Tag Archives: clinical trials

Didn’t you mention something about a clinical trial?

May 23, 2014 – 9:26 am

Yeah, so I started a new clinical trial almost two weeks ago. This one, like the others, is being conducted out of the Center for Diabetes Technology at the University of Virginia, and also at UC Santa Barbara and the Mayo Clinic in Minnesota.

If you missed any of my other references, I’ll tell you straight out: This trial has an artificial pancreas element to it. That’s exactly how I’m describing it, because really, the trial is literally weeks worth of work by myself and others to prepare for about 36 hours on a closed loop artificial pancreas system. Here’s the sequence of events as I know it right now:

First, I went to Charlottesville to get screened for the study. This meant going through a physical, getting blood drawn for an A1c, having an EKG performed, the whole nine yards. We also went through the consent form (about 20 pages or so), and I submitted my medical history. This included things like confirming I was Type 1, that I’m not currently seeking treatment for things like alcohol or drug addiction, listing any hospital stays I’ve ever had, and listing out all of the medications I take on a daily basis, and in what amounts. The hardest part about these visits is that my BGs get so ramped up driving down to Charlottesville that I’m always running high when I arrive. The Jersey Turnpike has nothing on Interstate 81.

After the screening visit, I drove back home (more stress—I don’t know if I made it below 200 mg/dL all day) and waited for the phone to ring, telling me whether I had been accepted or rejected from the study. I had been rejected from two previous AP trials (different reasons), so I wasn’t holding my breath over this one. But I was accepted, and I was thrilled.

The following week I started a week of data collection by inserting a Dexcom sensor. I also started using a meter given to me to specifically be used for this trial. And I started keeping a daily diary. It included information on whether I was sick, whether I did a pump site or CGM sensor change, how I was feeling, how stressed I was about hyperglycemia and hypoglycemia, and whether I worked out that day. In addition, I needed to record times, BG fingerstick numbers, and carb counts of everything I put into my mouth. For an entire week. At the end of the week, I uploaded pump, CGM, and meter data, and faxed the daily diary info to the research team.

What was the purpose of all this? So the team at UVA could use my data to help build an algorithm specifically for me. When we finally get to the point where I’m hooked up to the closed loop system, the algorithm will work to help anticipate BG trends and carb intake, and make updates to insulin delivery as a result. Cool, yes?

So what’s next? Next are two separate admissions in the Center for Diabetes Technology’s research house in Charlottesville. I don’t know which visit will be which yet, but I do know that one of the visits will involve being on the closed loop artificial pancreas system itself, and one visit will not. The idea, as I understand it, is for the team to compare results on the closed loop system versus results from an open loop system in which I’m making decisions on my own, just like I do today.

My first admission is next week. Wish me luck! Actually, no… wish the dedicated team of researchers, developers, doctors and nurses luck. They’re doing the hard work of creating something that could be a game changer in terms of insulin therapy for people living with diabetes. Remember this: In all of these studies conducted, there have been zero overnight lows. My hope is that I can help further research into this and other advancements that are making the lives of the newly diagnosed better than I ever could have imagined at my diagnosis back in 1991. You and I are worth the effort.

I’ll try to give as much of a play-by-play account of what’s going on as I progress through the trial. Watch this space and Twitter for more.
 
 
 

By StephenS | Posted in Artificial Pancreas, Clinical Trials | Also tagged , , | Comments (7)

#DBlogWeek is back! What fires you up?

May 12, 2014 – 10:31 am

DBlogWeek

Yay! Diabetes Blog Week is back!

For the 5th year in a row, diabetes writers from all over the world will be participating in a solid week’s worth of informative, educational, and inspirational blog posts. To find out everything you need to know about Diabetes Blog Week, click on the banner above. A big Thank You to Karen Graffeo for making this happen every year!

Today’s topic:

Let’s kick off Diabetes Blog Week by talking about the diabetes causes and issues that really get us fired up. Are you passionate about 504 plans and school safety? Do diabetes misconceptions irk you? Do you fight for CGM coverage for Medicare patients, SDP funding, or test strip accuracy? Do you work hard at creating diabetes connections and bringing support? Whether or not you “formally” advocate for any cause, share the issues that are important to you. (Thanks go out to Kim of Texting my Pancreas for inspiring this topic.)

Changing the world, eh? No pressure there.

I don’t know if what I’m passionate about right now is changing the world. But I do know of two things that I hope will be of use to others in the future.

You can find out the first by clicking on the button with the medals in the upper right portion of this page. Since November, we’ve sent out 11 medals to Athletes With Diabetes who do their best to fight through the scary things that come with taking along your diabetes to gym classes, bike rides, or half marathons. Our eleven winners (that’s right… we’re up to 11!) have all set an example of courage and determination that others will always look up to. So I didn’t really do much there except shine a light on something great that was already happening.

But I get such a huge kick out of shining that light, and introducing everyone to amazing people that maybe they haven’t met before. And a few that they probably have. In any case, it’s exciting to give someone a medal like that. I remember finishing my first triathlon three years ago, and the feeling I got when I crossed the finish line and received my medal. I wanted brave D-Athletes to feel the same thing.

The second thing I’m really fired up about right now is happening… right now.

Last week, I started participation in another clinical trial. This will make three in the past year, and it’s something I take very seriously. This study will be my first artificial pancreas trial. I’ll talk about it more as the study progresses. But I want to help you understand why participating in clinical trials is so very important.

All of us want to see new ideas tried out. New therapies, new drugs, new understandings of how our bodies-with-failed-pancreases work. Often, the only way we’re going to get those ideas tried out is during clinical trials. And clinical trials need volunteers. So here I am.

Participating in a clinical trial isn’t necessarily easy. The ones I’ve taken part in aren’t hard, either. What they do require is a lot of attention to detail. If you’re supposed to do something at a certain time in a certain way during the trial, you have to do that. Otherwise, you risk not meeting the parameters of what is being studied. Researchers might not get the proper data they need to move forward with their idea.

But trust me: The feeling of participating in a clinical trial is awesome. To know I’ve helped move the needle, even a little bit, for people living with diabetes is something that will stay with me forever. I’ll bet you’d feel the same way.

To look for clinical trials involving diabetes, you can always go to clinicaltrials.gov and put Diabetes in the search box. If you’re in the UK, go to the UKCTG—the UK Clinical Trials Gateway. Also, JDRF sponsors its Clinical Trial Connection, that helps connect potential participants with diabetes clinical trials.

And don’t miss day two of #DBlogWeek coming up tomorrow!
 
 
 

By StephenS | Posted in Diabetes Blog Week | Also tagged , , , , | Comments (8)

What a year.

December 30, 2013 – 9:12 am

Holey Moley, it’s been an amazing year. 2013 went by so fast.

Back in October, I wrote about how one thing at a time, over time, can add up to a lot if you just keep at it. This is very true for me when I think about the past year.

The following list is not designed to say “Here’s what I’ve done—what about you?”. Instead, it’s a reminder for myself, to remember during times when I feel like I’m not doing anything. Also, it’s a recap of the year that’s been, a Bridget Jones-like reference of the previous twelve months.

My life in 2013 included, in no particular order:

– One noteworthy anniversary

– Participation in two clinical trials

– Not participation in two other clinical trials. That’s right… I was disqualified from another AP study. Don’t want to talk about it.

– One entire week of gluten free eating (My Week with Celiac)

– Two 55 mile bike rides

– One 5K run with The Live-In Niece

– One Book Review (Shot – Staying Alive With Diabetes by Amy Ryan)

– A chance to meet Cherise Shockley for the first time, and begin to understand her passion for connecting others and helping them live better, more meaningful lives with diabetes. I left that meeting ready to charge up the hill for DCAF.

– A Chance to meet Scott Johnson in person for the first time, and an opportunity to meet Karen, Kerri, Shannon, and Christopher too. There were several others I met in passing that weekend that go unmentioned, but not forgotten. The CWD Focus on Technology conference definitely ranks as a major highlight of the year.

– One appearance on DSMA Live with Cherise Shockley and Scott Johnson

– Attendance at the DSMA Live meetup in Philadelphia in August. That meant a chance to see Cherise and Scott again, and meet Kelly and Allison and Brea (and her Mom) and Penny and Colleen and Maria and many more wonderful people who I can’t remember right now.

– While we’re on a DSMA kick, I should mention the countless #DSMA Twitter chats that I was lucky enough to take part in this year, including a special hour that I was honored to moderate on World Diabetes Day in November. Hands down, that was the fastest hour of the year.

– Also high on the list was the Manning Diabetes Symposium in Charlottesville back in April. Lots of talk about diabetes research from a number of experts in the field. I think I was the only one there that didn’t have a bunch of letters after the name on my lanyard, but I didn’t care. I soaked it all up like a sponge. Thanks to UVA’s Center for Diabetes Technology (I’m looking at you Molly) for letting me attend.

– One more event to mention: The JDRF Research Summit in the D.C. area back in March. There’s another coming up this March. Get all of the information at http://jdrfsummit.org.

– Finally: Five Medals were handed out to real bona fide Champion Athletes With Diabetes. And we’re just getting started. I can’t wait to hand out every medal we have, then order more to give away! To find out more, click on the medals image in the upper left part of this page. Or just click here.

———————————————-

Wow, did all of that really happen? It all flew by really fast. Even so, I think know I would rather have participated in all these things that seemed to have happened so quickly, rather than missing even one. I wasn’t responsible for a lot of the things I was a part of this year, but I was glad to participate or help wherever I could.

With all this said, even though I’m not a New Year’s Resolution kind of guy, I do have a few things on my list for 2014. I don’t know if I’ll get to all of them. But I know it’s shaping up to be another interesting year searching for the Happy Medium.
 
 
 

By StephenS | Posted in Milestones | Also tagged , , , , | Comments (3)

Clinical Trial Conclusion.

November 29, 2013 – 8:18 am

My clinical trial ended last week, after four weeks of measuring blood glucose variability.

I spent four weeks doing BG checks on a meter different from what I use at home.

I wore the Dexcom G4 continuous glucose monitor for the length of the study. I’m still not a fan of wearing a CGM. It’s a personal decision… I just don’t like having two things attached to me at the same time. But if I wanted to wear a CGM right now, it would only be the Dexcom.

There were four days during the study that I ate the same things, at the same times, checked my BG at the same time. It was weird when those days were work days. Kind of strange going into a meeting and saying, “Hey, I’ve gotta duck out quickly in fifteen minutes. Don’t worry… I’ll be back right away”. I also got a couple of strange looks on those days when the alarm on my phone would go off in the elevator or a quiet moment at my desk (setting the alarm is the only way I’d remember everything on those days).

I made two trips from Baltimore to Charlottesville for this study (about 220 miles each way). I spent one night in the team’s research house, and one day in outpatient testing at University of Virginia’s medical center, in the Clinical Research Unit.

Oh, and I realized I hadn’t shared the study documentation. So in the interest of full disclosure, from ClinicalTrials.gov, here’s all of the information on my study.

Clinical trials are important. They help keep bad ideas from making their way to the marketplace (although, sometimes they still do); most importantly, they help good ideas get the testing they need to make them successful once they reach the general public. As always, I was very happy to participate. And I strongly encourage you to consider participating too.

Interested in participating in a clinical trial?

The USA’s National Institutes of Health has a complete list of clinical trials taking place all over the USA, and even some outside of my country. To find them, go to www.clinicaltrials.gov and enter “diabetes” into the search box. A recent search found 10,366 studies.

JDRF has a very helpful web page that lists multiple sources for registering and finding out about clinical trials. Just go to www.jdrf.org/research/clinical-trials/ to find out more.

To read more about the University of Virginia’s Center for Diabetes Technology, including staff bios and more on Artificial Pancreas technology, visit the center’s website at www.medicine.virginia.edu/research/institutes-and-programs/cdt/the-center-for-diabetes-technology-at-uva.html
 
 
 

By StephenS | Posted in Clinical Trials | Also tagged | Comments (1)

Clinical Trial Update, Week Three.

November 11, 2013 – 8:46 am

Remember that thing I wrote last week about testing the Dexcom G5? It doesn’t look like that’s going to happen. At least not now. There’s a delay in delivery of the device, and it may not be until next year when it can be tested.

I’m finding out that this isn’t uncommon in clinical trials. And my feeling is: Dexcom did a great job developing the G4 and making sure it was ready before it was rolled out. I’m going to trust that there’s a good reason for the delay.

Nevertheless, my study continues. The goal is really designed to test glucose variability anyway, and that can be done with or without a new CGM.

Last week, I made the drive down to Charlottesville for an outpatient visit to the clinical research unit (CRU) at the University of Virginia Medical Center. The team was kind enough to put me up in their research house (where they do outpatient testing of the Artificial Pancreas) so I wouldn’t have to pay for a hotel room.

The next morning, I was at the CRU at 6:30 a.m. I had to be fasting for this test, by the way. Throughout the day, there was a lot of testing going on, but I spent nearly all of my time in a hospital bed, with IVs inserted in both arms.

It was a last-minute decision to wear my YouCanDoThis Project T-shirt. I didn’t think much about it when I put it on, but as the day wore on, I think it helped me stay strong. Read on to find out why.

photo

There was a lot of blood drawn from those IVs. Beginning at 7:15, they started taking blood out every 15 minutes. The procedure was the same each time: Use a syringe to draw out a little blood, and discard it. Then draw anywhere from 2 CCs to 5 CCs of blood to give to a technician, who gets two BG readings from the sample. Finally, a third syringe is used to inject saline into the IV, so blood doesn’t dry up in the tubing. That’s why the first syringe was always discarded… probably saline in it, which would change the BG reading.

Dr. Sue Brown was in the room almost all the time too, monitoring my BGs and making sure things were on schedule, and we were able to share cycling stories throughout the morning.

DSC01206

At 8:00 a.m., I was given a carb boost drink (chocolate!), designed to raise my glucose. It took about two hours, but I eventually got up to 297 mg/dL. Once I leveled off a bit, but while I was still high (around 10:00), I received an injection of regular insulin… right into an IV.

Then we waited about two more hours for my glucose to make it down. All the way down to 59 mg/dL. Beginning at 12:00 noon, the team started taking blood out of the IV every 5 minutes until the end of the test at 3:00.

You know, it’s a strange feeling waiting for your glucose to go up, knowing there’s nothing you can are supposed to do about it. But it’s even stranger waiting for your glucose to go down. Feeling the effects of hypoglycemia coming on. Feeling the fog entering your brain, and the world getting smaller, and talking about how you’re feeling while all of it is happening (that was not part of the testing– I just shared).

After that, they gave me a dextrose drink to help me get up to at least 80 mg/dL. Then another. Once I made it over 80 at about 1:30, they fed me lunch. A cheesy, lemon pasta with shrimp, a great salad, and fresh (no, really fresh) fruit for dessert. As you may have imagined, it was delicious. The blood draws and monitoring continued until 3:00 p.m.

Dexcom graph showing my BG variability during the test.

Dexcom graph showing my BG variability during the test.

So in all, I think there were 56 blood draws, 56 BG tests during my visit. I’ve written about this here so you could get a window into one day of my experience during a clinical trial. They’re not all like this. My previous study didn’t have any days like this.

Like I’ve said before, my job is to help researchers move the needle toward better outcomes for People With Diabetes. If that involves testing a website, or sitting still for intentionally induced hyerglycemia and hypoglycemia, it’s worth it because of what it could mean for those who need better outcomes. If you’ve been considering volunteering for clinical trials, I hope you’ll decide to do it. If you need help getting started, click the E-mail Stephen link on the top left of this page and I’ll point you in the right direction.
 
 
 

By StephenS | Posted in Clinical Trials | Also tagged | Comments (7)