What is a clamp study? I quickly learned that a clamp study means that my blood sugar, with the help of sugar and insulin, would be “clamped” at a certain blood sugar target to see how well it breaks down sugar (in this case, glucagon).
When asked about participating in this program, I quickly agreed. Of course I’ll participate in another clinical trial involving a drug that could be used in the bionic pancreas someday! I want every chance I can get to help make this thing a reality. But this was no “stay in a hotel and eat ice cream for dinner” day. This was the real deal in-patient drug testing kind of day.
The screening process was simply a one-hour appointment where my vitals were taken they asked questions about my current diabetes regimen. The trial would be a one-day in-patient stay to test out two different glucagon injections to see if one could be stable enough to use in a pump, and some day, a dual-hormone closed-loop system.
I was sent an email a few days prior and told I had couldn’t eat or give a bolus after midnight the night before. On Thursday, May 15, I arrived to the Clinical Research Center at Mass General Hospital at 7:00 a.m. sharp. I checked in and filled out a brief medical questionnaire. A nurse took my vitals, put a hospital tag around my wrist, and I plopped myself in a hospital bed for the next few hours. The nurses who would be with me the entire day introduced themselves to me. I was glad I wore yoga pants and didn’t shower, because I knew I’d be nice and warm and smelly by the end of the day, especially once I saw heated blankets and the “warming box” my hand would be laying in to keep my veins toasty.
Now rewind to a year ago, when we talked about the IV insertion process during the bionic pancreas closed loop trial. It was difficult. However, I needed two this time instead of one, one on each arm and I had zero food or drink in my system. Some of the nurses chatted it up with me while the TODAY Show played in the background to keep me company. One IV was going to be put in on my left arm, which was used to draw blood sample to check my blood sugar about every 5 minutes to monitor its direction. In my other arm the infusion was used for the dextrose and insulin drips. There were multiple tubes that led to an infusion of dextrose (form of glucose) in a bag above my head. That was dripped in to me along with diluted insulin to keep my blood sugar as close to 90 mg/dl as possible throughout the day.
Because I hadn’t eaten anything and my basals are somewhat consistent, my BG didn’t take long to stabilize around 90-ish. After about an hour of hovering around 90, pushing at what I was told to be 4 times my basal combined with the dextrose, the nurses prepped my abdomen for glucagon injection number one. I didn’t know which type of glucagon would be first, but this one just felt like a regular shot (although it was awfully close to my naval, which I wasn’t used to). During the hour after the glucagon injections, the nurses had to draw blood samples—wait for it—every two minutes instead of five, because the goal of this study was to monitor how my blood sugar reacted to two different brands of glucagon. Pretty sure they said I was going to be losing just over half of what I would be giving had I donated blood.
About a half hour into the process of checking my blood every two minutes, I realized I really had to pee. How could this be? All I was doing was sipping on water from a pitcher with a straw and hadn’t eaten anything. (Apparently fluids of dextrose are still considered a means of hydration—who knew?) So after dragging both IV stands with more tubing than I ever hope to see attached to me ever, I made it to the bathroom only about two feet from my bedside. Not only did I have to keep the door open, I had to step over the tubes and not get tangled up. Hmmm. Keep in mind I had torn two ligaments in my left ankle running from the Ragnar race the weekend prior, so there’s that.
Pretty soon it was time for the next glucagon injection. My BG had been stable for an hour after the first at about 90. The principal investigator overseeing the study hung out in the room for a while, and he told me that it seemed like I was slow to absorb the first injection compared to the other subjects, because my BG dipped a little closer to the 70-80 mg/dl mark and needed more dextrose than other subjects. Interesting.
Although I didn’t feel any nausea or pain after either glucagon injection, the only thing I felt was a terrible headache, only because I didn’t have any caffeine that morning. I was clearly going to be making a beeline for the nearest iced coffee after being discharged.
As I lay there in the bed staring at my arms lined with needles and half a dozen nurses all working diligently in an assembly line effort to stabilize my blood sugar, I really began to understand how much work and time and effort it takes to make research a reality. I wonder if this is what other study participants had to do in order to make Regular, Humalog, and Novolog insulin commercialized products? I can’t imagine still using Regular and Lente insulin peaking at certain times and it taking up to 30 minutes for the medication to take effect. It was amazing to see the steadiness of blood sugars over six-plus hours and how much effort it took from a team. We don’t give ourselves enough credit for the necessary effort it takes when it comes to taking over the job of a pancreas most people take for granted. I was grateful to be part of the study and see what the future may hold for us.
After another hour of stability after the second injection, I was finally able to eat something and start thinking about heading home. They wanted my blood sugar at around 90 for at least 20 minutes after they stopped the insulin before I was allowed to leave. I forced myself to eat the chicken salad sandwich courtesy of MGH dining, mostly because I could have eaten chalk at that point, and waited until I was given the green light.
There was a lot more medical equipment and people involved in this short day long trial and for that reason, I really hope the results will prove something to the FDA. Research is hard. It’s a long tedious process that takes years. We’re talking about drugs that affect people’s everyday lives, so of course it has to be precise and as perfectly documented as possible, but I don’t think we give doctors and nurses enough credit. If one of the IVs fell out, or one of the blood sugar samples using the Hemocue, or big red brick meters as I call them, was off, it could ruin a result, which could delay the approval process. Everything has to be perfect and all the nurses and docs on this team were on top of it all.
What impressed me the most during the Beacon Hill Study was the ability for glucagon to actually do its job in preventing low blood sugars from happening. We spend hundreds of dollars a year on wasted calories as medicine when we could be using glucagon, and I’m pretty sure there is no way our insurance companies would ever consider covering juice boxes or peanut butter crackers as a form of medicine. Glucagon, however, is already covered, but there is not enough of it. I can’t wait to hear the results and find out what the next phase of the trial will bring.
I highly encourage everyone when they can to be a pioneer and participate in research. How are we going to know what works if we don’t put ourselves out there? Yes, we may have to give a few more drops of blood and take a day off of work, but it’s totally worth it.