Bionic Pancreas Clinical Study: A Patient Reports - evansnakenceral74
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 nearly likely innovations in healthcare, with both the Joslin Diabetes Gist and Massachusetts Common Hospital Diabetes Research Center just down the road.
When I first acceptable an netmail about participating in a rising Engineering Pancreas study at Peck Worldwide, and the short timeline to come in, I was just excited to be a part of this amazing project once again — after having participated in the previous Beacon Hill read on Ed Damiano's Bionic Pancreas organization back in 2013.
The electronic mail tantalizing me to this new analyse stated, "Your stemma sugar control is not our main goal… since you are only tiring a artificial pancreas for 8 hours." Huh?? It went happening to state, "We are testing the iLet bionic pancreas in human beings for the first time, and the purpose of this study is to meet if the iLet works likewise as our original iPhone Bionic Pancreas. If this study is successful, we will use this information to help us fund larger studies victimization the iLet." Sol that's why were so eager to get the study skyward and running game and fully accomplished 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 viewing visit the next day that I complete that this would be the first time the new iLet twist would be old in humans! iLet is naturally the untried sprightliness-friendly image (undraped in mid-2016) that turns a bunch of cobbled-together technology into a more compact, more user-friendly artificial pancreas with a touch screen interface.
It was comic — at the start, my reaction was "wow that's cool," but it was still the same level of excitement as being engaged in the Lighthouse Hill report in which a cluster of us T1Ds ran some Boston for 5 years on a Bionic Pancreas system and 5 days on "regular" insulin heart therapy and the researchers compared results (check up on notes on the experiences of myself and a CDN friend here and here).
On the other hand, As I joked with a few friends that I would be a component part of history beingness the first to endeavour a commercialized-ready artificial pancreas, information technology started to get through that this really was a BIG deal and a huge come ou 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 article of clothing the iLet system one of the two days, and the trial organization the second day as a control. We would only be happening the systems from 9am to 5pm daily. I was irregular into the control group for the number 1 day, using the same trial system American Samoa the Beacon fire Hill field, 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 disregarded from my first get happening the BioPanc was that the first Day is the "become to know you phase"– which doesn't at all reflect the capabilities of the algorithm/organisation. Since the objective of this subject area was to gather data on the iLet gimmick in world to then submit to the NIH for further funding for the next phase, I knew my blood sugars would not glucinium "philosophical theory." The sharpen was on demonstrating that the iLet device was safe, and that it was an improvement o'er the tribulation system which relied connected Bluetooth connectivity and often tough disruptions in connection.
My second day was when it really got interesting. One of the different participants and I joked who could get to the clinic earlier the first morning to be the "1st" along the system. That morning, acquiring forth the train I power-walked my means to the clinic with my dog Arya and arrived just after my fellow participant – darn! But we distinct to make a pact to start at the same time to share the "1st human race" designation.
The iLet that I wore for this study still used a separate Dexcom Share pass receiver (until the next generation of Dexcom is out, at which metre the transmitter will read directly to the iLet itself). For now, the Share Receiver "shared" the data directly with the iLet system.
Every bit you might have already heard, the Bionic Pancreas squad has been working connected creating a 2-in-1 pump with Sir William Chambers for both insulin and glucagon and ideally, a single cannula. For this field of study, they used an early prototype of the situation with 2 steel cannulas which we had to manually insert and tape over. The paradigm does non one of these days take adhesive as part of the scheme itself. The device is definitely still in development — and we held nothing endorse in describing exactly how it matte going in so that they can secure IT gets improved. Flirt with a compounding betwixt a quarter round stable gear prick and a snake bite — and that's pretty much what it felt like…
Once the website was in, and the session started, we had to stay at the clinic for a few hours before beingness unleashed (with a wet-nurse) to roam around the City. At this maneuver we had been fasting since midnight, indeed food was the numerate one priority as soon as we could go out. In order to compare the two systems though, we had to keep the two years A standardized as possible — eating at the same clock time, the exact same meals, moving the exact equal amount, etc.
The College Diabetes Network offices are only a 5-minute walk from the study revolve around, so while being in the study was a big consider, the rest of my days beautiful much stayed the cookie-cutter, with me exit to work equivalent on a regular day. I was definitely one of the more boring study subjects… dreary Courtney (my awesome study harbour who hung out with me for two days).
Because of the "first day" algorithmic program adjustments I unfortunately didn't get to enjoy the congested Technology Pancreas undergo, as I was high all but 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, miniskirt-dose glucagon! Both mornings I arrived reactionist along the edge of being low, so by the time I was crooked up I would normally take to cover. Merely 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-every information technology was a pretty good set out for the #GoldenPancreas (my individual nickname for the system), and I can't hold for the next phase of studies to get cracking. Fingers crossed that NIH comes through (and quickly!). Just one more ground why advocating for government funding for diabetes research is so important!
Source: https://www.healthline.com/diabetesmine/my-time-ilet-first-human-trials
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