Guidelines for CGM and CSII in Diabetes

Continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) represent 2 of the recent technological advances in diabetes care that aim to improve glucose control and quality of life and minimize hypoglycemia. Reliable data on such technology are scarce, however, due to the rapid pace of advancement in such products and the less stringent US Food and Drug Administration (FDA) regulation, and thus less demand for clinical trials, of medical devices compared with pharmaceuticals.

In September 2016, a task force appointed by the Clinical Guidelines Subcommittee of the Endocrine Society published a practice guideline pertaining to the use of CSII and CGM technologies in adult patients with type 1 diabetes and type 2 diabetes, based on a thorough review of relevant studies. The guideline is co-sponsored by the American Association for Clinical Chemistry, the American Association of Diabetes Educators, and the European Society of Endocrinology. The fact that type 2 is even mentioned should be an encouragement that there may be hope for us to obtain this equipment.

“I think the guideline is making more clinicians aware of the established role of technology in the treatment of diabetes,” said Task Force Chair Anne L. Peters, MD, director of the clinical diabetes program and professor at the Keck School of Medicine at the University of Southern California in Los Angeles.

“It is a good starting point for a field that is rapidly advancing,” she told Endocrinology Advisor.

The task force made recommendations that they considered either strong or weak based on the quality of the evidence available. For the former, they used the term “recommend,” and for the latter, they used the term “suggest.” They denoted the quality of evidence for each area reviewed, which ranged from very low quality to high quality. “The Task Force has confidence that persons who receive care according to the strong recommendations will derive, on average, more good than harm,” they stated in the document. “Weak recommendations require more careful consideration of the person's circumstances, values, and preferences to determine the best course of action.”

Throughout the 6 covered areas below, the guideline authors emphasize the importance of patient and caregiver training and education, as well as capability and willingness to use the devices.

“Educating our patients on the use of these technologies is vitally important,” Matthew Freeby, MD, director of the Gonda Diabetes Center and associate director of diabetes clinical programs in endocrinology at the David Geffen UCLA School of Medicine, said in an interview. “Providing education increases the chances of using them well and ensuring safety.”

#1. Insulin pump therapy without sensor augmentation. The authors recommend CSII vs analog-based basal-bolus multiple daily injections in patients with type 1 diabetes who have not achieved their HbA1c goal, as well as those who, despite having achieved their HbA1c goal, continue to have severe hypoglycemia or high glucose variability.

They also suggest CSII for patients with type 1 diabetes in need of more insulin delivery flexibility or improved satisfaction. “The flexibility provided by CSII with rapid-acting analog insulin could be an advantage for those who exercise and potentially those with gastroparesis because the basal delivery dose and pattern can be modified,” they explained in the paper. The guideline offers a detailed description of how to select candidates for insulin pump therapy.

#2. Insulin pump therapy in type 2 diabetes. The task force suggests CSII for patients with type 2 diabetes who have poor glycemic control despite all reasonable efforts with insulin or other injectable therapy, oral agents, and lifestyle modifications.

#3. Insulin pump use in the hospital. The guideline authors suggest continuation of CSII in patients with type 1 diabetes or type 2 diabetes who are admitted to the hospital, as long as the hospital has established protocols for evaluating and monitoring the use of CSII in such patients. This approach is supported by both the American Diabetes Association and the American Association of Clinical Endocrinologists.

#4. Selection of candidates for insulin pump therapy. Before prescribing CSII, the authors recommend that clinicians conduct a comprehensive assessment of the patient's mental and psychological status, history of adherence to other self-care measures pertaining to the disease (such as carbohydrate counting and sick-day rules), availability for necessary follow-up visits, and willingness to use the device.

#5. Use of bolus calculators in insulin pump therapy. The task force suggests that clinicians encourage “patients to use appropriately adjusted embedded bolus calculators in CSII and have appropriate education regarding their use and limitations.” They do not recommend the use of non-CSII insulin calculators, such as those available via smartphone apps, which are not FDA-approved.

#6. Real-time continuous glucose monitors in adult outpatients. The authors recommend real-time CGM devices for patients with type 1 diabetes and above-target HbA1c levels, as well as those with well-controlled type 1 diabetes, who are capable of using such devices almost daily. They suggest short-term, intermittent real-time CGM use in adults with type 2 diabetes who are not on prandial insulin and have HbA1c levels ≥7%.

They suggest that both patients with type 1 diabetes and type 2 diabetes using CSII and CGM receive appropriate education, training, and support to achieve and maintain their glycemic goals. They note that data showing improved long-term glycemic control using GCM underscores the importance of the patient's skill in using the new technology.

Final Thoughts

“The authors of this guideline did an excellent job reviewing the recommendations based on the current available data,” said Dr Freeby. “As stated in the guideline, there are plenty of data to support the benefits of pump therapy and continuous glucose monitoring in type 1 diabetes, and anecdotally, these therapies really work in day-to-day practice.”

Dr Peters hopes clinicians will be excited about data analysis and how the new devices can help patients. “I don't think they should be oversold—type 1 diabetes is still a challenge, but these are all steps on the way to more fully automated systems,” she said.

Smart Phone Apps May Be Self-Management Savior

Smart phone apps could offer patients with type 2 diabetes a highly effective method of self-managing their condition, concludes a study by Cardiff University.

Yes, this may help some people, but in talking to members of our support group, of the 25 members, only two members were using apps and even they were not happy with the apps they had or were using. Both stated they could do better without the apps.

A systematic review of 14 previous studies found that all had reported a reduction in average blood glucose levels in patients that used an app, compared to those who did not, with an approximate reduction in HbA1c (glycated hemoglobin) of about 0.5%. The analysis also found that younger patients were more likely to report a benefit. No evidence was found to support the use of apps in type 1 diabetes, but further research is needed to substantiate this.

Dr Ben Carter from Cardiff University's School of Medicine said: "With the number of patients globally with diabetes expected to rise to over 500m by 2030, there is an urgent need for better self-management tools. Both of the members agreed that there is a great need for better tools, but until app developers start listening to customers, apps will not improve much to fulfill the needs of users.

As we enter an era where portable technology is increasingly used to improve our lifestyles, as can already be seen with physical activity technology, apps can offer a large percentage of the world's population a low cost and dynamic solution to type 2 diabetes management.

Diabetes management includes monitoring and managing blood glucose levels. This is done by controlling diet and knowing how foods affect blood sugar. For many people with diabetes, it also involves taking medications that help manage blood sugar levels. Current diabetes apps allow patients to enter data and provide feedback on improved management. They can provide low cost, interactive and dynamic health promotion by allowing patients to track medications, set reminders, plan meals, find recipes and plan for doctor's appointments and blood tests.

Dr Carter added, "By the end of the decade it is predicted that global usage of mobile phones will exceed 5 billion, so apps, used in combination with other self-management strategies, could form the basis of diabetes education and self-management."

The study comprised of a systematic review of 14 diabetes type 2 randomized controlled trials, involving 1,360 patients. This type of research provides the strongest evidence for drawing causal conclusions because it draws together all of the best evidence.

"Do Mobile Phone Applications Improve Glycemic Control (HbA1c) in the Self-management of Diabetes: A Systematic Review, Meta-analysis, and GRADE of 14 Randomized Trials," is published in Diabetes Care.

Weight-Loss Education Missing for Low Income Adults

A new study finds clinicians less likely to counsel less educated, and younger and older patients. According to a study in Preventing Chronic Disease, low-income adults who are overweight or obese are less likely to be counseled to lose weight than adults with higher incomes.

High-risk patients, such as those who are extremely obese or have comorbidities, are most likely to receive weight-loss advice. However, demographic factors also appear to determine who receives advice. Patients who have high levels of education are more likely to receive advice than those who have low levels of education and those who are middle-aged are more likely to receive advice than younger or older patients. Study results are unclear about whether health insurance plays a role in determining who receives weight-loss advice; some studies found that insurance is not associated with receiving weight-loss advice, whereas one study found that patients who had private insurance were more likely than uninsured patients to receive weight-loss advice. Income also appears to play a role; those who have high incomes are more likely to receive weight-loss advice than those who have low incomes.

This study is the first to explore the determinants of receiving weight-loss advice in a sample of overweight or obese individuals from communities with a high proportion of low-income, racial/ethnic minority populations in a multivariate analysis of race/ethnicity, age, sex, health status, income, health insurance status, and education.

Over 1,100 overweight or obese adults from New Jersey were surveyed about whether their healthcare provider had advised them in the past year about weight loss. A substantial proportion of participants had low incomes and were of a racial or ethnic minority.

Only 35% said they had recently been advised by a clinician to lose weight. After adjustment for health insurance status and other variables, participants whose household incomes were above 400% of the federal poverty level had a 64% increased odds of receiving weight loss advice, compared with those at or below the federal poverty level. Participants at 200–399% of that level had 56% higher odds.

The US Preventive Services Task Force recommends that all patients be screened for obesity and, if needed, be provided weight-loss advice. This study aimed to describe the determinants of receiving weight-loss advice among a sample with a high proportion of low-income, racial/ethnic minority individuals.

The finding that individuals in the lowest income group had significantly lower odds than individuals in higher income groups of receiving weight-loss advice from their health care provider is similar to the findings of previous studies. Patients who have risk factors such as obesity, poor health status, diabetes, and asthma would warrant special attention to weight. The finding that these risk factors increased the odds of receiving weight-loss advice aligns with the findings of other studies.

From the results of the study, it was concluded that income is a significant predictor of whether or not overweight or obese adults receive weight-loss advice after adjustment for demographic variables, health status, and insurance status. Further work is needed to examine why disparities exist in who receives weight-loss advice. Physicians should provide weight-loss advice to all patients, regardless of income.

Our November Meeting

On November 12, we met for our meeting. This happened to be the same evening as our competing group. Brenda brought the group to order and asked if there was discussion about new members. Barry said there should be as he has had four people talk to him about becoming members. One of the new members, B.J, said he had three people approach him about joining our group.

Julie said she had two people ask her about membership and Rose said she had been asked by three people. Allen said we should have a discussion then. He said that the number felt good with the present number of 25 and we had agreed on accepting new members at the October meeting only. Sue commented that maybe we should have them start a new group, as the group Glen led had stopped membership, Dr. Tom's group was now about 30 members, and the group that we separated from also had over 30 members.

Jason moved that we work with them to form a new group. Sue seconded the motion and Brenda introduced Glen to speak to the issue. Glen said the group he presently led had capped their membership at 25 and had eight more wanting membership so he could agree with the need for a new group. He continued that the twelve wanting membership and the eight from his group would make 20 members for a new group.

Brenda asked if there would be more discussion, and with no hand being raised, she asked for a vote. The vote was unanimous and she asked Barry and Allen if they would work with Glen or someone from his group to help form the group. Both agreed and Brenda thanked them. Allen stopped and told everyone that this is the first he has been thanked by a leader of the group and he said he wanted everyone to know why he would support Brenda. This brought a hearty round of applause.

Glen stated that he wanted to thank Brenda for helping keep members of the separated group out of his group, as three had tried to join his group. Brenda said we will need to work together in the future to avoid other problems. We will also be having a few meetings and inviting other groups. We hope you will find interest in some of them. We had planned this to be one of them, but the membership issue became important. In talking with you and finding out the numbers of potential members, we felt this required our joint attention, so thank you for your input.

Barry asked to speak and said a few potential members may back away from a new group, but this should be expected. Glen said this may happen, and these people should be told that the membership in our groups is capped at present and we don't anticipate any member changes in the near future. Allen said this is correct and Glen has explained this very well.

Brenda then asked if any one disagreed. No one disagreed and Brenda asked Julie, Rose, and B.J if they would work with Glen, Barry, and Allen to support the formation of the new group. All three said they would and B.J asked if he could be part of the group with Glen, Barry, and Allen as he wanted to learn from them, as he felt several could be in need of VA assistance like he was.

Allen said this was something Barry and he had discussed and this needed to be accomplished. Brenda asked Allen if he would work with the new members.  Allen said Barry and he should have done this in October and now this meeting was all but over, and it had not been done.

Brenda asked B.J if he needed the information now or later. He said there are three other new members and three in those he knew that wanted to join. Julie said both of her potential new members need this information. Rose said two of her three were also veterans.

Barry said this means about 14 are veterans and he asked Glen if he knew about those wanting VA information. Glen said he was not sure, but he would ask. Allen said there was a lot to be done to start the new group, but felt it might help start the new group.

Brenda asked if there was any other business. None was forthcoming and Brenda said cleanup is in order. She concluded by saying she would suggest those working on the new group stay in contact with her and each other. She said she would forward any information that she receives. The meeting is over.

Use Lantus – Be Ready to Change in 2017

Sometimes I’m amazed at how oblivious some people in this world can be. Actually, I should say it really doesn’t amaze me given this is the world of diabetes, which is full of clueless opinions. I mention this after some conversations on the nature of the insulin market. Yes, people are beginning to wake up to the fact (yes, those damn pesky facts again), that insulins have become a commodity. This is particularly true with long-acting insulins, of which there are now 5, one being a biosimilar.

Lilly has the biosimilar, Basaglar,which is winning the war that counts: formulary position. Lantus, the current leader, isn’t just losing the war, it’s losing by a mile. Starting next year, when formulary changes go into full effect, Basaglar will become the long-acting insulin of choice. Not because it’s any better than Lantus — it isn’t. It’s the same as Lantus, only cheaper — which is exactly the point.

Still, many seem to believe there will be pushback from physicians. Why would they switch any patient from Lantus to Basaglar, especially when Lantus works so well? First, as much as I hate to state the obvious, it really won’t be left up to the physician. It will be the payor and formulary position that wins, not the opinion of the physician. Think about the discussion a physician would have with a Lantus-using patient after these formulary changes take place.

“Mr./Ms. Patient, you know I would like to keep you on Lantus. It’s been a great drug that has worked very well for you. Now I could keep you on Lantus, but there is a slight problem: your insurance company no longer covers Lantus. You can stay on Lantus, but I must warn you that it’s going to cost you where it hurts most: in your wallet. Your alternative is to go on this new insulin called Basaglar, which is basically the same as Lantus and is covered by your insurance.

Now I know what you’re thinking: should you trust this new insulin, is it really the same as Lantus? Let me assure you that you have nothing to worry about, for two reasons. First, according to all the studies I have read, Basaglar works just as well as Lantus. Second, Basaglar is not made by some no-name company you have never heard of; it’s made by Eli Lilly, a company with a long and distinguished history in diabetes.

Now I want to say that I am not happy about the changes made by your insurance company, although I am not surprised by their decision. So, the choice, as always, is up to you. You can stay on Lantus and pay more — likely a lot more. Or you can switch to Basaglar and pay what you were paying before. You tell me.

This type of discussion is about to happen in physician offices in 2017; likely sooner, as we’re pretty sure insurance companies have been informing patients about the upcoming changes in formulary. Changes which they will support so that the patient feels comfortable switching from a drug that works very well to one they have never heard of. In the end, patients will accept these changes, as at the end of the day this isn’t about whether Basaglar is as good as Lantus: this is about money. While there may be some who will pay a premium for Lantus, the majority will not.

Try Walking after Eating

If you have type 2 diabetes, walking can be very helpful for you as a way to lower your blood glucose level. When is the best time to go for a walk to gain the benefit of walking?

According to a recent study, a short walk after eating may help lower blood glucose levels more than exercising at other times of the day. A measurement of blood glucose called postprandial glycemia, which has been linked with heart disease risk, averaged 12 percent lower when study participants took a walk after eating, compared with those who exercised at other times. The largest drop in postprandial glycemia, 22 percent, was achieved by walking after dinner, the study authors found.

"If you have type 2 diabetes, there is a guideline to be active for at least 150 minutes a week," said study author Andrew Reynolds, a researcher at the University of Otago, in New Zealand. But, he added, "the benefits we observed due to physical activity after meals suggest that current guidelines should be amended to specify after-meal activity, particularly when meals contain a substantial amount of carbohydrates," he said. "Consider walking after you eat as part of your daily routine," he added.

However, one U.S. diabetes specialist offered a caveat on that advice. Exercise is indeed part of good management and care for those with type 2 diabetes, said Dr. Joel Zonszein, director of the Clinical Diabetes Center at Montefiore Medical Center in New York City. But, he urged caution about the benefits of exercising right after meals.

Because heart disease is common among those with type 2 diabetes, "we need to be careful in encouraging exercise after a meal, as the demands on the heart increase with meals," he explained. "This is especially important in people with heart disease, as diversion of blood from the coronary or carotid arteries to the gut is not always best for these patients." The study findings were published Oct. 17 in the journal Diabetologia.

In the study, Reynolds and colleagues had 41 people with type 2 diabetes walk a total of 150 minutes a week. In the first phase of the study, participants walked for 30 minutes daily whenever they wanted. In the second phase, 30 days after the first phase, participants were told to take a 10-minute walk no later than five minutes after each meal. During both phases, blood glucose was monitored. Walking after meals lowered blood glucose levels more effectively among the participants, the study found.

Improvements in controlling blood glucose with exercise have been shown by many trials, Zonszein noted, but exercise and good lifestyle are often not enough. "In type 2 diabetes, a combination of good lifestyles and proper medications is important for successful outcomes," he said.

In a second study in the same issue of the journal, British researchers analyzed the findings of 23 studies on the relationship between physical activity and incidence of type 2 diabetes. In all, these studies included more than 1.2 million people. Among these participants, more than 82,000 developed type 2 diabetes, the researchers reported.

The researchers found that those who exercised at least 150 minutes a week had a 26 percent lower risk of developing type 2 diabetes. The results also suggested that exercising more than the recommended 150 minutes had even greater benefits in reducing the risk of diabetes, cutting it by more than half.

The British team was led by Andrea Smith, who's with the Health Behavior Research Center at University College London.

Many Sue Big Pharma Over Statins

As we are seeing, Americans are starting to wake up to the Cholesterol Myth and the Statin Drug scam, and those injured by these drugs are seeking damages in litigation at a very fast pace here in 2014, in spite of the mainstream media blackout due to intimidation from Big Pharma.

The $100 billion dollar cholesterol-lowering statin drug industry is under attack, as thousands of Americans are filing lawsuits against the manufacturers of cholesterol-lowering drugs such as Lipitor. Research continues to confirm just how dangerous these drugs are, with yet another study published recently linking increased statin drug use to type 2 diabetes.

Since the study was published by the American Diabetes Association, these known risks to cholesterol-lowering drugs can no longer be denied or defended, and the lawsuits are pouring in at a rapid pace. Most of the lawsuits at this point are from women who have suffered with diabetes as a result of taking cholesterol-lowering drugs, but lawsuits over breast cancer, Alzheimer’s, liver damage, and others may soon follow now that it is generally known how dangerous these drugs are.

This information regarding a tsunami of lawsuits against cholesterol drug manufacturers has yet to be widely published by the mainstream media, however. To find out the magnitude of the lawsuits being filed against statin drug manufacturers, we turn to law firms who are reaping the fruit of litigation against Big Pharma.

According to statistics supplied by various law firms, there were 464 claims filed against Lipitor as of April 15, 2014, which increased to 703 by May 15, and then to 846 by June 16. By mid-July 2014, over 959 claims have been filed for damages due to Lipitor alone, and that increased in August to 1162. There are also many claims currently filed against Crestor, the next nearest competitor to Lipitor, and undoubtedly other similar drugs now sold under generic labels. These lawsuits now number well over 1,200, and are increasing at a rapid pace.

Lipitor is by far the most profitable drug in the history of mankind among all pharmaceutical products, let alone being the most profitable cholesterol drug before its patent expired at the end of 2011. Sales to date from this one particular cholesterol-lowering statin drug have exceeded $140 billion.

Lipitor benefited from the change in marketing laws in 1997 that allowed pharmaceutical companies in the U.S. to advertise their products directly to consumers. Pfizer convinced an entire generation of Americans that they needed a pill to lower their cholesterol in order to prevent heart disease, in what will go down as one of the most brilliant and unethical marketing schemes of all time.

After Lipitor’s patent expired at the end of 2011, the FDA issued its first warnings against statin drugs, which includes: liver injury, memory loss, diabetes, and muscle damage. Soon after issuing these warnings, the lawsuits started trickling in. Today, with more and more studies being published linking statin drug use to various side effects, those lawsuits have become a tidal wave, even though you are not likely to hear about this in the mainstream media.

Big Pharma fights back – they do not want you to know cholesterol drugs are worthless and dangerous. As is often the case when learning about the criminal activities of Big Pharma, much of the research is conducted outside of the U.S. The above referenced study published recently by the American Diabetes Association, for example, was conducted in Italy.

Since the patent on Lipitor has expired, pharmaceutical companies have been searching for the next big blockbuster cholesterol drug to bring in profits as Lipitor did. One of these newer cholesterol-lowering drugs is U.S.-made Zetia by Merck. Alberto Donzelli, head of education, appropriateness, and evidence-based medicine at Milan’s public health authority in Italy, has issued warnings about the dangers of this drug, and advised doctors in Italy not to prescribe it. Merck responded with two cease-and-desist orders and the threat of suing Donzelli. Donzelli backed down, but Merck has received a lot of public pressure in Europe since the story was picked up by the British Medical Journal. It was also reported in the Wall Street Journal here in the U.S. When doctors and medical professionals oppose Big Pharma, they put their careers and sometimes their lives on the line.

The fact that cholesterol is not responsible for heart disease, and that cholesterol-lowering drugs provide no statistical advantages to prolonging life by reducing heart attacks, has been widely reported for many years now by those of us in the alternative health media. One mainstream media source in Australia, however, decided to air a documentary on the Cholesterol Myth and “Cholesterol Drug Wars”. The show featured Dr. Mary Anne Demasi and interviewed several doctors and health officials who dared to tell the truth regarding the cholesterol drug scam. It was broadcast by ABC Australia in late 2013, under vigorous protests from the pharmaceutical industry. The videos were eventually removed from their website, and the network issued a statement retracting their endorsement of the show.

Please read the full article here, as there is much more that is revealed about the actions of Big Pharma.

Diabetes, Reading Food Labels – Part 2

Nutrients - "% Daily Value" shows how much a serving of that food gives you for each key nutrient listed. These daily goals are set by the government, based on current nutrition recommendations. The percentages are based on a 2,000-calorie/day diet, which would be right for an average- or large-size man who gets little exercise. Women or seniors with diabetes, or people trying to lose weight, need fewer calories.

If your daily calorie intake isn't 2,000, you may need to do a little math. Some nutrient goals change with the number of daily calories. Some, including sodium and calcium, are based on things like your age, sex, or health, not the number of calories you eat. Talk to your doctor or your diabetes educator about how to adjust the % Daily Values on labels for your diet.

In general, when it comes to fat, saturated fat, cholesterol, and sodium, choose foods with a low % Daily Value. For total carbohydrates, dietary fiber, and vitamins and minerals, try to reach your daily target for each nutrient.

Ingredients - Every product should list all the ingredients in it. They're in order from the largest to smallest amount, by weight. This means a food is made up of the heaviest amount of the first ingredient and the least amount of the last ingredient.

Label Claims - Some food labels make claims such as "low cholesterol" or "low fat." A manufacturer can only use these words if a food meets strict government definitions:

LABEL CLAIM	DEFINITION (per standard serving size)
Fat-free* or sugar-free	Less than 0.5 gram (g) of fat or sugar
Low fat	3 g of fat or less
Reduced fat or reduced sugar	At least 25% less fat or sugar than the regular product.
Cholesterol free	Less than 2 milligrams (mg) cholesterol and 2 g or less of saturated fat
Reduced cholesterol	At least 25% less cholesterol and 2 g or less of saturated fat
Calorie free	Less than 5 calories
Low calorie	40 calories or less
Light or lite	1/3 fewer calories or 50% less fat

Other important terms found on food labels have to do with the amount of salt or sodium. Remember that 1 teaspoon has 2,000 mg.

LABEL CLAIM	DEFINITION
Sodium-free or salt-free	Less than 5 mg per serving
Very low sodium	35 mg or less of sodium per serving
Low sodium	140 mg or less of sodium per serving
Low sodium meal	140 mg or less of sodium per 3 1/2-ounce meal
Reduced or less sodium	At least 25% less sodium than the regular version
Light in sodium	50% less sodium than the regular version
Unsalted or no salt added	No salt added to the product during processing

Part 2 of 2 parts