Glucose Test Strip Accuracy Not Resolved

Will the Food and Drug Administration (FDA) actually do anything to insure quality in our test strips once they have approved them? Some people are hoping the FDA will take a stronger position and do more checking, but I certainly would not want to rely on this. I seriously would not even think they will do anything to enforce this. In the discussions to date, all they seem concerned about is the manufacturing plants and worry about how they will discover anything wrong with the test strips. This they claim because they announce that they are inspecting and the companies will be ready for them.


What I do not understand is why they must inspect the manufacturing facilities. Why isn't the FDA capable of walking into a pharmacy and purchasing a few vials of test strips and testing these? Oh, I had forgotten, this would cost money and the test strip companies are not putting up money paid to the FDA for continued certification. Therefore, the FDA will not likely do any further testing. Yes, the FDA will posture and say many things, but I seriously doubt any action will be taken.


It is easy for a FDA spokesperson to say, "Glucose meters have always been a priority for the FDA. This is an area that's complex, where lots of things happen… It's always been high on our list." Yes, Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health at the FDA did say this, but what does it mean? It just means that in the future, the FDA will seek assurances that the manufacturers will monitor quality control. With the attention drawn to strip safety, this is the preferred method of action. Notice how often this phrase “going forward” is used by all people speaking for the FDA. This is used to indicate everything is applicable... going forward, but means nothing in the present and is not a promise to do anything.


Katharine Serrano, diabetes branch chief, division of chemistry and toxicology devices, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH) at the FDA, is quick to dismiss studies by Roche Diagnostics. Her statement, “However, any decision by the FDA to pursue regulatory action or change policy in this area would typically be based on a review of multiple sources of information on the post market performance of these systems," means that they are brushing off the Roche studies. Bold is my emphasis.

Improving Type 2 in the Hospital

The more I read about diabetes management in hospitals the less I like the idea of having to utilize them. Some hospitals are better than others are, but all are inept in handling diabetes and maintaining management for diabetes patients. No, I did not make an exception – all are in one form or another inept.


The largest fault I find is the doctors and nurses do not attempt to find out from the patient what the insulin to carbohydrate ratio is that is used by the patient. This is a critical error and probably what drives policies of letting blood glucose levels stay in the 180 to 200 mg/dl. They generally do better for type 1 patients, but not for type 2 patients. I become so belligerent about managing my own diabetes that I am normally allowed to decide my own dosage based on the number of grams of carbs I consume after the fact instead of giving the injection before I eat or even see the food.


One time, I knew that I was not feeling like eating and was told that the carbohydrates for my meal was going to be 65 grams. I refused the short acting insulin until after I saw the food and knew I would only be eating about 15 grams of carbs from the tray. When the nurse started to give me the injection, I refused, as I could not see how many units of insulin were to be injected, and I was worried that I would have an episode of hypoglycemia. When I explained this to the nurse, she said that what she had would be injected and if I did not eat what was on my tray, I deserved hypoglycemia. And, I am to trust these people?


Yes, I called my doctor and the hospitalist and both were there shortly. After my explanation and the nurse's excuses, I was no longer hungry and said I did not feel like eating. My doctor was able to talk to me a little longer and supervised the removal of the tray of uneaten food. Just as he was ready to leave, back came the nurse with the syringe to give me an insulin injection. When the doctor examined the syringe, he laughed and told me to take it. After the nurse left, he said I know you calculate your dosage per grams of carbohydrates, but the nurse calculated it based on carb units so you should end up with a blood glucose level of about 120 gm/dl. After his office closed he came back to see me and measured my blood glucose and the reading was 116 mg/dl.


He in turn, called the head nurse and explained what had happened and that I was to tell the nurses what to inject. If they could not or insisted on their own calculations, I was to call him and then he would call the hospital administrator and the issue would be settled by the removal of a nurse if this would be required. The head nurse said she had complete faith in her nurses to calculate to correct amount of insulin so the doctor called the hospital administrated then.


The head nurse continued to back her nurses and the doctor and administrator put up a sign that I would calculate my insulin dose and they were to let me inject it. Instead of allowing me to submit my meal requests, the nurses took over this and every meal for the next day was about 80 grams of carbs or about 5 1/3 carb units. I still could not eat that many carbohydrates and refused. I was told that I needed so many units of insulin and the nurses would not bring any unless they agreed with me. The doctor said I was be discharged the following morning and to adjust as soon as I could. He was there early to get me discharged and once clear of the hospital, I took my blood glucose reading, which was 231 mg/dl. I injected my Novolog to my scale and drove home. Four hours later, I was back to where I wanted to be at 95 mg/dl and back on my schedule.


This leaves one more operation to undergo and I am still not sure where I will allow it to take place. I will be conferring with three doctors before I make up my mind and probably will be calling the new to me hospitals to find out what their procedures of diabetes management will permit and their guidelines are.

Should We Receive Lab Results From the Lab?

Obtaining our lab results directly from the lab and before an explanation from the doctor for translation has both pros and cons. I certainly understand the patient's perspective and wish the Department of Health and Human Services (HHS) would finalize the proposed regulations they released about two years ago - Federal Register Volume 76, Issue 178 (September 14, 2011). Two employees from the Center for Democracy and Technology have posted a blog on this topic on the Health Care Blog.


It is an excellent blog with some not so excellent comments and that is apparently one or two doctors that are real whiners. They are more concerned about providing free healthcare than translating the information for the patients. I may be fortunate that they haven't read my blog here. I have received an email from one doctor who could be in favor of the idea, but in general without legal safeguards would not support it. He agreed with my proposal and would add two additional safeguards, but did not list them.


In the discussion of releasing lab results directly to the patient, there is one thing in favor of not allowing this. A doctor recently blogged about being interrupted during Saturday dinner with his family by a patient that had received her lab test results the previous Tuesday. Granted this is very inconsiderate on the patient's part. In the blog, the doctor did not state when her appointment was to be, so no judgment can be made there.


That is one reason I think that doctors should have the right to designate who may and who may not receive lab results prior to an appointment. Many patients just use poor judgment and think they can call a doctor whenever they choose and the doctor has to jump to their beck and call. These patients should never receive lab results except during their appointment.


In summary, doctors should have the privilege of designating who should be able to receive the results when and from where. Those of us that are allowed to receive the results need to realize that doctors have office hours and act accordingly and not abuse the privilege if we are afforded receiving the results from the lab.


I guess I will never have that problem because I need to be at my doctor appointment at least 30 minutes early and have the blood draw for the results. Then at the doctor visit, I receive a copy of the lab results and the doctor's translation at the same time. For me this is great and takes care of the issue many are having about not even receiving a copy of their lab results.


Yes, I would advocate penalties for doctors that refuse to give patients a copy of their lab results with one exception. Mental health issues may dictate that the patient should not receive them and I agree. However, some doctors always feel that their patients have mental health issues when in fact it is the doctor with the mental problems.

Inaccurate Results from the A1c Test - Causes

Below is a simple graphic image of a red blood cell. One of the functions of the red blood cells is to carry oxygen to all the cells in the body. Hemoglobin within the red blood cells is the part that carries this oxygen. A vital part of the hemoglobin molecule is a fraction called hemoglobin A.



Glycosylation is the process of glucose binding to the hemoglobin areas of the red blood cells. Elevated blood glucose levels means more glycosylation happens.
A small, but measurable part of the hemoglobin A labeled A1 is formed when A is glycosylated. A further fraction of the A1 known as the hemoglobin A1c can also be measured. This A1c fraction is the area used for measuring the effective level of blood glucose management.


Red blood cells typically live for about 120 days, after which they die and are removed from circulation. New red blood cells are produced to replace those taken out of circulation. Therefore, at any given time, there are red blood cells that have just been born and those that are about to die. The average age for all the red blood cells present in the human body at a given time is about 2 months old, or half the total lifespan. Glycosylation occurs continually throughout the life span of the red blood cell. The amount of glycosylation of the hemoglobin depends on the level of blood glucose in the body, the higher the blood glucose level, the more glycosylation will occur.


Because the average age of the total pool of red blood cells is 2 months, the A1C measured represents predominantly, but not totally, the level of management during the previous 2-month period. This means that the higher the result of the A1c level, the poorer the diabetes management was during the preceding two months. Since the Joslin Diabetes Center follows the ADA guidelines, I can only suggest that what they advise should be adjusted for your own goals. Joslin says for any A1c 7.0% or higher, the treatment regimen needs to be adjusted. This is from Joslin's Diabetes Deskbook, Chapter 2.


Despite how much is dependent on the A1c test, there are conditions that cause inaccurate results. They include people with:
#1. Sickle cell anemia
#2. Women in early stages of pregnancy because the fetus produces its own red blood cells
#3. Recently had blood transfusions, many red cells have not been present the entire time in the patient.
#4. Splenectomy, which causes red blood cells to live longer
#5. Anemias, because many of the red cells can average younger in age


There are a few other conditions, which can cause erroneous A1c's, but in general, these are rare. Even with the above A1c problems, the use of the test is still a powerful tool in the battle of diabetes management.


For another view on the value of A1c and using the home A1c kit, read this blog by David Mendosa.

Cinnamon Back in the News

Again, cinnamon is back in the news. People just won't admit that there is very little benefit for blood glucose management long term with cinnamon use. There have been more studies, but even these have not proven any long-term benefits. There have been some short-term benefits, but to-date this has not translated into any long-term benefits.


The authors, researchers at Western University of Health Sciences in Pomona, California, who conducted the meta-analysis caution that the cinnamon supplement studies they looked at had been fairly short. Longer duration studies might show that cinnamon does have a positive effect on A1c.


What is not admitted is important. The funds for long-term studies are not available and probably never will be and small short-term studies are not yielding the proof of what the cinnamon advocates have claimed.


The best that can be expected to-date is this - “Now a meta-analysis of 10 studies of type 2 patients who have taken cinnamon supplements concludes that while cinnamon can have positive effects on cholesterol and blood glucose levels, it does not seem to have a significant effect on A1c levels.”


The opening statement from the abstract says, “Cinnamon has been studied in randomized controlled trials (RCTs) for its glycemic-lowering effects, but studies have been small and show conflicting results. A prior meta-analysis did not show significant results, but several RCTs have been published since then. We conducted an updated systematic review and meta-analysis of RCTs evaluating cinnamon’s effect on glycemia and lipid levels.”


Studies that are small have not proven valuable. This is also the conclusion of the abstract which states, “The consumption of cinnamon is associated with a statistically significant decrease in levels of fasting plasma glucose, total cholesterol, LDL-C, and triglyceride levels, and an increase in HDL-C levels; however, no significant effect on hemoglobin A1c was found. The high degree of heterogeneity may limit the ability to apply these results to patient care, because the preferred dose and duration of therapy are unclear.”


The full meta-analysis can be read here as well as the abstract.