Moments of Wonderful

…rather than a lifetime of nothing special. A diabetes blog.

Moments of Wonderful - …rather than a lifetime of nothing special. A diabetes blog.

One step closer to a mouse

I hope I won’t end up like the mice in Kim’s diabetes research studies, but I am seriously considering participating in an upcoming study through my endocrinologist’s practice.

I got a flyer in the mail a few days before my doctor’s appointment last week advertising the study. The only requirement listed was that you have Type 1 diabetes and manage it with an insulin pump. I was curious but didn’t think too much about it.

During my appointment, I was discussing a possible pump switch with my endocrinologist and she mentioned the study. It turns out they will be comparing the MiniMed Revel with the MiniMed Veo (currently approved everywhere that does not include the FDA). I think it would be awesome to try out the Veo and hopefully contribute to the research the FDA apparently needs to determine it is safe for use in the US but unfortunately my doctor and I have no “control” over whether or not I am in the “control” group.

So far, I have figured out a few pros and cons about being in the study and I am trying to figure out how important each one is for me.

Pros:

  • There is the potential that I get to try out the MiniMed Veo insulin pump and the low glucose suspend feature.
  • In the control or study group, I would receive a brand new pump and all my supplies paid for during the six month study. That is not a small amount of money.
  • Maybe, just maybe I would be contributing to the research that would help to get a feature on the market in the US that so many people are hoping will keep themselves or their family members safer.

Cons:

  • I currently wear the DexCom CGM system and for the study I would need to switch to the MiniMed integrated CGM system. I have worn it before for trial periods, and found it to be uncomfortable at times.
  • I found out during my follow-up phone call this week that the only insulins that are allowed in the study are Humalog and Novolog. I would need to switch from Apidra to one of those insulins. If I enroll in the study, I will not return to Humalog (trouble with tails), but am considering the switch to Novolog.
  • I could end up in the control group with a pump and CGM I don’t necessarily want, on an insulin I don’t necessarily want to take. Do I then just drop out of the study?
  • During the six month study I would be required to visit the office for once a month appointments. That is not a huge inconvenience as the office is about 2 miles from my current job. I did find out that the first appointment will be 4 hours, as I will be required to drink a Boost meal replacement drink and will have my blood drawn to measure digestion and glucose levels. I already cleared the appointments with my boss, but just because I CAN take time off work doesn’t mean I necessarily WANT to miss that much work time.

Random points of information:

  • Due to some upcoming travel and their appointment schedule, I won’t actually go in for my first appointment until mid-April.
  • They are sending me a packet in the mail with more information for me to fill out before my appointment.
  • They require that I test four times a day during the study (ha! not a problem) and upload my information to Carelink each week (currently would need to be done on my work computer as I am running Lion on my Mac).
  • I forgot to ask if I would have to switch infusion sets during the study. If I have to switch from the Sure-Ts, I am pretty sure I would not be willing to do that and would choose not to participate.

It’s still really early, but I figure all the feedback, support, and information I can get from all of you will be helpful. Plus, I don’t think it’s too often that members of our community have the opportunity to participate in things studies like this so hopefully I can continue to track the process.

  • Mike (everydayupsanddowns) says:

    As far as I know Sure-Ts are perfectly compatible with the Veo (though I haven’t used them myself).
    I also believe you *can* use Carelink with a Mac as long as you use Firefox as the browser and ignore the ‘unsupported browser’ warning. I’m sure a friend who started with a Veo at the same time as me has got it to work – though I don’t know what the version of the MacOS was and I’m still on SnowLeopard.

    February 9, 2012 at 9:37 am
    • Sara says:

      Sorry, I should have clarified. Yes, the Sure-Ts will be compatible with the Veo. The question is whether or not the study itself will let me use them. They have to control for so many things I wonder if they have to control for type of infusion set.

      February 9, 2012 at 11:30 am
    • Dave Sowerby says:

      Yes Mac compatible but was on SnowLeopard. Managed to get it working on Safari, Firefox and Chrome if I ignored all the warnings.

      I’d be tempted by the trial Sara, and the Veo is indeed very cool, but switching insulin would be a massive consideration for me.

      Good luck with whatever you decide.

      Dave

      February 9, 2012 at 3:50 pm
  • Bea says:

    I know next to nothing about insulin therapy, pumps and such. But I hope you get good feedback so you can make an informed decision. I applaud your intention to join a clinical study because you’re thinking of other people who could benefit in the future. Kuddos!

    February 9, 2012 at 11:08 am
  • Kate says:

    Hi Sara– I, too, have a Mac, and since I am a Paradigm Revel pumper, use CareLink all the time. For me, it seems to only load on Safari, and I have to make sure that Java is up and running each time I load data into the system. It’s a bit of a hassle, but totally do-able. If you need any walk-throughs, I’m here to help!

    February 9, 2012 at 1:42 pm
    • Sara says:

      Thanks! I hear they may be having some Lion compatibility issues but I always have my work PC for backup if I was to need it.

      February 9, 2012 at 2:37 pm
  • Joanne says:

    We were offered to take part in a trial with the dexcom when Elise was two. She would have been in a group that took either Lantus or NPH as the background insulin. The 6 months of free supplies, plus getting to try the dex (this was before we were ever on it) was inticing, but we ended up opting not to do it. Part of the reason was we were not into switching insulins (so if we ended up in the Lantus group, we would have backed out). But the main reason for us were the office visits. The trial was to start right after I gave birth the Mattias, and we were required to go in once a week for at least two hours. No thanks!

    For us, it was too much of a burden on our already pretty full schedule. When we were offered the study, my gut told me a very loud NO, but I really wanted to do it. Looking back, I’m glad we said no.

    February 9, 2012 at 1:54 pm
  • Stacey D. says:

    That would be a very interesting research study to partake in! But I understand there are cons to it as well. I hope everything points to the right fit for you 🙂

    February 9, 2012 at 3:39 pm
  • Briley says:

    First let me say that I do not know the answer to the questions I am about to ask, and that is why I am asking. So if the FDA wants to test the VEO so that it can be used in America, why would they need to restrict which type of insulin you use since if it does come to America you would use Apidra?

    February 9, 2012 at 4:53 pm
    • Sara says:

      I have no idea. But I have two guesses.

      The first is that Humalog and Novolog have been around longer and are more clinically acceptable (have been used in other research) so limiting to those is a type of control factor for the study.

      Some (including me) find Apidra to work faster than other insulins. Humalog and Novolog have similar patterns to each other so using either wouldn’t really affect the results.

      I will ask during my next follow-up with the researchers.

      February 9, 2012 at 5:16 pm
  • Colleen says:

    You need to let them know that you would be a spectacular participant! (Want me to drop a note over to them?:))
    Seriously, if you do this, I’d be very interested in reading your observations and experiences.

    February 9, 2012 at 5:53 pm
  • shannon says:

    i’m not sure if my anecdata will help you make this decision at all, since the situations are so different, but my kid did participate in a study last year. it was testing the effect of a certain diet on her BGs. she had to wear her CGM, which she doesn’t love, and we had several more appointments over the course of three weeks, which she found boring, but i was glad that she agreed to do it because i hope that the information gathered will help others down the line at some point. her main motivation i think was that she got paid a fee for her time and participation, which she later used to pay for (wait for it….) NEW PET MICE!

    FULL CIRCLE BABY!

    good luck with your decision, whichever way you go.

    February 9, 2012 at 9:55 pm
  • kathy says:

    Hi Sara,
    I’ve been in a few clinical trials and have found them all to be very rewarding experiences. Its fun to be trying something new and I believe that it does help the researchers to learn what works. It also pulls you into a situation where you are really focused on yourself and your BGs along with your doctor for a period of time. You feel like part of a team. You also usually get some free testing and supplies. It can be time consuming, but hopefully, will feel like time well spent. Best of luck to you, which ever you decide.

    February 10, 2012 at 7:45 am
  • Jess says:

    i think it would be awesome to be able to participate in a clinical trial! and free supplies are a bonus too.

    the revel may not be as exciting, but i’m a fan of mine. you’d still be able to have the predictive alerts and the adjustable high/low alarm ranges. everything but the LGS. but the decision is up to you.

    also, carelink is mac compatible, but not lion compatible, so you will have to upload at work until that gets fixed. i’ve been promised they’re working on it…

    February 10, 2012 at 3:37 pm
  • victoria says:

    My gut says no. I think being part of a trial is absolutely amazing! I think this trial is absolutely amazing. But after spending time with you and talking about types of insulins, I think you’d regret switching to Novolog (or back to H). The free supplies for six months is amazing (especially considering what your insurance split is), but I don’t know if the insulin thing is worth it. That’s my only concern for you. If you’re OK with switching, then I’d say “go for it.”

    February 13, 2012 at 3:03 pm
  • Mike Hoskins says:

    I have no idea what you should do. But it sounds pretty cool to me. I don’t exactly understand why you wouldn’t be able to go back to Aprida at some later point post-study – isn’t that your choice to use whatever you want, really at any point as long as you can afford/access that particular med? I’d be on the page of using it for the 6-month study and then deciding what I want to do once the study’s complete. Whatever you decide, good luck!

    February 13, 2012 at 8:08 pm
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