(Note: I probably should have posted this last week on Clinical Trials Day, but it was also #DBlogWeek, so it got delayed)
Where do new drugs and treatments for diabetes come from? The short answer, of course, is “from pharmaceutical companies and device manufacturers,” but there’s a long road from someone coming up with an idea for a new device or drug and that device or drug actually getting regulatory approval and making it to market so that your doctor can prescribe it for you.
Fundamental research, proof-of-concept, animal studies, safety studies, and efficacy studies are usually all required before a new drug or device can even be submitted to the FDA (or other regulatory body) for potential approval. It’s a lengthy, time-consuming, and costly process. Money alone isn’t the only hurdle. Actual human volunteers are required for some of these steps- real people with diabetes who take time out of their lives to spend a day (or a few days, or in some cases even weeks or longer) in a clinic or other controlled environment being poked, prodded, tested, and measured in a myriad of different ways while being given a potential new drug or wearing a new device. Volunteers do this for a variety of reasons, ranging from needing a few extra bucks (yes, volunteers almost always get paid for their time) to an altruistic desire to advance new treatments and see them come to market.
I’ve now participated in two different trials- one for Dexcom‘s next-generation G6 CGM, and one for Xeris Pharmaceuticals‘ new shelf-stable glucagon formulation. I wouldn’t call the experiences terribly pleasant, but they weren’t bad. Honestly, the worst part for me is that you usually need to show up early (and I mean crack-of-dawn early) at the clinic site. I’m the farthest thing from a morning person that exists, so having to be out of the house by 5:15AM to get to the clinic by 6AM for a trial session is rough.
Depending on the study model, there can be a lot of prep work before you even get started. There’s an initial screening visit to make sure that you’re healthy enough to participate in the study. This usually involves measuring height and weight, getting bloodwork done, and possibly stuff like an EKG and other testing. They want to make sure that the study isn’t likely to kill you, and also that there isn’t anything abnormal going on in your body that might alter the results.
On clinic days, there’s a bunch more preliminary work- re-measuring, starting IVs, and all manner of other fun. Both of the studies in which I participated involved blood glucose tests every 5 minutes. For the G6 study, this was done to compare the readings on the device against laboratory-verified values to gauge accuracy. For the glucagon study, it was done to accurately measure the effects of the new formulation. The way they do the actual tests is pretty cool- starting an IV so that they don’t have to poke you repeatedly, and attaching a pair of stopcocks with syringes to get clean blood draws over the course of the session. If additional medications are going to need to be administered, you may get an additional IV for those.
Once things get going, there usually isn’t much for the patient to do. They may ask you questions about how you feel, but other than that it’s usually a flurry of activity as technicians, nurses, PAs, MDs, and PhDs do their thing- taking samples, calling out numbers, deciding changes to medication rates, and all of the other things that go on.
When all is said and done, and the study team has their data, they’ll monitor you for a bit to make sure you’re medically stable. You’ll probably get fed at that point, too. Trust me- after 18 hours without food, a turkey sandwich and bowl of soup is all kinds of delicious. And then you go home. There’s usually a follow-up visit a few days later where they make sure you haven’t suffered any weird side effects. More blood samples may be taken and the like, just to make sure that nothing wonky is happening as a result of whatever they just tested. But that’s it.
You may not know the results. In some cases, you may not know whether you even got the drug that was being studied, or a placebo, or a current drug that’s being used for comparison. That’s the nature of these kinds of studies. They have to eliminate as many variables as possible, and even the patient knowing which medication they were given can sometimes affect the results. You can rest assured, though, that by having participated in a clinical trial, you’ve done a little bit to help bring new, safe, effective treatments for diabetes to market. I’ve now done it twice, and I’ll keep volunteering as long as I’m able to do so.
Interested in finding out more? A good place to start looking is ClinicalTrials.gov. Clinics and organizations that conduct the studies also have their own lists. In the San Diego area, both AMCR (Advanced Metabolic Care + Research) and ProSciento (formerly Profil Institute for Clinical Research) frequently conduct diabetes-related studies.