Updated Hypoglycemia Classifications

That the American Diabetes Association (ADA) and The Endocrine Society would undertake this project says that hypoglycemia has been of greater concern by doctors lately. Five members from each organization were called together by the Chair, who is a member of both. A planning conference call was held before a two-day meeting at which staff from both organizations attended. The writing group used data from recent clinical trials and studies to update a prior work group report. Some conclusions were developed from expert opinion.

The new report reviews the impact of hypoglycemia on patients with diabetes and provides guidance about using this information in clinical practice. Because this was developed for clinical practice, I will not approach that side of it. As a patient, I have many reservations and concerns about the definitions and lack of understanding for patients to help them determine the severity of a hypoglycemic episode. This is where I feel the professionals are writing only for each other, and not to assist patients or to help educate patients. This lack of concern for education of patients is probably why I become upset. If, only if, they had taken some extra time to have expanded some areas, and include more information about hypoglycemia in the report, they could have also provided some excellent advice and guidance for patients. Believe it or not, many of us do learn.

The information is contained in PDF files and three can be found in this article. This link will take you to the Diabetes Care site as part of ADA where you can click on the Full Text (PDF) and download and read the data and background. The same link also has a slide set which you will need to click on and this will take you to a second page where again you will need to click on Slide Set which will open a window on screen to download a Microsoft PowerPoint Presentation (1.3 MB). The image below (slide 5) in about the consensus process and process of finally bringing it to publishing where we are able to read it. I felt this could be interesting. What is disappointing is that it is only nine slides in length. 

 

 

In the on PDF file Hypoglycemia Classification there are only four classifications given; however, in reading the full text file, it lists five classifications. All are determined with a measured plasma glucose concentration less than 70 mg/dl (3.9 mmol/l). Since this is for clinical use, I can understand the plasma glucose being necessary. However, most patients do not have the facilities to do this test, unless they work in a lab and take equipment home with them. So we use blood glucose meters and hypoglycemia is still for us a reading below less than 70 mg/dl (3.9 mmol/l).

The following are the five hypoglycemia classes:

#1) Severe hypoglycemia.

#2) Documented symptomatic hypoglycemia.

#3) Asymptomatic hypoglycemia.

#4) Probable symptomatic hypoglycemia.

#5) Pseudo-hypoglycemia.

Please read the PDF files if possible as the discussion contained in the “Full Text” file at the Diabetes Care site is more meaningful than the short PDF files in the like above from Diabetes-in-Control. I would suggest that many people have what is termed #5 above, except they may have heard it as false hypoglycemia. This often happens when people are newly diagnosed and because of medications (insulin and oral diabetes medications) are taking effect. Because your body has become used to high levels of blood glucose, when it starts dropping, this can cause these false symptoms of hypoglycemia. This is when testing can be important to determine the actual level.

Then the authors say some things that may be necessary, but could cause added expense to physicians. They claim that there is a need for accurate meters in the less than 75 mg/dl range for treating insulin patients. True, insulin can drive blood glucose levels down faster than oral medications, but even these patients need accurate meters. The authors then continue that those outpatients who are taking medications that rarely cause hypoglycemia don't need the more accurate meters. A lot on the judgmental side in my opinion.

The last issue that concerns me is the instructions for bringing blood glucose levels back to normal. This is included in the “Treating Hypoglycemia” PDF in this Diabetes-in-Control article. I have seen many people with type 1 diabetes blog about keeping juice boxes for treating hypoglycemia, but even they are not as fast a glucose tablets. The authors seem to prefer juice over glucose tabs as they list their preference as juice, skim milk, Life Savors candies and then glucose tabs or gel. I will give them credit for their instructions for glucose tabs or gel. They advise checking the package, because doses vary from brand to brand.

Not to dispute their “experts,” but I prefer the list at cardio smart and the order recommended.

Doctors and Insulin Equals Fear

When it comes to insulin, is it really the patients that doctors are concerned about, or their lack of knowledge. Possibly, it could be that their ability to threaten the patient is what would be lost. I would not put much importance in a doctor survey that was conducted for this study. I have much more respect for the doctor telling a patient what this doctor did and working with the patient to find a doctor willing to do insulin therapy and in this case an endocrinologist.

The excuses presented are not laughable, but must be taken with a grain of salt. This is a small survey of only 71 primary care physicians at York Hospital in York, PA. The authors say that 66% of the doctors felt that putting a patient on insulin would be too burdensome. Too burdensome for whom, themselves or the patient. The next statement really may be true to a degree, but to say that 97% of their patients would be willing to start insulin, if it did not involve needles may be an overstatement. I could agree if the patients only had that choice and possibly were not trying to get off oral medications because of the discoveries of potentially deadly side effects.

Then add to this a Canadian study which found that doctors are more reluctant to start their patients on insulin than the patients are themselves. Read my blog here about the study. The following statements I made in that blog are very applicable here and I repeat them.

What they found is that doctor's fears of common side effects such as weight gain and low blood sugar were amplified compared to their patient's fears, and that doctors were more concerned than their patients about the possibility of injection-related pain and anxiety. They also discovered that many doctors where only familiar with the insulins of past usage and older delivery systems. They needed to be reeducated about the newer insulins and methods of delivery.

Like many of us now using insulin, we find it much easier to use, if we use care and learn to use it properly. Instead of eating to a certain amount of insulin, we need to learn to count our carbohydrates and adjust our fast acting insulin accordingly. This will prevent most of the risk of low blood glucose and by limiting our carbohydrates; we can prevent the weight gain many fear. Exercise, if medically able is another way of assisting the prevention of weight gain.

I would guess that this is what drives many primary care physicians to make the statements they did and why they don't feel insulin is right for their patients. Put this with the author's statement of 69% of doctors saying patients would perceive going on insulin as a failure to manage their disease. Is this because the doctors use this myth to keep their patients on oral medications?

I admire Yiyi Yan, MD, PhD for stating, "We know that education helps patients in their use of insulin, but our study indicates that there needs to be more education of primary care physicians on type 2 diabetes management and insulin usage as well. We think concern about how they think their patients will react is the biggest barrier to initiating insulin." This sounds very reminiscent of the Canadian study.

Other statistics given by the study include:

#1) 88% agreed that insulin therapy has better effect on glycemic control than oral diabetes drugs.

#2) 75% agreed that early initiation of insulin could prevent diabetes-related complications.

#3) 88% said they were comfortable initiating insulin therapy among their patients.

#4) 53% reported that the different types of insulin products created confusion in prescribing.

#5) About 60% thought insulin regimens were too complicated for most of their patients to understand.

#6) Only 6%% thought insulin therapy should be managed solely by endocrinologists.

#7) 16% deemed insulin therapy too expensive.

#8) 38% felt insulin therapy was too time-consuming.

Additional author comments include that those who were uncomfortable with insulin therapy believed that education was needed. Many physicians disagreed with the necessity of maintaining tight glycemic control. Although the authors state that experienced primary care physicians were more aware of guidelines and were more comfortable with insulin initiation, I am still concerned that education is needed for PCPs and especially education on the myths they still believe and follow.

Please take time to read this blog by Jan Chait at Diabetes Self Management. She uses her personal experience and the study to relay some excellent advise.

Discussion on the AACE Algorithm Shortcomings

The American Association of Clinical Endocrinologists (AACE) diabetes algorithm has been out about two months and in my meetings with different doctors that have diabetes patients, acceptance is less than favorable. One doctor even said he would not be using the Garber algorithms – calling them too restrictive. Two other doctors just stated they preferred the American Diabetes Association guidelines. Some doctors (four) have refused talking to me and several (six) would only make comments through their staff. All six were very negative about the algorithms. Even my own diabetes clinic will be using parts of it and using the ADA guidelines in most cases.

After our group meeting on the algorithm, we have tried to expand on the items not covered by the AACE algorithm. We may be mistaken or reached a little, but the following is the list we have come up with. The first items are definitely missing and what we see as patients.

#1. We agree with Wil Dubois that depression or a person's psychological state was totally ignored and we have to wonder if they were truly thinking about the patient.

#2. When Tom Ross listed exercise in his blog, we could not help but agree with him. Apparently, they don't consider exercise as a lifestyle change deserving attention.

#3. Apparently not starting on medications is not an option for these “experts” as this was not even mentioned.

#4. To go along with number 3 above, there is no provisions made for starting on medications and when lifestyle changes show excellent management, allowing the patient to stop taking medications.

#5. We all agreed that the “experts” had passed on prevention during prediabetes or even during early onset of type 2.

#6. We also were in agreement that they felt from prediabetes through diabetes that the “experts” were declaring diabetes as progressive and even the complications could not be prevented. This no hope attitude is depressing by itself.

#7. On the cardiovascular algorithm page, no alternatives for changes to prevent taking statins and blood pressure medications or circumstances of stopping them.

#8. There is very little clinical research available to support proper treatment of the elderly and the young. Therefore, for the majority of people with type 2 diabetes, it is still guesswork with no clinical evidence to support clear treatment paths for the elderly.  This is ignored by the algorithms..

#9. The final point that was evident to us was no route to stop oral drugs and go directly to full insulin therapy. There could be a lot of medical reasons for this to happen, but the “experts” chose to ignore this

The next points are by Anne L. Peters, MD, CDE, Professor of Clinical Medicine; Director, Clinical Diabetes Programs, Keck School of Medicine, University of Southern California, Los Angeles, California. Dr. Peters is well qualified to make the statements she makes. She does carefully word one point, but implies that the algorithm is not as peer-reviewed or vetted as other guidelines. She was involved in the ADA/EASD (European Association for the Study of Diabetes) guidelines published in April 2012 and knows the process they went through for approval.

Her list of shortcomings includes the following:

#1. This algorithm is somewhat confusing without text.

#2. The authors have eliminated hemoglobin A1c as part of the diagnostic criteria for prediabetes.

#3. The authors don't describe in much detail how to decide when to treat somebody with prediabetes.

#4. The algorithms go through profiles of the different anti-diabetic agents, but they don't include costs. In many practice situations, cost becomes important and is something we need to consider, particularly as we look at the burden that we are giving our patients with these different medications, some of which cost a lot.

#5. Then they suggest adding prandial insulin, but it is added in 3 split doses before breakfast, lunch, and dinner in a 50/50 ratio between basal and bolus insulin. (My note:) This means generally that the same number of carbs are consumed at each meal.

#6. They didn't list the practice settings of the authors or disclose any of the potential conflicts of interest. That is important to know as we try to make sense of where these algorithms came from and how they were developed.

#7. Individualizing targets is important, particularly in patients with longer-duration disease, more comorbid conditions, and increased risk for serious sequelae of severe hypoglycemia.

When Dr. Alan J. Garber, AACE task force chair, states, "The word that describes it is truly comprehensive," I would be in disagreement with him and say it is far from comprehensive for the medical community and the patient community. The algorithms are aimed at the patient, set targets for the patient, and put the patient in the algorithms with no hope of escape. Individual management of diabetes is prohibited and the patients are supposed to be compliant according to Dr. Garber.  How can we follow doctors orders precisely when the doctor has almost no supporting clinical evidence, especially for the young and the elderly.

To this, I say BS and let him keep his algorithms. I want a doctor that will work with me, individualize my progress, and assist me when I hit an area that is causing me problems. I wish to choose my management priorities with guidance from my doctor and not some restrictive algorithms.

If you have not read them and wish to read them, you may download the PDF file by clicking on this link.

This will allow you to download the PDF file or the Power Point Presentation format.

More Activities of Our Diabetes Group

The last six months have been very active for our group. We have gained and lost members, resulting in now three diabetes support groups for type 2 diabetes. I am very happy with our group now as we do have some organization and the biggest improvement has been the membership committee. Tim did an excellent job of establishing criteria and naming the members.

First, we will only accept type 2 people with diabetes and those with prediabetes. We have one exception for a high school type 1 to attend from time to time and that is Lilly and her parents. Everyone has now met Lilly. Max was the one that introduced her at our last meeting. Lilly is a member at large and presently the only one that will be allowed. Next, we will try to screen our members based on the criteria.

Tim announced that we now have two meeting places that are available to us with a weeks notice since we generally meet on Saturdays. Both will hold more members than we imagine having. All we have to do is notify them of our meeting and they will be unlocked for us. We must keep the rooms clean and notify them of the people using the room after each meeting. Tim has written letters stating what we understand and thanking those responsible for permission to use them.

What has been a surprise is the number of our members participating in speaking to the group in a town east of us and participating in peer-to-peer education of their members at their doctor's request. He had asked us to host his group with our local doctor working with us and brought over three vans of 13 patients of his to attend one of our meetings. Tim and Barry went to work with several of us to round out a program and include the program that Barry had presented to us. Tim asked if they could bring any portable computers they owned, and we would supply heavy extension cords for power. This worked very well and when we finished the program, the doctor asked if it would be possible to have two more meetings this year together, one in their town and another here. He felt that everyone learned from us and this led to a round of applause by the visiting group.

This was followed by about an hour of questions from them and this pleasantly surprised us and they were asking how we had stayed together as a group. Jason took the lead and said that each of us have email addresses for the other members of the group. When there was an interesting article or an article like the study on Januvia and Byetta, someone would make a comment about it and email it to everyone. This is also in one of my blogs. If questions came from this, the originator would restate the question, and he or she would send out an answer. Others might make comments if they had thoughts about the topic. We were asked what would happen if someone disagreed with what was being said. Jason answered; the disagreement would be stated and acknowledged. No one person was put down for disagreeing and if someone slipped on this, and then the person would be told so by probably everyone. This has only happened once that he could recall and the topic was very controversial to begin with anyhow. He stated that Tim and I had moderated the emails as the group had been almost evenly divided on the topic.

Then Sue said one thing that helped her and her husband Bob was that fact that two or more emails would be generated for each meeting and emailed to anyone absent. This was another reason we felt so close because we had permission to be absent and were kept in the loop. Sue then got the question she had been expecting. Why was she still attending since she was off medications. Sue answered that because she had support from the group when she most needed it after her diagnosis with type 2 diabetes. She felt a loyalty to the group and we had continued to support her and encourage her to stay off medications. She said diabetes is a battle by itself and to get the support she did from the group, she could not and would not abandon them.

Then her husband, Bob spoke up and asked how many had heard of the diabetes police. Almost every hand went up. Bob said this is another reason they were as loyal as he now had prediabetes and was still on metformin, but hoped to be off before long. He continued that he was the one that outed his wife as having diabetes because she had been the diabetes police to the group before diagnosis. He said he had wanted the group to give her payback, but that no one had. She was asked to be part of the group and was given support and encouragement that did not quit. He said how can you not be loyal to a group that does this for you. He continued that when he was diagnosed with prediabetes, he was welcomed into the group and was also receiving support and encouragement to get off medications. He said this support was verbal and in the form of emails about anything that might be helpful in their goals. This meant URLs for articles and studies showing what was possible. He concluded this support was done for all members by all members and even though most are on insulin, they still have concern for each member. He said this creates loyalty that can't be ignored.

I was then asked if the group gave me blog topics. I said they do, I am not expected to use every one, but some are good topics and others are off of diabetes directly, but are of interest. If they are of enough interest and can be tied to diabetes, I often blog about them. I said this has been most helpful and sometimes I just use these as topics for emails to everyone. I said that occasionally I am even supplied with the full study when the member can write and ask for a digital copy. This is then passed to the members to read as well. I commented that some of the topics are used for our meetings. I said the one part of the program this evening was used in a previous meeting and that I had blogged about it. I said some of you may have read it and were wondering why it was included. We added material to keep us on topic and still get everything across. One hand was raised and he said that it was significantly different, but well presented. He commented that the comments by our members did add value. Tim said this is what we do in our meetings. He admitted that sometimes we go off topic, but if it adds value, we let it happen. If it does not, it is stopped and we stay on topic.

Their doctor then spoke and said this is why he wanted a meeting like this so show them why he hoped they could develop into a group like this. He said that this may be hard to beat, but he still had hope. He said that the amount of research we do as a group may not be possible. He then asked our group how many actively do research and 11 raised their hands. Rob said he did not do a lot of research, but did read quite a bit and still sent out emails about different articles and press releases. Brenda commented that she did not because of grandchildren, but that she was happy to be the recipient of information from the rest of us. She felt that what she learned in the meetings and received in emails, kept her loyal to the group. She continued that like had been said before, even missing a meeting, she still was kept in the loop by emails.

Tim said we would be happy to have one meeting with them and have them back again. He was the contact person. He would let them know when, after receiving their schedule. We concluded the meeting then.