Why Oral Medications First?

It is seldom that I think that the people making comments are more knowledgeable than the author of the blog, but this blog site seems to be more this way the longer it stays in existence. I say bravo to the people good enough to make comments to a decidedly lackluster blog.

The question is why insulin is only considered after oral medications are shown not to work any longer. All we need do is look back at the April 2012 American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) hyperglycemia guidelines for an answer. Tom Ross blogged about it here and later I blogged about it. In addition, this has been part of the ADA guidelines for several years. They want oral medications used until insulin becomes necessary for type 2 diabetes..

Then if you add to this, the threat of insulin that doctors use to keep patients on oral medications, it is easy to comprehend why diabetes becomes progressive. Insulin should never be use as a threat and as a medication of last resort. This is the reason I enjoy listening to and reading information put out by Dr. William H. Polonsky of the Behavioral Diabetes Institute of San Diego, California. He correctly says diabetes causes nothing; it is the lack of diabetes management that causes the complications people develop. For those people interested, I would encourage you to use this link and subscribe to at least their newsletter.

I agree with a comment to the blog that recommends reading Dr. Richard K. Bernstein's book, "Diabetes Solution". This will help in understanding the importance of insulin as well as food plans to avoid blood glucose spikes. The author of this blog takes the safe route by using ADA recommendations, which are far from ideal for patients that wish to keep diabetes from becoming progressive. Insulin should be the medication of choice for many patients long before most doctors are ready to prescribe it.

The blog author lists some reasons that doctors are hesitant to prescribe insulin and some are probably true. Most doctors do have a strong fear of hypoglycemia (low blood glucose level) and this causes them to avoid prescribing, as they themselves do not know how to handle hypoglycemia. Many doctors also do not have the time available or access to diabetes educators and do not want the deal with the complexity of insulin therapy.

It is true that some doctors fear insulin more than the patients fear insulin. Even if this is a Canadian study, many US doctors fall in to this category.

Image courtesy of timeinsulin.com  [Image like now broken]

The author is correct in her statement, “Taking insulin doesn't mean that you've failed to manage your blood sugar.” And, remember diabetes is progressive – only if you do nothing to manage it.

Classification and Diagnosis of Diabetes

It is interesting how the American Diabetes Association dodges the classifications for diabetes. So there is no doubt, I will quote what they have in print.

“The classification of diabetes includes four clinical classes:

1. Type 1 diabetes (results from β-cell destruction, usually leading to absolute insulin deficiency)

2. Type 2 diabetes (results from a progressive insulin secretory defect on the background of insulin resistance)

3. Other specific types of diabetes due to other causes, e.g., genetic defects in β-cell function, genetic defects in insulin action, diseases of the exocrine pancreas (such as cystic fibrosis), and drug- or chemical-induced (such as in the treatment of HIV/AIDS or after organ transplantation)

4. Gestational diabetes mellitus (GDM) (diabetes diagnosed during pregnancy that is not clearly overt diabetes)”

At least for two years is a row they have been consistent, if that counts for anything. I do find it absurd that they lump genetic defects together with other diseases of the pancreas and drug- or chemical-induced diabetes. Yet again, prediabetes is only listed as a risk for diabetes. It is no wonder physicians do not take prediabetes seriously and in general ignore it. With research showing that diabetes can be stopped during this stage and full diabetes prevented, one would think this should receive more attention – maybe even rating it as diabetes so that insurance would cover treatment as a preventive measure since it has been proven that prediabetes intervention does help in the prevention of full onset of diabetes.

This means that the ADA only looks to something they can diagnose as a disease and treat as being important. Again, there is no incentive to diagnosis and treat prediabetes because without ADA making this a classification, medical insurance will have no incentive to reimburse for treatment or medications to stop diabetes. Even with the Centers for Medicare and Medicaid Services (CMS) expanding into many prevention services, the ADA does not see this as a value. Their mantra seems to be: “let them get diabetes and then we will treat them.”

Even if they did not change anything from last year in their statement after the classifications. They continue to give doctors a blanket to hide under when a patient is incorrectly diagnosed. They have stated, “Some patients cannot be clearly classified as type 1 or type 2 diabetic. Clinical presentation and disease progression vary considerably in both types of diabetes. Occasionally, patients who otherwise have type 2 diabetes may present with ketoacidosis. Similarly, patients with type 1 diabetes may have a late onset and slow (but relentless) progression of disease despite having features of autoimmune disease. Such difficulties in diagnosis may occur in children, adolescents, and adults. The true diagnosis may become more obvious over time.”

Then in the diagnosis area, they also repeat the information from 2012. In one short paragraph, they throw out the oral glucose tolerance test (OGTT) and then bring it back later – at their convenience. They cite costs and later use the OGTT when it suits their needs. They recognize that African Americans may have higher rates of glycation and then dismiss this as controversial. They cite epidemiological studies for their dismissal and then leave out other studies that show that Asians may also have higher glycation rates.

It seems that the people in charge do what suits them and ignore what they don't want to consider. With the increase of Americans from other countries, more consideration needs to be paid to their ethnic heritage and variances from the European and Scandinavian heritage of most of them.

DSME and DSMS to Assist Diabetes Patients

The subject of diabetes self-management education (DSME) of 2011, and 2012 has taken on a companion in the guidelines for 2013. It is diabetes self-management support (DSMS) and this has been the subject of the last six blogs. This is an interesting change and I suspect that this is a change happening because of the shortage of diabetes educators and the ballooning numbers of patients with diabetes. This discussion is found in section F of the Standards of Medical Care in Diabetes—2013. Go to “Navigate This Article” in the second column and then down to “D” which will take you to Pharmacological and overall approaches to treatment, and then page down to “F. Diabetes self-management education and support”

This could be a two edged sword for the ADA when the physician shortage happens. There will be a shortage of physicians to diagnosis and treat diabetes and a shortage of CDE's. They help a minority of type 2 patients now and there is a greater need for more education now.

It will be interesting now that the National Standards for Diabetes Self-Management Education and Support has been updated, to see if there is actually any increase in the education received by diabetes patients or if the situation continues as is or even decreases. This is just another reason for finding ways of bringing more patients with diabetes into training to assist other patients. Research has proven this works and often with better results than professionals.

Since this should be important for every patient to know and be able to know whether their doctor follows the ADA guidelines, I am quoting the recommendations:

“Recommendations

1. People with diabetes should receive DSME and diabetes self-management support (DSMS) according to National Standards for Diabetes Self-Management Education and Support when their diabetes is diagnosed and as needed thereafter.

Nice of them to say this, but even CDEs don't want to teach people with type 2 diabetes when they can spend all their time with type 1's. Read the first comment to this blog by Bennet at YDMV. Rather revealing.

2. Effective self-management and quality of life are the key outcomes of DSME and DSMS and should be measured and monitored as part of care.

This is what should happen. Unfortunately, until the rules are changed, it isn't going to happen.

3. DSME and DSMS should address psychosocial issues, since emotional well-being is associated with positive diabetes outcomes.

At least I must give them credit for trying, but the CDEs are not qualified to deal with depression and emotional well-being.

4. DSME and DSMS programs are appropriate venues for people with prediabetes to receive education and support to develop and maintain behaviors that can prevent or delay the onset of diabetes.

With the shortage of CDEs, don't expect any help for people with prediabetes. If the Centers for Medicare and Medicaid Services (CMS) continue to promote prevention, maybe another group will be able to move into this void and provide the help and education these people need.

5. Because DSME and DSMS can result in cost-savings and improved outcomes, DSME and DSMS should be adequately reimbursed by third-party payers.”

We know that many physicians in endocrinology are attempting to follow these guidelines when they have certified diabetes educators (CDEs) available, but some just don't have CDEs available. Most doctors outside the diabetes clinics are not following this and won't because of conflicts with CDEs. Others just don't have them available in many rural areas of the country. Therefore, this points out the need for other measures and methods that are necessary for people to educate themselves about diabetes. And then there may be a place for peer-to-peer workers and peer mentors that have received some training. Somebody needs to fill the holes that the CDEs can't be bothered with.

National Standards for DSME and DSMS - Part 6

Part 6 of 6 Parts

The standards are very well thought out in general and I can support them. There are several areas that need emphasis. The first is, “In the course of its work on the Standards, the Task Force identified areas in which there is currently an insufficient amount of research. In particular, there are three areas in which the Task Force recommends additional research:

1. What is the influence of organizational structure on the effectiveness of the provision of DSME and DSMS?

2. What is the impact of using a structured curriculum in DSME?

3. What training should be required for those community, lay, or peer workers without training in health or diabetes who are to participate in the provision of DSME and to provide DSMS?”

I mentioned this in Part 1, and I will cover more of this now. If you have not read the standards yet, please consider doing so. These were published back in September of 2012, but not on the ADA site until January 2013. This is the better read as it can take you to each standard, it has links to research papers, and the AADE website is a download of a PDF file and no active links to research papers. As of this writing, the American Association of Diabetes Educators (AADE) has not seen it necessary to correct prior publications or update those on the books for 2013. The AADE has written about their goals for 2013 to 2015, but did not mention anything about the national standards. This may be read by downloading a PDF file at this link, named the 2013-2015 AADE Strategic Plan.

This plan is mainly a generalization of self improvement for those already in the educator field and some general ideas for expansion. This means keeping their control of the educator field and not bringing in lay people to assist them in any way. With the continued shortage of CDEs, how is this any help to the expanding number of people diagnosed every day with diabetes.

I doubt there is any structured curriculum for DSME and what may exist is still thought of as DSME and DSMT. There is nothing presently for DSMS. In attempting to follow discussions and locate DSMS information, you will need to read DSMT (diabetes self-management training).

If you are looking for information on community, lay, or peer workers without training in health or diabetes who are to participate in the provision of DSME and to provide DSMS, you will not find anything. This is only on the books in the American Diabetes Association link above and as of yet, the AADE has rejected publishing any material about it.

What ever strengths or weaknesses exist in the current standards will need to wait until the next Task Force is activated in probably the fall of 2016. If the new regulations put forth by the Affordable Care Act create unforeseen problems for the ADA and AADE then we might see it happening sooner. The past Task Force was activated in the fall of 2011 and most of the material made public in September of 2012. Final publication did not happen until January of 2013 for most material.

“Members of the Task Force included experts from the areas of public health, underserved populations including rural primary care and other rural health services, individual practices, large urban specialty practices, and urban hospitals.” It is good to see that the underserved populations were included; however, I think that the elderly were not part of this underserved group. The following two paragraphs are important enough to quote as they do mark a point of change and an extremely large area that the AADE may not be able to meet.

“The Task Force made the decision to change the name of the Standards from the National Standards for Diabetes Self-Management Education to the National Standards for Diabetes Self-Management Education and Support. This name change is intended to codify the significance of ongoing support for people with diabetes and those at risk for developing the disease, particularly to encourage behavior change, the maintenance of healthy diabetes-related behaviors, and to address psychosocial concerns. Given that self-management does not stop when a patient leaves the educator’s office, self-management support must be an ongoing process.”

“Although the term “diabetes” is used predominantly, the Standards should also be understood to apply to the education and support of people with prediabetes. Currently, there are significant barriers to the provision of education and support to those with prediabetes. And yet, the strategies for supporting successful behavior change and the healthy behaviors recommended for people with prediabetes are largely identical to those for individuals with diabetes. As barriers to care are overcome, providers of DSME and diabetes self-management support (DSMS), given their training and experience, are particularly well equipped to assist individuals with prediabetes in developing and maintaining behaviors that can prevent or delay the onset of diabetes.”

The last paragraph before the definitions covers something many CDEs may not want, but is important. It is the risk for comorbidities (that is – heart disease, lipid abnormalities, nerve damage, hypertension, and depression) and other medical problems that may affect or interfere with self-care. What I find most intriguing is this statement - “The Standards encourage providers of DSME and DSMS to address the entire panorama of each participant’s clinical profile.” These may be some of the areas many CDEs are least comfortable and will not be able to use mandates to bypass.

This is where these standards become important for the patient to learn and be somewhat knowledgeable about to hold CDEs to providing high-quality education and support.

This information is from the National Standards for DSME and DSMS.

National Standards for DSME and DSMS - Part 5

Part 5 of 6 Parts

The eighth standard states, “The participant and instructor(s) will together develop a personalized follow-up plan for ongoing self-management support. The participant’s outcomes and goals and the plan for ongoing self-management support will be communicated to other members of the health care team.”

If the seventh standard is not completed, chances are this standard will go by the way also. The setting of goals is important for the patient and knowledge of the goals is also important for the healthcare team. This helps communications and lets all members of the healthcare team know what the others are working on. While DSME can be effective for short periods of time, it needs DSMS to reinforce the information and help the patient understand the importance of daily management away from the clinic or doctor's office.

While the primary responsibility for diabetes education belongs to the provider(s) of DSME, participants benefit by receiving reinforcement of content and behavioral goals from their entire health care team. It should not matter that the support (DSMS) comes from the trained peers, community health workers, or community-based programs. Because self-management takes place in participants’ daily lives and not in clinical or educational settings, patients should be assisted to formulate a plan to find community-based resources that may support their ongoing diabetes self-management.

Hopefully, DSME and DSMS providers will work with participants to identify such services and, when possible, track those that have been effective with patients, communicating with providers of community-based resources in order to better integrate them into patients’ overall care and ongoing support. This will be especially important in many rural areas where CDEs are in short supply and are not present on an every day basis.

The ninth standard states, “The provider(s) of DSME and DSMS will monitor whether participants are achieving their personal diabetes self-management goals and other outcome(s) as a way to evaluate the effectiveness of the educational intervention(s), using appropriate measurement techniques.”

For diabetes self-management to become the contributor to long-term, positive outcomes, the provider(s) of DSME and DSMS will need to assess each patient's personal self-management goals and the progress in achieving these goals. At least the AADE has their AADE7 list (found here) that outlines seven behavior changes that everyone needs to consider how they apply to them individually. Differences in behaviors, health beliefs, and culture as well as their emotional response to diabetes can have a significant impact on how participants understand and view their illness and engage in self-management. DSME providers who account for (properly assess) these differences when collaborating with participants on the design of personalized DSME or DSMS programs can improve participant outcomes.

Although this is not feasible yet, for people in rural areas may benefit in the future from telemedicine. At present, assessments of patients may be difficult in rural areas, but attempts must still be made. In some areas, guidelines from professional organizations or government agencies may prevail for time frames of this assessment.

The tenth standard states, “The provider(s) of DSME will measure the effectiveness of the education and support and look for ways to improve any identified gaps in services or service quality using a systematic review of process and outcome data.”

This could be a most important standard if this could be reviewed by a third party, but having a CDE review this is like letting the fox guard the chicken coop. Will the CDE be responsible? Will new advances in knowledge, treatment strategies, education strategies, psychosocial interventions, and the changing healthcare environment be incorporated into the ongoing education and support? If they are responsible, they will identify areas of improvement and make the necessary adjustments.

This should be in their mind at all times. “The Institute for Healthcare Improvement suggests three fundamental questions that should be answered by an improvement process:

1. What are we trying to accomplish?

2. How will we know a change is an improvement?

3. What changes can we make that will result in an improvement?

Once areas for improvement are identified, the DSME provider (CDE) must designate time lines and important milestones including data collection, analysis, and presentation of results. Process measures are often targeted to those processes that typically impact the most important outcomes and these must be properly assessed.

If you have read the standards, you should agree that this is putting a lot on the plate for the AADE and their CDEs. Unless they change their way of doing business, these standards will not become a reality for many people with diabetes and the people with prediabetes will continue to be ignored.

To this point, I have not mentioned the shortcomings of the ADA 2013 Guidelines. I can see many things left out of the ADA Guidelines that may impact the National Standards for Diabetes Self-Management Education and Support.

First, the ADA Guidelines totally ignore any mention of telemedicine, which could be an advantage for CDEs providing education and support for rural patients with diabetes. Second, while the group of patients who are at risk for diabetes are mentioned and some overall guidance is mentioned, this group of people need a name more descriptive than prediabetes and specific treatments need to be part of the guidelines. This could make it possible for the CDEs to be reimbursed for time spent on education in this group of patients. Under current ADA guidelines, reimbursements are very difficult for time spent on education, which discourages CDEs from even attempting education for this group.

 This information is from the National Standards for DSME and DSMS.

National Standards for DSME and DSMS – Part 4

Part 4 of 6 Parts

The sixth standard states, “A written curriculum reflecting current evidence and practice guidelines, with criteria for evaluating outcomes, will serve as the framework for the provision of DSME. The needs of the individual participant will determine which parts of the curriculum will be provided to that individual.”

Here again, the door is wide open for discrimination. CDEs are nefarious for deciding that individuals don't need some part of training when a mandate will work just fine. This means that the patient with diabetes is not taught something or possibly a key that is necessary in the self-management of diabetes. If the patient cannot figure out from the mandate what needs to be accomplished and why, they are left in the dark and wondering what they missed. I know this by the questions I receive in emails. People with type 2 diabetes are asking why is this so important or is this really necessary. You can bet I ask if they have had any time with a CDE. No all have, but those that have had time with a CDE, say they were told to do it with no explanation.

Another part of this that makes me wonder at the training of CDEs is the number of times people ask questions that should have been covered in an assessment. The time I had an individual say they had just seen a CDE and the question was what do I do now. He had asked the CDE what to do for depression as he was feeling very low and in addition to just having a diagnosis of diabetes, the previous week he had buried his wife of 46 years. His question was not answered and the session was ended without any indication that the CDE would talk to his doctor or anyone. As he said in his email – it was as if she could not get out the door fast enough.

Even my suggestion to call his doctor did not get him any help and it took almost two weeks to find someone he could talk with and actually give him the help he needed. He was doubly blessed that the person he got set up with also had type 2 diabetes and knew what he was talking about.

Why the next section is talked about really has me wondering, especially since most people with diabetes are not being serviced by CDEs and the people with prediabetes are not seen by CDEs. Yes, a very few have consulted with CDEs if they are a relative or close friend of the family. I even had one of these people email me telling me that they had been educated by a CDE, but they refused to answer the question of how close they were related or if they were a friend of the family.

“Individuals with prediabetes and diabetes and their families and caregivers have much to learn to become effective self-managers of their condition. DSME can provide this education via an up-to-date, evidence-based, and flexible curriculum.”

“The following core topics are commonly part of the curriculum taught in comprehensive programs that have demonstrated successful outcomes:

1. Describing the diabetes disease process and treatment options

2. Incorporating nutritional management into lifestyle

3. Incorporating physical activity into lifestyle

4. Using medication(s) safely and for maximum therapeutic effectiveness

5. Monitoring blood glucose and other parameters and interpreting and using the results for self-management decision making

6. Preventing, detecting, and treating acute complications

7. Preventing, detecting, and treating chronic complications

8. Developing personal strategies to address psychosocial issues and concerns

9. Developing personal strategies to promote health and behavior change”

The above areas are important and should be part of the content in a carefully planned program, but unless an assessment is performed and the program adapted to the individual, the curriculum may miss the target and not be absorbed by the individual. When a proper assessment is done and the approaches to education are interactive and patient centered, then it should be effective. Also necessary is the development of action-oriented behavioral goals that are creative and experienced based in delivery methods are effective. This should indicate that mandates are not effective, but they are too often used.

The seventh standard states, “The diabetes self-management, education, and support needs of each participant will be assessed by one or more instructors. The participant and instructor(s) will then together develop an individualized education and support plan focused on behavior change.”

The idea of individualized education is the key to this standard. This could or should be what every CDE strives for in the education. This seldom is the case because no assessment is done and the education is handed out almost willie-nillie based on the CDEs attempt to hurry through the education. Because the assessment is also a key to giving education on an individualized basis, I am quoting what is important in an assessment.

“The assessment process is used to identify what those needs are and to facilitate the selection of appropriate educational and behavioral interventions and self-management support strategies, guided by evidence. The assessment must garner information about the individual’s medical history, age, cultural influences, health beliefs and attitudes, diabetes knowledge, diabetes self-management skills and behaviors, emotional response to diabetes, readiness to learn, literacy level (including health literacy and numeracy), physical limitations, family support, and financial status. The education and support plan that the participant and instructor(s) develop will be rooted in evidence-based approaches to effective health communication and education while taking into consideration participant barriers, abilities, and expectations.”

The assessment and education plan, interventions, and outcomes must be documented in the patient’s records. This will facilitate and provide assistance to others on the patient's healthcare team and increase the likelihood that all the members will work in collaboration. This will create an atmosphere of learning and success for the patient resulting in improved quality of care.

This information is from the National Standards for DSME and DSMS.