April 27, 2013

Diabetes Tips and Applications

The previous month, I received an email asking questions that are quite common and important for people recently diagnosed with type 2 diabetes. First, this person wanted to know why he was having such a difficult time managing his diabetes. This reminded me of my blog here. Then he wanted to know if there were any applications that he could use to upload the readings from his blood glucose meter to his doctor. There were several other questions which I have answered in my emails with him and I may do another blog on reasons for using insulin and for avoiding some foods.

In exchanging emails, I discovered he was following the directions of a registered dietitian (RD) and eating the high carbohydrate – low fat meal plan. He also was still attempting to determine what I was talking about in self-monitoring of blood glucose (SMBG). He stated that the certified diabetes educator (CDE) had covered testing and how to do it and then just told him to test one hour after finish eating and moved on to confirm what the dietitian had told him about eating a set number of carbohydrates at each meal and snacks. Sounds like a mandate to do something without really educating him about the why, where, when, and how to use the results.

Is it any wonder I get upset with these “professionals” that cannot do education and live by mandates and mantras. I will not go any further with this, but get back to SMBG. I explained why we test our blood glucose so often at the beginning. This is done to determine how our bodies react to the foods or combination of foods and testing is the only way to determine this. His return email asked why the RD or CDE had not explained this to him. I explained to him that the CDE must tell him about testing and where to test, but generally this is where they stop, as they do not want you to realize the benefits of testing and finding out how the foods affect your blood glucose levels.

Of course, the RD will not explain this, as they want you to just follow their instructions without question. It is using the knowledge you gain from SMBG that tells you how the different foods affect your blood glucose levels and this in turn will let you know that what the RD and CDE issue in their mandates is not the whole truth. Some of the foods will spike your blood glucose readings to a high level. This tells you that you must limit the number of carbohydrates by reducing the quantity of these foods or removing them from your food plan. In addition, you will be looking for different results from different food combinations and also for determining if you are on the correct path to achieving your goals. If you are not moving in the right direction, as was the case for this person, you need to reevaluate the food plan and see what needs to be changed.

For this person, I suggested removing most whole grains and all highly processed foods. He reported back about a week later that his blood glucose levels were greatly improved and he had also reduced the quantity of potatoes he was eating. His fasting blood glucose levels were generally under 100 mg/dl and most of his after meal (post prandial) blood glucose levels were under 140 mg/dl. He was still having some problems with his evening and bedtime testing, but felt that with some additional reductions in food quantities and changing foods this was improving. His final comment was how much better he was feeling and that he was not gaining more weight and actually dropping a few pounds.

He commented that he felt he was gaining more benefits from his exercise and felt this was also translating into better blood glucose readings. Next we covered applications for transferring information from his blood glucose meter to an app and then on to the doctor. I discovered that he travels within a block of his doctor's office to and from work and asked if his doctor could read his meter. He checked and found out that his doctor could and had the software program to download his meter. They talked about how often the doctor wanted to do this and over the six weeks we have been corresponding, the doctor is happy with his readings and now has him doing it only at his appointments.

I had suggested that he purchase the software program and download the meter readings to his computer on a monthly basis. After comparing the two apps he had discovered, plus the cost of a new cell phone to handle the application and needing to manually log his readings to the application, he feels very good about not having purchased any and that the software cost was much cheaper, he wonders why he had not thought of that in the beginning. He now has the software download his meter daily and he is able to compare readings for the preceding week and any period of time.

He admits that he still has trouble maintaining his food log and health log, but as he solves more problems, he says that is getting easier as well. He is comfortable with his daily carbohydrates being in the 120g to 160 gram range and very happy that his weight is nearing the goal he and his doctor wanted. We have discussed his activity (exercise) level and carbohydrate level and he says that he may increase the carbohydrate level to avoid losing excess weight below the goal. He does not want to reduce his exercise level, as he feels good about this now.

He has a job that keeps him fairly active and is not a desk jockey. This helps him and he now feels much better with how he is managing his diabetes. His last A1c was 6.5 which is down from the 8.9 at diagnosis. He is now gaining confidence that he will get to 6.0 or lower in the months ahead. He is asking many good questions now and gaining confidence that he will be able to learn more on his own. He has canceled the next appointments with the RD and CDE, because he feels they would not be a help to him. I said that was up to him, but that maybe he should have kept the CDE appointment to see what was said, but he was determined not to waste any more time with them.

April 26, 2013

Diabetes – Does It Define You?

In March 2010 when I wrote about diabetes defining me, I had no idea of how much it defines me and shapes my daily schedule. Blogging about diabetes is my hobby and as such, I enjoy my time learning about different topics. Some are admittedly not about diabetes, and some are on the extreme periphery. Yet I still enjoy reading and learning about many of the topics. Many topics may not appear to be about diabetes, but often they are in one way or another.

Yes, I am aware that we are all involved in other activities and can have non-diabetes related hobbies, but without diabetes, would the hobbies be the same ones. Diabetes is what has driven many to certain types of exercise and other activities that help in our daily exercise. I think without diabetes, many of us would not be in as good health as we are today.

A great blogger and a mentor to me, David Mendosa says, “he thinks a lot about diabetes because that is his job. And since I do think a lot about it, I manage it. ” He continues, “But I hardly think about diabetes all the time. I think a lot more about getting out in nature and being there, hiking and taking pictures. I am also a big reader. And hardly just books about diabetes.” Yes, David, and thankfully we all gain from your writing, and photography. I do have to question, if it were not for diabetes and the management of diabetes with nutrition and exercise; would you be such a great photographer of nature and scenery? Probably – that is your nature.

Some of the defining points that I have noticed in people and especially friends with type 2 diabetes is the attitude about diabetes and the importance of diabetes education. The attitude pervades our daily activity, reminding us to care for ourselves and often care for others. Our daily activity incorporates our feelings about diabetes and how we perceive diabetes in our daily activity.

Then our attitude reflects about how we feel about diabetes management and mixes the education into our management routines. Our diabetes management efforts are reflected in our attitude, daily activities, and how we accept others with diabetes. This is often revealed by people that have diabetes and avoid contact with others that also have diabetes. This desire for diabetes secrecy is the unhealthy side of diabetes that prevents open discussions and often leads to poor diabetes management that is fostered by a poor attitude about diabetes.

So does diabetes define you? To some extent, diabetes may not completely define you, but I think that diabetes does strongly define us and who we are. It affects our attitudes, daily activity, and most importantly our diabetes management, whether it is the good or bad definition. Since diabetes is a 24/7/365 disease with no vacations, it has to affect us and define us to some extent.

When people actually stop and think about it, diabetes does affect the decisions those of us with diabetes make on a daily basis. It affects the foods we choose, which fortunately are healthier for us than the ones we were eating before diagnosis. It affects the restaurants we patronize, the snacks we eat and to a large extent, what we do.

While I could say I don't want my life defined by diabetes, I find it is, and in some ways, this definition is a good thing. It has caused me to be more conscious of my health and to be much more proactive in my health care. While some of my doctors may not be overly happy with my being proactive, most are happy and actually talk with me rather than at me. My diabetes has also forced me to be more social in the way I look at things, and more important, more willing to accept changes. While I am still feisty and ill tempered at times letting my negative side get me into hot water, I am finding myself mellowing and becoming more even in my approach to life.

Finally, thoughts of denial are no longer part of me. While I can't make the same claim about depression, it sneaks in now and then, but even these episodes are lighter and easier to conquer. Life with diabetes is better for me and I am more positive about life.

April 25, 2013

Incentives Needed for Docs to Engage Patients

I wonder why doctors need incentives to engage patients. Many doctors don't communicate well with patients, but give them incentives like more money – why? Their practices will shortly become extinct as it is and this is because patients are learning that they don't like being talked at, looked down on, or ignored while the doctor rushes to complete his time with you and move on to the next poor sole to treat them the same. I say let these practices fall by the wayside and good riddance.

In more studies, communication, aka, “patient engagement” is being stressed more and more. The studies are also hauling out more terms to hang on us as patients. My blog here describes one term “patient activation” as measured by the Patient Activation Measure. This is one of the measurements that they take of us so they can decide if we are compliant or non-compliant. The more activated we are the more compliant we become. This article also uses this as if it is a key to patient engagement (communication). Read my blog here on communications.

Now I will say something as I'm becoming very aggravated with how the authors treat us as patients. I say, let us use terms we are all familiar with hearing. Call us “patients” and we will use the term “doctors” and if you need to muddy up the terminology among yourselves, don't do it in writing we can read or in communication when we can hear you. Communication is the exchange of ideas and is needed to improve doctor/patient relations. If you wish to engage us in conversation during our appointments, that is fine with us, just don't label us and what you are doing as “patient engagement.” If the only way you have of communicate with us is by “patient engagement,” tell us so that we can move on to another doctor that is willing to communicate with us and not because it is the only way to earn your additional fee.

As patients, if we are viewed as a way to earn additional fees, sooner or later we will devise a way to cut these fees off and leave you wondering what you have done to be severed from your fees. I am not sure which group is to be blamed for this, but it is part of this article and shows just how doctors want to have that money to do something they should already be doing. “Several panel members, including Kaplan, noted doctors aren't incentivized to allow patients to ask questions or take a greater role in their care. A day-long workshop hosted by Health Affairs earlier this month included comments from many participants that pay models need to be developed to reward doctors for helping patients take a greater role in planning their care.” The bold is my added emphasis.

Another article echoed much the same feeling and there it was stated that the team approach could be handled by the nurses. To me this is a farce because the doctors have dug the hole they are in and want more money to be bailed out of their own system. They could not use communications before and now want to be paid for communicating. I have to disagree and say to these doctors – eat what you have fed us for years. It is your just desserts for your attitudes that you are so far above us that we don't deserve to be communicated with for our better health.

That we need to pay you more for your own ineptitude, and years of not communicating with us as patients; and now needing to communicate with us just to justify “meaningful use” criteria for additional monies, sounds like a lot of malarkey to me. We know what will happen. Just as soon as you have your hands on this handout, it will be back to business as usual and communications will cease.

April 24, 2013

Drug Ads Misleading for OTC Medications

Do you wonder why over the counter drug ads sound so appealing? You should, all the benefits are hyped, risks are downplayed, and most are completely absent, especially in short TV ads. Researchers have analyzed the ads for four drugs that have made the change from prescription to generic over the counter drugs (OTC). “The researchers looked at a sample of 133 television and print direct-to-consumer ads for Claritin (loratidine), Zyrtec (cetirizine), Xenical/Alli (orlistat) and Prilosec (omeprazole).”

Before going further, let’s be clear about the agencies overseeing drug ads. The U.S. Food and Drug Administration (FDA) is in charge of ads for prescription drugs and requires these ads to present a balance of both harms and benefits. Ads for the nonprescription drugs (OTC) are regulated by the Federal Trade Commission (FTC). The FTC has none of the requirements of the FDA. And now with an appeals court declaring that it is open season for free speech to promote “off label” use of prescription drugs, where are we headed for fairness in advertising?

It is becoming obvious that Congress needs to take corrective action to bring unregulated advertising under some regulation. As it is now, companies are getting away with less and less oversight in advertising and doctors are paying the price. Even I have heard some patients complaining about a doctor not being willing to prescribe a newly advertised drug. Yes, the complainers are hypochondriacs and think that what they hear is what they have and that the advertised drug is the answer to their problems.

Even I had a rather bad discussion recently when I asked a doctor about a different medication. This was not a newly advertised drug and is in a class of drugs I am already taking, but the doctor had apparently had a bad day and did not even pick up on this. He said I did not need any more medications – which I don't, but I was interested if the drug would be a better fit with the ones I was taking and would replace the one I was taking. When he realized this, he did say that he would look it up and see if there was a reason to change. About 9 days later, he called and said that at present he would not recommend a change. He did suggest that in a couple years when the current medication went generic, we should revisit to subject. He said the manufacturer did not have a good reputation with generics and we may need to switch to a name drug at that time.

When the researchers reviewed ads for the above four drugs that have gone from prescription to generic, they found only eleven percent of the ads mentioned side effects after the drugs became available without a prescription. This tells us that the drug manufacturers think sales are more important than safety. The study, which was published in the American Medical Association Journal, was supported by CVS Caremark.

Other articles can be found here, and here on the same topic,  This article here is about the "off label" advertising.

April 23, 2013

Doctors and New Technologies – Part 2

Part 2 of 2 Parts

This part covers the wished for options and information about medical devices.

What I’d like to see on the websites This is what the doctor would like. While I can agree with the list as a valuable list, there should not be a segregation unless the device is for mainly clinicians. If the device is primarily for patients and caregivers, then everything should be applicable to the clinician, patient, and caregiver. I will go one step farther by saying that often the website for most devices are for sales only and of little or no value for clinicians, patients, or caregivers. Most are all hype and have little usable information and then we know that the device is of little value. The more hype, the less value the device has.

Have a section formatted for clinicians in particular. If the device is primarily for clinicians, then I agree. If the device is for all, then the website should get rid of the glitz and hype, and cough up valuable information to let the customers know what the product can do in the real world, not the hyped world. Again, I have found that the more hype, the less value there is for the usefulness of the device.

Have a “how it works” section with screenshots and concise text. While many people seem to love videos, too often, they miss the points and the videos leave us wondering about why all the hype. And, this I mean sincerely. We are consumers and want information about a device, not glitz and hype. Whether the person viewing the site is a clinician, patient, or caregiver, we want to know what the device does for the patient, and what other devices it may communicate with to make it more useful. Videos are great for entertainment, but not so great for information. If you are a visual learner, great, but don't force non-visual learners to constantly replay a video. This will only drive them to abandon the website and your product.

Provide a downloadable brochure for patients/families and another for clinicians. Now if manufacturers want to make separate downloadable brochures for clinicians and one for patients/caregivers, I will not object as this could help both. I do strongly agree with the doctor on this point, brochures are easier to read and mark up than many PDF files. Both may be easily forwarded, but the brochure will be the easiest for the patient to understand.

Include information regarding the relevant evidence-base supporting use of the product. Yes, this would be nice for both the clinician and patients. The more hype we have to read the less likely we are to consider the device.

Include information on how valid/accurate the data collection is compared to conventional clinical practice. This would be appropriate for most devices, especially since the specifications will probably be not as restrictive as devices that are used in the proper way in a lab setting. Most clinicians will need to realize this to understand that the devices are not for use in a lab, but out in the real world by real patients trying to help themselves. Most websites are not properly set up clearly to explain what clinicians are seeking and often not what patients are seeking. Often there is so much “feel good” hype and glitz that patients and clinicians can find little useful information. This will lead both to look elsewhere and maybe overlook a device that could be very useful. When will manufacturers learn?

Offer a free 30-day trial. This is purely a sales pitch and why a doctor would suggest this is hard to understand. The reason many companies offer this is because they know that if people order something, they are seldom going to return it unless it is so bad that people are angry with the product. Even then some people will not return the product and companies are counting on this and know the sale has been made.

Summarize how the product is different or better than similar available products.
This is also a sales tactic and we see this done when a company feels they have a superior product, but be careful, as often this is done to hide weaknesses as many are familiar with in software products.

Summing it up. The doctor has in general done her homework and offers good advice to manufacturers. Like many products, medical devices will be one product that doctors will often be called on to give an opinion about. Some doctors are blogging about devices and some patients are doing this. Should we rely on the information? This is difficult to answer, as not everyone is honest about relationships they may have with a manufacturer.

Some doctors are very reputable and will clearly state if they have any relationship with a manufacturer. In general these devices can be relied upon. Most patients are also very clear that they have a relationship with a manufacturer or if they are speaking from experience with the device. If they are actual users speaking from experience, generally these reviews can be relied on.

The weakness is that there is seldom a database of device reviews and everyone is not privy to the reviews that have been made. As much as we want to have information we can rely on, I seriously doubt this is a priority for manufacturers as most are only concerned about sales and will continue to put out all the hype they can to “convince” consumers their device is what they need.

Maybe the doctor was engaging in some wishful thinking, but until enough people speak up, we will not have reliable information for most devices. Until manufacturers understand what may drive sales, we will continue to have hype, glitz, and very little information of value. If people, doctors, patients, caregivers, and others will refuse to promote medical devices from manufacturers that have poor glitzy websites and refuse to give the information needed by all concerned, then we have lost and hype will continue in device promotions.

Yes, I have been overly expressive about hype and glitz, but from experience, this is the biggest turn off for me about the few devices I have investigated. Websites that say “This is a must have for your peace of mind,” or similar statements have made me leave the website and look elsewhere for something similar. My peace of mind is knowing that this is probably the poorest product available.

April 22, 2013

Doctors and New Technologies – Part 1

Part 1 of 2 Parts

This doctor has a lot to say about new technologies, some good and some bad. I agree with her for most of the statements and I must question some of her qualifiers. She is right that deciding if a new technology will help a patient or a patient's caregiver is important. Often this is as difficult for a physician as it is for the patient or caregiver. Since this doctor is working with the elderly, her decisions are compounded by what the patient or caregiver may be capable of managing.

One question that many people forget to ask or consider is, does this device communicate with other devices and if not, does this make the device less of a help. Too often, our high-tech devices are proprietary to the extreme and therefore useless except in very narrow limits. Until ethics can become part of doing business, most products available today are more of a hindrance because most data has to be transferred manually between devices. When time is important, devices that don't communicate are a fraud on the buying public to say nothing about medical care.

Here are her questions and my comments as a patient.
Does it help me do something I’m already trying to do for clinical reasons?
This is a question every doctor must ask and every patient should want to know. For the patient or caregiver, they also need to ask if it will meet their needs. Also, what does the device handle and is it a tool that would be useful.

What evidence is there that using it will improve the health and well being of an older adult (or of a caregiver)? This is the one question that this doctor fails, as she uses a meta-analysis study to say there is no clear benefit for non-insulin people with type 2 diabetes to regularly self-monitor blood glucose. I have blogged about rigged studies here and do not doubt that many of the studies in the USA were also constructed to give the desired results. Then in my email of Feb 5, 2013, I received my newsletter from The Behavioral Diabetes Institute, which has this link to information in Diabetes Care on the ADA website. The link is to a file that is a PDF and you will need to use Adobe Reader or a PDF compatible reader to download it. It has seven pages and is good reading with the ADA “experts” for the first three pages and the rest is written by Dr. William H. Polonsky and Dr. Lawrence Fisher. They are a voice of reason about self-monitoring of blood glucose (SMBG) and how important it is to all people with diabetes. Then they cover people with type 2 diabetes not on insulin as they are the ones not given the education and training in SMBG and could really benefit.

How does the data gathering compare to the gold standard? Talk about being vague, gold standard is what? When medical people refer to this, there are too many meanings that could be applied and this leaves all types of variables open for speculation. I sincerely wish they would use lay-speak. I do doubt that many devices actually meet gold standards since some may not have gone through FDA approval. If they have, then they should be more reliable, but maybe not reliable enough to meet a gold standard. Also, we need to remember that specifications for some devices will be more liberal simply because the manufacturer knows that the device may not be used under ideal conditions when used by patients or caregivers.

How exactly does it work? Come on doctor, they are not going to give away these secrets. They are only going to disclose what the device is made to do and if it communicates with other devices and which ones. If we are able to read through all the hype, we may discover what the outcome of its use is, but don't expect much until you get the device and instruction book in hand. As a doctor, you have to expect little information about clinical use, unless it is for clinical use. Most of the devices are not made for doctor use, but for patient use and many manufacturers could care less about what the doctors find useful. In fact, they might sell more devices if they did care about what doctors thought of the device.

How easy is it to use? Now this would be a good place to have a doctor's opinion and to know if it is easy to use by a wide range of patients including the elderly. For the elderly, ease of use is a must because often the elderly may have limited vision and or lack of dexterity in their hands.

How easy is it to try? This can be the key to many medical devices. Does it require a large financial outlay, or cost of training, as this could very easily send it to the back of the list of devices finding unfavorable recommendations and interest.

How cost-effective is using this technology? Here the doctor really nails it when she says, “Sometimes we have simpler and cheaper ways to get the job done almost as well.” Some devices will be overly complicated in what they can accomplish when a simpler method may work more effectively.

Can this technology provide multiple services to the patient? Many patients may have more than one medical condition. This is especially true among the elderly and knowing whether a device has only one function or multiple areas that it covers, may make it more desirable than a single function device. Here is where one device may have a clear advantage by being able to export or import information to or from another device.

Does this technology work well for someone who has lots of medical complexity? This is where a medical device will shine, or show that it is useless. It must be operable by patients having multiple medical problems. If it is too complicated, it will not be worth the money, unless it is operated by a caregiver that is with the patient every day.

While this may not be an exhaustive list of qualifications for a medical device, it is a great start and shows that the doctor has a good understanding of her patients. This will be a must for any doctor giving an opinion about medical devices. This should also be a strong consideration for patients and caregivers and serve as a way to avoid being misled by the inevitable hype on many websites.

April 21, 2013

Key Diabetes Issues Not Being Addressed

When I read the title of this article, I had to clap and hope that I was reading it correctly and that the title was not all hype. The article did not disappoint me. They did not come out and state (the authors are being polite) that many studies were practicing age discrimination, but they did state, “despite the fact that nearly 20% of adults worldwide aged 65 years and over have diabetes, less than 1% of trials specifically targeted this age group, while 31% actually excluded patients over 65 years and almost all excluded those over 75 years.” Also only a small percentage of the studies included children 18 years and younger.

Of the studies they analyzed, just one in ten studied prevention or behavioral therapies and two thirds focused on drug therapy. The research has been published in Diabetologia, the journal of the European Association for the Study of Diabetes (EASD). The research was done by Dr Jennifer Green, Duke University Medical Center, Durham, NC, USA, and colleagues. Why they had to publish outside the USA would be speculation on my part, but does raise some interesting thoughts.

The one shortcoming I can see is that they emphasize some trials, but never account for the total number of the trials or 100%. In one method they account for two thirds or about 67% and one in ten or 10% for a total of about 77% and then in another method they list 75% of the studies as being therapeutic and 10% as preventive or 85%. This leaves 15% to 23% of the trials unaccounted for which is a major fault.

It is interesting that they mention that most of the studies were small to medium size. The statement that most were designed to enroll 500 or less participants (91%) is just outrageous for developing studies of clinical importance. Then the fact that many of the studies had a mean/median time to completion of 1.8/1.4 years also makes the studies of little clinical value. It is like they were looking for specific results and running the trials for longer periods would have exposed undesired results. This last statement is my thoughts.

Since the trials were taken from those registered with ClinicalTrials dot gov we must be concerned about some of the discussion. This statement does come into the discussion and we need to raise the validity concern, “"Only a tiny proportion of the trials analyzed--1.4%--listed primary outcomes including mortality or clinically significant cardiovascular complications," says Dr Green. " Furthermore, distribution of registered trials by country does not reliably correlate with diabetes prevalence."”

ClinicalTrials dot gov does not include 100% of trials around the world, but does include many when a pharmaceutical industry wants product approval from the Food and Drug Administration and wants the test results available to the FDA.

Even though this type of study is needed, I do feel that more material should have been evaluated and disclosed. I would like to see a study like this for USA studies only and see how skewed the results are. I am very concerned about the age discrimination in most trials. Not only because they discriminate once you reach the age of 65, but they also discriminate against those under the age of 18.