who have family involvemnt in a certain cause, type 1 diabetes for example, tend to want to sit on a board looking to cure type 1 diabetes, or do they want to sit on save the whales? Do they donate their own money? Might their company make a profit? Sure. Might our children benefit from the whole deal? Sure. Would it be better that no money be put into product development? Is it a crime that companies make a profit from selling equipment? Where would the products come from if they had not been made available from the companies? Im just wondering...

    JDRF board member, heir to J&J, parent of type 1 child who is now dead..philanthropist, rich guy not sitting back and not contributing, trying to do what he can..some people can question his motives..I am just grateful that work is being done..will it take years? yes...do they have the technology down now? no, that is why they need to work on it....product development AND research is going to make the difference..it does not have to be one or the other..
     
    Last edited: Jan 14, 2010
  5. Darryl

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    I think that we all support product development, and have all benefitted greatly from it. The question is whether the JDRF should be investing its funds into development of software to place under closed-loop control commerical products that are not reliable or accurate enough for closed-loop control; whether they should be touting the concept as an "artifical pancreas" when it is not, and whether their money would be better spent on developing sensor technologies that would be accurate and reliable enough for closed loop control. Herein lies the conflict of interest, because if the JDRF developed such a sensor, the sensor companies would not own the patent. The AP project in my opinion puts the cart well before the horse.
     
  6. badshoe

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    Isn't the point that since current technology wouldn't work investemnt is needed to advance the tools so it can work?

    JDRF hasn't exactly hidden the fact that this is an area they are intereted in. It isn't their only avenue of pursuit. It isn't even the largest.

     
  7. Darryl

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    Yes - they need to advance the tools before they should invest into the closed loop concept. Right now, it's like a non-profit organization trying to develop a cruise control for a car before anyone figures out how to make a reliable speedometer.

    With companies having their own patents on their own existing sensors, there is little incentive for these companies to push the JDRF to come up with a better (and presumably JDRF-patented) sensor design, but lots of incentive to pay the JDRF to design software to help sell the currently patented sensors.
     
  8. jade

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    Novocell isn't working on Smart Insulin, they're working on encapsulating human islet cells for transplants.
    Smart Insulin is owned by SmartCells inc. I think this insulin is a much much better alternative to an Artificial Pancreas, the best thing about it is that hypoglycemic reactions would be virtually eliminated. JDRF is also funding them, and I believe the NIH/NIDDK awarded them a $1.5 million grant in September for Phase II toxicology/pharamacology studies. I'm keeping my fingers crossed for this one, it seems like the most elegant solution.
     
  9. hawkeyegirl

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    The comments to Amy's article on this over at Diabetes Mine were initially positive, but have become increasingly...testy.
     
  10. sooz

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    Not to be argumentative, but I dont believe that JDRF is in the business of developing products to patent itself, are they? I dont think they need to be. They are investing in projects and research by others that will ultimately help my granddaughter. In the grand scheme of things $8 million is not that much money.

    Of course the knowledge of how to do it does not exist now. If it did, they wouldnt have to work on it would they? Of course it wont work great at first. I bet the first pumps werent that great either. I truly dont understand the negativity about JDRF and its policies. They are there to help.

    What might have happened if in the early 1900s someone said..well..we dont know how to develop insulin for diabetics so we arent going to do it and we arent going to spend the money on it because it just cant be done? Put anything you want into that sentence..kidney dialysis, x rays, chemo therapy, mri's, mammograms..someone had to develop the technology and spend the money..kidney dialysis is a good example because in the beginning it was so expensive and so big that only a few people could benefit from it, but as time went on and more work was done it is now much more available and affordable.

    Whether we would choose to use the 'artificial pancreas' (I agree I hate that name) or not is a question. It took us a long time to choose the pump and we are not even using a CGM yet. But I am glad that the CGM is there for people who choose to use it, and I would be happy if there were an AP product too.
     
  11. Darryl

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    Susan,

    If the JDRF receives money and funds research that leads to a new sensor, the patent would be shared in some way. All inventors have to be named on a patent, and all inventors have rights to commercialize the patent unless the rights are assigned to a specific company from the outset. No one will care about the value of the closed loop algorithms - the software itself has little monetary value, but the sensors are worth $3,500 per year, for every person with T1 who uses the "AP". That's potentially billions of dollars per year in sensor sales to the companies that own the sensor patents.

    I'm ALL for research, but there is only a certain amount of money and attention to go around. The "AP" is dominating the diabetes news lately, with slogans such as "fully automatic control for millions of people with diabetes". The only people who stand to benefit from such public relations are sensor companies, whose stock will surely rise with these press releases raising the prospect of selling billions of dollars of sensors per year.

    WE will not benefit until the sensors are improved, and as far as I can read in the press releases, the JDRF research is not going to improve the sensors. The sensor companies are very happy to sell their currently patented sensors, which are good, but not good enough for closed loop control. I think that JDRF should do research on a closed loop system, starting with developing sensors that are accurate and reliable enough for closed loop control. When that is accomplished, the current investments in algorithms, etc. will make sense.
     
  12. Sarah Maddie's Mom

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    As in ... " JDRF -- Walk for the Bandaid" :rolleyes: Well, I though it was funny ;)
     
  13. joan

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    This is amazing and pretty depressing. It seems like it is all about money. What concerns me about the closed loop is that you need to eat when you are low. I would hope this device would prevent the lows then we could run the sugars lower. If it doesn't prevent lows then its no help to my son.
     
  14. Flutterby

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    Its not that JDRF is helping to fund the project, interested in it or being a partner.. We've all benefitted from what JDRF does at one point or another. *MY* problem with what is going on is the fact that JDRF's old CEO is also the heir to the J&J fortune. J&J produces and owns huge amounts of diabetes supplies, including Animas (the also own CWD:cwds:). The fact that JDRF, who's CEO most likely had a large influence, went with JUST the Animas and dexcom to produce this AP.. where J&J has the potential to earn loads of money off of it, in turn the heir (the old CEO of JDRF) would be making more millions and millions.. Why weren't these other companies, MM and omnipod, brought into this loop with JDRF? why? because their CEO was the heir to J&J.. simple as that and so so wrong!!
     
  15. BrokenPancreas

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    JDRF is giving money to SmartInsulin.
     
  16. Flutterby

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    And isn't their new CEo part of the company that is working on smart insulin?
     
  17. BrokenPancreas

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    :confused:
    I honestly don't know?
    I don't care if Mickey Mouse was working on it to be honest with you.
    SmartInsulin can prove to be a major breakthrough:)
     
  18. Flutterby

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    Its not the fact that someone is working on it.. I was looking for the connection between the CEO of JDRF and smartinsulin.. :)
     
  19. Aaron Kowalski

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    Hi. I'm Dr. Aaron Kowalski, the research director for JDRF's Artificial Pancreas Project. As many of you know, I was diagnosed with Type 1 when I was 13 and one of my brothers also has Type 1 and was diagnosed when he was 3. I look at the Children With Diabetes website all the time, and wanted to make a few comments on the results of the poll that I saw about yesterday's announcement from JDRF and Animas that we are working together to develop a first-generation artificial pancreas.

    More than a third of people said they don't support the project because it is not a real cure.

    Well first of all, I would agree. To me and to most people I talk with, an artificial pancreas is not a cure. But we believe an artificial pancreas could provide a bridge to a cure. And, very importantly may help us get to a biological cure faster.

    At JDRF, we fund a wide range of research, from immunity and regeneration and complications to artificial pancreas, hypoglycemia and glucose-responsive insulins. Our research focuses on every stage of diabetes - from how to cure it in adults, to stopping its progression in the newly diagnosed, to stemming complications and improving the lives of people living with it for years, to preventing it in people at risk. Some of those projects have a longer-term focus on cures, while others will have a shorter-term impact, keeping people healthy until a cure is found.

    That?s where artificial pancreas systems come in. We've heard from people who have been living with type 1 diabetes, particularly adults who have had the disease for significant periods of time, that an artificial pancreas is the next best thing to a biological cure. The near-term impact on quality of life that even a partially automated artificial pancreas system can have is huge. This first generation system represents a major advance in how diabetes can be treated, and should result in significantly better and healthier lives for people with type 1 diabetes. It will lower their risk of complications until a cure is found. It will lower the risk of dangerous hypoglycemia until a cure is found. It will make dealing with diabetes day in and day out easier.

    Could an artificial pancreas help achieve a biological cure faster? As a scientist here at JDRF, one interesting aspect of our artificial pancreas work is the mounting evidence that improving metabolic control (such as reducing the incredible amount of hyperglycemia a person experiences each day and reducing glycemic variability) may provide a much better 'environment' for a cellular approach to have the highest likelihood for success. We are looking at clinical trials that combine artificial pancreas technologies and islet transplantation and NIH is currently funding trials examining closed-loop control in new onset diabetes. The hypothesis in both cases is that reduced hyperglycemia will allow beta cells to have a better chance to survive.

    An artificial pancreas in no way precludes us from continuing to focus on cures for diabetes and its complications. The majority of our research funding goes to what would be traditionally thought of as ?cures,? while other research we fund will have a shorter-term impact, keeping people healthy until a cure is found.

    I feel everyone's passion and love the CWD community. We?re all striving for the same goals - to live healthy and happy with our diabetes and to walk away from diabetes as soon as possible. I hope that the realization of artificial pancreas technologies will help us achieve both goals!!
     
    Last edited by a moderator: Jan 15, 2010
  20. BrokenPancreas

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    Thank you for your post!
    I have watched your video at least twenty times since yesterday.
    Thank you again for all that you do!:)

    Aaron, is four years really a possibility?
     

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