The Clinical Trial Experience

Keeping the Big Picture in Sight

I’ve put more trust into the closed-loop artificial pancreas (AP) system. I typically have a low carb diet and am not a huge dessert eater. This week, it seems I have consistently picked the most carb-filled item on the menu on top of dessert and a sugary beverage at almost every meal. The fourth day of my trial I had a beef brisket sandwich for lunch… the brisket was layered between TWO grilled cheeses!!! Why did I do this? Because I could!! During those five days, I never tired of watching my sugar levels stay in a straight line around 120–145, both during and hours after my gluttonous meals! My final dinner while on the CGM consisted of Italian cheeses and prosciutto, pasta carbonara (and I typically don’t “do pasta”), and apple cinnamon sugar donuts with a vanilla bean sauce. I also strategically had my mom order the ice cream Sunday so that I could get some of that, too! Go big or go home!

At the end of the trial, I participated in a focus group about the study. I was asked questions about what I liked, didn’t like and wanted to tweak about the closed-loop system. At one point I was asked, “If you could take the system with you today, would you?” For some reason that caught me off guard; I was so busy critiquing the device during the trial and trying to come up with good feedback for the team that I lost sight of the “big picture.”

photo-kady-icecreamFlash forward to being at work on Monday morning… I was back on my usual CGM and pump regimen. It was around 11:30 a.m. when it dawned on me that I needed to check my CGM and my sugar levels and decide whether I needed insulin or not. After five days on the system, I needed to actively get back in the habit of micromanaging my diabetes—and it was frustrating!!

I was expecting some huge life-altering experience of feeling like I had no diabetes during the trial. Once I started it and saw that I still went over 160 with the system, I got discouraged and immediately ignored my pre-trial expectations. It wasn’t until I was without the AP system that I understood what a mental burden had been lifted. It was such a treat to have something monitoring my sugar levels every five minutes and reacting to it. I only really had to focus on T1D at mealtimes. I knew that in between my meals the AP system was doing the work for me and keeping me in range. Sure, I still have a CGM that tells me my sugar levels, but I can’t check that every five minutes and make miniscule adjustments. The AP system gave me back time during the day and took away my worry about the “diabetes rollercoaster” of highs and lows.

Do I think this system is safe? 100 percent. It was frustrating how sometimes I would get kicked out of closed loop (the machine would sound an alarm and automatically put me back on my regular basal rate) if the sensor reading was off from my actual blood glucose. If I could change anything, I wanted the system to be allowed to give me MORE insulin! I never had one low, not one time below 70 during my trial. I am used to having to restock my purse with gummies or juice boxes, and it was noticeable that I didn’t have to during the trial. I loved it because I was cutting out roughly 200 needless calories a day from treating lows.

I am so looking forward to having this technology in the market and in MY hands!!! It was encouraging to see how far the system has come since I participated in “in-hospital” closed-loop studies years ago. I know it can be frustrating to wait for FDA approval, but the algorithms that make this device so smart are still being perfected, and I wouldn’t want something that wasn’t the best it could be on the market yet. I also know that when this is available that the sensor technology will be more accurate, and pump sites and sensor sites will become better and last longer. Even more exciting is that the next round of this trial won’t have the cellphone and transmitter— all of that information will be present in the pump—so there will be only one device instead of keeping track of three. There are many pieces to this puzzle, and I couldn’t have been happier to be a part of pushing the research forward!

Clinical Trials Connection is an online service that allows you to “opt-in” to get information about trials, and access to them. It contains information about all currently active diabetes trials in the U.S and U.K. Based on the criteria you choose, the connection provides you with information about selected trials and how to contact the researchers conducting them. You can also choose to receive regular updates so that you’ll know when new trials that meet your criteria become available. If you find a trial that interests you, you can discuss it with your doctor and also contact the trial’s primary investigator with any questions or concerns.

Read Kady’s previous blog post

9 thoughts on “Keeping the Big Picture in Sight

  1. Dr. Dan

    Thanks for sharing Kady! Closed-loop AP systems will be a huge step forward, particularly with overnight glucose control. We must be honest; however, with the limitations of these systems. Hybrid systems will use the same analog insulins for meal boluses, so post-meal glycemic excursions will persist. Every PWD should have the freedom to go all out for some meals just as you describe in your post, but the truth is that the post-prandial peaks will be just the same. A good algorithm should be better at bringing the glucose back into range though.

    Closed-loop systems will make a huge difference in improving quality of care and quality of life for PWD. However, it will not mean perfect control. Until there is an effective ultra-rapid insulin, post-prandial spikes with high-carb, high glycemic index foods will persist, even with a closed-loop system. That’s not at all to say that you can’t go “all out” sometimes.

    My hope is that the diabetes community will continue to champion the tremendous value of closed-loop systems, but also remain honest about the limitations (namely prandial glycemic excursions). Hopefully the day is near when AP systems are used routinely in diabetes care. Future users must have realistic expectations, so that systems can be used practically and effectively.

    Your perspective is greatly appreciated! Your blogs have been wonderful to read. Keep up the great work!

  2. Kelly Nash

    I have been T1D for 38 years and this sounds pretty reassuring it’s been a long time waiting to hear some good news. If this all works out I really hope it comes to Canada soon because I would love to help with the research of this working for all T1D and basically being a Guinea Pig for the trials of this happening..way to go Kady’s you are a brave girl for doing this trial for all T1D waiting on the side lines for some good news…keep up the great blogs on this trial it is always good to hear..

  3. Amy Boulas

    Thanks for sharing this amazing journey, Kady!!! I have learned so much by following your AP adventure. I hope you will have an AP permanently one day very soon. Take care, my friend. Thank you again!

  4. James Pierce

    Working in an Automation HVAC system an algorithm called a PID (proportional, integral, derivative) loop is employed to control temperatures in an ever changing environment. That is constantly checking temps and making adjustments as fast as the computer can go. Having said that I can see where checking glucose levels only every five minutes would not be helpful to tight control. However it must still be far better than checking glucose very five hours or so. I am so excited about how far it has come though keep up the good work folks and I thank you greatly.

  5. walt crocker

    Thanks Kady. Hoping this system will get FDA approval quickly and get all the kinks worked out. I am also excited about encapsulation research. I have had Type 1 for 45 years now and am an advocate for the ADA and JDRF. I am also the author of a book on diabetes. Anyone who has had diabetes for 20+ years can almost not believe the progress that has been made lately.

  6. kelly weschler

    Pls send me info available about this. Cost, when it may available, etc. Reading Kady’ s story is very inspiring. Having diabetes 30 years is tough on your body, life, family, etc.
    Thank you for your help if your able to send me some.

  7. Kelly Smith

    While so excited about the progress being made (and I am) I really don’t want something like a beeper attached to me. It can’t be comfortable and how can you dress? Sleep? Have sex? I was so excited when I first started reading about it, I must have missed the fact that you still have to wear a pump like thing. I’ve had diabeties for 20 years and am sooooo ready for something new. I’d really love to be involved in the experiments. How do you get information on being involved? I’m also looking for a specialist in the Portland, Oregon area as mine has retired. If anyone has a suggestion, that’d be great! We all know how hard it is to start over with a new doctor.
    Thank you~

  8. Profile photo of a1csplendaa1csplenda

    I have been following this new closed loop AP system and it sounds amazing. I hope it is affordable when it supposed to hit the markets in 2017. Reading the blogs of those who have been tested on this system makes me want it that much more. I tip my hat off to the doctors and technicians who has mandated this product, created it, and pushing hard to get this product into the well deserved people who has lived half their lives and more with T1D. I have lived with it for 20 years now and what I will do for just one day to feel normal. I hope this bionic pancreas will help those individuals with T1D to feel as normal as possible, helping us to take our minds off the disease enough to better enjoy life, walk into a Italian Restaurant, eating whatever pasta you want, and not to worry about how badly your body will pay for it. Before closing your eyes at night to sleep, not having to wonder if you have crossed all your “T’s” and dotted all your “I’s” in regards to waking up to a scary low blood sugar in the middle of the night. Once, I laid my head down to sleep, just to wake up to 6 paramedics standing over top of me, the dog barking in the background, my wife standing over me in tears, and my kids crying not knowing what was happing in their bedroom. The first thought I had, as I promptly tried getting up fighting the paramedics, I had initially thought my family was in danger. One of my most fearful moments. The paramedics advised me to go to the hospital, I said no. It was about 4:30 am, when the paramedics left my house, I took a shower and left for work!! I hate diabetes and I hope this new product will help with some of these types of concerns listed above.

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