Archive for March 2010

Dr. Faustman and the BCG Trial

March 31, 2010

Have you heard about Dr. Faustman? I have been following her work for about a year now. She is testing whether BCG (Bacillus Calmetta-Guerin) can be used to cure type 1 diabetes.

You know, I don’t normally get too excited when I hear the word “cure.” We’ve been hearing it for decades, and here we are, still testing and bolusing, and treating lows and highs. But this study looks different.

BCG is a generic drug with an impressive safety profile. It is currently used as a tuberculosis vaccine and to treat cancer. Dr. Faustman’s lab believes that, at higher or more frequent doses, the drug can actually target and kill the rogue T cells that destroy our beta cells.

In 2003, Dr. Faustman was the first person to actually cure diabetes in naturally diabetic mice. When the mice received BCG, the defective T cells were killed, while the healthy T cells remained. Perhaps even more amazing, the mice actually began to generate new beta cells and, as a result, the insulin they needed to survive.

The study went on to test and confirm that splenic stem cells could be used to create new beta cells in case the pancreas was not able to do so.

Of course, we know that mice and humans are two, very different … well … animals, and if we got our hopes up every time a scientist cured diabetes in mice we would spend a lot of time disappointed. What makes this study different, though, is that the mice had natural diabetes (not diabetes artificially caused in the lab,) the mice had reached old age with the disease and, perhaps most importantly, the study has been repeated and verified six different times.

Despite this success, Dr. Faustman has met with skepticism and even opposition in the field. Most striking is the JDRF’s refusal to provide monetary support, even though three labs that were funded by the JDRF confirmed Dr. Faustman’s findings. This opposition limited Dr. Faustman’s ability to raise funds to move forward with human trials for quite some time, but then the Iacocca  Family Foundation stepped up and provided a hefty donation so that the Phase I human trials could begin.

The Iacocca Family Foundation was established by Lee Iacocca in honor of his wife who died of complications of type 1 diabetes.

The latest news from the Faustman Lab is that Phase I of the human trials is complete and it was a success. Phase I was a safety trial in which the team demonstrated the safety of the treatment. The trial was a double-blinded placebo, controlled trial and the team found no severe reactions to the vaccine other than the expected inflammation at the injection site. The safety reports are now filed with the FDA and the Massachusetts General Hospital data safety monitoring boards.

Dr. Faustman is now working to raise funds for Phase II, in which the team will identify the best dose and the best timing of administration of BCG. The study can begin as soon as they have the necessary funding.

The team expects the trials to take about another eight years, and three more phases. According to the Faustman Lab website, the team is still enrolling participants and is actively seeking and accepting donations to bridge the funding gap for Phase II. You can learn more or make a donation at http://www.faustmanlab.org/index.html

Resources

27 Weeks and an Ultrasound

March 30, 2010

This morning my husband and I visited the High-Risk OB for my 27 week checkup and for an ultrasound. Now that I am an old pro at navigating the crazy, unmarked streets in the “big city,” I had no problem arriving on time, even though I left after my husband. He, on the other hand, got lost and arrived late, despite the directions he printed out before he left (perhaps it’s time we finally join the 21st century and purchase a GPS …) The nurse admitted that even though she has lived in the city forever, she still gets lost from time to time.

The appointment took about an hour, all told. First I did the standard pee-in-a-Dixie cup-and-then-stand-on-the-scale routine. Let me tell you, it’s getting harder and harder to aim for that little Dixie cup. I won’t give you the gory details, but when the cup disappeared below my belly, I had to take it on faith that my sample would make it in there. Luckily I made it another week without any accidents.

Then the nurse checked my blood pressure, which was a little higher than usual at 126/86. She said we will just keep an eye on it. I mentioned to her that the blood pressure cuff I bought seems to giving me low readings, and she said I can bring it in so that we can figure out what the deal is. At the very least, we can see how far off it is from the one in the doctor’s office and then I will know what my reading really is.

The ultrasound went very well. Baby NoName was wriggling and bouncing around in there like crazy. The technician kept saying things like, “Now where are you going” and “He just wriggled right out of my picture!” Luckily we got two great shot of his face and confirmed, once again, that he is definitely a boy. Even though the pics are just fuzzy black and whites, I am already convinced that he is going to be a heartbreaker. He’s just SO cute! More importantly, he is measuring right where he should; Everything is at 26 weeks and a few days, which is just a few days short of his actual age. His tummy measurement is actually 27 weeks, but the doctor says that, while it’s slightly bigger than everything else, it is close enough that we don’t need to be worried. He weighs 2.2 pounds.

Diabetics are at a higher risk of growing bigger babies due to the higher level of glucose in our blood. This is why we have to try so hard to keep our BGs in the “magic” range during pregnancy. You see, when my BG is high, Baby makes extra insulin to compensate, which makes him gain weight (fat.) This weight is seen most obviously in the torso/tummy. Luckily, my awesome A1Cs seems to be paying off. I’m thinking his big belly is just genetic 🙂

The doctor is not at all worried about my swelling, so my worry-fest was pretty much for nothing. He says every pregnant woman swells, and what I am experiencing is just plain old pregnancy-induced swelling. He said the compression stockings were a great idea, though, and that I should keep wearing them if they make me more comfortable. They really do help with the achy, tired feeling, so I will keep it up. He also encouraged me to get back to the pool (this has been difficult given my aching hips,) and even said a hot tub would be fine as long at the temperature was turned down. Apparently the weight of the water helps push the fluid out of my swollen limbs.

We talked a little about my BGs, which seem to be pretty stubborn lately. Numbers in the 150s and 170s are hanging around a lot, despite my best efforts to bolus them down. He suggested an increase in my basal rates of .1 around the clock, and said that this is right about the time that he expects my insulin needs to start really creeping up. I see my Endo next week, which is good because I’m sure that some hard-core rate tweaking is in order.

What Healthcare Reform Means to Me

March 29, 2010

I have been digesting the news about the new healthcare reform law for the last couple of days. Here are the most important takeaways for me:

My pre-existing condition is now covered.
In the past,I could not purchase private insurance on the open market because insurers would simply not cover me. Their explanation was that I had a pre-existing condition, Type 1 Diabetes. With the passage of the new bill, insurers are required to offer me the same coverage as someone without a pre-existing condition.

I don’t think I need to remind this audience that Type 1 Diabetes is an autoimmune disease and that we have no control over who or when it strikes. It is certainly not my fault that I developed this condition and there is nothing we can do to cure or prevent it. But there is something we can do to reduce the complications (and the costs associated with those complications): tight control. Unfortunately, without health insurance, most of us could not afford the test strips, insulin pump supplies, frequent A1C tests, annual kidney tests, podiatrist evaluations, dental cleanings, and annual retinopothy and glaucoma screenings that are required to keep our diabetes in check.

And don’t let the naysayers fool you. For many of us, there was simply no insurance coverage available, at any cost. Only 35 states offered a high risk pool, and mine was not one of them. In addition, most of us were not eligible for Medicaid because we had too many resources. I looked it up … my husband and I would have had to earn $18,900 a year or less to be eligible for Medicaid, and we could have a maximum of $6,000 in “Resources” — things like savings, 401ks, a house, and investments. Sure, we could have used the free clinic in our area … where people routinely waited for hours only to be turned away and where the medications we needed were not available. And those “free drugs” that the pharmaceutical companies offer? You must go through an arduous application process  every month — and the process is different with each pharmaceutical company that sells you a drug. You can be turned away, but if you aren’t turned away, the amount they offer is usually not always enough to your monthly needs.

I cannot be penalized with higher costs because of my pre-existing condition.
We all know someone who has developed some sort of condition while insured on the private market (borderline high blood pressure, sleep apnea, or borderline high cholesterol, for example) for which the insurance company decided not to drop them from the policy altogether, but instead decided to raise their rates until they could no longer afford the coverage. My biggest fear with this bill was that insurers would use this caveat as a workaround to prevent me from purchasing their plans. But the new  law requires the insurance companies to cover me for the same cost as my so-called “healthy” fellow insured.

I have more flexibility and choice in my day-to-day life.
Up until this point, I have been forced to stay employed full-time with a large organization that offered health insurance to its employees. These were the only types of companies that, by law, were required to offer me insurance, even with my pre-existing condition. If I were to lose my job, or choose to work as an independent contractor, I would lose my insurance coverage. Now I have options. I can buy insurance on the private market, and if I can’t afford it, I can receive a subsidy from the government to help me cover the premium.

Is the new law perfect?
Certainly not. We could go on and on about how we would have done things differently. And we might find that, after the law is implemented, some of the ideas we implemented turned out to be really bad ones. But is it a start? Without a doubt. And as someone who has been fighting with the insurance industry for fair treatment and adequate care for nearly thirty years, I’ll take it.

Relatively Quiet

March 25, 2010

It’s been another relatively quiet week on the pregnancy front.

Except for the ongoing Pain in the Rear, that is. I had a traumatic experience with the orthopedic specialist who gave me steroid shots that, so far, only seem to have made things worse. I am still working the ice packs during the night, and hobbling around during the day. I am exhausted, sore, and cranky. On the upside, the BG spikes from the shots seem to have worked themselves out of my system. It took about three days before everything returned to normal. I have a follow-up appointment with the same doctor in about a week and a half and I am really dreading it. I am not sure whether to cancel and forget about the whole thing, to go to the appointment and ask him about other treatment options (perhaps physical therapy or prenatal massage as some of you have suggested), or to just go through the whole ordeal again. I’m thinking that I will not take the last option, though. This has just been an awful experience with no real benefits. I have an appointment with the high risk OB next week, so maybe I will ask him what he thinks.

Speaking of the high risk OB, I also need to ask him about this swelling. While it’s not been nearly as bad as it was last Friday and Saturday, it’s definitely there. Thankfully, the compression stockings are keeping most of the fluid squished out of my ankles. My weight is creeping up again here at the end of the week. I’m gaining something like a pound a day. Maybe it is some sort of pattern? On the plus side, I think I might have figured out the problem with the low readings from the blood pressure cuff I bought. I think I have been holding my wrist too high during the reading, even though that’s what the picture on the cuff indicates. When I lower my arm a bit, the reading seems much more accurate. I think I’ll ask the doctor about that next week, too.

Baby’s R Us was having a big one-day sale yesterday, so we bit the bullet and bought a crib and bedding. Now if we could just decide on one of the paint swatches that are littered all around the soon-to-be-nursery …

There are still a ton of things on our “to do” list, but our house is slowly filling up with baby gear. We still haven’t figured out where to put it all, so the stroller is hanging out in the dine-in section of the kitchen, and the pack and play is parked in our bedroom. The place is starting to look like baby central!

We have a list of prospective baby names that is a mile long, but we can’t make a decision. Do we want a distinguished name or a creative name? A modern name or a classic name? A unique spelling or a traditional spelling? What type of name will best suit the little guy? What type will carry him through from toddler-hood to adulthood? Which fits best with our last name? Who would’ve thought that picking a name would be so hard?

Baby No Name is still kicking up a storm in there. Yesterday morning on the way to work, he managed to give me two swift kicks at the same time, one to the ribs and one to the lower gut. It temporarily knocked the wind out of me. Is he doing jumping jacks in there, or what? The other day I was reading a magazine and I had the edge resting on my belly. His kick sent the magazine bouncing into the air. Maybe we are growing a soccer player!

I’m still amazed every time I catch my reflection in a mirror or window. I swear my belly is bigger every time I look at it. And my rear end just keeps getting wider. I try to avoid looking at it. It’s just too traumatic.

Research Tidbits: Leptin and GAD

March 24, 2010

I have been following a couple of recent research topics in the news related to Type 1 Diabetes. Here is a rundown:

Leptin
I’ve read several stories in the last week or so about Leptin, a hormone that is produced by fat cells and that is involved in the regulation of body weight. Research at the University of Texas Southwestern Medical Center in 2008 showed that rodents with Type 1 Diabetes were “restored to full health” after one injection of the leptin gene, even without any insulin.

A new study by the same research group shows that diabetic mice that were treated with injections of the hormone leptin thrived without insulin. In fact, many of the side effects of insulin use were also abated, including hard-to-avoid swings in blood glucose levels, and increases in bad cholesterol.

The secret of leptin seems to be its ability to suppress the larger-than-necessary amount of glucagon a Type 1 Diabetic creates in the liver. The result is profoundly reduced food intake, which reduces body fat. Also, by suppressing glucagon, leptin helps increase lean body mass.

The team at UT Southwestern is now setting up human tests. There is still a long way to go in the research process, and there are many caveats, including the fact that most Type 1 Diabetics produce normal leptin levels while the mice in the study were leptin-deficient. Nevertheless, the researchers believe that, at the very least, leptin could be useful in reducing the amount of insulin Type 1 Diabetics  require to regulate their blood glucose. This, in turn, could lead to lowered cholesterol levels, healthier weight, appetite suppression, and a reduction in blood glucose swings.

Resources


GAD
Another topic that caught my attention was GAD, or glutamic acid decarboxylase, an enzyme in the brain and pancreas that apparently serves several purposes in the body. You might be familiar with GAD because most Type 1 Diabetics are tested for GAD antibodies to verify that they in fact have type 1. In the Type 1 body, the immune system mistakenly identifies the insulin-producing beta cells as enemies and produces the GAD antibodies to attack them. Once the beta cells are destroyed, the body can no longer produce insulin.

Researchers are now looking into whether injections of GAD at the time of diagnosis, before the beta cells have been destroyed, could prevent the immune system response. Past research has shown that, at least in mice, when GAD is administered before the autoimmune attack and even shortly after it has started, the disease can be prevented. Apparently GAD activates a type of T cell that calms the immune cells that are destroying the beta cells.

GAD was discovered by UCLA in 1990, who licensed the technology to Diamyd Medical, a swedish diabetes company, in 1994. Diamyd is now conducting human trials of their Diamyd Diabetes Vaccine.

Resources

More Pain in the Rear

March 23, 2010

I went to the orthopedic specialist yesterday to see about my pain in the rear. Surprisingly, the pain had subsided a fair amount since the last time I reported. In fact, I have managed to avoid sleeping in a chair for the last three or four nights, which makes for a much better night and much more rested Nici. I decided to keep my appointment anyway in case the pain gets worse again. At least I would have an “in” with the only guy in town who would care for a pregnant woman with a pain in the rear.

I arrived for my appointment early, even though the office is all the way across town. The nurse took me right back to a room, but I waited for the doctor for what felt like an eternity. After sitting on that hard exam table for so long, my rear was starting to complain again.

But that was nothing compared to what he was about to subject me to. He twisted my legs this way and that. He asked me to bend backward and forward at the waist. He made a lame joke about his weird-looking reflex hammer being for a rectal exam. SO NOT AMUSED. And then he got crazy. He jabbed his thumbs into my butt cheeks so hard that I thought I might die. OMG. The pain was immediate and intense. “That must be where the problem is,” he says. No shit. For good measure he did it another couple of times all over my butt cheeks. Holy crap. I wondered if it would ever end.

In the end, he suggested the steroid shots and I gladly took them. Just before he injected the steroids, he poked around on my cheeks again. It felt a bit like he was shoving a hot fireplace poker into my flesh.  “Is that the spot?,” he’d ask with each jab. How could I tell, every poke was pure agony?!

Through the pain, I only managed to remember bits and pieces of his explanation of the condition, but it was something like this: The muscles in my rear are tight (maybe he said inflamed?) and they are probably pressing on my sciatic nerve which is causing the pain in my hips and thighs. The steroids would actually make the pain worse for two days and then it should get better as the inflammation subsides. My BGs would spike about 12 hours after the shots and the highs will last for about two days. I have to go back in two weeks and he might do more shots then, depending on my condition.

He was right about the pain getting worse. Three hours after I had the shots, the pain went from manageable to OMG-I-Can-Hardly-Think-Straight. By evening I was a wreck. The doctor said to avoid heat for one day, but that I could use ice for a measly 15 minutes every three hours. I ended up using ice all night long. It was the only thing that could give me enough relief to fall at least partially asleep.

My BGs rose steadily all evening until they reached a high of 193 around midnight that would not budge, even with a generous correction. Per my Endo’s advice, I doubled all of my insulin rates, but even that was not enough. I rang in at 194 at 2AM and at 199 at 4AM. By morning, I had it down to 174, but that was the best I could do, so I changed my basals to 250% and increased my correction rate, too. Breakfast, with a double bolus rate, was a disaster, resulting in a 211 at one hour postprandial and a 243 two hours postprandial. I am going to try a 250%  increase in my bolus for lunch, but I am also really restricting the carbs. Lunch has about 15 grams, or one exchange. We’ll see how that goes.

So I’ve got another day of this pain and suffering to deal with and then I should have relief. I’m starting to wonder if it will be worth it.

Swell

March 22, 2010

It started Friday morning. I was ueber-concerned about a shocking five-pound weight gain in less than a week. Holy cow. My guess was that my raging appetite was finally catching up with me. But then I noticed the puffiness around my eyes. I worried all day. And Friday afternoon I developed one of those pregnancy headaches that just wouldn’t die.

By the end of the day, my ankles were so swollen that my feet hardly fit in my shoes. They were achy and throbbing, too. Immediately, I panicked. I googled preeclampsia and ran through the list of symptoms. As a precaution I bought a blood pressure cuff and checked my BP. It said my BP was low. Maybe it’s not working? My PB is almost always “just right” when I’m in the doctor’s office.

Saturday morning when I woke up, my ankles were much improved, but still a little puffy. Before we ran our errands, I picked up a pair of those hot mama compression stockings. They were a bear to get on my feet, but I think they did help a little. Still, by Saturday afternoon, I was sporting a fair amount of bulk around my ankles.

By Sunday, my weight was back down a couple of pounds and holding steady. I spent the day at home, puttering with chores and propping my feet up on a pillow whenever possible. The swelling was considerably improved. Today, I am still sporting the compression stockings and they seem to be keeping the swelling mostly at bay. I’ve got some aching and throbbing, but the girth of my ankles is near normal. So I guess it’s probably not really pre-e. Just plain old pregnancy-induced swelling and my over-anxious mind.

Sometimes I think I might be a hypochondriac … According to Google, I have all of the symptoms.