Move Insulin to the First Line of Treatment

I hope Patrick Totty of Diabetes Health is right. With all the problems being discovered with the oral medications, insulin may soon be the medication of choice. Presently the only safe oral medication seems to be metformin.

Early-use of insulin isn’t a new notion. Over the past decade, numerous studies have supported the early introduction of insulin in some type 2 cases. One example of research into the concept is available at the National Institutes of Health. Googling “early insulin treatment” brings up many similar studies. Read the Diabetes-in-Control report here.

I do like this idea, but, yes one of these, I have to wonder if doctors will accept this and knowing what some doctors say, many do not believe in insulin and only recommend oral medications on top of oral medications. I think that making insulin a first- rather than a last-resort medication should be seriously considered.

In the past, the initial treatment for type 2 diabetes has been a sulfonylurea and metformin. This means the sulfonylurea is used for increased insulin production and metformin is used for a decrease in liver-produced glucose levels. As is the case of sulfonylureas, eventually begin to lose their effectiveness. This then leads to diabetes becoming progressive.

Patrick Totty has talked to Professor John Wilding, a British endocrinologist and diabetes researcher, who said he has been recommending the early use of insulin as a routine element in the treatment of many recently diagnosed type 2s. I have heard this from a few endocrinologists in the USA and as Mr. Totty has heard, the reason for doing this is to overwhelm early type 2 diabetes and its unwanted effects on blood sugar levels. This says that the progress of diabetes may be delayed indefinitely, and occasionally permanently.

The great thing is that insulin provides a “rest period” for pancreatic beta cells that have been heavily stressed as patients move from metabolic syndrome or pre-diabetes to full-onset diabetes.

One of the good things about starting on insulin is that it’s compatible with some other type 2 drugs, such as metformin or gliflozins. Because those drugs are directed at other organs than the pancreas (metformin/liver; gliflozins/kidneys), they can join insulin in as an effective team. By separately acting to reduce blood sugar levels, those two drugs can bring down blood sugars to a point that allows insulin users to inject lower doses than if they were using insulin alone.

Nor only is it needles that cause people with newly diagnosed type 2 diabetes to

resist adding insulin out of the gate to their medicinal routines. The news that you’re diabetic is hard enough by itself to wrap your mind around, never mind committing to a treatment that involves sticking yourself several times per day. Much of people’s dread of needles comes from mental images of being on an endless treadmill of self-administered shots.

Modern needles are very short and incredibly thin, much of the public and many type 2s still perceive insulin as a last resort, a sort of final defense when all of the other available defenses have crumbled. But, for many endocrinologists and healthcare providers delaying insulin is like refusing to use the best weapon in the arsenal in the years-long struggle against diabetes.

The prospect of being able to overwhelm early onset type 2 will persuade many of the newly diagnosed to start with insulin. As patterns and evidence develop in favor of early insulin treatment, other type 2s, formerly reluctant to make the jump to insulin, may rethink the whole matter.

Once this is accomplished, the doctors will need to be convinced and the people with type 2 diabetes will need to learn how to change lifestyle habits and strongly consider low carb/high fat meal plans.

Why Are Doctors Waiting to Stop Diabetes

We have learned that preventing diabetes through lifestyle interventions is possible. This has been consistently reported in other clinical trials. While this is somewhat less effective in the real world, even translational studies of combined diet and physical activity programs have shown reduced diabetes risk. We are talking about people with pre-diabetes.

These programs are cost-effective and relatively inexpensive, especially when delivered in a group format, with a median cost per participant of less than $500. Unfortunately, no cost-benefit studies were identified, so we do not know how much of a long-term impact diabetes prevention may have on healthcare costs.

However, given that patients with diabetes incur medical expenditures that are more than twice as high as those of patients without diabetes, simple logic suggests that the impact could be substantial, even when considering that costs for people with pre-diabetes are already elevated. The biggest problem is we do not know the extent to which evidence-based diet-and-exercise diabetes prevention programs are being offered.

Although somewhat less effective than lifestyle, metformin has been shown to prevent diabetes in clinical trials. Metformin has been shown to be a cost-saving intervention and is clearly easier to deliver on a population-wide basis than diet and exercise programs. In patients with newly diagnosed diabetes, metformin is most effective when given at diagnosis and at lower A1c levels than if delayed, suggesting that beginning metformin before diabetes develops may further enhance its effectiveness.

Despite this evidence, and even though metformin is included in the American Diabetes Association guideline for diabetes prevention, only a small minority of patients at risk for diabetes are receiving metformin. If a relatively simple and inexpensive intervention is reaching less than 5% of its target population, we can imagine that a more complex and costly intervention will not fare any better. Of interest, the 5% treatment rate is actually an improvement over a previous study based on 2005-2006 National Health and Nutrition Examination Survey data, in which no patients with pre-diabetes were receiving metformin and only about one third had received advice about diet and exercise.

We know that type 2 diabetes is a major public health crisis and we know that it can be prevented. The Community Preventive Services Task Force has just issued a recommendation for promotion of combined diet and physical activity programs by healthcare systems, communities, and other implementers. For those unwilling or unable to participate, metformin offers a simple, low-cost, and effective alternative. What are doctors waiting for?

I am only guessing, but I feel that many doctors are not interested in treating pre-diabetes. I have heard doctors laugh about pre-diabetes and say they would not treat these people until they had something treatable. One doctor and I had a heated discussion about this in a hospital cafeteria until two other doctors ushered him away and one came back to ask me to leave and was none to polite about it. As I was leaving, I asked why it was that some doctors like to do harm to patients.

What is AADE Up to Now?

If this is true, what is happening to our diabetes educators? This may be why the project I included in this blog about having Associate Diabetes Educators under the umbrella of the AADE has not been in any notice of the meetings since or even mentioned on the American Association of Diabetes Educators website. Now I will stand by that blog about having concerns about the new AADE leaders.

Could it be that the AADE is trying to outdo the Academy of Certified Diabetes Educators (ACDE) and limit what they can do. This surprises me because of the actions by the ACDE in the state of Indiana when they opposed a law passed by the Indiana legislature to allow non-CDEs to help educate other people with diabetes.

At this point, only the state of Kentucky has passed the bill allowing the AADE to be the source of diabetes education. Like the AND (Academy of Nutrition and Dietetics), the AADE has attempted to create mandatory certification requirements at the state level, but has been almost completely unsuccessful.

Now the AADE seems to be trying its luck on the federal level. A bill before Congress called the Access to Quality Diabetes Education Act of 2015 (HR 1726, S 1345) will make it more difficult for patients with diabetes to get the help they need to overcome the disease.

The so-called Access to Quality Diabetes Education Act (which opponents are appropriately calling the #DiabetesMiseducation Act) would turn this currently voluntary certification into a legal requirement under Medicare, a costly, unnecessary obstacle for thousands of healthcare workers. If passed, this would leave countless diabetic patients without access to important, life-altering services and possibly limit who could educate the diabetes patients about diabetes.

There is something else you need to know about AADE. It is not an independent, objective organization. In fact, it receives large sums of money from Big Pharma. The organization’s 2014 annual report shows that its top two corporate donors were pharmaceutical giants AstraZeneca and Novo Nordisk, with Eli Lilly not far behind.

Diabetes is a rampant, ever-worsening health problem. One recent study found that half of adults in the US have diabetes or are in the pre-diabetes stage. Diabetes is often, but not always, the result of poor diet and lack of exercise. The standard American diet (SAD) tends to create insulin resistance. New studies have emerged showing that consuming highly processed starches is like eating sugar, causing rapid glucose spikes that may over time induce insulin resistance and, eventually, type 2 diabetes.

Conventional doctors often lack the resources to provide much support to diabetic patients. Often they do not have the time to do diabetes education, or they provide seriously misguided information on how to manage or reverse the disease. Health coaches and diabetes educators become particularly important.

And, if the AADE gets this passed, what will happen to those diabetes knowledgeable people that are helping doctors in rural areas? Will they be criminalized? Even scarier is diabetes bloggers; will they criminalize us as well? The future looks very grim and we will be facing two organizations that will be competing to be the only organizations allowed to teach nutrition and to do diabetes education. This will mean that patients will no longer have a choice in learning about diabetes and will suffer because of the advice being promoted by two exclusive organizations.

Because of the AADE leaders that have two titles, CDE and RD after their names, it is not surprising that our diabetes education will take on a new twist – more and more whole grains and more and more carbohydrates. BIG FOOD must be licking their chops with this bill, as well as Big Pharma.

Patients will be advised to consume more high carbohydrate and dense carbohydrate foods and cover their high blood glucose spikes with more diabetes drugs. It will mean that diabetes will become more progressive for the people that willingly follow the advice of CDEs and RDs (registered dietitians). Those of us that have learned the consequences of following this advice know that we cannot go there and need to continue limiting our carbohydrate consumption and increase our fat consumption. Covering increased carbohydrate consumption with more diabetes drugs is not the answer and leads to more overweight people with diabetes.

I have sent my objections to my senators and representative. Read this article for more information. I would suggest that you read this blog by Steve Cooksey.

Foot Exams Are Necessary for People with Diabetes

This is probably one of the better topics covered at the 2015 American Association of Diabetes Educators meeting. Many clinicians are still failing to perform foot exams at all clinical visits with their patients who have diabetes, and their feet are telling the story. Preventing diabetic foot disease begins with proper foot care.

Many doctors are being so pushed by the insurance companies to cut their time with patients that those patients needing the time for a foot exam are often completely overlooked. If you have a doctor that does this, always schedule ahead to know if the doctor will have the time or needs extra time for a complete foot and lower leg exam.

The above is important because if an amputation is needed because of poor foot care, your prognosis for a second amputation gets much higher and your life expectancy greatly decreases. These two facts should encourage you to get the foot exam.

“In 2010, about 73,000 of non-traumatic lower limb amputations, representing about 60% of all non-traumatic lower limb amputations, were performed in adults aged 20 years or older with diagnosed diabetes. And another study showed that 9% to 20% of people with diabetes who experience a lower limb amputation will undergo a second amputation within 12 months of their first surgery.”

“Additionally, 5 years after the first surgery, 28% to 51% of patients with diabetes who have undergone amputation will undergo a second amputation. Also, it is now estimated that up to 55% of patients who experience a lower extremity amputation will require amputation of a second extremity within 2 to 3 years.”

A simple lesion left untreated can lead to ulceration, infection, and amputation in a very short time span. However, one major problem is the fact that the feet of patients with diabetes are so often insensate that they may be unaware of the trauma they are experiencing until it's too late.

All the components of each patient's unique issues are essential for the proper selection and fitting of padded socks and shoes. Further, all patients with diabetes should be counseled about the importance of preventive foot health practices so they can take the proper steps to prevent foot pain and dysfunction farther down the road.

Sources of Great Diabetes Information

It has been too long since I presented websites of value for those of us with diabetes can use. The last was back in February 2013.

http://bobsdiabetes.blogspot.com/2013/02/useful-aids-for-people-with-diabetes.html

I presently have a few links that I have found useful for me and hopefully you will find them useful for your diabetes living.

http://www.dietdoctor.com/lchf This link is for a very good discussion on low carb/high fat meals. The website explains why this works and why you lose weight and stop losing when you reach your ideal weight. Many people are following this diet and seeing improvements in their cholesterol levels and some with hypertension improvement.

http://www.diabetesforum.com/diabetes/10209-useful-links.html#post131687

While this is part of a diabetes forum, it is at least a topic that they use. Not enough people follow the principal of “eating to your meter.” This forum combines this with several other of the sites in this blog for a well-rounded low carb/high fat meal plan and managing diabetes.

http://www.phlaunt.com/diabetes/19712644.php This is important when you have to be in a hospital for an accident, surgery, or disease treatment, this is important to read. These give instructions that you should follow to minimize the damage hospitals or nursing homes can do to your diabetes management.

http://www.phlaunt.com/diabetes/14045524.php This will help those not wanting to use low car/high fat or not believing in high fat to get started after diagnosis. As you learn that fat is not your enemy, the meal plan will come together to help you manage your diabetes.

http://www.phlaunt.com/diabetes/14046739.php Don't fall for the toxic myth that you caused your diabetes by reckless overeating. This if often promoted by doctors that don't know better. People with diabetes often are seriously overweight; there is accumulating evidence that their overweight is a symptom, not the cause of the process that leads to Type 2 Diabetes.

http://www.phlaunt.com/diabetes/ This will take you to the site and allow you to read more on diabetes.

http://www.healthcentral.com/profiles/c/17 You may need to join the website to get to this. You can do this by using everything before profiles. This is one way to follow an author and in this case, it is David Mendosa. David is following a vegetarian style plan. I cannot because I like my red meat and dairy products. I have eliminated the processed red meats, but I like my well marbled meats and I would use lard if it was not for my wife who keeps it out of the house. Therefore, I use a lot of butter for cooking and use olive oil for some cooking.

 

http://www.diabetes.org/diabetes-basics/common-terms/ There are many terms we as people with diabetes often encounter in our reading and I have learned many of the terms out of necessity.

http://www.diabetesincontrol.com/images/issues/2015/09/ListofErrorProneAbbreviationsSymbolsandDoseDesignations.pdf#EHS_ID;101050

This is a two page listing of common medical errors and why.  Much is based on misread abbreviations and shows common misreading errors. 

Can Algorithms Solve Patient Diabetes Education?

I seriously doubt this. Why? Because there are too few Certified Diabetes Educators (CDEs) to effectively do this. Plus, there are too few CDEs in largely rural areas of the USA to serve the needs of these people without using telemedicine, which CDEs are presently refusing to use. Yes, reimbursement is a problem, but they even refuse to investigate or advocate further.

Linda Siminerio, RN, PhD, CDE is speaking about where she works, “I work at the University of Pittsburgh Medical Center. I am a diabetes educator and I do research in healthcare delivery systems. I am very excited to be at this meeting, where I was fortunate enough to be a part of developing a position statement on diabetes self-management education for people with type 2 diabetes. The American Diabetes Association, the American Association of Diabetes Educators, and the Academy of Nutrition and Dietetics jointly published this position statement. We are very excited about this position statement because it presents all of the evidence that we have of the benefits of diabetes self-management education for people with type 2 diabetes.”

She continues that they know from the literature that diabetes self-management education works. I find that what I have been writing about the lack of diabetes education is echoed by her and she uses the term abysmally low. Yes, recent reports say that Medicare participants are only about 4 percent and for commercially insured is at a 6.8 percent. This means that the CDEs are not doing their job and providing diabetes self-management education to those needing education.

I am not surprised at another statement she makes. She says that the referral rate is particularly poor. In order for patients to receive self-management education from a trained professional, they have to have a referral from a physician. She does try to avoid the true reasons for poor referrals, by saying physicians are too busy. To this I would add that the mantras and mandates by many CDEs have caused physicians to lose trust in the CDEs. Many CDEs openly contradict what the doctor says and feel their mandates are more important than what a doctor says.

Please read my blog here about the reason I don't think there are enough CDEs to accomplish the goals put forth in the joint statement. Also consider why I don't think the ACDE professional group will be much help by opposing doctors training other people with diabetes to be peer mentors or peer to peer workers.

Then this blog about a Canadian study proving group diabetes education helps more than individual education. And the last blog I suggest is this one about the leadership of the AADE and a program I have not heard any more about for training people with diabetes to help other people with diabetes. Apparently the idea has lost favor among members of the AADE because of pressure from the ACDE.

Is It Time for Free Speech in Medicine?

Look out folks; Big Pharma has more power to promote medicines! This is a two-edge sword and I fear that patients will suffer. Others are claiming this as a victory for free speech in medicine. I can see some advantages and disadvantages on both sides.

Pros:

• Maybe patients will see a decline in the cost.
• Maybe patients will have to take less medication.

Cons:

• There may be more adverse events on “off-label” medications.
• Doctors will be under more pressure to prescribe “TV advertised” medications.

The Food and Drug Administration (FDA) regulates both safety and “efficacy.” This causes a drug maker to prove its medicine works to the FDA before marketing it to doctors. However, the cost of clinical trials to prove claims is monumentally high, so drug makers will not always invest in clinical trials for every medical condition where the drug may work.

Once a drug is used, doctors will find that it is effective for more medical conditions than indicated on the label. The new indications are often supported by peer-reviewed, published research. However, the drug makers have not yet invested the time and money to negotiate with the FDA to get the new claims onto the label. The FDA says drug makers cannot talk about these off-label uses. A federal judge just decided they can.

Judges are chipping away at government censorship of communications about prescription drugs. The Food and Drug Administration exerts great power over a medicine’s label, which describes the medicine’s therapeutic claims. Drug makers and the FDA sometimes spend years negotiating a label.

Oncology is one specialty where off-label prescribing is common. Indeed, off-label prescribing is so common that some states mandate insurers pay for coverage of prescriptions written for off-label use! Surprising how the regulatory bureaucracy is behind the curve on this issue. Nevertheless, the FDA has asserted power to stop pharmaceutical reps from even distributing reprints of peer-reviewed studies supporting off-label uses to doctors.

This does not mean that we are talking about the “snake oil” salesperson. We are talking about high-level discussions with relevant specialists about new evidence-based medicine. This is part of why judges have been ruling for Big Pharma lately.

In this case, a judge recently found – on First Amendment grounds – that representatives of Amarin Pharma can distribute such information to doctors despite the FDA’s disapproval.

Established in 1906, the FDA has consistently increased its power. Not until 1962 did it win the power to adjudicate efficacy. Removing that power, and limiting the FDA to regulating safety, would return authority to doctors and patients. The 21st Century Cures Act, which passed the U.S. House of Representatives in June does not go that far. Nevertheless, it allows more “real world” evidence to be added to a drug’s label, which is a step in the right direction.

Our September Meeting

Our September 12 meeting was different to say the least. Most of our members were present, but we were surprised by the number of new people present. Tim introduced everyone and said that we have 14 possible new members. I recognized six of them as I had met them over the last few years. I knew they had type 2 diabetes. Three had not wanted to join earlier as they were still working and did not want the additional time taken from family. The wife of one of them was there and she said she now had type 2 diabetes.

Sue said she knew four others and thanked them for coming. Barry and Ben also knew them and said they could join when a vote was taken. Tim stated that he had invited five of them and one was one I knew. They all wish to join and this is the reason we do not have a program, as we want to spend time with the potential members before asking them to join.

Then Tim asked how many were receiving veteran's benefits and four indicated that they were. Three others said they were also veterans and were not receiving benefits. Tim asked Allen and Barry to ask them questions. With that, we dispersed into groups and started to get to know each of them.

About 30 minutes later, Tim called us back into the meeting and asked if there were any questions. Only one question and that was about dues. Tim said we do not have dues presently and we ask people to bring their own snacks if they need them. We ask everyone to pick up any trash that may be found at the end of a meeting and to put the chairs up and help with cleanup.

Then Tim asked for a show of hands from the new people that still wanted to join. When all hands were raised, he said then the current members will vote on acceptance. When that was unanimous, Tim asked if we wanted to change leaders for the coming year. Brenda moved that we keep the same leaders and Allen seconded the motion. A show of hands confirmed that we all agreed. This meant we went from 28 to 42 members.

Next Tim asked each of the new members to give him their email address and phone number. He explained that these would be used for sending out notices of a meeting and for emails after a meeting about what happened during the meeting so that if someone needed to miss a meeting, they did not need to feel they were being ignored and would know what happened. He explained that some of us exchanged emails between meetings about meeting topics and special things we might want covered. He continued that if someone is hospitalized, and wants visitors, this is a way to spread the word.

He collected the information and then said that they each would receive a master email list of all the members and their phone numbers. Then he asked if he should ask Beverly to give the presentation that we canceled at the last minute the first Saturday in June. Everyone agreed and then Tim asked Brenda and Jason if they would give their presentation in November. Brenda said that would be okay and she and Jason were ready, but could polish it after the long delay.

Tim stated that the meeting was over and cleanup started.