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Low Glucose Suspend - ASPIRE study

Discussion in 'Research' started by Jeff, Feb 15, 2012.

  1. Jeff

    Jeff Founder, CWD

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  2. Deal

    Deal Approved members

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    I stopped reading after this: "Medtronic, Inc. (Northridge, CA) funded the study"

    There really should be a law against marketing via self funded medical studies.

    What they say just may be 100% true but that conflict is one I can't overlook.
     
  3. DadCares

    DadCares Approved members

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    Thank goodness someone is starting to publish a study. This is such a no-brainer. The vast majority of us would respond to the FDA with "Duh." No one should be surprised and it's time to implement obvious safeguards such as this. I'm OK with them spending longer for other aspects of closed loop testing if truly necessary. But this is such a no-brainer.

    And, yes, it would be nice when others produce results of their studies in addition to Medtronic. But, thank you to Medtronic and any device company who attempts to produce a study in the meantime.
     
    Last edited: Feb 16, 2012
  4. MommaKat

    MommaKat Approved members

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    I'm not sure I understand this - the commitment to and large amount of R&D ongoing by Medtronic is one reason I chose them for pumping. We may not like it, but it is the way research funding is conducted these days. There simply aren't enough dollars for someone without a vested interest to pull it off. While I might wish that would change, it's been this way for decades, and if I want a cure in my kids' lifetime, it is what it is. Will you disregard any Medtronic device that receives approval while their former CEO is still doing his entrepreneurship in residence at the FDA? He's there to shake things up, make it more efficient and reasonable, and will likely still be there when stuff from each of the companies gains approval. It could be construed as a conflict of interest, but is it really? And is it in our children's best interest to go down that road?

    What I can say about medtronic is that they are very committed to R&D, and they self disclose their vested interest. I can't say that for a lot of companies out there.

    I know several researchers who work for the spinal R&D division in our area - these are incredibly smart (cream of the crop), 100% committed individuals who truly want to innovate and discover / develop reliable treatment interventions to help patients. When dd was dx'd, her friends dad (works in spinal) immediately got in touch with friends of his who work in the diabetes, metabolic disorders division so he could stay up on what's in development and share it with us. The amount of research Medtronic is involved in, whether fully funded by Medtronic, partially with federal support, or JDRF backing, etc. is simply astounding.

    ETA: looking at the pdf, this wasn't just Medtronic - yes they provided funding and equipment, doctors involved in conducting the study also work with: Barbara Davis Center for Childhood Diabetes, Rainier Clinical Research Center, AMCR Institute Inc., Stanford University Medical Center, and Mills-Peninsula Health Services. This is the only way university affiliated research physicians can afford to complete research.
     
    Last edited: Feb 15, 2012
  5. Ali

    Ali Approved members

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    One of the things I found most interesting with this study (second link/full study)was the discussion on the impact of low blod sugars on subsequent levels. There is always much discussion about hyperglycemia following lows and "do lows produce more lows". This study discusses both of these areas with some discussion of what happens and why. This is a recent study so I hope is current on research in those areas also. Thank you for posting Jeff.:)ali
     
  6. joshualevy

    joshualevy Approved members

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    Obviously, you can do that if you want. But it is important to remember, that right now, the law is exactly the opposite of what you want: Companies are required to pay for the studies that get their own drugs and devices approved. If company X wants drug/device/treatment Y approved, it is expected that the company will pay for the studies that the FDA will later rely on to show safety. You may not like that (and I may not like it), but that is the way that is.

    Every drug, every device, and every treatment that is currently approved in the USA, has been approved based on studies funded by the manufacturer.

    Joshua Levy
     

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