For some people, it’s like receiving a letter saying a grant you spent hours preparing for wasn’t approved. For others, it’s the news your house offer was not accepted, or for eager high school seniors, that thin rejection letter from your first-choice college.
For me, however, I experienced something new related to diabetes last week. I didn’t meet the requirements to participate in a study. Since I’d been in the bionic pancreas study, I was convinced I would be accepted into every forthcoming trial to get this thing to market. Guess not.
One aspect of working at Glu that I am so incredibly thankful for is the education and insight I’ve been exposed to through all the T1D Exchange research, and more specifically, the process of research. From the time an idea is presented to a group of clinicians to the when the study is published or presented at a big conference often takes years, and one of the most important parts of that process is being incredibly particular about who can participate.
When I opened an email about an upcoming glucagon study I was stoked. This study, funded by the ADA, was going to allow me to wear the bionic pancreas but with glucagon only, so I would wear it and go about my day with my normal insulin routines, but be low-free with glucagon on board based the trends from the blue-tooth connected CGM. It was exciting to me!
I work and live within 5 miles of where the bionic pancreas project is being studied and designed, so naturally I want in, and want to be part of every procedure I can get my callused fingers on.
So I read (i.e., glanced) at the study protocol (a PDF the trial is required to put together and have each participant sign) and scheduled my screening appointment with the study nurse coordinator.
Having done this routine before, I expected to have to do the usual—vitals, urine sample, A1c tests, etc. I then had to answer a series of questions, one being, “On average, how many lows do you have per week below 60?”
“Eh…it depends on the week,” I answered. Lately I’ve been having a few days in a row where if I walk for 5 minutes, I drop under 80 and hang there all day, other times I ride my Dexcom’s yellow line at 160 for hours.
The next question however, little did I know, that if I answered it a specific way, I’d be disqualified.
“Do you have hypoglycemic unawareness when your blood glucose falls below 50 mg/dl?”
“Um, no. I always feel my lows,” I responded. I’m one of those people that will wake up drenched in sweat at 2:00 a.m. if I’m low, or start to feel my tummy grumbling at about 65 mg/dl. I’m grateful that I feel them, because too many people don’t and that would scare the crap out of me.
“I’ll be right back,” she stated.
A few minutes later she returned after speaking with one of the nurses. “I’m so sorry Anna, but you don’t qualify for the study.”
WHAT? How could I not qualify? Am I not low often enough? I thought okay, maybe sometimes I don’t feel my lows, but really, that is the reason I’m not getting in?
I left the clinic feeling down. I was so excited to be a part of another step leading towards one of the biggest breakthroughs in type 1 technology. Not so much.
As I took the elevator down to the lobby, I started to realize that perhaps I was being selfish. The clinicians and nurses have specific criteria for a reason, and ultimately they want what they want because later down the road it will benefit us all. Also, duh, it’s a good thing that I feel my lows, because I was explained, they need subjects who don’t feel their lows to see if the glucagon given through the pump has a positive reaction on the blood sugar level. If I feel mine all the time, I’d most likely never be given the glucagon in the first place, thus negating the purpose for me to participate.
Moral of the story is, researchers have a specific set of qualifications for a reason, and we might not always meet them. Everyone should have a chance to participate in a clinical trial, and I hope that the MGH team fills their 20 person quota ASAP so we can all take advantage of the results of research sooner rather than later.