What Kind of Mom?

The hardest part of Ryan's diagnosis (so far) has been making an impossible decision around whether or not to participate in a study.

When Jake was diagnosed, he was too young for any of the studies looking at protecting the remaining beta cells, so we didn't have to consider any research with him.

But Ryan was diagnosed a month before his 8th birthday, which made him eligible for the phase III Protege Encore study as soon as he turned 8. This study is evaluating the use of Teplizumab, a monoclonal antibody. Monoclonal antibodies have been used to treat Crohn's Disease and Rheumatoid Arthritis, and the premise is that they help preserve beta cells for years after diagnosis.

And having some beta cells, as anyone who's been through or witnessed a honeymoon period knows, is a good thing. According to the study doc, 75% of the people who are on the drug are maintaining A1c's under 6.5% two years after starting (don't quote me on that, I heard a lot of info that day.)

That, I think, is a very good thing, as is the overall 'greater good' aspect of research. I owe my life to those brave souls who were willing to inject mashed up pig pancreas extract. I'd like to be able to contribute in some way to the general knowledge and treatment of diabetes.

So, on the one hand, I thought, "what kind of Mom wouldn't jump at the chance to enroll her child in this study?"

But the 'cons' list is pretty overwhelming. The study requires 2 rounds of 14 days of 1 hour IV infusion. For a child, that means a picc line, which is put in under sedation. It also means bloodwork before and after each 14 day stint. And that 1 hour IV infusion ends up being the better part of a whole day in the hospital, while waiting for bloodwork to come back before and after the infusion. Side effects include flu-like symptoms. Risks include (though very, very rare) tuberculosis. If we did it while in school, it would mean 2 weeks missed. If we waited until after school ended, he'd miss 2 weeks of swimming and baseball and soccer camp (and that would also mean that round #2, which is done 6 months after round #1, would coincide with Christmas.)

And, as is true with all studies, it's a double blind study. Three groups of participants receive the drug in varying amounts, but the fourth group gets a placebo.

And that made me think, "what kind of mom would put an 8-year-old through all that?"

The more I thought about it, the more I stressed. My husband was not inclined to pursue the study. Ryan wanted nothing to do with blood draws from the arm. I tried to get feedback from the many people in the business that we know. I searched the Children with Diabetes website for other study participants (and only found one young teen in Colorado). I talked at length with the doctor and the study coordinator. I wanted someone to tell me, "You're flat-out crazy NOT to do this" or "you'd be insane to enroll him."

To be honest, and without sounding too dramatic, it was breaking my heart.

And then I had a conversation with Jake that settled everything.

He asked me, straight-out, "are you going to ask Ryan if he wants to do it?". Well, yes, of course... but Ryan's 8. How can he understand the benefits? So I asked Jake if he would participate, if he could. I explained what was involved, and what the benefit would be if he got the drug and not a placebo.

"So I could be in the study and not even get the drug?" Yes.

"Would I still have to take insulin?" Yes.

"Would I still have to check my blood sugar?" Yes.

"Would it be a cure?" Well, no.

"Then, no, I wouldn't want to do it."

And so it turns out that I am the kind of mom who would not put her generally healthy 8-year-old through 28 days of IV therapy and multiple blood draws on the chance that this drug will keep some of his beta cells alive a little longer. Even though, when Jake was diagnosed, I prayed that if Ryan was going to get it, he'd be a little older and have a few more days of functioning islets. Given the chance to extend the life of those islets, I chose not to enroll him.

Parents of kids with diabetes often wish that they could take on their child's diabetes. I wish I could take on this study for my kids and for all the kids being diagnosed. But 24 years into life with a broken pancreas, I'm obviously not eligible.

I'm sad about my decision, because I don't know what we're giving up by not participating. But I also recognize that there's no perfect choice to be made in this situation, and we've made ours, and I'm (mostly) at peace with our choice.