Whoa. I've been trying to document Sam's experiences with the Defend-2 study, but my mind is fried at this point from driving back & forth to Indy and sitting in the hospital for hours. Hospital sitting is really draining, for those who haven't spent hours/days/nights enjoying that atmosphere. And the driving! Guess I will have to forget my life goal of being the person in the car with the OVERSIZED LOAD sign, traveling in front of a semi. I'm just not cut out for it.
Anyhoo, Samantha finished up infusion days 5, 6, 7, & lucky number 8! She really had little to no side effects. Her pulse and temp rose slightly with each infusion. She had a slight headache. She wasn't overly tired -- just from driving back & forth, going to school in the morning & then going back to Indy for another dose.
The other strange thing this week was that Sam's BG actually rose. She hadn't been taking bolus (Novolog) insulin, just her Lantus at night (5 units). This was keeping her blood sugar around 120 or so, and she had a couple of drops into the 60s. She is very active and usually has practice for softball after school, so she gets a lot of exercise. Plus, we've really changed our diets and try to eat low carb most of the time.
So, there are a lot of variables for this week. Her blood sugar went up in the 200s and 300s. She was taking her Novolog. She was eating junk food all week because we were on the road (cheeseburgers, fries, pizza, you name it). She wasn't exercising. Plus she was getting whatever they were giving her as a study drug. Placebo or otelixizumab? Who knows?
The study doctor says he's seen this happen with "the drug." What does that mean? He's seen it happen during the study? He doesn't know if she's getting the drug or placebo. I wish I knew for sure that it meant she got the drug, but I don't have any real indication.
The doctor said Sam is only the 4th Defend-2 participant at his location in Indy. They really need more to get this trial moving! But on the other hand, I'm thinking 2 out of 3 get the drug, so if she's the 4th, let's just say that 1 & 2 got the drug, 3 didn't, and Sam did because she was 4th!! Right?