Letters to the Editor

November 2001

Nov 1, 2001

Correction About How Much Magnesium To Take

Editor's note: We mistakenly printed a recommended dose of 800 mg per day of magnesium in the August issue of Diabetes Health ("Herbs, Supplements & Vitamins," p. 50). The correct dose of magnesium recommended by Dr. Keith Campbell is one dose of 400 mg daily. We apologize for the error.

 

In the article in your August issue ("Herbs, Supplements & Vitamins," p. 50) Keith Campbell, RPh, CDE, recommended taking two 800 mg doses of magnesium daily. I would like to point out that this recommendation may be misleading and dangerous. The highest dose I have seen mentioned is 1,000 mg per day, and this is already a very high dose. The normal recommended daily dose of magnesium is 400 to 600 mg a day. This dose is given in the book "The Protein Power Lifeplan" by Dr. Michael Eades.

However, some manufacturers write on the bottle the amount of magnesium plus the amount of the chelating agent that has been used, which is what the author might have been referring to. If you may pick up a bottle of magnesium supplements and it says that each pill contains 1,000 mg, it may (and will most of the time) only contain 160.200 mg of actual magnesium. So you've got to be careful and look at the back of the bottle for the actual amount contained in each pill.

Rabbi Hirsch Meisels
Friends With Diabetes-For Jewish People with Diabetes
Spring Valley, New York

 

Is the A1cNow Test Accurate?

Your article on A1c and Metrika ("Bringing It All Back Home," September, p. 29) was misleading and inaccurate. Diabetes Health has gone out of the way to focus a considerable amount of reader attention on a new device (the A1cNow) that, according to Randie Little, PhD, at the University of Missouri, would not qualify for National Glycohemoglobin Standardization Program (NGSP) certification based on its poor and unacceptable precision (according to NGSP certification criteria).

Unfortunately, a lot of diabetes patients are not as knowledgeable about their illness as they should be. That leads to unscrupulous manufacturers taking advantage of them. As a professional member of the American Diabetes Association (ADA), I feel that other members and I have an obligation to warn them when we are aware of such manufacturers. The test numbers from the A1cNow can do nothing but mislead the patient and/or doctor.

The cover of your September issue was obviously meant to raise awareness of the importance of monitoring A1c on a regular basis. The illustration should have depicted Paul Revere warning the readers of the poor coefficient of variations (CVs) and the unacceptable precision of the A1cNow.

Prior to the ADA meeting in Philadelphia, I spoke with a representative of Metrika, and was informed that the A1cNow has a CV of 9%. According to many attending the ADA conference, where they received the test, the system was determined to be unreliable, both in comparing several test results on the same day in the same person, as well as comparing the test results to a NGSP-certified laboratory.

Irv Oppenheim
Pittsburgh, Pennsylvania

Editor's note: This is the very first A1c test that gives a reading at home and has been approved by the FDA. All other at-home tests must be mailed to a lab, and require a wait-time of days or weeks to get the result.

It has always been Diabetes Health's editorial mission to focus attention on any new technology that could possibly give people more control over monitoring their diabetes. After the A1cNow's introduction at the ADA scientific session in Philadelphia, there was much buzz about the device and it was our obligation to let readers know that an at-home A1c test would soon be available. After all, according to a survey of Diabetes Health readers, 71 percent of you would test your A1cs at home if you could ("There's No Place Like Home," September, p. 30).

In the article "Bringing It All Back Home" (September, p. 29), we did state the fact that the 8% coefficient of variation of the A1cNow is well below NGSP standards, and sources at Metrika and the NGSP confirmed this in the article.

Editor's note: Candace Glider, marketing administrator for FlexSite Diagnostics, a manufacturer of a mail-in A1c test, also wrote to us about this article.

Regarding "The Diabetes Battle Cry" (September, p. 24), while I commend your emphasis on the importance of A1c testing, it seems that the lure of new technology obstructed your clarity in reporting about the importance of accuracy in A1c testing. A1c is considered to be the most important test for long-term diabetes management; therefore, it's crucial that the results are accurate. Unlike daily blood glucose testing, which is used to make instantaneous decisions about medications and diet, A1c results are used by physicians and their patients as a guideline to establish diabetes treatment goals. Time is not of the essence, rather, accuracy is. If the results are not accurate, they are of no value to the patient.

I was especially confused by the part of the article under the subhead "The Problem with Standardization." There already is a standardization for A1c testing, yet several statements in your article would make one believe otherwise. The National Glycohemoglobin Standardization Program (NGSP), which you referred to on page 28, certifies laboratories and testing methods that meet their requirements. Your article mentions "NGSP-sanctioned" methods, but they are actually "NGSP-certified" methods. Clearly, there's a difference between sanctioned and certified. Retaining NGSP certification is a major priority at our laboratory, and you can be sure that it requires a significant investment of time and resources. As you know, there are only about seven labs in the U.S. that are currently certified. The list can be found online at www.missouri.edu/~diabetes/ngsp.html.

The fact that FlexSite Diagnostics' A1c AtHome filter paper test technology and laboratory are both NGSP certified assures our customers that they will get lab results that meet the gold standard while having the convenience of collecting their fingerstick blood sample at home.

As you mentioned, the ADA recommends using an NGSP-certified method. In addition, the American Medical Association (AMA), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the National Committee for Quality Assurance (NCQA) have issued a Consensus Statement, which can be found online at www.ama-assn.org/ama/pub/category/3798.html. The statement reads, "It is important that laboratories only use assay methods that are certified as traceable to the Diabetes Control and Complications Trial (DCCT) HbA1c reference method."

Candace Glider
Marketing Administrator
FlexSite Diagnostics
Palm City, Florida

We asked Randie Little, PhD, at the National Glycohemoglobin Standardization Program, to respond. The NGSP is the organization that certifies A1c monitors.

In response to Candace Glider, marketing administrator from FlexSite, I agree with her concerns about the Metrika A1cNow kit, which is not certified by the National Glycohemoglobin Standard-ization Program (NGSP).

Your readers should know that the American Diabetes Association (ADA), the American Association of Clinical Endocrinologists (AACE), the American Medical Association (AMA) and several other important organizations recommend use of A1c methods that are NGSP certified as traceable to the Diabetes Control and Complications Trial (DCCT) reference method. The ADA further states that A1c results "should be used with caution if the A1c assay method is not certified as traceable to the DCCT reference method."

NGSP certification insures that, at least under optimal conditions, the method can provide results that have minimal bias from the DCCT reference and also have a certain level of precision or repeatability. The manufacturers of the A1cNow test have worked hard to insure that their results have little bias. However, the precision estimates cited for this test are quite high and would not pass NGSP criteria for certification.

As an example of the importance of good precision, take an A1c result of 7% from a method with a CV (coefficient of variation) of 8%. We are assured only that most of the time (i.e. 95% of the time) a true result of 7% A1c (the ADA recommended goal) will read between 5.9%, which is within the normal range, and 8.1%, which is just outside the ADA "action limit." This rather large confidence range makes the result not as clinically useful as it should be. Remember that the DCCT showed that a difference of as little as one point A1c made a large difference in risk for complications.

In contrast, using a method with a CV of 5% (the NGSP certification criteria) we can be assured that 95% of the time the result will be between 6.3 and 7.7% (slightly above normal to midway between the ADA goal and action limit).

The optimal CV is actually 3% or less. This would narrow the predicted range for a 7% A1c reading to between 6.8 and 7.2%. The NGSP goal for methods is actually 3% and we hope to see most methods at this level of precision in the near future.

The question has come up about why this test was FDA approved, since it is not NGSP certified. The criteria for FDA approval (which is mandatory in the United States prior to market) is different from certification. The FDA requires only that the manufacturer show "substantial equivalence" to a predicate device (one that is already on the market). It is likely that the FDA will tighten their criteria for GHb methods.

Currently (September 1, 2001) there are more than 38 NGSP-certified methods and 14 certified laboratories. For more information on the NGSP, including a current list of certified methods and laboratories, please visit the NGSP Web site at www.missouri.edu/~diabetes/ngsp.html.

Randie R. Little, PhD
NGSP Network Coordinator
Departments of Child Health and Pathology University of Missouri School of Medicine
Columbia, Missouri

 

Organ Donor Sales Should Be Allowed

I thought the article in Diabetes Health entitled "Complications" (July and August issues) was fantastic and extremely informative. It was filled with suspense, intrigue, hope, despair and rationalization. As a long-term person with type 1 diabetes with healthy kidneys, this story, like no other, opened my eyes to the plight of thousands of fellow people with diabetes in desperate straits. I agree with Dr. Michael Friedlaender when he says in the article, "We allow people to give up a kidney for no payment at all." Why won't we allow people to pay for an organ transplant? After all, everyone else in the transaction profits—the doctors, the hospital, the nurses and, of course, the recipient of the organ. Why does the person losing the most have to do it for free? That is a very thought-provoking question.

My congratulations to the author, Michael Finkel, for this well-written, provocative story. It would make an excellent movie, and bring diabetes complications to the attention of millions of people.

Pat Shermer
Rapid City, South Dakota

How I Treated My Post-Meal Spiking

I was diagnosed with type 2 diabetes in June of 1993 and my fasting blood glucose reading was measured at 291. My doctor said I could bring it down with diet and exercise. I asked for a medication to control it, so he put me on Glucotrol, a sulfonylurea that stimulates insulin from the pancreas. After two or three months, my blood sugar levels were low enough to go off of the medication. I continued to control my diabetes with diet and exercise until about a year ago, when my fasting blood sugars began increasing from the 95.125 range to the 135.155 range. My doctor then put me on Glucovance, a drug to control high blood sugar levels. It has helped lower my fasting rates very much.

In December of last year, I saw my podiatrist and found that I have peripheral neuropathy. I was told that the best thing to do is to keep as close to normal readings as possible. I went back to my internist and he increased my dose of Glucovance. After that, my numbers were looking much better, and I thought all was well. I continued having my A1c level measured every three months. My A1c was 7.6% before taking Glucovance, 7.6% three months after going on it, and 8.1 % the next time I tested. My doctor had told me that if my A1c did not start going down while taking Glucovance, I was having a postprandial problem and he would start me on Starlix, a post-meal sulfonylurea. Three months after I started taking Starlix, my A1c went from 8.1% to 5.9%. It turns out that the Glucovance was working, but it did not cover my post-prandial spiking. As a result, my averages were worsening.

The combination of Glucovance and Starlix has worked very well for me, but it may not work for everyone. Now I know the importance of testing my pre- and post-prandial (meal) readings daily. It's important to find out which meals are the hardest to keep in the normal range (after dinner, in my case) and which foods raise my blood sugar the most (baked potatoes and rice seem to be the worst for me).

Scott Olmsted
Fletcher, North Carolina

 

Neuropathy Can Cause Muscle Weakness

I have type 2 diabetes and was diagnosed at the age of 69 (I am now 73). When I was diagnosed, I realized the new sensations I was feeling in my toes had to be diabetic neuropathy. I attended a week-long diabetes education class twice. I read Diabetes Health magazine from cover to cover every month for a year. I attended support group meetings and learned that diabetes can affect your eyes, heart, stomach, kidneys and feet.

I walk two miles every day, and do my own house and yard work. Despite my physical efforts, I was puzzled by my loss of strength over the years. I wondered if it was old age or arthritis.

Then, last week I was reading the book "Your Pain is Real" by Dr. Emile Heisinger. One of the sentences caught my eye. It read ". diabetic neuropathy results in wasting of the muscles of the upper legs, with resultant pain in the thighs."

I do not have to be a rocket scientist to see that the muscles in my thighs are mush. Despite all my efforts to educate myself about my diabetes, I was clueless about this symptom. Tighter control of blood sugar levels is the one thing that we must do to avoid complications. I take Lipitor, an anticholesterol drug that causes muscle disintegration. When I was first diagnosed, my A1c was 8.9%, and it is now down to 7.2%. I take 500 mg of Glucophage three times a day.

Elza B. Ulpis
Omaha, Nebraska

 

Doctor/Patient Relationship Is Seriously Lacking

What's next, public floggings for people with type 2 diabetes?

I just read that managed care is buying a computerized system to remind people with diabetes about their doctors appointments. Diabetes treatment centers are places of pain, in my opinion. The reason that people with diabetes have to be reminded to visit their doctors is because it is an unpleasant experience. When I arrive, I am weighed. Health care professionals then scorn or ridicule me for not losing enough weight.

I am told "We'll send you to a dietitian again." Then, the dietitian punishes me for not losing weight as well.

I have major trust issues with the current approach to treatment of diabetes by doctors. They have to earn my trust. Also, I don't think that there should be any "insider" information about medicine that is not available to patients. Why would doctors want to keep information to themselves? When I go to meetings by my HMO, I cannot tell if the insurance company is trying to help me or control me. I will not be controlled.

I cannot help wondering: is medicine still hung up on paternalism?

When it comes to treatment of type 2 diabetes, doctors are not going to succeed unless they take the time to establish an intimate relationship with their patients. I want to know what my doctor's fears and concerns are, and I want him to ask me about my fears and concerns. Everything else can be handled with a computer print out.

Until my doctor says to me, "Let's discuss your quality of life and diabetes together," I am going to blow off my doctor's appointment reminder. It reminds me that my current diabetes doctor/patient relationship is inequitable and inhumane.

Phyllis Matalis
Cotati, California

 

Lantus Isn't a "One-Shot-a-Day" Insulin

I have just read the article "One-Shot-a-Day Insulin Is Here" (July 2001, p. 41) on Lantus, a new insulin with a level basal range of a day. There is some contradictory information in the article. You write "any patient who uses it will need to take four shots per day." But the title of the article reads "One-Shot-a-Day Insulin Is Here."

I urge you to hire an editor who understands the English language. Or, take some time to scan the headlines more closely before you go to press.

Although I appreciate very much your role in providing information about diabetes management, I don't like to see public discussion of diabetes presenting itself in so embarrassing a fashion.

Michael Powell
Eugene, Oregon

Editor's note: Thanks for your well-written letter. You make a good point but it is not an editing mistake.

We assumed when we put "basal" in the cover title and in the article sub-title, that we had been clear.

I'm glad we stated in the article "However, be advised that this does not mean you should only take one shot of insulin per day."

Those who take Lantus, plus eat three meals and take three meal-time shots each day will need to take four shots of Lantus a day. You can't mix Lantus in the same syringe with other insulins. Your letter shows us that there was confusion.

 

Does Eating Meat Really Cause Insulin Resistance?

In the article "Stick With Your Veggies," (September 2001, p. 19) researchers from the University of South Florida in Tampa say eating less animal protein and sugar may improve A1c levels in your body. That is interesting. But I would like to see another study where eating less animal protein and less sugar are studied separately.

I suspect that less sugar alone would have the same results. In other words, keep the animal protein and drop the sugar. The study of two variables at once doesn't seem fair.

Marge King
Walnut Creek, California

I have subscribed to the e-mail newsletter for six months. My father has type 2 diabetes and my maternal first cousin has type 1. As a mother of two, I am very interested in preventing the onset of type 2 diabetes in my own family. I believe that my own metabolism has been affected dramatically by the consumption of sugar as a child, and later in life I realized that I was feeling the effects with symptoms of hyperinsulinemia.

I knew that I had to stop eating sugar. I discovered endocrinologist Dr. Diane Schwarzbein and Suzanne Somers' eating plan and found that it made sense for me. I tried it and the benefits are astounding! It took three months to lose 20 pounds of excess fat that had taken me four years to accumulate after returning to a sedentary job. My peptic digestive system calmed down and my energy levels smoothed out, sustaining me at a constant level of energy throughout the day instead of having highs and lows. This eating plan eliminates sugar, all highly-refined carbohydrates and some very starchy vegetables. It says to eat only whole carbohydrates, but never in combination with fats or protein, and to eat lots of vegetables and fruits, but eat fruits on an empty stomach and alone. The theory is that eating more meat will boost the metabolism and meat will not trigger an insulin release.

I ask you to look at the research that supports this plan. Your article ("Stick With Your Veggies," September 2001, p. 19) summarizes research saying that eating less animal protein and eliminating sugar improves A1c levels and lowers insulin resistance. I question these findings in that researchers did not isolate only one change in diet. They made two changes — reduction of meat and elimination of sugar. How can they be sure that less meat alone helps A1c levels if sugar was cut out too? Research in support of Schwartzbein's plan would help consumers like myself know what substances to avoid. I think the sugar, not the meat, improved A1c levels in the study. I hope that animal protein does not stimulate insulin response. This would contradict the Schwartzbein/Somers plan, which claims that meat does not stimulate the secretion of insulin.

Suzanne Moreau
Victoria, British Columbia, Canada

Editor's note: We asked Joy Pape, RN, CDE, one of our advisory board members, to respond.

I, too, found this study very interesting. It seems to show the value of decreasing sugar intake and the amount of animal protein in the diet of people with type 2 diabetes. The problem with the study, as you state, is that there are confounding factors. Are the improvements in A1c levels due to a decrease in sugar or animal protein? This is not clear. We also have no information about exercise and other factors that affect insulin resistance like stress, medications and sleep. The suggestion of this study is good. I hope to see a study in the future that shows a transition in diet from animal to plant protein in isolation, rather than confounded by other factors like sugar intake, which can affect A1c and lipids.

Joy Pape, RN, BSN, CDE, CETN
Joy Pape Health Consulting
Columbia, Missouri

 

Correction

On page 28 of our September feature article, "The Diabetes Battle Cry—Get Your A1c," we accidentally referred to the A1cNow as the A1c At-Home. We apologize for the error.

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Categories: A1c Test, Blood Glucose, Blood Sugar, Diabetes, Diabetes, Food, Insulin, Lantus, Letters to the Editor, Losing weight, Syringes, Type 1 Issues, Type 2 Issues


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