Tag Archives: clinical trials

CGM Data… how do you feel about yours?

June 10, 2013 – 9:57 am

Let me tell you, reading CGM data is hard sometimes.

I don’t usually wear a continuous glucose monitor (CGM), but I’m wearing one for the next few weeks as part of a clinical trial I’m participating in. Every day, I’m fascinated by the data that I’m getting about how my blood glucose handles the food I eat, the workouts at the gym and work around the house, hot days and cool days.

And I hate to admit it, but occasionally it’s sort of affecting how I feel about things as I watch that CGM graph line go up or down.

Saturday, I was so frustrated because it seemed like no matter what I did, I was still sinking under 70 over and over again. That was after a false high reading I was getting early on (second day of the sensor… probably not fully calibrated yet). On Sunday, it was the opposite: I was low continuously for a couple of hours until I had a late lunch a little before 1:00, but high after that for the rest of the day. Despite how I had carefully checked where my BG was, how much insulin was on board, and how much insulin I needed to get back within range.

I’m not talking monster stress here; I mean, hey, diabetes throws us curve balls all the time… these things happen. I’m merely saying that I get mad occasionally when I carefully analyze what I’m doing to manage everything, and I’m still out of range, and I still have to wait hours before I’m back in a good range again.

I know this: CGMs are a great source of information and a huge help in managing glucose levels overall. I also know this: A couple of times in the last week, I would have rather been blissfully unaware of how my BG was trending for a few hours.

I’m working on becoming more comfortable with knowing my BG trends 24/7. It’s a work in progress.

What about you? Are you a CGM user? If so, do you let what it’s showing you affect how you feel about your diabetes? Do you have any tips for dealing with that?
 
 
 

By StephenS | Posted in Diabetes | Also tagged , | Comments (5)

And now, back to our regularly scheduled research.

May 31, 2013 – 9:44 am

The clinical trial that I’ve been participating in since April has officially resumed after a brief hiatus.

The trial is designed to measure how patients handle their glucose levels while interacting with a specially-designed website. The purpose of the website is to produce data and information to patients based on daily logging of BGs, meal intake, exercise, and other factors. I’ll be uploading Dexcom™ G4 data every day too. The main goal of the study is to “improve glycemic outcome”. A lofty goal, and let’s hope it’s achieved. It’s really much more than I’ve just described. If you really want to find out everything that it’s about, check out the full description at the clinicaltrials.gov website:
http://www.clinicaltrials.gov/ct2/show/NCT01767831?term=ibolused&rank=1

So anyway, after taking a break so some web development issues could be ironed out, we’re back at it. I think the hardest thing about starting up again is going to be learning to swim with the Dexcom™ stuck in my gut. Those turns and pushing off the wall will feel funny at times, but I’m sure I can get over it. Besides, I only have to swim another two weeks anyway to get ready for my triathlon, and then I can take a break from it.

As before, I’ll try to give an update every week or so to let you know how it’s going. There’s only so much I can reveal while the study is ongoing, but I’ll let you in on as much as I can. Once the study is published, I’ll be able to talk about it in full if you’re still interested.

If you want to find out more about the kind of studies taking place out there, just go to the clinicaltrials.gov website and put Diabetes into the search box. A recent search found 9,688 separate entries.

I’m glad we’re starting this up again. And again, I hope it’s a big success.

P.S. This study is still recruiting participants! It’s a great way to get your feet wet in the clinical trials swimming pool, so to speak. Also, it’s a great opportunity to try out the Dexcom™ G4. If you think you might be interested in participating, send an e-mail to: mkm6x@virginia.edu
 
 
 

By StephenS | Posted in Diabetes, Diabetes Technology | Also tagged , | Comments (4)

So, how’s that clinical trial going?

May 3, 2013 – 9:17 am

Funny you should ask.

First, let me bring you up to speed: I started participating in a clinical trial back in the middle of April. Participation means wearing a Dexcom™ G4 continuous glucose monitor (CGM), and giving daily updates (keeping a diary, if you will) about glucose readings, boluses, meals, how I’m feeling that day, and a host of other things. If you want to read about it, here’s a link:
http://clinicaltrials.gov/ct2/show/NCT01767831?term=iBOLUSED&rank=1

Okay, so how’s it going? Pretty well so far. I should tell you that we’re taking a break from the study for a short time so web developers can work out some details with the website we’re accessing. Our group in this study is the first to use this system, so it was inevitable that we’d run into a blip here or there.

But I am getting first-rate information on how my glucose is trending on a daily basis, and which foods really help or hurt my BG management. Hint: being away last weekend and eating out for every meal meant mostly high readings all day Saturday and Sunday. Being home this week and eating homemade meals has meant significantly lower readings and lower variability too. Too bad, ‘cause I like eating out. But I also like cooking for myself, so life’s a balance, I guess.

Also, I’m starting to think about my answers to all of the questions I’m asked when I log on daily and give my information. I’m thinking about meals and exercise, and stress and other things that I’m giving information on. I suppose that’s part of what they’re trying to find out in the study.

At any rate, I’m still happy to be participating, and I’m finding the CGM to be more of a help than a nuisance. As the study rolls on, I’ll give you what information I can without compromising the trial.
 
 
In the meantime… in case you’re interested in participating in a trial of your own (and not the legal kind), here are a couple of places to start:

From the USA’s National Institutes of Health:
http://clinicaltrials.gov/

Also, the Clinical Trials page on JDRF’s website lists a number of helpful links:
http://jdrf.org/research/clinical-trials/
 
 
Have a great weekend!
 
 
 

By StephenS | Posted in Diabetes | Also tagged , , | Comments (1)

And so it begins.

April 15, 2013 – 10:19 am

Okay… my clinical trial is underway! This is the trial I wrote about around a month ago.

This past weekend, I received my notice and started wearing the Dexcom™ G4 provided to me for the study. The first week, I’ll be responding to a survey, but other than that, not much to report at this time. Except that insertion of the Dexcom™ was remarkably easy and nice. The receiver is easy to use. I’ll probably do some sort of product review later on. For now, I’m just saying… all CGMs should be like this.

Of course, I have to get used to having one more robot part attached to me around the clock. And I have to actually remember that said robot part is actually attached, so I don’t rip it out putting on my shirt or taking it off. But this is what I signed up for, so if I can just keep my eyes off of the receiver (‘cause I’m obsessive-compulsive like that), I’ll be okay.

More to come as the study continues.
 
 
Speaking of surveys, April over at Nerdy April’s Space Adventures (which is about the coolest blog name ever) is working on her grad school capstone project. The title of her project is… wait for it…

Evaluating the Feasibility and Safety of Type 1 Diabetic Astronauts.

Seriously, it sounds that good. I’ve been thinking about it all weekend. You should go and read about it. Thanks to Scott Johnson for the tweet that turned me on to this post.

Hope your week is blasting off to a high-flying start!
 
 
 

By StephenS | Posted in Like these links | Also tagged , | Comments (5)

I’m going to be a guinea pig.

March 19, 2013 – 9:44 am

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!
 
 
 

By StephenS | Posted in Artificial Pancreas | Also tagged , , | Comments (4)