JDRF Research First Hand – Clinical Trial Connections

 

Clinical trials are research studies performed on people to evaluate medical, surgical or behavioral therapies. Researchers use clinical trials to figure out whether a new treatment like a drug, device (insulin pump or CGM for example) , or diet might be safe and effective to use to treat people with various conditions. These clinical trials are VITALLY IMPORTANT for type 1 diabetes research and they are the reason JDRF is able to advance so many treatment options for people living with T1D across the pipeline of T1D advancement.

The JDRF Research Pipeline.

JDRF is constantly and carefully vetting different scientific research happening all over the globe to see what brilliant researchers are doing to better treat, prevent and cure type 1 diabetes and it’s complications.   When our expert scientists find a study they believe in JDRF supports that study through funding to get important research out of the lab and into clinical trials.   Once this research is approved as safe and effective through clinical trials, JDRF again jumps into support the efforts through advocacy and FDA approval.   Once FDA approval is received, JDRF works hard to educate insurance companies and  healthcare providers about the treatment to make it affordable and prescriptible.  JDRF wants to get the right treatments into the hands of the patients who need them by making sure they are prescriptible and affordable. Learn more about these efforts by going to our JDRF Advocacy page.

Step two of this process, clinical trials, can make or break brilliant scientific advancements.   Often times, clinical trials don’t fail because they’ve failed to work in people, rather, they fail simply because they were unable to recruit enough participants required for the treatment to pass the clinical trial phase.   This is where we, as informed, passionate, driven T1D advocates can jump in and save the day!

The first time I ever participated in a clinical trial was more than 20 years ago. There have been many trials I’ve done between now and then too. Most of them have not had immediate use results but rather, have been catalysts for the technology we’re seeing now as tools to treat T1D.

Currently, I’m participating in a 6 month Eversense CGM Clinical Trial at the University of Colorado Anschutz campus.   For 180 days, I’m wearing the first implantable CGM device from Senseonics. While it’s already approved for wear in the US for up to 90 days, this clinical trial will give Senseonics the data they need to go to the FDA and get approval for 6 month wear – already happening in the UK.  If you were to wear this device, your doctor will make a tiny incision in your upper arm (pictured) where they will implant the CGM.   You’ll wear a sticker with the transmitter stuck to it on your arm every day.  This sticker/transmitter combo serves as your battery charge/transmitter to your smart phone with real time blood sugar readings.   In 3-6 months, your doctor will remove the implanted sensor and put a new sensor in on your other arm for another 3-6 months.   Pretty Cool!

During Clinical Trial days where we’re in the infusion room for tests our arms have to be in a heating pad to help the IV’s not clot.
The clinical trial research technicians are the nicest! Hi, Scott!
You can get a lot of work done in the research room as long as you can do it one-handed!

Here are some initial thoughts after the first 90 days:

It’s spot on!

For this trial I’m allowed to wear both my Dexcom CGM and the Eversense by Senseonics and frequently compare data. They’re both accurate and Eversense doesn’t seem to have the slight lag time other CGMs that sit in the interstitial fluid tend to have.   Eversense uses a little light membrane to measure glucose in the blood and that little change in technology seems to make a difference.   I’ve also not experienced any compression lows like I do with my other CGM when I sleep.

It’s a sticker!

I think I’m most impressed with the idea that you never have to worry about your sensor ripping out or coming off like you do with other CGMs. Each day you change out the adhesive patch that the transmitter is stuck to and voila – that’s it!   No pokes, needles, or anything needed. Additionally – if you want to just take it off for an evening or for an outfit when you don’t want your transmitter to show – you can.   No evidence of CGM unless, like me, you have a propensity to develop tan lines quickly.

The transmitter is a small, flat clamshell device. Every day you charge it for about 10 minutes and switch out the sticker.

Minimal/No scarring!

I was most worried about scarring going into the trial – I was certain I’d have a bump scar but, much to my surprise – you can’t even see the incision spot unless you really look after 90 days.  See?

Incision cut 3 days after the implant. The lidocaine shot was the only part of the procedure I felt!
Incision 90 days after implant. You can’t even see it!

 

 

I share clinical trial updates on my Instagram page frequently – you can follow me on IG: @ Kelli_roo for more updates and to ask me any questions you might have!

Other benefits of clinical trials, besides knowing you are impacting research that will potentially help millions living with or at risk for T1D are many.

I’ll list a few:

  1. You get access to the latest technology or medicine in T1D research
  2. Study mediations and devices are provided to you at no charge
  3. You can be reimbursed for your time by the different clinical trials — $$
  4. You meet cool people
  5. You receive more frequent care and checkups by the study care team

Because clinical trials are so important to the work we are doing, JDRF has created an extremely easy to use site to help you find clinical trials near you to participate in.   I used the tool with my information and was shown more than 100 trials  to participate in as an adult. There are trials for any age and diagnosis state. The first time I did a clinical trial I was 8 and did not have T1D, now I’m 36 and have lived with t1D for 18 years and I’ve participated in clinical trials all along the way.

 

Go to JDRF.org/ctc and put your information in.   Once you’re registered, you will get emails anytime there is a trial near you that you or your family members might be eligible to participate in! While on the site, learn even more about the Myth’s vs. facts surrounding clinical trials.

Kelli Raleigh is the Outreach Manager for JDRF Rocky Mountain. She was diagnosed with T1D at age 18, joining her older brother who was diagnosed at age 11. Kelli is passionate about JDRF outreach and research. You can email her questions at Kraleigh@jdrf.org