Archive for the ‘research’ category

Washington D.C. Council Approves Stricter School Lunch and Exercise Standards

May 6, 2010

Things have been pretty hectic around here lately, what with the SIX doctor appointments I have this week, so I’ve been kind of slacking on the blogging front.  I read an interesting story about a possible improvement to school lunches, though, so here is a quick review.

The article, from the Washington Post, reports that the Washington D.C. Council approved stricter school lunch and exercise standards for the school district.

In particular, the standard requires public and charter schools in the district to add more fresh fruits and vegetables and whole grains to school meals. In addition, the standard encourages schools to buy their food from organic farms, and to triple the amount of time that students spend exercising. The schools are also required to serve a different fruit and vegetable every day, to only offer low-fat or nonfat milk and whole grains, to ban trans fats, and to limit sodium and saturated fats.

While the measure is definitely a huge step in the right direction, it does fall flat on a couple of levels. In particular, the original measure also limited calories in the meals, but this stipulation was removed at the request of the USDA, even though the Institute of Medicine issued guidelines last fall that recommended calorie limitations.  You might remember from my first post about school lunches that the USDA establishes a minimum requirement for calories, but no maximum. My guess is that the USDA does not want to limit calories because this could potentially limit the amount of food purchased as part of the school lunch program. Luckily, the article reports that health professionals and nutrition advocates are working to get federal calorie limits lowered.

In addition, the measure limits milk to low-fat and nonfat, but does not restrict flavored milks. And we all know that 2% milk, so-called “low-fat,” is actually not low in fat at all. In fact, a half-pint serving of 2% white milk contains 120 calories and a full 5 grams of fat – a whole fat serving. In comparison, the same amount of skim milk contains 80 calories and no fat, while still providing the same amount of Vitamins A, D, C, and Iron as its 2% brother.

The measure also does not re-define a vegetable. So it seems that corn, peas, beans, and potatoes will still qualify as vegetables and will meet the new requirements as long as they are fresh.

Perhaps the most troubling issue is that the council has not yet decided how to pay for the upgrades to the lunch program. Estimated at nearly $6 million per year, the sponsor of the legislation, Mary M. Cheh, proposed a one-cent per ounce tax on canned and bottled soda to cover the increased costs. This tax would generate $16 million annually, but was rejected by other council members.

Nevertheless, it goes without saying that fresh fruits and vegetables, lower-fat animal products, reduced-sodium meals, and the return of exercise to the curriculum are definite improvements over the status quo. Hopefully the D.C. school district will succeed with this measure, and more schools will follow suit.

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US rank drops in annual State of the World’s Mothers Report

May 4, 2010

Save the Children released their annual State of the World’s Mothers Report today.  The report indicates the best places for mothers to live and is based on indicators of women’s and children’s health and well-being, including access to education, access to health care, maternity leave policies, and economic opportunities.

Topping the list as the best places for mothers to live (in order from best to worst) are Norway, Australia, Sweden, Denmark, New Zealand, Finland, the Netherlands, Belgium, and Germany.

The United States fell one position, from 27th place in 2009 to 28th place in 2010, largely as a result of its mortality rate – 1 in 4,800. This rate is one of the highest in the developed world. The press release also points out that the US “also ranks behind many other wealthy nations in terms of generosity of maternity leave policies.” Boy, don’t I know it .

Why did I move away from Germany, again?

It could always be worse, though. At least I don’t live in Afghanistan. According to the report, this is the worst place in the world to live if you are a mother.

In Afghanistan, child mortality rates are 1 in 4. In comparison, in Finland, Iceland, Luxembourg, and Sweden, only 1 child in 333 dies before his or her fifth birthday. Most females in Afghanistan receive less than five years of education, compared to more than 20 years in New Zealand and Australia. The risk of dying during childbirth is 1 in 8 in Afghanistan. Meanwhile, in Ireland, the risk is 1 in 47,600.

You can read the press release here, and the full report here

Review: Balancing Pregnancy with Pre-Existing Diabetes: Healthy Mom, Healthy Baby

May 3, 2010

If you’ve been paying attention to the DOC for the last couple of years, you are probably familiar with this book’s author, Cheryl Alkon. You might know her better by her moniker: Lyrehca, or by her blog: Managing the Sweetness Within, where she chronicled her journey through infertility and a successful pregnancy all against the backdrop of pre-existing type 1 diabetes.

I have been anxiously awaiting my copy of this book for months now. In fact, I first placed my order with Amazon in February when I was a mere 21 weeks pregnant. For some reason, Amazon kept delaying my shipment, so it wasn’t until last Friday that it arrived on my doorstep. Finally!

Cheryl noted recently that you can avoid the delivery delay by ordering straight from her. She uses Paypal, and, as an added bonus, she will autograph the book, and you’ll be putting more of your valuable dollars into her pocket, instead of the pockets of the distributors and publishers. If only I’d known!

Now that I am EIGHT MONTHS pregnant, I was worried that the book would not be a very good resource for me, but I was SO wrong. I decided to start into the book from the end instead of from the beginning. I figured that this tactic would allow me to skip to the parts that deal with the later stages of pregnancy.

Right off the bat, I found valuable information. For example, lately I’ve been stressing about breast-feeding. What if it doesn’t work? How will I handle the frequent feedings? And the low blood sugars? What if I have to resort to formula? I was freaked out about the potential connection between formula in the early months and Type 1 diabetes.

Thankfully, Cheryl devotes nearly ten pages to the topics of breast-feeding and formula feeding and her writing style and content put me at ease right away. A mix of scientific evidence, quotations from doctors, and first-hand accounts from REAL diabetic moms, the book helped me realize that there are lots of ways to “skin a cat,” as they say, and provided me with the information and knowledge I need to make informed choices.

In the case of breast-feeding, I am still nervous, but feeling much more confident because I now understand the  potential connection between formula and type 1 diabetes, and am armed with the information necessary to make the best choices for my baby. Whew! What a relief!

I was also really impressed with the sections that deal with delivery and the postpartum period. There are first-hand accounts of birth stories ranging from the very natural to the emergency c-section, and everything in between. Cheryl also tackles topics like sleep deprivation, birth control, infertility, and loss, and how the big D plays a part in all of it.

I was also surprised to find that the earlier sections of the book were also useful for me. For example, it was nice to get a refresher on advocating for my health and my baby’s well-being in the medical community as I am preparing to hand over some of my control to doctors and nurses at the hospital. And as I read the section on morning sickness and low blood sugar, it was nice to be able to relate to the stories. Finally, I felt like I was not the only one who struggled with these issues.

The book was an easy but informative read — kind of like a cross between a conversation with a good friend and an appointment with a doctor who just happens to have diabetes. I’m so glad that Cheryl took on this project. I would recommend the book to anyone with diabetes who is considering pregnancy now, or in the future, and even for those who are already pregnant.

FDA crack-down on insulin pumps?

April 28, 2010

This story at Diabetes Health caught my attention today. Apparently the FDA has launched a program to further evaluate the safety of external infusion pumps, including insulin pumps.

You might have heard of the tragic death of Steven Krueger due to a massive dose of insulin. Apparently his insulin pump malfunctioned, reverted to prime mode, and then proceeded to empty his entire reservoir of insulin into him one night while he slept. While there has been no admission of fault on the part of the pump manufacturer, this story has had me a little nervous ever since I read about it. For details, see the story here.

Then there was the recent recall of Lot 8 infusion sets. I had wondered why my sugar was running high after I changed my site. I figured it had to do with the new insertion and that my body was just adjusting to the new “hole.” I had doubled the amount of my fixed prime to try to account for the change.  Months later, I received the nondescript letter in the mail. The manufacturer was recalling all of their Lot 8 infusion sets because the pressure in the set was not quite right, resulting in either too much or too little insulin. I guess I’m just lucky that I was on the “too little” end of the spectrum, not the “too much” end.

Shannon does a nice job of summarizing both of these situations in this post over on her blog.

And then there was my personal experience with one insulin pump manufacturer over five years ago when I upgraded from my first-ever insulin pump, to the latest and greatest. Despite repeated calls to the support line, to my CDE, and to local company reps, and having returned my brand new pump and three different refurbished replacement pumps, I could not get a good resolution from the company.

The pumps were all faulty, with issues ranging from blouses stopped after delivering .2 units, low battery and battery failed warnings immediately after inserting a brand new battery, and, worst of all, failure to deliver basal insulin after infusion site changes, sometimes for hours. All four returned pumps required a response to the FDA, and all three responses were a canned form letter stating that the manufacturer could find no fault with the product.

Nearly a year later, having moved to a new state and having found a new Endo, l requested a prescription for a new pump from a different manufacturer. This new Endo finally put me in contact with a local company rep who admitted that the company had been seeing these problems frequently. After that, I received a new pump with a new software version that worked as designed.

Each time something like this happens, I wonder why there is not more regulation on such a critical piece of equipment. How can these malfunctioning products make it to market and how can the manufacturers get away with brushing aside the health consequences they cause?

So it probably goes without saying that I am happy to see that the FDA is taking a closer look at infusion pumps and their safety. According to the FDA’s press release, they have received 56,000 reports of adverse events associated with the use of infusion pumps in the past five years, including 500 deaths. The press release goes on to say that “many of the reported problems appear to be related to device design and engineering.”

The FDA has also sent a letter to pump manufacturers informing them that they may be required to conduct additional risk assessments before new or modified pumps can be cleared.

They are holding a public workshop May 25-26, 2010 in which participants will discuss observed safety problems and ways to improve designs in order to reduce pump malfunctions and errors. According to the FDA’s Infusion Pumps Website, the workshop is open to the public, but space is limited to 300 participants. You can register online at (http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm203299.htm)

You can also report an infusion pump problem at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/ucm202503.htm

For more information about the FDA’s infusion pump safety initiative, visit the Web page at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/GeneralHospitalDevicesandSupplies/InfusionPumps/default.htm

News Tidbits: Artificial Pancreases, Nanovaccines, and Regenerated Beta Cells

April 14, 2010

Artificial Pancreas Maintains Normal BGs

According to this Reuters story, an “artificial pancreas” maintained normal blood sugar levels in 11 patients for 24 hours. This stat is pretty impressive given that, even with my crazy attention to my readings lately, I can only manage to be in range  about 55% of the time.

The artificial pancreas was actually more of a collection of diabetes management gadgets, comprised of “a glucose monitor, two pumps and a laptop.” The story is vague. It does not specify who sponsored the study and which pumps and glucose monitor were used, but I’m guessing that the study was part of the recent partnership between the JDRF, Animas, and Dexcom, and that the “glucose monitor” is not a simple BG tester, but instead a Continuous Glucose Monitor, or CGM.

The JDRF’s first generation artificial pancreas is not expected to include the glucagon pump, but they say that they hope to incorporate it in a later generation.

Scientists Cure Diabetes in Mice … Again

Scientists in Calgary, Alberta Canada, recently treated mice with a “nanovaccine” which helps a certain type of immune cell police the rogue T cells that are killing off our beta cells. The results are promising, but not overwhelming. The report states that over 75% of the mice had their diabetes reversed and that the vaccine also prevented the development of diabetes if they injected it into the mice before onset of the disease. In other good news, the scientists used mice whose disease closely mirrors the disease in people. The vaccine is still several  years from human trials, though, and I wonder how a 75% cure rate in mice translates into people.

Seeing as Dr. Faustman’s trial is already into the human testing stage, and her vaccine is a well-known, inexpensive, and safe drug, I’m thinking that her solution is more promising. Still, it’s nice to know that there is another possibility on the horizon.

Alpha Cells in the Pancreas Can Transform into Beta Cells

Researchers at the University of Geneva Medical School recently discovered that if they kill off all of the beta cells in mice, some of the alpha cells in the pancreas actually change into active beta cells. Beta cells are the ones that produce insulin and the ones that are killed of by the immune system in type 1 diabetics. The hypothesis is that as soon as our bodies convert the alpha cells into beta cells, our immune system attacks and kills them. If we could prevent the autoimmune attack, the newly created beta cells might actually thrive and produce insulin.

What is most interesting to me is that this research actually supports Dr. Faustman’s theory that if we can stop the immune system from attacking, the body will regenerate the beta cells. And it looks like we could regenerate them from a number of sources, including the splenic cells that Dr. Faustman tested, and the alpha cells that this team tested. Again, this research was done in mice, so our enthusiasm should be curbed until further testing can be completed. Still, maybe it’s another bright light on the horizon.

Decisions, Decisions … Cord Blood Banking and the University of Florida Study

April 1, 2010

I posted a while back about my struggles with the decision about whether to bank my son’s cord blood. My doctor did give me the information he promised, and I have been researching like crazy.

During my research, I stumbled upon one small study that was performed at the University of Florida in 2007. You can read about the study here.

In the study, seven recently diagnosed children between the ages of two and seven were infused with their own cord blood and then their outcomes were compared with 13 children with similar ages and disease durations who received traditional treatment.

After six months, the children who received the transfusions had lower average A1Cs (7% compared to 8.04% in the control group), and they required significantly less insulin per kilogram of body weight. They also had about the same C-peptide levels after the six months as they did at the beginning of the study. This indicates that their beta cells might be living longer and continuing to produce insulin. However, the study did not indicate how their C-peptide levels compared to the levels in the control group.

The conclusion from the study was that cord blood infusion might be useful in newly diagnosed children because it can slow down the progression of the disease, which can lead to tighter control and reduce or prevent the resulting complications.

Of course, this conclusion was determined after just six months. Who knows how these children are doing today, nearly three years later? I looked for an update online, but could not find anything. I did hear from the father of a participant in the study on TuDiabetes, who says his son is still in the “honeymoon phase” after three years. He does admit that his son was one of the better performers in the study. You can read this father’s opinion here.

The report goes on to conclude that it is cost-prohibitive to bank the cord blood of all potential type 1 diabetic children. Instead, the goal of the research is to pinpoint what part of the cord blood is providing the benefit. The theory is that the regulatory T cells in the cord blood prompt a type of immune regulation. Surprisingly, the team thinks that the effect has nothing to do with the stem cells and their ability to become beta (insulin producing) cells. Instead, it is about the regulatory T cells, of which cord blood has a rich supply. These cells seem to somehow neutralize the body’s attack on the beta cells.

Nevertheless, all of the big-name organizations, including the JDRF and the American Academy of Pediatrics, do not recommend private cord blood banking at this time. The evidence to support it is simply not there.

I’m still researching, though, and I’ll let you know what I find. My mind tells me that private banking is a big waste of money — it’s a longshot that we would ever use the blood anyway. But my heart tells me that it would be an awful big gamble not to save this valuable resource.

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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

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