Stanford’s Bionic Pancreas Study — A Patient’s Point of View
The Division of Endocrinology and Diabetes at the Stanford University Medical Center is renowned for its work in clinical research, education and care. Its clinical studies are ground breaking, helping to determine methods of better care in endocrine disorders. Under the leadership of Dr. Bruce Buckingham, clinical research is ongoing. Garrett Jensen, a graduate of Santa Clara University in accounting and political science and a person with type 1 diabetes for 10 years, is an avid promoter of clinical research and new technology that improves the lives of those living with type 1 diabetes (T1D). Currently, he works at EY in the Americas Corporate Responsibility Group and recently participated in the Stanford’s Bionic Pancreas Trial that took place over the span of three weeks in January of 2016. This is what he had to say leading up to the experience and what followed.
BT1: How did you hear about the Stanford Trial?
GJ: Through my diabetes circle and living in the Bay Area I figured there would be fantastic diabetes research opportunities to participate in. Not only is Stanford University on the edge of new methods of diabetes management technology, they also have one of the greatest and most fun groups of professionals I’ve had the privilege of working alongside. I was immediately a part of the family, and even though we are blind test subjects, the team at Stanford Endocrinology, led by Dr. Bruce Buckingham, embraces every bit of your T1D self. Before participating in the iLet bionic pancreas study designed by Dr. Ed Damiano of Boston University, I’d already been engaged in two other studies: one about hypoglycemia unawareness and insensitivity the other about improving insulin efficacy by shortening the rate at which insulin becomes active. When I heard Stanford was going to do a bionic pancreas study in two waves of eight subjects, I made it my business to get a spot. Being a frequent flier helped.
BT1: What is a bionic pancreas and how do you get one?
GJ: The bionic pancreas (BP) is a closed loop system that seeks to remove the T1D patient from the treatment equation. Similar to a non-diabetic’s functioning pancreas, it responds to food consumed so the amount of insulin injected via an infusion set is appropriate for the amount of carbohydrates. It’s dynamic, using information gathered from a Dexcom continuous glucose monitor (CGM) to make decisions about insulin needs to achieve a blood glucose goal. In this case, the objective is 7.2 mmol/L130 mg/dL. For example, when the CGM reaches its goal, the insulin will stop entirely. This concept of an adaptive basal is promising.
BT1: What about carb counting?
GJ: The BP removes the need for counting carbs and matches the behavior of a working pancreas by utilizing an adaptive algorithm that learns what “your normal” is. Under this system, you must announce meals, which consists of informing the device if the food you are about to eat is above, below, or about average. This bionic pancreas study is somewhat different because it is a single hormone study, meaning that insulin is the only hormone administered by the system. In a previous trial, glucagon was also infused to prevent lows, termed a “bihormonal system;” however, because of the unknown long-term behavior of glucagon being continually infused, the insulin-only system will come to market first.
BT1: What were your fears going into the trial?
GJ: I had always felt that being a person with type 1 diabetes, I had a responsibility to be willing to push limits, test boundaries and explore new, perhaps uncertain methods to curb the effects of diabetes and maybe even cure it. I am fortunate to live in an area where much attention and some of the best experts are engaged in trying to make our dreams as T1Ds a reality. I really never thought about my fears of participating in this study. Perhaps I should have.
BT1: What has been the most challenging thing participating in the trial?
GJ: What is most challenging in being a part of this study is a loss of control. Because the bionic pancreas is closed loop, and because it learns about your behavior over time, you will have some highs that you may have been able to prevent. You know your body best, the algorithm is adaptive and still somewhat reactionary. If you go high, there is no action for you to take. You just wait. The system will respond, but what is so great about this system is that transitions are smooth. If my blood sugar graph on this system were a roller coaster, it would be the most boring in the world. (And that excites me!) Sure, it can be annoying when you are tired of being high (hyperglycemic), but in the grand scheme is a phenomenal achievement.
Other challenges are: because this is by no means the final consumer version or product and because safety is the number one concern of the FDA, you must carry around quite a bit of supplies (hence, the neon pink fanny pack): iPhone for communication, Brick (a CGM attached to an iPhone), t-slim insulin pump, and glucometer (to calibrate the CGM twice per day and send blood sugar readings to the Stanford research staff). One of the obstacles is ensuring a secure connection between devices via Bluetooth. When they do not communicate, you can bet on getting a call from medical direction on-call 24 hours a day. I oddly enjoy these occasional interactions with doctors and nurses at 3:00 a.m. (Although, I’m not sure they do.) How awesome to have MDs, RNs, and CDEs checking in on you and you having their phone number. My medical team and diabetes advocates have tripled, thanks to participating in research. Could I be any safer? My mom loves it too.
BT1: What are your expectations?
GJ: Ultimately, my expectation is to be a T1D who doesn’t have to always think about T1D. As the device, algorithm and introduction of glucagon improves, a bionic pancreas provides diabetics a new sense of freedom. Not to mention, it will greatly impact how newly diagnosed people with diabetes are trained. I am incredibly optimistic about the effectiveness of closed loop technology. In fact, I don’t want to give it back!
Results from Stanford’s Bionic Pancreas Trial by Garrett Jensen HERE.
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