Tag Archives: clinical trials

Diabetes By The Numbers: Clinical Trials and an invitation.

Clinical trials come and go, and often they may seem like the same thing is just being tested over and over again. But it’s really not like that at all.

Case in point is the clinical trial beginning at the University of Virginia Center for Diabetes Technology. Jess Robic and Jennifer Pinnata from the CDT are here to talk about this trial specifically, and to answer a few questions surrounding clinical trial participation in general.

This trial is specifically recruiting MDI (multiple daily injections) users, but it’s using algorithms developed for use in artificial pancreas systems. There are many super interesting aspects to this study.

The best part is all the diabetes stuff you get as part of participation in the trial. It includes:

– Insulin for the length of the trial
– Use of an innovative insulin “smart” pen
– Use of a Dexcom G5 continuous glucose monitor
– Test strips for the length of the trial
– A stipend, dependent on the number of in-person study visits you complete before the end of your participation.

Seriously, if I was an MDI user, I would sign up for this trial yesterday.

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A quick note: this interview was conducted two days before the unrest in Charlottesville, Virginia on August 12. If you’re wondering why we’re so cheery in the interview, and why we’re not even acknowledging anything about the racial discord of that weekend, or the fact that someone lost their life, it’s because it hadn’t happened yet.

In the aftermath of that sickening weekend, all of us decided to wait a bit before airing the episode. If you qualify, I hope you will consider signing up for this study… I believe it will help lead to something truly unique in insulin delivery for people living with diabetes.
DBTN

Reference Material – Click below for more information on this topic

Jess and Jennifer talk about CDT’s Recruitment Database… to join the pool of potential clinical trial participants, CLICK HERE.

To see the clinical trials currently recruiting and taking place at the University of Virginia, CLICK HERE.

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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

 

Now is the time– Make an impact.

I have one piece of semi-big news for Type 2s today, and one very big reminder for Type Anythings…

First: Abbot Diabetes Care is going ahead with clinical trials of its Freestyle Libre system. Already available to People With Diabetes in Europe, it promises glucose monitoring without performing fingersticks. That’s a potential game changer for many PWDs. But there’s a lot more to it than that. For a super write-up on the Libre, check out this review from diaTribe.

Now Type 2s have the opportunity to take part in 14 day clinical trials of this device. Trials will be held in California, Michigan, Missouri, North Carolina, and Texas. So there might be one near you.

I’ve written many times about the importance of clinical trials, and the importance of your participation in trials. So consider taking part in this trial and helping to advance device options for others living with diabetes in the USA. For all the lowdown on the trials, CLICK HERE.

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Diabetes Hands Foundation and Diabetes Advocates sponsor MasterLab, the (now) two-day diabetes advocacy workshop happening July 7 and 8 at the Friends For Life conference in Orlando. DHF and DA are offering 19 scholarships to participants who are looking to get their advocacy on by attending this event. Scholarships include airfare to and from Orlando, hotel accommodations, and other considerations. I received a scholarship to attend MasterLab last year, and it made a huge impact on me. What I learned there helped me tremendously when I spoke at an FDA workshop later in the year.

This year I won’t be asking for a scholarship. So you already have one less competitor! But you must apply by April 3. To find out more about MasterLab and other scholarships available through Diabetes Hands Foundation, CLICK HERE. NOW.

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Very exciting stuff folks. I’m looking forward to hearing more about the Libre clinical trials and MasterLab from some of you. Please let me know if you take part, and what it does for you. Good luck!
 
 
 

Clinical trial participation: The one helping the many.

This post is appearing today over at the Diabetes Community Advocacy Foundation website.
 
 
Clinical trials… what’s the big deal?

Everyone knows that clinical trials are important.

What about clinical trial participation?

Full disclosure: I’ve participated in three clinical trials in the past year, the last testing an artificial pancreas device. More on what that means to me below.

There’s absolutely no question that research and discoveries that happen as a result of clinical trials is of great importance to all of us living with and affected by diabetes. That means that participants in clinical trials are a vitally important part of the research and development process. Critical clinicals, if you will.

Don’t believe me? Think about the important discoveries that would not have been made available to the general public without the assistance of clinical trial participants. Insulin pumps, continuous glucose monitors, meters and test strips, long-acting and fast-acting insulin. Better syringes, infusion sets, reservoirs, and sensors. None of these could have made it to our D-lives without clinical trial participants who made it their mission to try them first.

Those are just the good ideas that made it through the testing and approval process. What about the bad ideas? If not for clinical trial participants, bad ideas would… well, I don’t want to think about it. Let’s just say that without patients willing to play an active part in discovery, we might not know the good ideas from the bad ideas until it was too late to do anything about it. As one of the doctors on my last clinical trial put it, there is no bad data. All data is good if it helps us get to a great conclusion. Who is the source of that data? Right… patients who participate in clinical trials.

Need another reason to participate? How about the great feeling that comes from taking an active part in making things better for people living with diabetes? Many of us don’t have the resources, the networks of supporters, or the money to take on meaningful advocacy initiatives on our own. But your participation in a clinical trial means that you, just one person, can help make a difference for more people than you’ll ever know, and for a long time to come. Oh, and the money thing: Many entities compensate patients for participation in clinical trials. Don’t expect to get rich. But if you need an extra incentive, there it is.

In addition, patients who participate are screened thoroughly prior to the start of any study. Once the trial is underway, doctors and nurses watch you closely. Partly to see how the research is going, and partly to make sure that you, as a patient, are free from adverse reactions or unintended consequences of whatever is being studied. The goal of testing is never to have the study team watch you get worse. If you don’t feel comfortable participating at any point in a clinical trial, you can always opt out at the very moment it begins to be too much.

I can think of no other form of diabetes advocacy where one person can have such a profound impact on the future for so many people. For me, it’s been exciting and fulfilling. In a way, I feel like a researcher myself. If you’re one of the many patient heroes participating in clinical trials, Bravo. Thanks for moving the needle for all of us. If you’re thinking about participating, or if you’ve already decided to put on the cape and begin participating, here are some links you might find helpful:

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.

In the United Kingdom, the UK Clinical Trials Gateway is a great resource for finding out about trials happening all over Europe. To perform a search and find out more, go to http://www.ukctg.nihr.ac.uk

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.
 
 
If you’ve participated in a clinical trial, or if you are participating in a trial, won’t you leave a comment below?
 
 
 

Clinical Trial: First Admission.

This is one in a series of posts detailing my participation in a clinical trial with an artificial pancreas element. I’m writing about this to chronicle my experience, and because if I were reading, I’d want to know about every aspect of what was going on. For more on this clinical trial, click here.

Last week, we reached the first admission for the clinical trial I’m participating in. This trial includes time hooked up to an artificial pancreas system. The AP system and the algorithm running on it was designed at University of California Santa Barbara, and is being tested there as well as at University of Virginia and the Mayo Clinic in Minnesota. As much as I can, I’m going to give you the play-by-play of everything that occurred over 48 hours or so from May 27th through May 29th.

The first thing I had to do was insert two Dexcom CGM sensors two days ahead of the admission. We needed to make sure there was enough time for the sensors to get calibrated, and for all of us to make sure things were working properly. There were two sensors because we needed one to work with the artificial pancreas system we were testing, and one as a backup, just in case. For the record, during the day and a half of closed loop testing, I had 2 Dexcom sensors and 2 infusion sets (one for the pump used in the trial, and one for my own) inserted around my midsection.

DSC01591

Then I had to actually get there. That meant driving to Charlottesville Tuesday night, so I had time for my BG to calm down before the admission officially began on Wednesday around noon. I could have gone down on Wednesday morning, but the concern for me was that among the many guidelines (read: rules) in this study, I couldn’t be admitted if my BG was 250 mg/dL or over. My glucose level really spikes after I drive anything over two hours. Since Charlottesville is about four hours away, I went down on Tuesday night.

This admission (and next week’s too) took place at the research house that the Center for Diabetes Technology has in Charlottesville. It’s close to the university and the hospital, but a lot less clinical, and that’s nice. Anyway, after a comfortable night’s sleep and breakfast the next morning, I gathered with the other participant in this trial and the staff working on the first part of this admission.

We began with a BG check, then lunch. What a great way to start! About the meals: We could eat anything we wanted, including snacks, as long as they were under 90 grams of carbohydrates. The thing is, however: Anything we ate at last week’s admission (with the exception of potential hypo treatments), we have to eat during this week’s admission. Exactly. At the same time.

After lunch, the teams started the process of getting us hooked up to the closed loop system. We had to bring our own insulin, and it’s used in an Animas Ping pump for this trial. Good for me, since I’m still thinking about a pump change, and I hadn’t used a Ping before. Once we were hooked up to the pump, and I disconnected my personal pump, we went into another room while more team members completed the rest of the steps to get the closed loop system started. There are a number of detailed steps in the process. So many that a written “sequence of events” is followed.

All went well, and I was introduced to everything I needed to have in close proximity to me for the rest of my time there. This included a tablet that the artificial pancreas system ran on the entire time. But it also included:

– Insulin pump (of course)

– Receivers for the two Dexcom sensors

– My OneTouch Ultra2 meter to be used in the study

– Since it’s a Ping pump, it included the meter remote that’s usually used in conjunction with the pump. In this case, the meter remote was getting data directly from one of the Dexcom units, then sending the data to the AP algorithm loaded to the tablet. That algorithm was designed to take that data and use it to give micro boluses every five minutes during the trial. For this part of the trial, for me, something between .05 and .25 units at a time. Are you still with me?

– A phone. The idea of this phone was to be able to receive messages when my BGs could possibly get dangerously out of range.

I should tell you that the tablet had one of the Dexcom receivers (the non-backup) attached to it with velcro, and the meter remote was attached with velcro to the back. Here’s a shot of everything working together:

DSC01603

Still, that’s a lot to carry around. Imagine having all of that with you, and having to have it in close proximity to you all the time. Including in the kitchen, in the shower,etc. I had a bit of exercise both days, and that meant someone on the team had to be with me with the tablet close enough to me to read the Dexcom and send insulin via remote. It was working right next to me while I participated in the Wednesday night DSMA Twitter chat.

Here’s what one of the screens looked like. The top number is my BG readings from the Dexcom sensor (the black part of the line are actual readings, and the blue part is predicted readings), and the bottom graph is the amount of insulin being doled out every five minutes during the same time. The red vertical bar in the insulin graph marks my bolus from lunch.

DSC01599

As you might imagine, there were regular fingerstick BG tests throughout the admission. And every 15 minutes, night and day, someone was coming by to check my tablet and write down specific data.

Now, you might be thinking: Hey, this is crazy… Who, in real life, would put up with all of that? To which my answer is: This is a test of a system that is in development. It’s not the ready-to-take-home version of something you’ll be filing insurance paperwork for soon. At this point, I think they just want to see if what they’ve worked on so far is doing what they want.

I also realized that something like this, which in theory eliminates basal rates, requires a complete change in thinking. I can’t quite put it into words yet. I spoke a little with the doctor in charge of this testing, and between us, we understand that comparing the management of my diabetes with an AP system versus what I’m doing now is like comparing apples to artichokes. I came away with a completely different way of looking at my diabetes, and a fresh set of questions about what we need from a fully integrated artificial pancreas system once it’s ready for approval from the FDA. More to come next week!
 
 
 

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