TrialNet. Breathe.

This would be the first drug to change the natural course of type 1 diabetes since insulin.

Photo1

Confusion is inherent in some note-taking systems.

OK, TrialNet. Why information surprise Bigfoot every time?

Only information not surprise would be We are so sorry. We had your results all wrong. You and your son are absolutely fine.

Mental sift through information swirls while driving not wise. Pull over before cause accident. Look, it windblown farm stand; farmer stand up so hopeful make sale. Bigfoot just sit. Sit. think. Farmer stand at attention. Sit, think. Then buy million vegetables from guilt. Ratatouille.

Yesterday, speak w. TrialNet anti-CD3 study director. Thinks Jack must come soon, because if wait, will already have diabetes + not be eligible for study. That too dramatic this brain.

This is not an actual transcript of the conversation, but a re-enactment, pieced together from my notes, which were taken on many small slips of paper with a broad-point Sharpie and without pagination.

BIGFOOT: Wait, so you mean you think he will definitely have diabetes, or you think it is likely?

YALE: Well, he’s definitely in the highest risk category, because of his multiple auto-antibodies and abnormal OGTT result. I mean, usually we describe high risk as a 75% chance within five years, but with your son…

BFOOT: Higher? Lower?

YALE: It’s really much higher. Because he already has that abnormal OGTT, and the 75 in 5 figure is more just for kids with multiple autoantbodies who haven’t even had an abnormal OGTT screen yet. That’s why we don’t want to wait too long. As it is, about a third of the high risk participants identified for this study have developed diabetes by the time they come for the initial screening

BFOOT: But maybe he will be more like me

YALE: Yeah, It could be more like a LADA situation, but from what I’ve seen, it happens faster than that with kids, and with your son it’s really just a matter of time**

**this chilling phrase actually used. Pretty sure also said he’s in the group of people we know will get diabetes, but maybe just include that sentence in phone call notes for randoms.

Ineligibility bad not only for study, but also for Jack, obvsly. (Bc miss opportunity block autoantibodies from more wreck pancreas.) Deep breath.

Today speak w. Study Coordinator about nuts and bolts and schedules and forms.

Mention kind of was hoping we could come in the summertime, not miss school. That too far off. Offer up Well, in February we have one week off, that way, he’d only miss one week; how about February? No, too far future. Should be this fall.

BIGFOOT: I’m just trying to wrap my head around, what I don’t understand is, who are the people who can drop everything suddenly for two weeks? I mean, how do they not have to go to work?

YALE2: Most jobs offer family medical leave of some kind, and they utilize that

BFOOT: I know we could use that if one of our kids needed treatment for…an illness

YALE2: Uh huh

BF: And so I guess this is like that? Like we should think of ourselves as having an actual sick child? I just don’t think of him as sick. I mean I don’t think of us as a family with a sick child; it’s not like he has…

YALE2: I know it’s hard

BF:..?

This fall? Fall = RIGHT NOW PRETTY MUCH. But Bigfoot anatomy class; automatic F if miss two cat dissection days. Then deep breath, realize of course ok postpone school; probably can even apply tuition to same class next semester, and Bigfoot already super-old for community college, no diff add on few more months. Middle school teachers can send Jack’s work online; already so much middle school online anyway. Also Yale, science experiment, very education. Like elaborate field trip. Maybe Ira Glass offer come along, increase literary factor. Okay. All set—then remember Bubs.

Who can care for Bubs in morning/after school? Maybe bring Bubs Yale too? Two weeks so boring! Too tedious! How keep boys happy hotel room/medical zone of rather uninteresting city/every day Ikea? Try think what would a normal family do with two children requiring medical treatment in distinct locations?

Aha! JOE! Yale2 mention Family and Medical Leave Act, dawn on Bigfoot use this for Joe paternity leave @babytimes. Call Joe. Yes. Uh-huh. Important. Medical treatment. Yes. Ok. Joe’s school Principal agree. Gotta do whatcha gotta do. So now think:

End of September: visit Yale TrialNet for initial screening (repeat OGTT, also blood tests for health, also maybe repeat Ab tests). If no T1D yet: begin 2 consecutive weeks infusions sometime October, Joe & Jack live New Haven; Bigfoot & Bubs stay home, maybe rendezvous New Haven weekends. So sorry for this vile and untimely thought: I have always wanted to go to Frank Pepe.

Next skim consent form. HOLY SHIT. Skin peels off, shaking, fever, nauseated. And if skin not peeling off, probably placebo, and whole thing waste of time. But not waste of time because science. Valuable for science. Seriously willing torture child for science? But torture part only kick in if not placebo. In which case maybe stop diabetes. Round and round and round it goes.

Glad not need concern this, perhaps worst, bit. Imagine this slab o’heartache: Parents signing a consent form for a daughter over the age of 13 years will not be told of the results of the pregnancy test. Only your daughter will be told the results. We will, of course, counsel your daughter to seek appropriate healthcare and the support of an adult if she were found to be pregnant. A positive pregnancy test means that your daughter cannot participate in this study. Because she will be asked to leave the study, you may find out that she is pregnant. If you or your daughter is uncomfortable with pregnancy testing, then we would recommend that she not participate. If she is under 13, you will be told and we will be required to report this to the Department of Children and Families (DCF).

Meanwhile, try explain Jack some risks, benefits. Jack sad. Interested study for stop diabetes, but Bigfoot not describe skin falling off yet. Just wants Pastiche chocolate cake and The Stack** before shit hits fan.

**three separate beef, Chourico, and thick cut Bacon piled tall with melted cheddar, American, and jalapeno cheeses layered between toast, lettuce, tomato, onion jam, mayo and mustard.

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18 responses to “TrialNet. Breathe.

  1. Jess

    Oh Bigfoot. So much of the feels. And the worries. And the stuffs. However I can help. Awesome opportunity for potential new treatment? Tell Joe – I taught a little from home via skype to keep my kids in the loop of responsibility – it helped.

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  2. Oh honey. Im sorry. Its a big decision. I had the same phone call a few times last fall regarding middles. Same as Jack – 75% because of all antibodies. He hadn’t failed the OGTT at that point. They wanted the 2 week infusion study. I said no – sorry can’t with two other kids, so far from home, hubby can’t take off, life can’t go on hold for that long. Said ok if they can bring the study closer to home – Nope couldn’t, no study – we said we would wait till summer. He failed his first OGTT on June 11th. He would have to pass his next OGTT to still be eligible – failed second OGTT, diagnosed – no longer eligible.
    At least you read all the paperwork. I did not read it because we simply could not participate for 2 weeks during school because all three kids would have to come with and miss school.
    I never learned of the possible side effects. Not sure if it would have made a difference in my decision. Im all for science – Im thankful to all those who have gone before and have helped advance science and diabetes care. I think had Middles not failed in June we would have participated in August but it is easy to say that now since the decision to not participate was not left to us.
    I have at times wondered if I had agreed to study last fall, and he had received the actual medicine, if he would have avoided the diagnosis on Aug 1st. My brain is my worst enemy.
    What ever yall decide know I will be thinking of you and your family all the time.

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    • Katy

      Right. It’s hard to believe the experimental treatment will make the difference between one life and another. And we *like* (sort of) D-life. I mean, we don’t think it’s SO SO SO horrible. Is it worth it? Definitely worth it for the science, but worth it for the boy himself?

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  3. Risks: Focus on the common risks – the ICF should tell you how often the side effects occur. I’d be willing to bet that skin falling off is probably in the “rare” category. Not saying it couldn’t happen but it would probably be less likely to happen than something like nausea or pain at the infusion site.

    I don’t know if this helps or not, but when I got this news on Livie, I felt like I had to do everything possible so that I would never look back and think to myself: what if. Unfortunately (or perhaps fortunately?) for me, because she’s so young she doesn’t qualify for any trials so I don’t have to make this decision. And yeah, you may go through all of this and he may end up getting placebo and there’s nothing you can do about that.

    But at the end of the day, I think it all comes down to this: IF (and I still say if because I am still open to the possibility of miracles for both Jack & Livie) Jack were to get it, what decision would cause you to look back and silently suffer with the “what if?” – doing the trial or not doing the trial?

    My heart really hurts for you right now. For me, the “it’s coming” with Livie was, in some ways, was worse than the “it’s here” with Ella. Totally sucks. Take time to grieve. I think I might go drink some vodka & crystal lite now.

    XOXO

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    • Katy

      If he gets it, I’ll be OK. If he doesn’t get it, I’ll be always thinking he’ll probably get it. If he gets it before the 2-week drug trial starts, I’ll be kind of relieved. If he goes through the 2-week drug trial and has no side effects, I’ll be relieved but I’ll think it’s because it was the placebo. If he goes through the 2-week drug trial and gets the skin-falls-off rash, I’ll be kind of glad that he’s getting the real drug, but then waiting to see if he gets it anyway.

      The rash is something like…70% of participants get a rash. The skin falling off is the extreme case of the rash. So that simmers down to, in my mind: everyone’s skin falls off.

      I feel like you understand me. Thank you so much. Your IF question: if he gets it and we haven’t done the experimental treatment, I am worried it will become a news-worthy discovery in 5 years and he will say “That sounds familiar. Wasn’t I going to be in that study? Why didn’t you make me go?” That would be bad.

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  4. PS – I finally threw caution to the wind and said: screw it. If she’s getting diabetes, she’s going out in style. I’ll deal with the “what if” when it comes…what if I had given her massive amounts of Vitamin D? What if I had stuck with my “no dairy” decision? What if I had breast-fed beyond 6 months?

    I now let her eat donuts and drink a juice box now and then <> and eat ice cream and string cheese.

    It’s so much less stressful & was the right decision for my family.

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  5. Well this all just sucks. 😦 I mean, Pepe’s is awesome and all, but it’s also really kind of a dump and definitely not worth all that Yale / TrialNet stuff. Ugh. Please let me know if there is anything I can do.

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  6. Oh man, this is tough. I’d be lying if I said that part of the reason we’re not putting our kids through TrialNet is because things like this might happen. (But if we don’t, and it would have happened if we did, it would still happen if we didn’t). There are other reasons, but that’s the one that gives me peace. (Yes, I recognize that it’s largely denial).

    But let me ask you this question: if you could go back a year or so, and change your mind about participating in TrialNet, would you?

    This is not an easy thing to figure out, and I wish I had the answers for you. Part of me questions Yale and Yale2’s motives – are they motivated by doing what’s best for your family or what’s best for their study? I’m sure participants are hard to come by.

    Whatever you do, I’m sure you’ll do what’s right for you, and I’m sure you’ll figure things out. My family (of three, at the time, the youngest wasn’t born yet) spent a month subletting a one-bedroom apartment and then living in a hotel room (for what turned out to be 2 months, but we didn’t know how long it would be) after selling our house and before buying another. I didn’t see how we’d make it in such tight quarters, but we did, and it turned out to be a great family-bonding experience. It’s not the same as your situation, but it shows how a living situation you may dread could turn out making great memories.

    I wish you all the best.

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    • Katy

      Oh, I’d not change my mind about participating in TrialNet. I think it is so interesting and will ultimately be helpful to us, whether or not we get any experimental drugs. Just knowing what’s coming is a good thing. I mean, what’s happening to Jack and me is sort of…the reason for doing it.

      I was thinking Yale and Yale2 might have these sort of sales quotas, and rub their hands together like classic villains. “Eli Lilly says we need two more this month. Let’s scare this lady into thinking her son will get diabetes by Christmas if she doesn’t act now. MWAH HA HA HA HA” But they’re very nice people, just doing science is what I think.

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  7. Ann

    I agree with Chrissy , look for the info in the ICF about frequency of the scary stuff. Ask every question you and Joe and Jack can think of, then make the best decision for him and your family.

    This is a hard decision. I know you and Joe will figure it out.

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  8. Pancreastic Mom

    good grief, sitting here bawling for you. compare skin falling off to hair falling out with chemo, only skin falling off sounds like it would hurt. Makes me think of the drug Herceptin for breast cancer which was developed ah, probably 30 years ago now, but took forever for FDA approval and all. Before it came along women with this type receptor on their tumor..it was pretty much a death sentence with diagnosis. And I had that. And I received the Herceptin. And now I am living 3 years after treatment and living well and am healthy with a head full of hair and caring for my t1d child. So, point of all that is I am SOOO thankful for the women who participated in the studies and trials so that I could be here. So I get where you’re coming from with the “all about science” and if it helps him even at least POSTPONE the diabetes, that’s at least something. SO…all that said, what would I do if it were mine….I don’t know. It would help if he WANTS the treatment. But, if he doesn’t then when gets older and thinks (or SAYS…ack!) “why didn’t you make me?” . OK…now I’m crying again. Sorry. Maybe this is random and inappropriate. Just thinking about you and your family.

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    • Katy

      i think i read this the second you left it. it gave me shivers. thanks for being so thoughtful.

      this situation could go either way. we could regret doing it, and we could regret not doing it. i am stumped.

      we are taking the step of going to yale for the one-day screening (to make sure he is still eligible—w. abnormal, but not yet diabetically high, blood sugar during an OGTT), and i don’t think i can think beyond that yet. but of course i’m thinking about it constantly.

      thank you for sitting with me for a minute. i appreciate it.

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  9. Ugh, I have been thinking about this all week and wondering what would I do if it were me and I had the info that you have. My gut feeling is that I would do it. SO many variables here…maybe this will prevent type 1 forever, maybe for 5 years, maybe for a year, maybe not at all. Maybe he won’t even get the real deal but the placebo (which I know that they have to do for science but I hate that you have to go through all this and maybe not get the real infusion.) But the bottom line is that it is a chance to avoid or delay a shitty disease. A disease Bubs lives with and you guys handle beautifully but still a shitty disease. And Jack is willing to do it The rash does suck. I thought I remember you writing that it normally goes away after the infusions? I wonder how long? If his skin started really reacting, can you just stop the infusions immediately? Anyway, I understand the stress of the decision. Huge. And btw, I am a big hypocrite because I say go for it but my 8 year old hasn’t been tested yet. We tried 2x but he had complete meltdowns & became hysterical. We would have had to hold him down to get the blood draw, so I gave up. I tested & was OK.

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  10. Pingback: Easy Being Green: a defensive post for my imaginary stalker | Bigfoot Child Have Diabetes

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