Week 57 - Back to our life's routine

After the last post, we took a vacation in the US.It was a junk food raid. Basically we let "the kid be a kid". Though we were not particularly proud on how we were dealing with compensations, the BG was between 100-130 or so. Then we had a couple of months -we were back home, school started, and so on-, and we tried not to overly change the slow acting doses, and BG average was (February-March 09), between 120 and 160. We had an a1C done by March 20th, and it showed 6.7%. Worst than last time (6.5 %), but considering the vacation and the months of adjustment (back from the long trip in the US), not too bad. In fact, the endo was quite happy with the value. Now, since April, with slow acting at the same dose (11 of NPH for the day, 12 for the night) and the standard Carb corrections (avrg. 10 to 15 units of fast acting per day), the averages for BG are: 10 days avrg., 114.6 - 30 days avrg., 125.5 - 60 days avrg. 136.1. Again, no special diets here. Just food every 3 hours, control, and normal compensation for the carry over of the previous control and for whatever he might eat at the meal. In June we'll get another a1C done, we'll see there how this average reflects on the value. By then I'll do the next post. In short: BG averages rather decent, only one very very bad hypo episode in February (I think we over compensated, then there was a while with no meals) that scared us a lot, BG at 26. Since then, when we need to compensate more than 9-10 units, we split the compensation like 6-7 units now, the rest one hour later. That's working very well. Anyway, after that episode, no hypos episodes at all, he goes low every now and then to 40 (very few times at 35) but this is about the time when his due for food, so no issues there really. For the hyper, the worst peak in the last month was 284 (twice), and some 15 times above 200 (we make 4 measurements a day), which is an improvement since 3 months ago, were we had a few excursion up to 450. Not a lot, but a few. Anyway, I enclose the BG 10 days average measurements for the last 30 or so days. Day 365, is one year after the diagnosis.

Week 36 - So far in a nutshell

I'm back. I've been a bit busy (moved house, schools changed, business trips, etc.) and I couldn't find the concentration to sit down and write. However, for the benefit of our selected public, I'll put what has happened so far in a nutshell -and it's all good-:

1) A1c: When diagnosed, 12.1% - When treatment was initiated, 8.5% - 3 months later, 7.1% - 5 months later 6.5%. We are not doing a low carb diet, we just count carbs and compensate. Intake is at least 150-200 grams of carbs per day as we are told they are critical for growth. Diet includes pizza and icecreams, and other than the nuisance of injecting after the meal and spacing the meals 2-3 hours -to keep better control of the BG measurements and allow the insulin to act-, there are no substantial differences with the other kids diet. Yes, no candies or cookies in between, only at fixed times.

2) Blood glucose: Mostly on the low side, occasionally going high: we measure 4-5 times a day, and some four measurements a week will go over 200, one over 300, the rest between 50 to 150. Some lows also, but they can be traced to us overcompensating with fast insulin. Following the regular schedule, we had no longer hypo episodes, not a single call from the school, no worries when he goes to bed. The last 2 weeks of treatment there was no physical activity (PICC line in place), and we had to put a lot of extra insulin, but after that we went back to normal.

3) We just made the second set of infusions in December. This time we've put the PICC line and it went more than smooth. In a previous post I've said that I was not too hot about it. Well, of course, I was a bit concerned with general anesthesia, but after my 3-4 hours of concern, the boy enjoyed some 15 painless days, with no need for needles at all.

4) Insulin intake. For basal (slow) insulin, if physical activity is there, 20 units a day. Without, about 30. Compensation with fast insulin still at 1 fast unit for 15 grams of carbs. Doing the dose/weight ratio, we are yet at 0.5 to 0.8 units/kgr. Physical activity makes a big difference here.

5) A word on the people of Research Dallas (the center where we are doing the infusions): SUPERB is an understatement. If you want to understand what personal, compassionate medical care and concern means, you have to see them at work. I won't say more, otherwise it'd be several pages of praise.

Conclusions: For what I've talked with other parents, it seems we are having a way easier time keeping the right values of BG. A1c, which is critical to preserve his body in good shape, looks rather good without having made strong diet adjustments . And we've really forgotten the stress of the lows. No effects of the treatment were noticed throughout all these months. There was one cold that got him real hard, and kept him in bed for a week, but I cannot trace it as a direct consequence of the treatment, though I've dutyfully reported it to the brains behind the operation.

I'll wait a little while for the next post, to see if there are some news after the second set of infusions, or if things keep doing the same.

Week 11/12 - The infusions

Now we're informed that the tests are OK, he's in. So off we go to Dallas, get a room at a Marriott some 400 yards from the RIoD, ready to start 2 weeks of treatment. There will be a blood draw in the morning most of the days, to get a starting value and to monitor blood indicators to ensure that there's no harm to the patient; then, the infusion in the afternoon with an IV with the drug for half an hour, and saline solution for the next half, so to flush the line.

1) The catch. Like in every clinical trial, some will get the drug, some will get a placebo. The latter are called control group, and are used to compare the effect of the drug against a patient that does not get it. Well, here we'll have to take some chances. There's no way to know what you get in the random draw. Will he get it? Will he not? OK, some people, not all, have some reactions that will tell from a mile away that they got the drug. Some other might not. Time will tell. It is most unfortunate that we'll have to live with that surprise.

2) The needles. Fortunately, the lab tech that will make the draw -and everyone we are meeting here- she gets to make great friends with the boy, which makes the pricking not such a bad thing for him. On the other hand we are using a numbing cream -after a while we've learned that the cream needs some 60 minutes to make effect against the 45 that say in the box-, so the draws and infusions don't go that bad. Not a picnic, but not that bad either.
However, by the 7th day, there are no more veins left in decent shape. We think of using a pick line (like a fixed tube that goes deep into the vein -but I'm not too hot on that as the boy moves a lot and this needs a lot of care to last several days, and you need to go to the hospital to get it in); or to use a catheter, a plastic tube that also goes in to the vein, not as deep, but lasts only 1 to 3 days. But even so, that'll give a bit of rest to some of the veins, and will avoid the everyday pricking. I personally think that's the best solution, way less traumatic than the line.
That we do, though it requires a bit of work once is in (like flushing the catheter with saline solution every 2 hours, with the utmost cleanliness and care so not to build up pressure when flushing. The pressure buildup is painful for the patient and indicates that the catheter is clogged, so we are not to try to unclog it). Mom takes the day shift, dad the night shift. With that, we manage to finish the infusions with way less pricking in the arms, which made the last days more rested than the first ones, and gave the veins a chance to recover.

3) What's next. After the first set of infusions, there's a second set in 6 months time (that'll be end of December), and meanwhile we'll have to visit the RIoD every 1-2 months to get a blood draw, as it is required by the trial's protocol.
For the next set, we'll see to go straight with the catheter. OK, you have to do some work with the flushing, but you don't have to see the boy being pricked everyday. Again, nurses, lab tech, and all the personnel were wonderful -and wonderful is an understatement- doing this, cheering up the boy, doing the procedure with the utmost care. But this was day after day after day after day after day... I think that the catheter will save these gymnastics in the next visit.

Week 10 - Waiting on results - Some extra info here...

After the test, we bid farewell to our hosts, and now to wait for the lab results. Which is no more than a confirmation that the boy is diagnosed with diabetes, and that he has some reasonably normal values of his blood components.

A bit of info here, we are now at 14 units for the day and 4 units for the night of NPH insulin for basal, and few corrections during the day (4-5 units of fast acting perhaps at lunch and dinner). These have been the values we've been having for the last weeks. We are being very careful with the diet, trying to give him little flours, zero sugar, and the rest a decent balance of veggies, meat, whole grains, dairy products and so on. This to avoid an array of shots during the day, and minimize his discomfort for needles. We all follow the same diet (except his sister), and I shall say is not bad at all. As a matter of fact I've managed to even put some weight down myself.

By the way, I came to know this week that his latest A1C was 8.5 (down from 12.5 three months ago).

Week 9 - Oh dear, what a moment.

Now that we made our mind up, here we are parents and kid ready to start the process. First we need to sign the waiver, the 'informed consent'. Then the boy will get a Mixed Meal Tolerance Test (MMTT), then we'll get the final answer if he's accepted into the trial, according to his blood test results.

The waiver. With all the tact in the world, Nurse B. lets us know that without the 'consent' signed they cannot even put the kid on the scale. So please mom and dad, take your time, read, ask any questions you might have, and if you agree, sign it. We'll give you of course copies of each and every sheet. We'll leave you alone to your thoughts so you can decide. Meanwhile the boy was having the time of his life, with most of the nurses playing with and treating him.

Here we are then reading the paper, which of course states all sort of horrible things that can happen since the drug is still experimental. Mom really had a big emotional moment, feeling like I believe she never felt before -not precisely on the sunshine sidewalk-, Dad trying to keep up with the decision. A word here: On one hand, I wouldn't expect the consent to say nice things, and on the other, my research -good or bad-, did not result on too horrific stories related to that drug. Yes, a guy had some rash for 2 months, another had high liver enzymes -which went down when the treatment was interrupted for this very reason-. Besides that, I haven't heard of anyone dying of the thing, not even getting admitted to the hospital. In any case, we'll be watching for the smallest sign of trouble. I think that if I have to pick one of the toughest moments through all this process, yes, it was signing the papers.

The test. Well, in retrospective it did not go that bad. The boy had a bit of a rough time when he got the needle in his arm -he fought like a cat, and at that time we did not think of using some numbing cream-, then he was given a bottle of "Boost", that he deeply dislikes, and from there every 15/30 minutes he had a blood sample drawn, throughout a few hours of the day. He actually spent most of the time resting, and when the test was over, we just left to get some lunch. No biggie here.

Week 7 - First impression counts

I'm referred then to the Research Institute of Dallas, a research extension of Endocrine Associates of Dallas, which is a group of physicians that give support and education to diabetic patients.

I exchange a few mails with the nurse coordinating the trial, and from the very first mail I get the impression to communicate with someone that is as concerned as I for the health of the boy, making a genuine compassionate effort to help us out with our problem. A few mails later, letting them know background, diagnosis, etc., I get to go there and interview the director of RIoD. Then again, I'm talking to people, that are going well out of their way to accommodate me and answer each and every question, even the most unkind ones.

True, they are interested in conducting the trial, but every time I've got more and more the impression that: 1) they want to do the trial yes, but 2) they are more than genuinely interested in the patient wellbeing, making plain clear that patient is first, trial is second.

So after a lengthy -uninterrupted- interview with Dr. A., and seeing that all I hear, and the extra information he volunteers to me matches perfectly my independent research (not only in the net but also with other physicians), I make my mind up. I hope more than anything that I'll never regret this decision, but this is the way to go.

Week 4 - Getting in touch

Here we are now trying to get in touch with someone. Looking at the Clinical trials site, Tolerx was only taking people older than 18, Diamyd was doing the thing in Sweden, but I had not a single reply to my mails inquiring how to get into the trial -even if it meant to go to Sweden-, and then, I approached the Teplizumab people, that are doing 2 separate trials, one called ABATE and the other PROTEGE. Abate is in New York (and some other place, I think San Francisco), and Protege all over the place, even in Dallas, where I travel all too often for business. After a few mails with a company that coordinates the trials, there I'm referred to Dallas, and I start to talk with someone...