A clinical trial rant

I found out about a clinical trial for a rfaster acting insulin (faster than the current ones: Humalog, Novolog, and Apirda). And...so excited they are running one of the trials in my area.

So I called the 800 number, then got the name of the group actually doing the trial. And...my A1C is too good (they want people between 7 - 9). Why can't I be rewarded for working so hard, and getting it right? I under that they want to prove (of find out if) this new insulin works to lower BG, but isn't it valuable to know how it works in people who are well-controlled.

I'll step off my soap box now. Thanks for listening.

Please understand that in order to demonstrate superiority they need to show improvement. If you are already going well, it is really hard to show a big effect. Nothing personal, but I suspect they are choosing people who can show some substantial effect.

I know. But still if I can't rant here, where can I rant? I just hope that once this faster insulin is approved by the FDA, all patients can have access - especially if it is indeed faster. I pride myself on my discipline and control. I recall when CGM s would be covered if the patients wasn't in good control. Hopefully the reason that those who do have coverage for it now (with good control) got it covered because "they" (the posers that be) saw that the CGM that allowed a person to achieve the good numbers, would be valuable in helping them keep the good numbers. Now I'm getting snide - my bad.

I had that happen too, either my a1c was too good, or I was the wrong age, or I have had type 1 for too long now. Dr. Faustman was the only one that didn't care about any of these things- the only criteria, to donate blood anyway, was to have type 1. To be in her human trials you also have to demonstrate T cell attack and certain types of T cells present which I think I did because although I didn't donate again, this year, I was too tired to go to Boston, I haven't been ruled out. I went with a friend as my control. It was hard to find a control because they could have no D of any kind or any autoimmune diseases of any kind, the control or anyone in their family. Since then, his brother was diagnosed as type 2.

Anyway, I hope this insulin does come out soon and help some of us.

I didn't mean to toss of your feelings on the matter. I know it can be frustrating and this issue was really at the forefront with HIV/AIDs. Patients were literally dying while the FDA and pharma dragged their feet doing trials to make sure the drugs were safe and worked. Safe in the face of certain death? The same thing is still playing out with cancer drugs and other things. According to the FDA, there are two ways to get access to investigational drugs, take part in a trial or make an argument to them for compassionate use (like you are dying). You aren't allowed to make your own decision about whether you are willing to accept the risks, the government will make that decision for you cause the are so very, very smart.