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The cover headline of your May article ("Stomach Stapling, Some Are Turning to this Last-Resort Surgery to Lose Weight and Cure Type 2 Diabetes,"), stopped me in my tracks. Good Lord, I thought, they went and found a cure for diabetes and I hadn't heard anything about it!
I have referred my patients to your publication as an informative, legitimate source of diabetes information. I now, however, have some misgivings. On one occasion in the article, a statement was made by a supposed professional (an MD) that this procedure cures diabetes. Hidden well within the article (on page 37) was the truth, a quote by researcher Dr. Poires, MD, of Greenville, North Carolina, who said, "The operation provides long term control of diabetes"—control being the key word here. Weight loss—achieved in any way—controls diabetes. I shudder to think of how many calls from patients I will be getting next week asking me about this procedure and if they are candidates. I am glad that the patient featured in the story, Ms. Badler, is now in a healthier state. I can only hope that her caregivers informed her that if she begins binging again (the article didn't indicate if she was being counseled for her eating disorder) and if she gains her weight back again, her insulin resistance will rear its ugly head again. Unfortunately, I failed to see that indicated anywhere in your article.
Jo Colville BSN, MA, CDE
Bay Medical Diabetes Center
Panama City, Florida
Editor's reply: Your point brings up the question: if someone goes off all diabetes medications and attains normal blood sugar levels after receiving bariatric surgery, does the surgery offer "control" or a "cure?"
Robert Brolin, MD, who stated that the surgery provides a cure for diabetes, is a well-respected doctor and an expert on the topic—he performs approximately 300 surgeries annually and has been conducting the procedure for the past 20 years.
In regards to who can get the surgery, we stated that a patient needs to be 100 pounds overweight to even be considered for it. And we devoted significant space in the article to discussing the risk factors, the importance of adhering to doctor's instructions and following a strict dietary regimen in order to maintain good health on a long-term basis after receiving the operation.
Results of Inhaled insulin Research Questionable
I read with interest your article "Alternative to Injections" (May issue). I had previously read the original research in the February 6 issue of the Annals of Internal Medicine regarding inhaled insulin.
The report in Diabetes Health gives the impression that the only variable in the study was the inhaled insulin. The researchers selected only 26 people for the study. The patients had been taking two and three injections a day for about a month. Before the trial began, the patients "were instructed on a weight-maintenance diet; performed home-glucose monitoring; assessment of glycemic indices, and a standardized meal study," as stated in the Annals article. According to the Annals article, the patients were also hospitalized for two days and instructed in self-administration of inhaled insulin. It also went on to say that, for each patient, glucose records were reviewed weekly. If the target range was not met, adjusted insulin dose was recommended.
While inhaled insulin may have improved glycemic control, it may also have been the meal plan, the weight maintenance diet or the weekly adjustments of the insulin dose. To imply that it was only the inhaled insulin that improved the glycemic control makes one question the validity of this research. Inhaled insulin sales will be driven by patient demand, but patients shouldn't necessarily expect "significantly improved glycemic control" from inhaled insulin alone.
Alan Shields, BSN, CDE
Editor's reply: Thank you for your comments regarding research on the effectiveness of inhaled insulin. We appreciate your insight. The study's authors stated, "Inhaled insulin significantly improved glycemic control," but your observations show the flaws in their summary. Several companies have spent well over $100 million to develop this product, which, unfortunately hit a recent snag. The latest news about the device involves a case of pulmonary fibrosis, or scaring of the tissue in the lung. See coverage on p. 21 of this issue for further details.
Standardizing the HbA1c Test
The HbA1c test is very important to monitor and treat diabetes. There is, unfortunately, only a minimally effective effort made to standardize what a normal HbA1c level is when reporting about it in Diabetes Health.
I recently ran an informal, unscientific poll in the misc.health.diabetes newsgroup about the standardization of a normal HbA1c level. Only two out of almost 50 respondents receive their HbA1c values compared against the standardized DCCT normal range of 4-6%. Assuming my survey reflects reality, this means that only a few percent of people with diabetes can compare their levels to the reports and recommendations that use the DCCT normal range as a standard. What's worse, most people with diabetes do not understand this situation. The standard target value for HbA1c that is quoted most often is 7% in DCCT terms. Someone who reads such a recommendation—and whose laboratory test is in a 5.5-7.5 normal range—is reaching for a pretty tough standard. If they are injecting insulin, they are also dramatically increasing their chance of experiencing severe hypoglycemia.
Diabetes Health should always report the normal range of each and every HbA1c level when it is mentioned in a story. This practice should be become a standard format. If HbA1c is the primary topic of an article, you should include a couple of sentences addressing the lack of standardization of the normal range and what that means to patients.
San Diego, California
Editor's reply: You couldn't be more right. We agree that the normal range should be standardized. In addition, we will endeavor to report the normal range when it is possible in the future. Unfortunately, much of the research we report is provided without this information. In such cases, we will point this out.
There are additional issues surrounding the complexity of standardizing HbA1c results by the scientific community. We asked Art Williams, BS, of Diabetes Technologies in Thomasville, Geargia, to further clarify this point. His response can be found below, after the following question we received about the importance of the HbA1c test.
Could you please expand on the significant differences between HbA1c and GHb? It sounds like GHb would be a more valuable test, but in what way? Is it a three-month reflection of blood sugar and insulin levels?
Calgary, Alberta, Canada
GHb is the result of glucose (G) being bound to hemoglobin (Hb) to form what is known as glycohemoglobin (G + Hb = GHb). Nomenclature used to describe the reaction include: glycohemoglobin, glycated hemoglobin, glycosylated hemoglobin, A1 and A1c.
The method used to measure the GHb reaction determines its nomenclature and/or expression i.e., HbA1 (earlier clinical expression), Total GHb (all glucose adducts), Total A1 (A1a, b, c) and specific HbA1c fraction. The comparative method for measuring glycohemoglobin is the DCCT (University of Missouri) method. The DCCT measured over 75,000 glycohemoglobin samples during its eight-year trial.
To date, 13 separate manufacturers methods are used to measure glycohemoglobin. According to the American Diabetes Association (ADA), "Proper interpretation of HbA1c test results requires that health care providers understand the relationship between test results and average glucose, kinetics of HbA1c, and specific assay limitations."
Compounding the confusion surrounding the glycohemoglobin issue is the fact that none of the big three national reference testing laboratories performing the bulk of glycohemoglobin samples in the U.S. are NGSP certified by the National Glycohemoglobin Standarization Program (NGSP). In fact, only a few (less than five) out of the current 5,000 . 7,000 plus labs are certified. Having an NGSP certified method run in a non-NGSP certified lab is meaningless. Both need to be certified to gain optimal results and meaning.
Clinical use of glycohemoglobin as a differential diagnostic tool for the diagnosis and assessment of diabetes mellitus and glycemic control is being recognized by many scientists. Since he test can provide an accurate average of the glucose concentration in the body over the past 90-20 days (reflecting any abnormal glucose concentration). This test can be of clinical significance relative to diagnosing type 2 diabetes and/or impaired glucose tolerance (IGT), often times associated with postprandial BG excursions not typically detected through fasting blood glucose tests. The issue of assay method sensitivity and specificity (less than 2 %) will become increasing recognized. Currently there are no ADA standards that relate the diagnosis of diabetes or IGT to a specific glycohemoglobin level. In addition there are no ADA standards to relate a specific mean blood glucose (MBG) equation to a specific level of glucose. Both need to be studied for adoption to standards.
Arthur G. Williams, BS
Chief Scientific Officer
Diabetes Technologies, Inc.
Editor's note: We also asked Peter Lodewick, MD, of the Diabetes Care Center in Birmingham, Alabama, to share his perspective on this issue.
Actually, HbA1c is the better test of the two. As you are probably aware, hemoglobin is contained inside red blood cells, which lasts about three months before new cells replace it. While hemoglobin is contained within the red cells, glucose attaches reversibly followed by irreversibly to create the hemoglobin forming "glycohemoglobin."
There are varying types of glycohemoglobin in red cells. The most common type is the hemoglobin A1c, or HbA1c, which, in most people (except patients with sickle-cell anemia and a few other conditions), consists of more than 94 percent of all hemoglobins in the body. The DCCT used HbA1c as a way of measuring the degree of one's blood-sugar control. Depending on the amount of glucose in the blood over a three-month period, the greater the hemoglobin A1c will be, as indicated in the following chart:
Ideally, a person's HbA1c should be under 6%, but that level is very hard for the majority of people with diabetes to obtain.
Peter Lodewick, MD
Diabetes Care Center
Correction: Please note the following correction in the feature story "Stomach Stapling, Some Are Turning to this Last-Resort Surgery to Lose Weight and Cure Type 2 Diabetes," May, p. 35. The sidebar on liposuction mentioned that Dr. Sharon Giese, MD, will be conducting a study being funded by the National Institutes of Health (NIH) on the effects of liposuction on obese women with or near developing diabetes. In fact, the NIH is conducting the study independent of Dr. Giese. Dr. Giese will be also conducting similar studies, but they will not be funded by the NIH.