Battling Diabetes

Before we review what’s going on in diabetes clinical trials let’s review the basics of clinical trials for our new readers.

What is a clinical trial?

A clinical trial is scientific research involving people that studies the effects of a new medication, therapy or device to determine if it is safe and effective.

In the United States, clinical trials are monitored by the Food and Drug Administration.

The Phases of a Clinical Trial:

Phase I evaluates dosage parameters.

Phase II continues to evaluate safety and begins to study efficacy.

Phase III compares the new drug with standards of care or if there are none, a placebo.

Phase IV is used if the drug normally used as a standard is to be used for another condition or if the formulation is changed. This phase may also be used for extended studies on drug side effects.

Diabetes clinical trials may involve studies of prevention of diabetes or the treatment of diabetes.

Types of Diabetes Clinical Trials

• Action studies (doing something) - These focus on finding out whether actions people take, such as exercising more or quitting smoking, can prevent diabetes or their impact on current diabetics.
• Agent studies (taking something) - These studies examine whether taking certain medicines, vitamins or food supplements (or a combination) have an affect on preventing or treating diabetes.

Why Participate in a Clinical Trial?

People participate in clinical trials for many reasons including the opportunity to try new cutting edge therapies under the care of leading researchers and health care providers, and for the opportunity to contribute to research to help themselves and others.

Clinical trials do have side effects including the possible negative effect of the therapies and/or no effects at all and they can be more time consuming than originally anticipated.

If you are considering participating in a clinical trial not only is it important to explore all facets of the trials through informed consent, but it is important to determine the cost and funding of a clinical trial and how your insurance coverage or Medicare comes into play. While often the medication being tested is free, there may be additional costs such as lab tests and hospitalization which are not.

Get answers ahead of time.

In depth resources on clinical trials and registries for clinical trials:

ClinicalTrials.gov not only lists registries of current clinical trials in the U.S and other countries but breaks them down according to condition, drug, sponsor and location.

World Health Organization International Clinical Trials Registry Platform. “The mission of the WHO Registry Platform is to ensure that a complete view of research is accessible to all those involved in health care decision making.”

CRISP, Computer Retrieval of Information on Scientific Projects. “A biomedical database system containing information on research projects and programs supported by the Dept. of Health and Human Services.”

Center Watch: Clinical Trials Listing Service. This site provides a notification services for new clinical trials.

American Diabetes Association provides basic information on clinical trials.

Juvenile Diabetes Research Foundation International lists current JDRF funded clinical studies and provides information on what phase those studies are currently in.

The Children With Diabetes site lists current clinical trials.

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Diabetophobia or fear of diabetes.

What exactly is a phobia?

From dictionary.com:

“a persistent, irrational fear of a specific object, activity, or situation that leads to a compelling desire to avoid it.”

Perhaps something occurred in your life that stuck in your subconscious mind that triggers a fear of diabetes.

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Check out this diabetes news item that was released from the American Diabetes Association by John E. Anderson, MD, Chair, ADA Advocacy Committee.

Legislative Updates:Major victory in fight against discrimination

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The September Diabetes Forecast discusses 10 Ways to Get Healthy Right Now; a really informative article by Tracey Neithercott that also discusses the sleep and diabetes connection.

Big Idea #2 Get More Sleep

…in a 2006 study published in the Archives of Internal Medicine, researchers found that people with type 2 diabetes who reported shortened periods of sleep or poor sleep quality had higher A1C’s than those who had long, restful slumber.

U.S News & World Report article, January 3, 2008. Lack of Deep Sleep Raises Diabetes Risk

According to the researchers, three nights of interrupted sleep effectively gave people in their 20s the glucose and insulin metabolisms of people three times their age.

Sleep–Here’s The Big Picture

The sleep cycle consists of four stages, going from light to deep sleep and finally REM (Rapid Eye Movement). The sleep cycle takes about 90 minutes. Per SleepDex, “infants spend almost 50% of their time in REM sleep. Adults spend nearly half of sleep time in stage 2, about 20% in REM and the other 30% is divided between the other three stages . ”

So what do you think? Are you sleep deprived?

Find out.

Test your reaction time at Sheep Dash.

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Our thoughts are with those affected by Hurricane Ike, Gustav and Hannah, many of whom are diabetics.

PRNewsWire, Sept. 11, 2008.

Feeding America Issues Urgent National Plea for Funds to Feed Hurricane Gustav Victims in Baton Rouge and Throughout Louisiana

The public is urged to visit feedingamerica.org to make a financial donation to the disaster relief fund.

 In the days before the storm hit, an estimated 2 million people evacuated coastal towns. Some of the most pressing needs are not directly related to storm damage, but rather the effect of the mass evacuation. Thousands of at-risk families were forced to spend their limited resources on transportation, lodging, dining out and other expenses. Many have returned to homes without electricity, meaning that all food left in refrigerators and freezers had spoiled. Many are without the funds to replenish their food supplies — or even the ability to access groceries.

 Donations made to Feeding America are used to secure and distribute easily prepared food such at canned and shelf-stable goods such as soups, peanut butter, and tuna, which required no refrigeration or preparation; meals: ready-to-eat (MREs); and hand-held snacks like granola bars. The organization also secures frequently requested items such as bottled water, baby formula, disposable diapers and cleaning supplies, which are more difficult to acquire following a disaster.

 

From the American Red Cross:

Prepare for Disasters Before they Strike: Build A Disaster Supplies Kit

 There are six basics you should stock for your home in the case of an emergency:

water, food, first aid supplies, clothing and bedding, tools and emergency supplies, and special items for medical conditions.Or purchase your emergency kit at the Red Cross Store.

How You Can Help Hurricane Relief

When people are victims of a hurricane, the American Red Cross is ready to provide shelter, food, emotional support and other assistance. You can help people affected by the Hurricanes of 2008, by making a financial gift to the American Red Cross Disaster Relief Fund. Go online to www.redcross.org or call 1-800-REDCROSS to donate today! You can also use your cell phone to donate $5 to the American Red Cross Disaster Relief Fund by text messaging the keyword “GIVE” to “2HELP” (24357). Donations will appear on monthly bills or be debited from a prepaid account balance. All applicable text rates apply.If you wish to designate your donation to a specific disaster, you should call 1-800-REDCROSS. To learn more about hurricane preparedness, visit RedCross.org.

More Diabetes News:

 The Financial Express, September 12, 2008. Novo Nordisk Launches New Diabetic Device. The new generation Flex Pen needs 30 percent less force, making it more comfortable for patients and encouraging more compliance.

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Here’s an update on the best of the late summer and early fall releases on the topic of diabetes.

And if you are a book addict like myself some of these sites for sharing your passion and perhaps your books, might interest you.

Shelfari-Shelfari is a social networking site for readers, reviewers, librarians (authors, bloggers, publishers) and anyone who enjoys a good book.

The site enables you to build virtual bookshelves of books you are reading, want to read or have read and discuss them. These bookshelves can also be put on your own blog or webpage. Launched in 2006, Shelfari was bought by Amazon in August 2008.

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The Hormone Foundation, is the public education affiliate of The Endocrine Society, a leading source of hormone-related health information for the public, physicians, allied health professionals and the media. Their mission is to serve as a resource for the public by promoting the prevention, treatment and cure of hormone-related conditions through outreach and education.

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Basic common sense rules should make your flight a smooth one and keep your diabetes under control.

Hope for the best and plan for the worst case scenario–which means be prepared for delays, emergencies and lost bags.

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Unbelievable weather here in the Rockies. Temperatures hovered at 48 degrees. Can snow be far off?

Here’s what’s going on in the world of diabetes…

• September 24-26 is the 4th annual Joslin Under the Stars presented by Walgreens. Whether you are fitness fanatic, an avid golfer, corporate executive or long time Joslin friend; this three-day event has something for everyone. Come celebrate Joslin’s 110 years of excellence. As the world’s preeminent and largest diabetes institution devoted to diabetes research, treatment and education, Joslin is uniquely positioned to lead an extensive international campaign to prevent and cure the disease and its complications.

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The dairy cow knows the value of Vitamin D.

And now so do researchers.

Study participants were given Vitamin D supplements (typical infant multivitamins) from birth on and after a tracking period of 15 to 30 years it was found that they were 29% less likely to develop type 1 diabetes than those infants who did not receive the supplemental Vitamin D. (Archives of Disease in Childhood) You can read the entire story here.

Low levels of Vitamin D apparently leads to insulin resistance.

Sources of Vitamin D:

• Vitamin D is synthesized in the human skin when it is exposed to ultraviolet light
• Fortified milk
• Swiss Cheese
• Beef Liver
• Fish (mackerel, tuna, sardines)
• Eggs
• Cod liver oil

And according to this associated article from USA Today News: June 14, 2008, Vitamin D Tests Soar As Deficiency, Diseases Linked—more doctors are testing for Vitamin D deficiency related diseases than ever before as more than 35% of adult Americans are found to have low levels.

How Much Vitamin D Do We Need?

Per the Mayo Clinic:

“You’re unlikely to get too much vitamin D from the food you eat, and prolonged sun exposure doesn’t seem to cause vitamin D toxicity. Over time, however, megadoses of vitamin D supplements can cause

nausea, vomiting, poor appetite, constipation, weakness and weight loss. More seriously, excessive doses of vitamin D can raise the level of calcium in your blood — which can cause confusion and changes in heart rhythm. Generally, the upper limit for vitamin D is 2,000 IU a day.”

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