One of our good D-advocate friends is Christina Roth, founder and director of the College Diabetes Network (CDN), headquartered in Boston. Christina lives there with her adorable dog Arya, and when not working can usually be found doing yoga or on the back of a horse, we're told.
She's been lucky to have the opportunity to participate in several clinical studies with Boston University's Bionic Pancreas project -- the latest of which is pretty darn exciting. Today, she shares her "first human" experience...
Testing the iLet Bionic Pancreas, by Christina Roth
One of the perks of having the CDN national office in Boston, MA, is that we are a short walk away from some of the most promising innovations in healthcare, with both the Joslin Diabetes Center and Massachusetts General Hospital Diabetes Research Center just down the road.
When I first received an email about participating in a new Bionic Pancreas study at Mass General, and the short timeline to come in, I was just excited to be a part of this amazing project again -- after having participated in the previous Beacon Hill study on Ed Damiano’s Bionic Pancreas system back in 2013.
The email inviting me to this new study stated, “Your blood sugar control is not our main goal… since you are only wearing a bionic pancreas for 8 hours.” Huh?? It went on to state, “We are testing the iLet bionic pancreas in humans for the first time, and the purpose of this study is to see if the iLet works as well as our original iPhone Bionic Pancreas. If this study is successful, we will use this data to help us fund larger studies using the iLet.” So that’s why were so eager to get the study up and running and fully completed in just 6 days!
Despite the mention in that email, at the time I didn’t realize the implications that this particular study was going to have. It wasn’t until I was in my screening visit the next day that I realized that this would be the first time the new iLet device would be used in humans! iLet is of course the new life-friendly prototype (unveiled in mid-2016) that turns a bunch of cobbled-together technology into a more compact, more user-friendly artificial pancreas with a touchscreen interface.
It was funny -- at first, my reaction was “wow that’s cool,” but it was still the same level of excitement as being involved in the Beacon Hill study in which a bunch of us T1Ds ran around Boston for 5 days on a Bionic Pancreas system and 5 days on “regular” insulin pump therapy and the researchers compared results (check out notes on the experiences of myself and a CDN friend here and here).
But then, as I joked with a few friends that I would be a part of history being the first to try a commercial-ready artificial pancreas, it started to sink in that this really was a BIG deal and a huge step forward in a very promising technology for people with diabetes.
The study itself only lasted 2 days: 10 of us (how many study participants?) would all wear the iLet system one of the two days, and the trial system the second day as a control. We would only be on the systems from 9am to 5pm each day. I was randomized into the control group for the first day, using the same trial system as the Beacon Hill study, made up of two separate Tandem t:slim pumps, one with insulin and one with glucagon, connected to a Dexcom CGM and an iPhone.
What I had forgotten from my first experience on the BioPanc was that the first day is the “get to know you phase”-- which doesn’t at all reflect the capabilities of the algorithm/system. Since the objective of this study was to gather data on the iLet device in humans to then submit to the NIH for further funding for the next phase, I knew my blood sugars would not be “ideal." The focus was on demonstrating that the iLet device was safe, and that it was an improvement over the trial system which relied on Bluetooth connectivity and often experienced disruptions in connection.
My second day was when it really got interesting. One of the other participants and I joked who could get to the clinic sooner the first morning to be the “1st” on the system. That morning, getting off the train I power-walked my way to the clinic with my dog Arya and arrived just after my fellow participant – darn! But we decided to make a pact to start at the same time to share the “1st humans” designation.
The iLet that I wore for this study still used a separate Dexcom Share receiver (until the next generation of Dexcom is out, at which time the transmitter will read directly to the iLet itself). For now, the Share Receiver “shared” the data directly with the iLet system.
As you might have already heard, the Bionic Pancreas team has been working on creating a 2-in-1 pump with chambers for both insulin and glucagon and ideally, a single cannula. For this study, they used an early prototype of the site with 2 steel cannulas which we had to manually insert and tape over. The prototype does not yet have adhesive as part of the system itself. The device is definitely still in development -- and we held nothing back in describing exactly how it felt going in so that they can ensure it gets improved. Think of a combination between a thumb tack prick and a snake bite -- and that’s pretty much what it felt like…
Once the site was in, and the session started, we had to stay at the clinic for a few hours before being unleashed (with a nurse) to roam around the city. At this point we had been fasting since midnight, so food was the number one priority as soon as we could leave. In order to compare the two systems though, we had to keep the two days as similar as possible -- eating at the same time, the exact same meals, moving the exact same amount, etc.
The College Diabetes Network offices are only a 5-minute walk from the study center, so while being in the study was a big deal, the rest of my days pretty much stayed the same, with me going to work like on a regular day. I was definitely one of the more boring study subjects… sorry Courtney (my awesome study nurse who hung out with me for two days).
Because of the “first day” algorithm adjustments I unfortunately didn’t get to enjoy the full Bionic Pancreas experience, as I was high most of the afternoon… the algorithm just didn’t have enough data to know the correct dosing. However, I DID get to experience one of my favorite perks of the system, mini-dose glucagon! Both mornings I arrived right on the edge of being low, so by the time I was hooked up I would normally need to treat. But thanks to the system, I got a micro-dose of glucagon instead which brought me up just enough, and kept me coasting at “perfect” for hours (cue “Halleluluah” playing the background…).
All-in-all it was a pretty good start for the #GoldenPancreas (my personal nickname for the system), and I can’t wait for the next phase of studies to get started. Fingers crossed that NIH comes through (and quickly!). Just one more reason why advocating for government funding for diabetes research is so important!