Newly Diagnosed 13 year old son and clinical trials

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Permalink Reply by SFMAMA on March 15, 2010 at 10:39pm

Hey April!

we're also in SF and go to the UCSF clinic--they are great! My daughter, Abbie, is 7 and was dx 18 months ago. We had the option of enrolling her in a trial and really came close. The big drawback for us -- and reason we didn't go forward with it-- is that the trial she would have been in involved monthly infusions and the infusions were done in the same facility as the adults and children going through chemo and other cancer treatments. The trials person at UCSF was really good about explaining the setting to us so that we would know that Abbie would be spending a significant amount of time with people who were gravely ill. From day one of her diagnosis, we all had told Abbie that she wasn't 'sick' but that she had a condition to be managed. It just felt like the emotional/psychological impact of putting her in that setting would have contradicted everything we were saying. So we didn't go ahead with it. Your son is old enough that he'll be able to help you make that decision. It still feels like it was the right decision for us...but I do sometimes wonder if we should have done it.



Also, if you have a chance, go to the UCSF family symposium this weekend. It's a great place to get practical advise from other parents.

Good luck!

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Permalink Reply by April Durham on March 16, 2010 at 7:52pm

Thank you for your reply. It is a difficult decision and every family has to do what is right for them. I think regardless of what we decide there is always "what if..." We are far from making any kind of decision and still in the education gathering mode. We will be at the UCSF Symposium, we just found out about it yesterday and were able to register at the last minute. I really respect your basis for your decision and hope that we can all come to a decision that feels comfortable for us. Thanks for taking the time to respond.

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Permalink Reply by Sam F on March 16, 2010 at 8:28am

I wouldn't tinker with this. The one thing drugs have in common is that they are all toxic to the liver; other than that, it's a crapshoot. Your son doesn't have a condition that warrants taking such risks.

If you don't mind me throwing out a different perspective, what I would do is work with a knowledgeable naturopath and work on addressing food allergies (especially wheat and dairy), digestive issues (especially the need for supplemental pancreatic enzymes and the likely existence of dysbiosis, parasites, and fungus), heavy metal or other toxin overload, and nutrient deficiencies. Your son without a doubt has some or all of these issues. If you really want to get your son on the right track, join him in starting to eat quality whole foods (chemical free, local, no preservatives, no sugar, etc) with lots of fresh squeezed vegetable juice.

Best of luck.

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Permalink Reply by April Durham on March 16, 2010 at 7:47pm

Hi Sam,

I appreciate your comments. I am an assistant homebirth midwife and doula and have used homeopathic medicine for years. My kids were all exclusively breastfed and we have followed an alternative vaccination route. We eat a whole foods organic diet due to MSG and several other food additive sensitivities and have for years. I do all of our own canning and preserving.

Are you type 1 and has your disease been changed by your diet and following this path?

The naturopath we have worked with, when told of his diagnosis won't treat him until his blood sugars have been stabilized through the use of insulin and even then were told that any treatment would be strictly supportive in nature. I feel like we were low risk for type 1 diabetes to have struck our family, we have no family history on either side of families. I am a natural birth and breastfeeding advocate and educator. We eliminated processed food, dairy and have limited wheat and gluten in our diet before even becoming pregnant. I am obviously sensitive to your comments, feeling a bit like we are being blamed for creating this disease in our son. I hope that was not your intention.

We are heavily weighing this decision and do not take it lightly. I feel let down by the life we have led and that all the effort of living a healthy lifestyle has been a bit of a let down. I might have felt different if this were to happen to me, but to have it happen to our child feels especially painful. When I read that our son has a chance of losing his sight, having chronic neuropathy, heart disease and worse I feel like I owe it to him to consider every option. At the very least he has a disease that requires constant management and changes his quality of life. We are grateful that it is a disease that can be controlled and managed and recognize we could be in a lot worse of a situation. And being that I thought we had done all would could to prevent this sort of disease from striking our family I feel like we have to consider conventional medicine as well.

Thank you for your comment and if you have recommendations in the north bay area for a naturopath who is actually willing to treat our son we will consider all options that are in his best interest.

April

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Permalink Reply by awillie on March 16, 2010 at 9:07pm

Hi April!

What an excellent discussion you've started. Thanks so much. I'm a college student and T1D interested in research as a career. Although I'm not involved as a patient or researcher in the clinical trial aspect of medicine, I wish I would have been told about the numerous opportunities for being a part of something larger than myself in the D world. It sounds like you've done your homework on the subject and are continuing to do so. You've also asked a great and knowledgeable group of people here at TuD!

The only real input I have is regarding your quote: At the very least he has a disease that requires constant management and changes his quality of life.

Yes D requires constant management (whether it is T1 or T2 or somewhere in between).
No my quality of life has not changed.

I'm still the same me that I was almost two years ago when I was diagnosed. In fact, I'm more passionate, more understanding. I'm involved in more activities than I ever imagined. Has my life been negatively impacted... by the finger-poking 10x daily (no, it's kinda like a miniature science experiment... what will this do to my body, how can I adjust, how perfect can my ' guessing ' get?)... by the ever-changing technology (nope, it's kinda cool that I have access to a whole plethora of gadgets)... by the fact that I know the nutritional content of most foods... by the sheer number of people I've met through doctors/nurses/nutritionist visits, TuD, college!?! NOPE. Quality increased.

I know I got a bit carried away. Keep searching for answers. Think positively. Have hope.

~a.willie

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Permalink Reply by Sam F on March 17, 2010 at 4:33am

Right on April,

Sorry for coming off so intense, I definitely did not mean to infer that there is something you've done wrong. There is nothing preventable about type 1 diabetes.

I just threw out the issues that I think are important for treatment over the long time. Other than those mentioned, the most important thing is tightly controlling blood sugar levels and getting to be generally healthy. Focus on that, one thing at a time. He'll do great.

All the best,

Sam

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Permalink Reply by Sam F on March 17, 2010 at 4:33am

Cute haha

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Permalink Reply by Emily F on March 16, 2010 at 6:01pm

I actually work in the research industry, and I have to disagree with the statements about the major issues with these clinical trials. Any and all of the ones that have made it as far as Stage 3, when they can take clinical patients, has passed superior FDA criteria, and is really not as dangerous as we sometimes are told. If I myself were a new diabetic, or mother to a new diabetic, I would immediately enter my child/self to the trials at a local company here called TolerX. They are one of a few companies who have made something really awesome out of all the knowledge we have gained about diabetes.

I will look into this study, now I'm curious. But in the meantime, speak to as many physicians as you can find, and even some of the research specialists involved. Tell them you want the good and bad news, what could and could not happen. These are big decisions to make about your kid, so I empathize with your caution! I hope you are able to take advantage of this time in medicine.

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Permalink Reply by April Durham on March 16, 2010 at 8:00pm

Thanks Emily for your response.

I appreciate any insight you have regarding the trial. I have looked at the thymoglobulin and the CD3 trial.

I haven't seen anything about a TolerX trial anywhere. Do you have any information regarding trials available from this company? I am unconvinced that the risk versus benefit is substantial enough for our son to participate in the thymo trial.

Thanks for taking time to respond. I appreciate it.
April

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Permalink Reply by Jackie on March 16, 2010 at 8:14pm

I have a friend that worked at TolerX until recently. Do you have an affiliation with them?

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Permalink Reply by Jackie on March 16, 2010 at 8:23pm

When I was diagnosed a few years ago, I was immediately steered toward 2 clinical trials. One involved immunosuppressants, which I decided was not worth it for me. I live w/ a nurse and a teacher and use public transportation. I did not want to be sick all the time, especially as I was finally feeling much better after months of high blood sugars. I did end up participating in the other one. That was more of an informational building exercise than a specific trial. They used MRI to look at my pancreas and see if there were physical changes to it. There were also some blood draws too. Not to scare you, but I ended up in the ER w/ an allergic reaction to the MRI imaging agent. I had a wheezing cough, so the doctor did not think it was safe to send me home by myself, so I had to be observed in teh ER for about 5 hours.
I think that there are pluses and minuses to any trial. Would I participate in another one if they asked me? Probably. You need to make the best decision for your family.

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Permalink Reply by Marps on March 17, 2010 at 6:29am

Here's what I've found and I'll add my two cents (whatever that's worth) at the end.

Thymoglobulin is an infusion of horse or rabbit-derived antibodies against human T cells.
However, medical opinion remains divided as to when the benefit of this profound reduction in T-cells outweighs the concomitant increased risks of infection and malignancy.

What I've gathered from the few websites that I've read about this on is that the Thymoglobulin will kill the immune system (the T cells) completely in order to save the few beta cells that are leftover in your son's body.

I've been involved in a few clinical trials over the past 12 years of Type 1 and have learned that the most hopeful cure is coming from Dr Faustman's research in Boston MA. She believes that our pancreas aren't DEAD, but SUPPRESSED. She believes that if we kill off the specific "type" of T cells that are suppressing the pancreas, then we will be able to have normal, functioning pancreas again. (Her team has found a way to target only the T cells that are attacking the pancreas and leave the rest of the immune system alone)

I would ask if Thymoglobulin will kill your son's immune system completely, or if it's going to target only the "type" of T cell that are attacking the pancreas.

Also, see if your son even has beta cells left in his pancreas. If he doesn't, then I don't understand how this clinical trial is going to work.

Have you asked anyone about bone marrow transplants used as stem cells? Your son could possibly use his own bone marrow, then have them create beta cells from the marrow, and inject them back into his pancreas. I've heard of it working in the UK and China, but I don't know if anyone is doing this in the US yet. If anyone was... I'd be the FIRST person in line. (Except I don't have any functioning beta cells anymore)

There really isn't much information on the START trial. I wish they gave us more info.

I'm all for researching cures while he is still newly diagnosed. I hate this disease. I've dealt with it for 12 years and I am just so tired and stressed and learning of all these new complications that I'm coming up with. Insulin shock comas, Ketoacidosis, insulin resistance, seizures, allergies to types of insulins, allergies to pumps, allergies to foods and carbohydrates... basically I'm sick and I can't do hardly anything to fix it.

Personally, if I had a chance to stop this... I would have.
For whatever my opinion's worth to you- I'm just another Type 1, not a doctor.

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