Diabetes Tests, What Is Wrong?

The American Society for Clinical Pathology (ASCP) is going after doctors and endocrinologists while not pointing the fingers totally at themselves. Labs are not always giving the proper ranges of what the test results mean, especially in the area of HbA1c. There is plenty of room for criticism on both sides, but for one profession to point the finger at another profession seems like the wrong way to get cooperation.


Although I don't think that the HbA1c test should be a monthly test, if the Society of General Internal Medicine (SGIM) holds to their “Choosing Wisely” tactics, then I think that the HbA1c tests should become mandatory on a monthly basis. Some people with extremely well-managed type 2 diabetes are currently using the home HbA1c tests on a monthly basis and very seldom see a doctor. Read this blog on Health Central by David Mendosa about the fate of our home HbA1c test. And, to see why I would recommend monthly HbA1c tests if the SGIM continues on their ill-advised campaign.


In the study findings presented at the ASCP 2013 Annual Meeting lead investigator Ross Molinaro, PhD, from the Emory University School of Medicine in Atlanta stated, "We're hearing about overuse of this test, but even when it is used appropriately, the result may not be. Of the less than 20% of patients with diabetes who meet the nationally recommended frequency for glycated hemoglobin (HbA1c) testing, more than a third are not prescribed treatment changes when their levels increase significantly.”


They then use the American Diabetes Association (ADA) and I am guessing the American Association of Clinical Endocrinologists (AACE), even though the author of the article uses the term “other organizations,” recommend that the HbA1c test be performed every six months for people in the target range. Then the article continues that if the person with diabetes is not in the target range or if their therapy had changed, that the HbA1c test be done every three months.


Even if Dr. Molinaro says, “The survey results show that endocrinologists are unclear about what constitutes a statistically significant reference change value and would find that information useful; I might believe that the questions may have been twisted to elicit this response. My conversations with endocrinologists lead me to believe that they do understand what a statistically significant reference change value means but maybe those surveyed do not keep records to compare current results to past results.


At least Dr. Molinaro puts his organization on notice that they need to do more when he states, "Our study suggests that better communication between the lab and the clinician is needed on when to follow up with a patient who has a significant change in HbA1c. I think the onus is on the lab to find a better way to communicate test results."


ASCP president-elect William Finn, MD (not involved in the study) said that it is possible the study data does not give a complete picture. Still, the study highlights a well-known issue; however, the information given to the clinicians needs to close the process to be sure the physician is counseled on what the test means. At least the ASCP incoming president understands that the significant change in HbA1c results should apply to other laboratory test.

Reference to My Blog of May 8, 2013

It has been longer than I thought, but finally the person I blogged about in this blog has received her notification letter and had her appointment with the VA. She apologized for not returning my email sooner, but she had her appointment almost immediately after receiving her notification letter. She needed to coordinate with her endocrinologist and her VA doctor to get the correct amount of each insulin and was happy that her doctor worked so well with the VA.


In addition to her insulin, she received a flu shot and was advised to have a Vitamin B12 shot because she was deficient. They suggested that she should have the endocrinologist check her in a month and give a second shot if needed. She said she had read one of my blogs about Vitamin B12, but could not find it. She remembered that it listed some of the sources of Vitamin B12. I sent her the URL and in the return email said she could eat some of them, but did not like liver, kidney, sardines, salmon, and was lactose intolerant.


I said that she should talk to the endocrinologist about taking Vitamin B12 supplement and she said she would. Then she talked about her VA benefits and thanked me for pushing her to get the paperwork in. She said what I knew about the help of the Veteran Affairs officer and that made everything go very smoothly. Then she thanked me again and wished she had contacted me earlier as this would have helped with the oral medications as well.


She said she had been to her doctor and he had a copy of the VA test results now. She commented that she was surprised that he had advised her to take a daily multivitamin after looking at that page. The next question I had correctly anticipated as it was about statins. She did include the results of her lipid panel and they were within range, but near the high side. She did ask if she could avoid statins as she had been reading some of my blogs and other sources and had discouraged the doctor this time.


I sent her several URLs about them and the troubles women seem to have with them. I would only say that my thoughts were similar to the articles and that she did need to have a good talk with her doctor if the lipid panel showed an increase at her next appointment. I told her that only her doctor that knew her history was qualified to advise her. She did say that she had asked because she knew I would give her something to read and said they had answered many of her questions.


We will be staying in contact, but I doubt I will blog about her situation unless she raises some issues that should be blogged about.

Meeting with George

George asked Ben to bring him to see me on Sunday. He had many questions on several blogs and said he had followed the links, but still did not understand the meaning or the importance. He had the titles, so I found the first, which was an early blog listing different book titles. I asked what the problem and he said most of the books are several years old and why would I push them. I told George I was not pushing books. I said I found them helpful at the time and felt that if people wanted to buy them, that was up to them.

Since I had the books on a shelf, I reached over, took each one down, and let George look at them. He asked if he could borrow one and since I had two copies, I said yes. Then he asked for another and I asked him if all he was going to was read all vacation. He admitted that he planned to take them home with him, and I admit I thought about it. I asked if his library might have a copy of both and he knew that they did. I said no then and asked why he could not get them from the library. He said he did not like the area where the library was located. I asked if city buses went by the library and he said he had not thought about that and it would work. I then asked if the city had a branch and George lit up with a big smile and said only eight blocks away.

I then asked George why he had not thought about that. He admitted he had not really thought about using the library, but had called to find out if they had certain diabetes books available. Then he relaxed and admitted he didn't mean I was pushing books, but wondered if I actually had them. I surprised him when I asked what was the real reason he was seeing me. He hesitated and I pushed a bit, telling him to spit it out so we could discuss it.

He fumbled for a bit, looking for the right words. Finally he said, you don't hold back much on topics and make some hard to swallow statements. I said this is my writing style and I think Barry and Ben will agree. I don't follow the teaching of the ADA and other organizations and I think you can understand that. I continued that I have my beliefs and at the same time to not say you have to follow them. George said he agreed with that, but some of the words I used really upset him. I had guessed that it probably was being your own lab rat in experiments. I could see George wince so I knew I was right.

I laughed, and said that is my way of telling you to experiment and gain knowledge from the experiments. Since you cannot experiment on anyone else, you only have yourself to experiment on. George then stated that is the reason for saying what works for you may not work for me. I agreed and said another saying is “your mileage may vary.” George admitted this he did not follow. I said when Ben or Barry, or anyone else of our group says that something works for them and tells you what they do, you may not obtain the same results. Therefore, the result (mileage) may not be the same for you. George said the two sayings are all but equal. I grinned and said yes.

I said some people prefer one way of saying something over another and if you go to any of the diabetes forums, you may see both. George said he had and wondered what was meant. Now he said he has a better understanding and the two ways won't have him shaking his head when he sees YMMV. I agreed this should help him and that when he thinks of a bell-curve and several million people representing the curve, this should indicate that you could be very similar to many people, but if you met them, you may wonder how they could be so close to you. Each person varies in their abilities and the way of getting to almost the same result that it makes you wonder.

Next, George asked me to open a couple of blogs and we started with this one. George said even though he has had diabetes for almost a year, if he had not come to see his friends, he probably would not have the management skills he is acquiring. He said this blog hit home for him and even though he does not like being a lab rat, the rest of the points made him take notice and realize what needed to be done. George continued that for the first time since diagnosis, he could say that he was finally accepting his diabetes and being on insulin has been a real challenge. He said the endocrinologist he is seeing now really works with him and he has asked a lot of questions and received answers to all of them. He continued that going from an A1C of 11.3% to 7.4% in seven weeks was a shock to him, but his new doctor said he may be at 6.0% or less, if he continues to learn.

I congratulated George for that and said that all of the support group should know about this. George said that if it was not for his friend Barry, he might not have been able to achieve this. He said that with the help of Barry's friends, he has learned more about diabetes than he planned on learning, but it is all for the best. Then George said he would be asking to remain on the email list. I said this could continue to help him and then he mentioned this blog and asked me about other things that could create variances. I said that there could be other variances, but that I had listed the main points.

George stated he had asked his new doctor about the internet and he had said to be concerned about poor sites and sites promoting cures. So the second time he had opened it up for the doctor and he had read it. His only comment was that I had more variables than he had thought about, but it was good. George said he had one more, but the doctor said not this time and then gave him his home email address on the condition that he not abuse it. George said he had sent him one on Thursday and telling him he had two more URLs to two more of my blogs and this would be it for now as he was leaving Friday for Iowa. He also told the doctor that unless he found something wrong, not to answer the email and this would be the last until he came across something that puzzled him. For medication questions, he would call the office.

I told George that was good and if he could establish a good communication, not to abuse the email privilege. George said that at the first appointment, the doctor had sent our letter to the insurance company for reimbursement of extra test strips and they had agreed for four months and then it would be back to three. He says that he hopes that with the VA approval he will be able to obtain more test strips. I said that should be possible and he would not need the insurance, but could use them for the three if needed. George said that was the plan as Medicare would only cover the three and he would be on that in another month.

At that point, the doorbell sounded and Barry was there to get his friend. We talked for a while and they left with George saying now that he knew where I lived, he may be back. I told him to call first in the event my wife and I were shopping or busy doing other things. George said he would and would get the phone number from Barry.

Communications With a Doctor

The Monday following our meeting with the doctor that Jason knew the family, I received a long email full of questions. I knew from some of the questions that he had been reading and I would need to respond. His first question was why we would not meet with certified diabetes educators (CDEs) and registered dietitians (RDs). He did comment about my interview with Adele Hite and said this means at least you follow one RD. I admit I follow several and mainly those that do not completely agree with the national organization. Then I pointed him to several blogs that point out the failings of the national and state groups and how they are working to criminalize other nutritionists that are not members of their organization. Also on the list of links are several blogs that show how the Academy of Nutrition and Dietetics (AND) is tied to Big Food and working to become the only source for nutrition information.


Then I answered his question about CDEs and stated that in general they do not feel that type 2 should take any of their time and especially those on oral medications. I gave him several links about this and how they seem to run away from patients needing help with depression.


His next question was why we don't follow the pronouncements of the American Diabetes Association (ADA). For me this was an easy question. I did send several links, but said that the ADA way as well as the AACE did nothing to encourage patients to take charge of their diabetes and prevent it from getting worse and the complications becoming part of the treatment. The fact that both organizations had leaders that did not think testing for those on oral medications was important except of the A1c test quickly soured us on their teachings.


I then stated that when the two organizations stopped putting out information that promoted progression of diabetes and started working with patients to show them that diabetes did not have to be progressive we would consider respecting them. Then I said that with the conflicts of interest existing in both the organizations and the officers behind the guidelines, we had no reason to respect anything coming out of the ADA or AACE. Then when the Society of General Internal Medicine (SGIM) chooses to follow the advice of the officers of both and recommend stopping testing for those on oral medications, even they lose our respect.


There were several more questions, which I will only answer to him, but I know that he will have more questions. Jason said he received many of the same questions and said he agrees with my answers and hopes that the doctor understands what we have said.

Doctors/Patients Delay Diabetes Treatment Intensification

Apparently, UK doctors are similar to US doctors in taking care of diabetes type 2 patients. The same applies to patients in both countries. It is no wonder we are facing a diabetes epidemic.


Doctors are afraid to intensify diabetes treatment, and patients are not doing anything to manage their diabetes. Both the doctors and patients need a good kick in their posterior and even then, I have doubts about how effective this would be. Doctors are fearful their patients may have episodes of hypoglycemia and this keeps them from intensifying treatment. They also believe diabetes is progressive and many feel like - why waste money on these patients.


Patients by contrast, go to the doctor for more medications and expect the doctor to manage their diabetes. How naive patients can be. I have heard many of the excuses offered by patients and this tells me they are looking for that one pill that will allow them to return to their life, as they once knew it. A couple of these excuses are, “my blood sugar is out of control and nothing my doctor tells me will fix it” or “my doctor isn’t listening to me when I say my medication isn’t working.” Do these really sound like the patient has taken ownership of their diabetes? Hardly, these excuses sound to me like they expect the doctor to manage their diabetes and it isn't happening and won't happen.


Doctors and patients both need to reconsider their positions and act accordingly. The doctors know from the A1c that the patients are not managing their diabetes. The patients are refusing to take ownership of their diabetes and expecting the doctor to manage it for them. I can only advise patients to take ownership of their diabetes and learn how to manage their diabetes.


#1. Stop expecting miracles from the doctor. Your A1c tells them how you are managing your diabetes and gives them concern that more medications will not help.
#2. Start educating yourself about diabetes – start reading and acting like you should by changing your lifestyle habits. See my blog here about the lifestyle changes that you can or should manage.
#3. Find someone that is managing their diabetes and ask for their help. No, I did not say do what they do, as this may not work for you. Learn how they manage their diabetes and try these ideas, but don't become tied to them as something may work better for you.
#4. Develop a food plan that works for you. If you are able to afford the extra tests strips, test more often and learn to trust your meter as it will show you what works and does not work in a food plan.


Remember, the diabetes is your diabetes and you must manage it. The doctor can offer suggestions, but you are the only person that can put the suggestions into practice.

Sub-Classes for Type 1 and Type 2

This study heightens the need for sub-classes not only for type 2, but also for type 1. When I first blogged about sub-classes for type 2 diabetes back on August 5, I expected to have a lot of dissension, but received none. Now I am seeing others promoting this possibility, but no one is actually saying classes, but phenotypes of diabetes mellitus in relation to their immunological, metabolic and genetic profiles. I admit I like the term sub-classes, but I will work with a technical definition.


“The DiMelli (Diabetes Mellitus Incidence Cohort Registry) study examines the frequency and characteristics of diabetes phenotypes in children and young adults below the age of 20. The study was commissioned to investigate the increasing incidence of diabetes mellitus, particularly in childhood and early adulthood. The project is funded by the German Center for Diabetes Research (DZD). Bioprobe measurements were performed centrally by the Central Medical Laboratory (LMZ) at the Helmholtz Zentrum München (HMGU) so as to guarantee the high quality and comparability of laboratory parameters. The study is based on the DiMelli Bavarian Diabetes Register, the only register of its kind in Germany, which collects data on biological parameters in the blood of newly diagnosed diabetics as well as their phenotypic characteristics, i.e. their physical symptoms and features.”


I quoted the above to give some background that we are talking about children and young adults. Yes, I do think this type of study needs to be undertaken for all ages. This could be a boon to driving research in the right direction for the different age groups. A blog published on September 24 covers some of the findings for the elderly and shows at least two sub-classes.


The one idea from the discussion that really drove the above home for me is that the youth are generally type 1, and yet there are increasingly more type 2, and possibly some that are type LADA. With the growing number of youth developing diabetes, this is an area needing more study.


The authors conclude that the latest scientific findings no longer support such a rigid classification of diabetes. Rather there appears to be a continuum of forms and a mixture of diabetes phenotypes. In order to be able to introduce the right steps in treatment and to offer patients accurate information about their disease, it is essential to refine the criteria for differentiating and diagnosing the different forms of diabetes. Further studies are now needed to shed light on the long-term development of the phenotypes, the distribution of different types of diabetes, and the way in which their features present themselves in adult patients. This is required to provide more clinical evidence for physicians to use.