Just got a call from an Endo office (he is the big-shot Endo who is hooked up with all the clinical studies). They wanted to talk to me about clinical studies and see if I would be interested in any. They had a ton of them - pump, MDI, and device related.
We talked a lot, she asked me a lot of questions. And then the killer question came up…she asked the result of my most recent A1C. And then she told me I would not qualify for any of the studies. They all have a range in their requirements, generally from 6.0 to 9.0, sometimes 7.0 to 10.0. I was told my A1C was “too good” to qualify. (she told me it was possible I could get on some of the device ones, but none of the MDI or pump ones).
It strikes me as crazy. I swear I am a diabetic.By excluding diabetics with A1C’s in the 5’s, they are completely missing a segment of the diabetic population in their studies…
Any opinions on this?
Ahh, as someone who has been around a large number of clinical studies, I think I can shed some light.
Company Sponsored Device Clinical: The goal of a study done by a company is to approve a product, or support a claim. Therefore they will figure out the population that gives them the best chance to get a positive outcome with the lowest number of patients enrolled. They do this because they have to pay physicians for each data set, and so studying everyone, or especially people that would have a hard time improving won’t help their numbers and would cost them more money and increase the risk that they don’t meet their endpoint.
Company Sponsored Drug Trial: The goal of these studies is usually developing data the shows the drug is effective and safe. Again, enrolling people with very low A1c’s would make the company feel like they are at a higher risk of having adverse events that would negatively affect their submission.
Finally, research is often based on prior studies. A significant number of diabetics with very low A1c’s wasn’t a real thing until the latest drugs and devices were on the market for enough time for diabetics to figure these approaches out. So when you design you study, and review past studies you often will include similar conditions so that your data can be put in context, also if you are really trying to do the study on the cheap, you will include a control group from a different study, and therefore need a population with the same characteristics so you can use the first study in your analysis.
These are just some of the reasons, but remember, no one is doing research for research sake. There is always money tied to it, and unless they can make money off of you, they probably won’t be studying your population. Sad, but true. This is just one of the reasons so little research is done on pediatric conditions.
That was incredibly well stated. All of that makes sense. Great post!
The same thing has happened to me in Boston and Rochester (MN) as well as across the pond. It’s frustrating yet understandable from the pharma/researcher POV.
They need to show statistically significant improvements. The bigger, the better. How do you “improve” on nondiabetic numbers? QOL (Quality Of Life) would be about it. Unfortunately, this isn’t a target for most studies.
Funding is also why there aren’t any large-scale low carb studies.
Perhaps some diabetes researchers need to lobby the beef, pork, and chicken industries for money, then they could get the low carb study funded.