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conflicting Trial Net results

Discussion in 'Parents of Children with Type 1' started by Momto3, Oct 15, 2011.

  1. Momto3

    Momto3 Approved members

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    We were contacted by the Trial Net folks again to tell us they made an error when they told us our DD has the protector gene back in August. For whatever reason they retested her bloodwork three months later and realized this error and want her to start oral insulin right away.

    We declined the oral insulin and asked to have both our non D children removed from the study. The woman on the phone was very apologetic and said she has never seen this happen before and didn't want to cause us any stress.

    I'm confused about the oral insulin. If the presence of anti-bodies means the person is at an increased risk for T1D and not guaranteed to get it, then why experiment with oral insulin? I had also heard insulin cannot withstand stomach acids.

    I'm pretty disappointed on a number of levels. :(
     
  2. Kimby

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    I'm so sorry! I can't imagine being told you had the protective gene. No, oops, you don't. I can certainly imagine feeling like you can't trust them anymore.

    I have had a good experience with Trialnet. My daughter doesn't qualify for the oral insulin trial, but I have heard about it. You are right that oral insulin can't be digested. That's why our kids have to take shots. But in a small group of kids (the ones with high levels of that insulin antibody), it seems to desensitize their bodies the way that allergy shots work. Statistically, the group of kids who took the oral insulin had on onset of type 1 almost 5 years later than those who didn't. I'll see if I can find some links for you.

    You are right that the presence of antibodies doesn't mean that someone will get diabetes. I hope she never does.
     
  3. Kimby

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    About the study:
    http://www.diabetestrialnet.org/studies/oral-insulin.htm

    Here is a good article on Trialnet, but it is from 2006:
    http://research.utu.fi/dipp/content/files/TrialNet_General_English.pdf

    Here is a quote from the article above:
    "The treatment with injections didn't prolong the pre-diabetic stage and it didn't prevent diabetes either. Overall, the same was true in the oral insulin trial. But, there was a subset of patients [in the oral insulin trial] who appeared to respond favorably; they experienced a delay in their diabetes onset."
     
  4. Momto3

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    Thanks for the links Kimberly.

    I think clinical trials and studies are great for advancing treatments and finding cures. I'm just not sure I want my child taking a drug she may never need....and yes, right now I'm questioning the accuracy of the testing.

    Live and learn!
     
  5. mmgirls

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    My 3yr old is in the Trial Net Oral insulin Study. The thing that sold me on it is that there are no know side effects and it is so simple to do daily, besides remembering daily.

    The kids that they are trying it with have been selected because in the original new onset study the kids with multiple auto-antibodies and did not have the protected gene DID have a possitive significant reaponce compared to all the others.

    If I can give my dd a few more years without a DX and get past these preschool years I will be happy. If she is on the placebo well then at least she is being followed by people lokking out for D and will be able to pick up on it before we do.

    besides the bloodwork the only other negative is that it is a blinded study. I wish I new her BG numbers after the OGTT's and I wish I was privy to the Auto-antibody levels. But we are adding to the information and hopefully if any of the kiddos being followed were to develope T1D some smart Dr or scientist will figure out the triggger at the start of the diseace path and there for figure aout a cure.
     
  6. Kimby

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    After Kaitlyn's high numbers in June 2010, I always test her at the end of the OGTT with Andrew's meter. They aren't allowed to suggest it, but they can't stop you from doing it. They will even give me a drop of blood that they collected so that she doesn't have to prick her finger.
     
  7. mmgirls

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    can I ask how high did she get?

    My dd at 30 minutes got up to 175 but right back down to below 100 at 2hrs. BUT 6 months prior to that she did not go over 125. When it was ther regular study i was able to get all re BG reading after the fact, but now in the clinical oral insulin trial no such luck. I would test her, but then she will want to be tested more often and right now I don't want these trips to be "does sister have D yet?" Right now there is still the disconnect for my one with D to her sister in this trial, but once she see us "testing" her then it will hit closer to home for everyone.

    We go in November for her first check up after starting oral insulin, no OGTT but a regular physical and blood draw. Then off to Disneyland!
     
  8. Kimby

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    Kaitlyn's numbers in June of 2010 were:
    time 0 min 86
    30 minutes 169
    60 minutes 221
    90 minutes 232
    120 minutes 194
    A1c 4.8

    This summer, she began and ended in range, but hit 208 in between. Her A1c is still 4.8.

    Have fun at Disneyland!
     
  9. Momto3

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    I'm not sure what a positive signifcant response means. Are you referring to her BS numbers before and after the test? Our daughter's BS before the OGGT test was 89 and upon completion was 83.
     
  10. Kimby

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    You can't get any better than that! My understanding is that the positive response was not immediate like that. Although antibodies doesn't mean you will definitely get diabetes, it does unfortunately increase the odds. When they put kids with that specific positive antibody into two groups, those who took the oral insulin and those who did not, and study them for years, the group who took the oral insulin had an average length of time until onset of the disease of around five years longer than the group who didn't take it. I'm sure there were kids in both groups who were never diagnosed. Statistically though, the oral insulin seemed to buy the kids five years without diabetes.
     
  11. mmgirls

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    In the original trial for new onset, they did not show significant benifits to everyone Oral insulin, BUT, when they looked at those that did either have a delay or a a milder onset they looked more closely at those people and found that they where kids with mutiple auto-antibodies and an un-protected gene.

    So they made this new currecnt study to see if Oral insulin can significantly benefits those with these particular genes and auto-antibodies. If they can show again that Oral Insulin did indeed prevent, delay, or cause a milder onset then children could be given this prevetative very easy to do Oral insulin.

    Right now my 3yr has a 25-50% chance or developing T1D in the next 5-10 years, if by taking Oral insulin daily we could change those chances to less than 25%, I would choose to pay for that RX.
     

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