I’m going to be a guinea pig.

Well, not a guinea pig really… but I am going to take part in a clinical trial. Where did that guinea pig thing ever start anyway?

Sponsored by the National Institutes of Health (NIH), the idea of this trial is “to assess an investigational simulation-based educational tool for persons with type 1 diabetes”.

Since the trial hasn’t started yet, it’s probably easier for me to tell you what I’ll be doing rather than what it’s all about right now.

When the trial begins, I’ll be starting on a Continuous Glucose Monitor (known to most of us as a CGM). It will be the Dexcom G4™, and I’ll be wearing it every single day for several weeks. During most of those weeks, I’ll be sharing data with the research team on a daily basis. I’ll be telling them about my CGM trends, my insulin usage, my diet, my exercise, how I’m feeling… the whole nine yards.

The information I’ll be giving will be used to fuel an algorithm that will be used to provide feedback so patients can potentially adjust insulin intake or make other adjustments, if necessary, to achieve optimal target BGs in the future. I guess the general idea is to see if an idea like this will achieve positive results. In the end, researchers want to find out if this tool “can be useful in diabetes management with the artificial pancreas system”.

I hope that explanation made some sense, at least. I’ve read everything about it a couple of times, and I’m still waiting for it to sink in all the way. What I can tell you for sure is that I’m very much looking forward to potentially helping other Type 1s through my participation in this study. As I go through the different phases of the trial, I’ll let you know more.

I went for my initial medical screening last week. Not having done this before, I can’t tell you that they are all the same. But I will share my experience on this occasion.

In advance of my visit, I had to complete about six pages of paperwork. Everything from doctors and emergency contacts to all the drugs that I take. You know, the usual. I also had to detail my pump’s basal settings and my insulin usage over the previous week. There were some additional questions in there that I probably shouldn’t share—not because they’re particularly personal, but because of the proprietary nature of the study. Nothing too shocking though. I also had to make sure I familiarized myself with the Dexcom™ online tutorials, so I’d have an idea of what I was getting myself into.

After I arrived and handed over my paperwork, I sat down with the clinical trial coordinator and signed a few important papers, answered a few questions, and asked a few too. After that I had a question and answer session with the endocrinologist working on the study. I don’t want to give short shrift to this part of the screening… there are important parts of the study that they’re covering in these meetings, and I was giving them information that they would need to determine if I was even eligible to participate.

Once I finished these two sessions, it was time to get my blood drawn. Again. Two weeks earlier, I had donated blood. A week earlier, I had blood drawn at my endo’s office for lab tests. And now I had to get blood drawn again for the study. It turned out that my Hemoglobin A1c result was 0.3 percent higher than it was the week before. Still in the good range, but WTF? Maybe they just didn’t take the blood out of the good arm this time. Whatever that means.

Finally, I met with the principal investigator on the trial. I got a basic explanation of the tasks I was expected to complete for the study. And we had a brief discussion of what I can and cannot blog about regarding this adventure. One of my basic rules applies here: When in doubt, leave it out. I’ll tell you as much as I’m sure I’m allowed to tell you without compromising the study.

Not having worn (or even seen up close) a DexCom™ unit, I’ll be looking for some advice on best practices. Got any ideas? Think about it and get back to me, if you can. The study will commence in about two weeks. Thanks!
 
 
 

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Comments

  • scully  On March 19, 2013 at 11:58 am

    WooHOO!
    love the guinea pig aspect and I think what your doing will benefit everybody!

    Like

  • Scott K. Johnson  On March 19, 2013 at 12:48 pm

    Very cool! Thank you for putting yourself through this. Clinical research is a very important thing for everyone living with diabetes!

    Like

  • theperfectd  On March 19, 2013 at 5:03 pm

    I love opportunities like this. You get to test drive a Dexcom G4 (I love mine!) and help others. Bravo! You can’t take Tylenol with the Dexcom, but other than that, it’s a great CGM. (Insertion needle doesn’t hurt much at all and I’m a wimp.)

    Like

  • Kim / Diabetes (@txtngmypancreas)  On March 19, 2013 at 5:11 pm

    So awesome!

    Like

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