February 2, 2013

Hyperbaric Oxygen Therapy Useful in Brain Injury

I have looked at this for several days now and have decided that even though this is not about diabetes, it is important for everyone to be aware of the potential. This is only the tip of the potential importance of this study. Hyperbaric oxygen therapy (HBOT) has been useful in diabetes wound healing and has been used for a long time for treating divers with excess nitrogen in their system. Now it is helping resuscitate activity in damaged brains.

In Israel, doctors have now used HBOT to show dramatic improvement for stroke patients. “Now Dr. Shai Efrati of Tel Aviv University's Sackler Faculty of Medicine has found a way to restore a significant amount of neurological function in brain tissue thought to be chronically damaged - even years after initial injury.”

If this does not get you attention, maybe this information will. “Patients experienced improvements such as a reversal of paralysis, increased sensation, and renewed use of language. These changes can make a world of difference in daily life, helping patients recover their independence and complete tasks such as bathing, cooking, climbing stairs, or reading a book.”

Think about a family member that has had a stroke, traumatic injury, and metabolic disorder that may have caused major brain damage and permanent disabilities, including motor dysfunction, psychological disorders, memory loss, and more. If HBOT could restore their brain to near normal function, would you not want to have this tried?

This will still need to be approved in the USA and I'm sure the Food and Drug Administration will insist on regulating it, but there is much more that needs to be done and studies to be conducted. Then the need will be there for insurance to cover the treatment. But, and this is big, if the results can be proven, think of the quality of life that may be possible for those that now have no quality of life.

According to Dr. Efrati, this study opens up more possibilities and researchers are currently conducting a study on the benefits of HBOT for those with traumatic brain injury (TBI). Think of the possibilities as an anti-aging therapy for disorders such as Alzheimer's disease and other dementias. HBOT maybe the treatment before the full onset of dementia, where recovery still has potential. I say this is important and these researchers are on the correct tract to do much good.

February 1, 2013

What Is This Charge From the Doctor?

Even though this information from Trisha Torrey is from Jan 7, 2012 and repeated on Jan 17, 2013, it is very applicable. Doctors are looking to stay afloat financially and are looking for ways to cover costs the government is making more onerous. Then add to this the requirements that the insurance companies are requiring from the doctors, this all adds up to costs the doctors are unable to continue to cover.

What is different today? Read this, “Up until a few years ago, if you needed a test or a procedure, then it was scheduled, you had it, the doctor billed for it, and the insurance company paid for it. With few exceptions, that's not the case today. Today, if you need a test or procedure, then someone from the doctor's office has to call and get permission for you to have it. With no permission, it doesn't get paid for - and not only will the doctor not get the money from the insurance company, but YOU will have to pay for it out of your pocket. That is why you sign all that paperwork that says you'll be responsible for anything that's not covered.”

I will let you read the article by Torrey and move on to the reason I am thinking this charge may get a lot larger. In my blog “ADA Changes Blood Glucose Monitoring”, I mentioned that the ADA wants insurance companies to be more flexible in reimbursing for test strips. Insurance companies are thinking about having meter downloads sent to them. Doctors will then be required to have software available to download the meters and most primary care physicians do not presently have the software. They will not accept the cost and the patients with diabetes will be the ones charged.

Chances are only the patients on intensive testing will be the ones charged, but it would pay to know what the doctor is thinking beforehand. If the costs the doctor will pass on are more than the cost of extra test strips, then it may not be wise to want them reimbursed. Of course none of this has happened yet, but insurance companies are considering their options to comply with the ADA especially if they get more specific next year.
One option may be for you to have the software on your computer so that you can download you own meter, and forward this to the insurance company. However, you will need to find out if this will be acceptable once your insurance company decides this is the requirement.

This is just one more example of how our insurers are being greedy at our expense and we end up paying double for their greed.

January 31, 2013

ADA Changes Blood Glucose Monitoring

If the American Diabetes Association believes they have undone the damage that their 2003 Guideline set in motion; they may have another thing to consider. What happened in the 2003 Guidelines was a recommendation for people with type 1 or type 2 diabetes who use insulin in multiple daily injections or with an insulin pump should self-monitor blood glucose “three or more times daily.” Most payers interpreted this to mean that three tests per day was sufficient for all patients on insulin.

To find out if the new 2013 guidelines had changed any minds, I have decided to correspond with my insurance company, Medicare, and inquire from a few other medical insurance companies that cover part D. I now have a response from the medical insurance companies and a brief statement of “no anticipated changes” from Medicare. Even the Veterans Administration stated that there are no anticipated changes. One medical insurance company said they are taking a wait and see stance about what other companies are thinking. My medical insurance company stated that since I don't use them for my test strips, they are not responding further. I talked with my agent and he asked. He was told there would be no changes at present. The last medical insurance company said they are still asking questions, but anticipate only minor changes if accompanied by an order from the doctor.

This made me contact another company and I was told in a phone conversation that there would be no changes until the ADA decided that a certain number was needed. This raised my hackles, and I said they did. We discussed the section and I was told the key words were “many patients” and that until ADA clearly stated for “most” patients, they would continue the current limit. Then I was asked about the Joslin blog of January 16. I stated I had read this. I was told that this also confirmed the current position of no change. This is about as big a slap in the face as you can get. This insurance company said the the Joslin blog is also the reason they will be limiting type 2 diabetes patients not on sulfonylureas to one test strip per day. It had been two per day.

I can also envision insurance companies requiring doctors to forward meter downloads to prove that the patients need as many test strips as requested. I know that this is on the mind of one of the companies I have corresponded with as they asked if I would be willing to do this. I know many diabetes clinics and a few doctors do have the software to do this, but most primary care physicians do not. Think of the cost and if you think they are not going to pass this on to the patient, you are in for a surprise. Another statement one insurance company clearly made is, “if this was that important, why did they (ADA) wait ten years to make a statement like this?”

I personally think that until ADA includes more people from the medical insurance industry and a few patients (type 1 and type 2), they will continue to be laughed at and not believed to be setting recommendations and guidelines for the patient, but in their interests only. In recent years, this seems to be the trend. Even we, as patients, have to wonder what they are doing for the patient. They are great at wording that means and says very little. This has to be what the medical insurance industry thinks about their wording and their reasoning for no anticipated changes. Even though ADA is saying they made some changes, in the real world, there may not be changes.

One section says the following, “The frequency and timing of SMBG should be dictated by the particular needs and goals of the patient. SMBG is especially important for patients treated with insulin to monitor for and prevent asymptomatic hypoglycemia and hyperglycemia. Most patients with type 1 diabetes and others on intensive insulin regimens (MDI or insulin pump therapy) should do SMBG at least prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving. For many patients, this will require testing 6–8 times daily, although individual needs may be greater.” The bold words is my emphasis and is the wording used by two companies below.

The above is the section quoted back to me by two of the insurance companies, one that will make no changes, and the one that will use a doctor's order and consider the need.

Another area that was also used is, “Because the accuracy of SMBG is instrument and user dependent, it is important to evaluate each patient’s monitoring technique, both initially and at regular intervals thereafter. Optimal use of SMBG requires proper review and interpretation of the data, both by the patient and provider.”

In reading the section, type 1 is specifically mentioned, but other areas only use the term MDI (multiple daily injections) and self-monitoring of blood glucose (SMBG). This leaves those of us with type 2 on insulin wondering if we will be excluded from obtaining support for intensive testing.

Again, the ADA has played down the importance for people with type 2 diabetes on oral medications and on no medications of the need for testing and also the need for being tested more than two times per year by the A1c. This statement is typical of the ADA's attitude, “The evidence base for SMBG for patients with type 2 diabetes on noninsulin therapy is somewhat mixed. Several randomized trials have called into question the clinical utility and cost-effectiveness of routine SMBG in non–insulin-treated patients. A recent meta-analysis suggested that SMBG reduced A1C by 0.25% at 6 months, while a Cochrane review concluded that the overall effect of SMBG in such patients is small up to 6 months after initiation and subsides after 12 months.”

For me this is almost criminal in both the attitude and actions they have about not educating these people with type 2 diabetes and then preventing those that know the importance from obtaining the necessary testing supplies.

And if you doubt what I am saying, why then would the Joslin Diabetes Center post the blog they did on January 16, 2013 (mentioned above), in which they ask the question, “When Should I Check My Blood Sugar?” “The answer depends on the medications you are taking, your current level of control and what information you are looking for. For example, people with type 1 diabetes who take insulin four times a day need to check at least as many times. People with type 2 who control their glucose levels with lifestyle or lifestyle and metformin may check only once, or perhaps twice, a day.”

Patients at Joslin need to be concerned about the side Joslin is on, as it clearly is not for the patient. This blog seems a clear rebuttal of the 2013 ADA Guidelines. Don't think the medical insurance companies won't see it this way (two companies have). This is just one more reason they have for not making changes. When a well known and prestigious diabetes clinic publishes information like this for patients, they are not doing us any favors.

The two companies (mentioned above), did have me call them and talk to an office that make the determination. They admitted that there will be controversy over this, but that with a leading diabetes clinic saying only four times in difference to the ADA of six to eight times, the decision will remain no change until everyone is in agreement. When I asked about meter downloads for proof that a person was testing more frequently, the answer was that this was under consideration, but that not all physicians would be capable of submitting this information. They did say that to force this issue now could be considered discriminatory, but that it is under consideration for future years. They said with a doctors order for the testing and the meter downloads being submitted, this could be a factor when everyone is in agreement as to the number of testing requirements for both type1 and type 2 on insulin.

In the phone conversations I also asked about those type 2 people on oral medications. Both companies stressed that they will be allowing two test strips for those on sulfonylureas and will be allowing more if there is a doctors order because of repeated episodes of hypoglycemia. Others, to include those on no medications will remain on one test strip per day without a doctors order proving the need for more test strips. They would not discuss what the doctors orders needed to state.

Then to read another article also questioning ADA's attempt to change the minds of insurance companies, read this from Diabetes in Control. Dr. Richard Grant, incoming chair of the ADA Professional Practice Committee says, "We're trying to say it's very situation-dependent …. both by the patient and the patient's context." This really says nothing even if they are claiming otherwise.

This statement really drives home the point that ADA has not succeeded, “With regard to the removal of the three-times-daily number, Dr. Yehuda Handelsman (Metabolic Institute of America, Tarzana, CA) expressed concern that insurers might actually interpret that as endorsing less frequent testing for patients who use insulin. How messages are conveyed matters, he said. "It's about how you define the goals and where you put the emphasis."

According to Grant, the new document was the ADA's best attempt to balance the evidence from the literature with the needs of the individual patient. "Evidence-based guidelines apply to populations of patients with diabetes, but we really need to tailor these population-level recommendations to the individual in front of us."In other words, this is why insurance companies are saying loud and clear, “no anticipated changes” So forget what ADA claims.

For other perspectives and more hope in others areas of the country, read this blog from Diabetes Mine and this blog from Diabetes Self-Management.

January 30, 2013

Is It Possible?

Every now and then I get to wondering about the different types of diabetes and if there is more to the diagnosis than the medical community is acknowledging. With the new guidelines from the American Diabetes Association which can be read here (and I urge you to take time to read this), I often read this more carefully than any other provision or discussion in the guidelines. Then I start to look for what they may not be telling us. In any of the discussions, they seem to like to paraphrase some areas by saying that there is much to be determined at the clinical level.

The definition by its very nature leaves many questions, “Diabetes is a group of metabolic diseases characterized by hyperglycemia resulting from defects in insulin secretion, insulin action, or both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of different organs, especially the eyes, kidneys, nerves, heart, and blood vessels.”

I am using only the first part of the long definition because I think this is where some defining needs to be done. Yes, I agree that diabetes is a metabolic disease and maybe a group. Why the term hyperglycemia is not defined as being a certain measurable amount or number leaves me wondering what they are looking for in not defining this. Certainly they have a number in mind. Then they use chronic hyperglycemia to define what may happen to certain organs. I can understand why some organs are missing from the list because of the lack of conclusive studies for hearing and cognitive decline (brain). I do question why they are not given any mention and a statement of lack of conclusive evidence. That could then spark studies to prove that. I suspect they are not mentioned to avoid these studies from taking place, but why?

The classification for the last several years has gotten more restricted and only includes four classifications. Table one below shows the four classes.
Table 1 Etiologic classification of diabetes mellitus:
1. Type 1 diabetes (β-cell destruction, usually leading to absolute insulin deficiency)
1. Immune mediated
2. Idiopathic
2. Type 2 diabetes (may range from predominantly insulin resistance with relative insulin deficiency to a predominantly secretory defect with insulin resistance)
3. Other specific types
1. Genetic defects of β-cell function
1. MODY 3 (Chromosome 12, HNF-1α)
2. MODY 1 (Chromosome 20, HNF-4α)
3. MODY 2 (Chromosome 7, glucokinase)
4. Other very rare forms of MODY (e.g., MODY 4: Chromosome 13, insulin promoter factor-1; MODY 6: Chromosome 2, NeuroD1; MODY 7: Chromosome 9, carboxyl ester lipase)
5. Transient neonatal diabetes (most commonly ZAC/HYAMI imprinting defect on 6q24)
6. Permanent neonatal diabetes (most commonly KCNJ11 gene encoding Kir6.2 subunit of β-cell KATP channel)
7. Mitochondrial DNA
8. Others
2. Genetic defects in insulin action
1. Type A insulin resistance
2. Leprechaunism
3. Rabson-Mendenhall syndrome
4. Lipoatrophic diabetes
5. Others
3. Diseases of the exocrine pancreas
1. Pancreatitis
2. Trauma/pancreatectomy
3. Neoplasia
4. Cystic fibrosis
5. Hemochromatosis
6. Fibrocalculous pancreatopathy
7. Others
4. Endocrinopathies
1. Acromegaly
2. Cushing's syndrome
3. Glucagonoma
4. Pheochromocytoma
5. Hyperthyroidism
6. Somatostatinoma
7. Aldosteronoma
8. Others
5. Drug or chemical induced
1. Vacor
2. Pentamidine
3. Nicotinic acid
4. Glucocorticoids
5. Thyroid hormone
6. Diazoxide
7. β-Adrenergic agonists
8. Thiazides
9. Dilantin
10. γ-Interferon
11. Others
6. Infections
1. Congenital rubella
2. Cytomegalovirus
3. Others
7. Uncommon forms of immune-mediated diabetes
1. “Stiff-man” syndrome
2. Anti-insulin receptor antibodies
3. Others
8. Other genetic syndromes sometimes associated with diabetes
1. Down syndrome
2. Klinefelter syndrome
3. Turner syndrome
4. Wolfram syndrome
5. Friedreich ataxia
6. Huntington chorea
7. Laurence-Moon-Biedl syndrome
8. Myotonic dystrophy
9. Porphyria
10. Prader-Willi syndrome
11. Others
             4. Gestational diabetes mellitus
The third item seems to be the catchall for everything not fitting into the other three classifications. Notice that for all the things listed, prediabetes is not among them. This is only considered a risk for type 2 diabetes and nothing more. “In 1997 and 2003, the Expert Committee on Diagnosis and Classification of Diabetes Mellitus recognized an intermediate group of individuals whose glucose levels do not meet criteria for diabetes, yet are higher than those considered normal.”

They then define the blood glucose impairment range as “having impaired fasting glucose (IFG) [fasting plasma glucose (FPG) levels 100 mg/dl (5.6 mmol/l) to 125 mg/dl (6.9 mmol/l)], or impaired glucose tolerance (IGT) [2-h values in the oral glucose tolerance test (OGTT) of 140 mg/dl (7.8 mmol/l) to 199 mg/dl (11.0 mmol/l)].” Then they state that these have been referred to as having prediabetes, but do not go on to use any other term. This is the only use of the word.  They only use the term individuals to describe these people with A1cs of 5.7% to 6.4%. They emphasize that they are to be informed of their risks for diabetes and cardiovascular disease. Like all good doctors, they want them counseled about effective strategies to lower their risks.

So what is purpose of the Expert Committee on Diagnosis and Classification of Diabetes Mellitus?  Is this the end of the use of the term prediabetes and how soon can we expect another term?  All good questions we will have to wait for an answer.  Is it possible we may have another term or will diabetes be expanded to include this range?  Even this discussion on prevention or delay of diabetes only uses the term prediabetes once.  Or will it take another decade or more to make the change?

January 29, 2013

Alternate-site Blood Glucose Testing

I had not thought to do a blog on alternative site blood glucose testing. I am doing this at the good natured ribbing I am taking from one of the people from the site where I do some peer mentoring. She is a person that uses an alternate site and is thankful I covered it for her and did give the warnings about when not to use alternate sites. She sent me some URLs and said I had better use this topic. So for her I am writing this blog.

I admit that I very seldom use an alternate site because I use insulin and prefer the now factor in my test results. Most of the alternate sites are shown in these images.

The above also shows other areas that people do use for testing. I would say that you will need to experiment to find out what works for you. Basically the hands give the more accurate readings and are current. I have not run into anyone that uses the marked areas of the earlobes so I cannot speak for that.

The biggest warning is for those that have had hypoglycemia. Do not use alternative sites as the readings are from 15 minutes prior on the arms and about 20 minutes prior on the thighs. The calf area is about 20 to 25 minutes prior. Why the lag time?  The BD dot com site gives this explanation, “With all meters, routine testing on an unrubbed forearm, upper arm, thigh or calf gives a test result that is 20 to 30 minutes old. We will call these sites 'lagging' alternative test sites. The fingertips and the palm hold the most recent 'memories' of your blood glucose. Fingertip and palm testing tell you what your blood glucose level is right now.”

Basically this means if you are going low, the readings from alternative sites may be 20 to 30 minutes old and not an accurate reading of where you are now. This you need to be aware of, as relying on readings from these sites during hypoglycemia, may delay correction and cause your death. So at times like these, rely on your finger blood glucose readings.

The U.S. Food and Drug Administration gives these guidelines:
1. People with hypoglycemia unawareness should not use alternate site testing at all.
2. Don't use alternate sites when a seriously low blood glucose might go undetected:
  • When you have just taken insulin, or any time during or after exercise.
  • When there are unknown variables occurring in your day, such as illness.
  • Any time you just feel "low".
  • Whenever you are about to drive.”
Like most sources say – talk to your doctor before using alternate-site testing and please, please ignore the television ads that say you don't need to test on your fingers anymore. All they are doing is taking advantage of people that don't stay in touch with their doctors and basically do little talking during an appointment. My endocrinologist did ask me about some of the TV ads about alternate-site testing and I explained that was a fabrication as far as I could see and I would not test there because I am on insulin. The doctor thanked me for that and said he had two patients that had fallen for the TV ads and wanted prescriptions for the test strips. The office would not give prescriptions since they were on insulin. Both doctors spent quite a lot of time going over the problems if they were having hypoglycemia. They did not think they had convinced them not to use alternate-site testing.

The FDA site also says the following. Can you test blood glucose from sites other than your fingers? Some meters allow you to test blood from sites other than the fingertip. Examples of such alternative sampling sites are your palm, upper arm, forearm, thigh, or calf. Alternative site testing (AST) should not be performed at times when your blood glucose may be changing rapidly, as these alternative sampling sites may provide inaccurate results at those times. You should use only blood from your fingertip to test if any of the following applies:
  • you have just taken insulin
  • you think your blood sugar is low
  • you are not aware of symptoms when you become hypoglycemic
  • the results do not agree with the way you feel
  • you have just eaten
  • you have just exercised
  • you are ill
  • you are under stress
Also, you should never use results from an alternative sampling site to calibrate a continuous glucose monitor (CGM), or in insulin dosing calculations.”

If you are a person with type 2 diabetes and have it well managed, then talk to your doctor about using alternate-site testing.  One last fact, alternate site testing can also be painful.

January 28, 2013

Tips To Make Testing Less Painful

When I wrote the series on testing, I completely forgot that I had this tucked back for use. So rather than leave this for another blog on testing I will complete it now. There are other tips people should make use of when blood glucose testing to make the experience a little less painful and possibly help in setting the lancet device to a less deep setting.

Pain is caused when the lancet device is triggered and the lancet is released and it penetrates the skin. The deeper the lancet penetrates, the more pain it will generally cause. Also, this is necessary to produce enough blood for the test strip. The following tips may help reduce the pain and possibly provide enough blood for testing. I have covered this before, but it is still worth repeating. Always, if you are able, wash your hands with soap and warm water. This cleans the testing site and helps dilate (make larger) the blood vessels in the finger to increase blood flow. Always dry your hands and fingers carefully to not handle test strips with wet fingers.

The next step is to massage the finger downwards to the tip of your finger. The purpose for this is helping the blood move toward the fingertip and making more blood available when the area is pricked. While doing this, if possible have the hand pointing downwards below your waist. This helps gravity keep the blood in the hand and more importantly your fingertip.

If you use the tips to this point, try resetting the lancing device to a lower setting that you have been using or maybe set to the lightest setting. When you have enough blood, this should be your setting if you follow the above tips.

Many people say to find the correct meter that does not require much blood, but I will only say that you should contact you medical insurance company to find out which meters and test strips they cover. A free meter and only ten test strips does not go very far if the insurance company will not reimburse for the strips. If you are given a list of strips and meters that will be covered, then research the meters for the one you want to use.

Alternate the areas on your fingers and thumbs. Please do not use the same finger over and over. Using your fingers and thumbs, this will give you 20 areas to use, your fingers will recover rapidly, and blood flow will not diminish like it will when you use one finger over and over. Now if you have missing fingers from an accident, you will have less for testing. If you are a person with type 2 diabetes and your diabetes management if great, then you may wish to read the next blog about using alternative sites as well.

This tip is one I do use quite religiously. In the wintertime especially, my fingers can become harder on the surface and blood flow can be reduced. Therefore, I try to use a skin moisturizer on both hands at night and the hand I will not be using during the day. This softens the skin and creates better blood flow.

I have covered using the sides of your fingers near the fingernail (see this blog) so I will move on to the suggestion of using a new lancet each time. Many people do suggest this and this is generally less painful that doing like I do and change maybe three or four times per year. Fact is, I am changing to once a week just to see how it affects me.