Every six months Jack has a TrialNet appointment at Joslin with an OGTT. Today was the day for one of those. A few things were different this time.
Different thing one: DT #1 was my perspective. I’d read more about teplizumab, the experimental drug (or its placebo) that was infused into Jack for two weeks, two years ago. I’d read that clinical trials have demonstrated this drug works, but that its power to rein in beta cell destruction dwindles after a year or two. One participant in a different teplizumab trial put it like this: teplizumab acts as a body builder standing outside of a restaurant where autoantibodies hang out. As the autoantibodies walk out of this restaurant, the body builder steps out of the dark alley and knocks out the autoantibodies. They are not dead; they eventually wake up and wander “home,” back to their usual hang-out spots. They go back to doing the beta cell killing they were doing before, but because of the harsh blow from Body Builder Teplizumab, it takes them about a year to fully return to work. This information is not new, but I hadn’t really absorbed it (i.e. the fact of the wearing off of the drug’s effect), and hadn’t considered that the curtain on Jack’s magical teplizumab (or placebo) window might be closing.
Different thing two: our nurse said she would no longer tell me the results from her BG meter. The data for this study has always been kept secret (science), and most of the blood is shipped to Miami (or an equally unexpected city). But in the past, the results of three BG tests have been shared in real time during each of our OGTTs: the fasting BG, BG one hour pp, and BG two hours pp. However, this time our nurse said she could only tell us whether Jack’s BG was under or over 200 mg/dL.
Of course I respect science & its rules, but I wondered why the protocol had changed. Had something changed about Jack physiologically, or had something changed about the study, or does the nurse just think I’m too curious, or, since the curtain is possibly (likely?) closing on the teplizumab (or placebo) effect, maybe it is better to obfuscate that curtain closure to participants and/or their overly curious mothers. Regardless, no access to numbers does not stop me from believing I’ve cracked the code.
Not actual quotes, but pretty close:
FASTING: It is normal. It is where we want it to be.
ONE HOUR: (Silence.)
TWO HOURS: It is under 200.
Meanwhile, I acknowledge it is silly to guess what these few words mean numerically. But.
I’m nearly positive this collection of words means Jack’s fasting BG was under 100 (“normal”), his BG was over 200 at one hour pp (therefore silence), and under 200 at two hours pp, but just squeaking in under 200 (therefore “it is under 200,” instead of, “It is normal,” or, “It is where we want it to be.”)
And then, on our way out of town, I got a call. Jack had left his hat at Joslin. Our nurse said she would hang on to it for him until we returned. That made me think—but I promise not in an insane, overly-anxious way!—she thought we would be back soon (i.e. rapid follow-up required, things not all hunky-dory/see ya in six months.) Then she texted: she’s going to mail the hat. I believe this indicates nothing, except possibly the presence of a hat-shaped envelope in the supply closet.
Different thing three: A fun part of TrialNet is the fill-in-the-dot questionnaires about how frequently the test subject eats specific things like margarine, pizza, ground beef, fruit, Triscuits, and salad. This time there were new questions, or maybe they’ve been there all along, but I’d never noticed them before: How many times a week do you eat cookies, lamingtons, vanilla slice, or Twinkies? and When you eat candy other than chocolate, such as lollies, are they regular or sugar free? I had to Google lamingtons. Jack eats those zero times/week.
Different thing four: Jack and I each had to answer a multiple-choice questionnaire about our feelings. I don’t recall having this set of questions before. Do you think you got teplizumab or the placebo? How sure are you? How likely do you think you are to get diabetes? How worried are you? How upset do you feel when you imagine getting diabetes? Has being in this study been a good experience? And things like that. Jack said I could read his answers. So I know we are in agreement: we are both pretty sure he got teplizumab, not very worried about diabetes, not very upset about possibly getting diabetes, and we both consider this drug trial a good experience.
Different thing five: In the questionnaire about feelings, at least one question mentions that the length of the study is four years. I had not heard that before, or if I had, I’d forgotten. I’d thought the length was undetermined and/or interminable. It sounds like there will be a big reveal in October 2017: You had the teplizumab! or You had the placebo! Here’s all of your A1c’s from the last four years! Here’s all of your c-peptides! We mailed you your hat in October 2015 because we didn’t want you to think we thought you had diabetes!