Tag Archives: NIH

Sign up for these public meetings.

Hello…. I hope everyone’s week has been grand. For me, life has been a series of meetings and appointments and lots of work. While I have a moment, I want to let you know about two upcoming meetings that offer both educational and advocacy opportunities.

On April 26 and 27, there will be a meeting at the offices of the National Institutes of Health in Rockville, Maryland. The National Institute of Diabetes and Digestive Kidney Diseases (NIDDK) is chairing an interagency coordinating committee meeting where, in this case, they will be talking about prioritizing Type 1 diabetes research.

Like so many meetings, this one is open to the public. There will not be an opportunity to make public comments in person, but there is a way to e-mail your concerns ahead of time. Then, if you are able, you can go to the meeting and be the eyes and ears of the community, so to speak. We need that sort of thing in these forums.

To find out more, and to register, CLICK HERE.

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On May 12, there will be another public workshop at the U.S. Food and Drug Administration. This one is specifically advocacy-based. In this workshop, attendees will get direct input from FDA staff on the roadmap for approval of new drug therapies. You’ll get tips on how to make your voice heard in the approval process. And you’ll get additional information on how FDA uses the patient voice to help make informed decisions, while protecting patient safety.

This is a great opportunity to learn how the sausage is made. Metaphors! I’m full of metaphors today!

The workshop takes place at the FDA’s sprawling White Oak campus in Silver Spring, Maryland on Friday, May 12. To find out more, and to register, CLICK HERE.
 
 
That’s what’s happening near where I am… what’s going on in your part of the world?

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Diabetes By The Numbers: Molly McElwee Malloy talks about TypeZero’s NIH-funded study, and its partnership with CellNovo.

Welcome to Episode Ten of Diabetes By the Numbers.

Today we have our first returning guest. It’s Molly McElwee Malloy, Head of Patient Engagement at TypeZero Technologies in Charlottesville, Virginia. TypeZero is in the news this week for two big undertakings.

First, there’s a 12.7 million dollar artificial pancreas study funded by the National Institutes of Health. It will begin very soon. In this study, they’ll be testing TypeZero’s inControl platform, using a spiffy new device:
inControlAPapplication image
Cool, right? This study will include as many as 240 participants! The studies will take place in nine locations… six in the USA, and three in Europe. To find out more about participating in this important research, scroll to the bottom of this post.

The second big piece of news is this: Type Zero is entering into a partnership with CellNovo, which makes an integrated diabetes management system in Europe. They’ve gotten a lot of good press here in the USA, and we talk about that and what this partnership means for TypeZero. Have a listen:
DBTN

Reference Material – Click below for more information on this topic

Find out more about the inControl diabetes management platform by going to the Type Zero Technologies website:
http://typezero.com

Clinical trial participants are necessary and appreciated! Though the study will take place in several locations, the overall management of the trial will be handled through the Jaeb Center for Health Research. To contact the Jaeb Center to volunteer to participate, Send an e-mail to:
info@jaeb.org

To find out more about artificial pancreas testing through the University of Virginia’s Center for Diabetes Technology, send an e-mail to:
artificialpancreas@virginia.edu

CellNovo makes a diabetes management system that includes a patch pump, an activity monitor, a hand held cell-enabled handset, and a continuous glucose monitor. Data can be shared via the cloud. To learn more about CellNovo, go to:
CellNovo.com

Follow Molly McElwee Malloy on Twitter:
@MollyMacT1D

 

So, how’s that clinical trial going?

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!
 
 
 

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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