Looking Beyond HbA1c: Research To Find New Diabetes Biomarkers Gains Traction

The discovery of several new biomarkers in the blood may further our understanding of exactly who’s at risk for diabetes
BETA cells within the pancreas produce and release insulin. Loss of the function of these cells compromises the body’s ability to control blood sugar and underlies the development of diabetes. So, one of the next frontiers of diabetes therapeutics is to change the progression rate of beta cell failure.

Recognizing this as a research priority, the Foundation of the National Institutes of Health (FNIH) Biomarkers Consortium announced Tuesday the launch of a multi-year clinical study to improve tools for measuring the function of insulin-producing beta cells in people with type 2 diabetes mellitus. Researchers hope the initiative will lead to improved techniques for tracking progression of the disease and pave the way for more effective treatments.

The project ‒ “Diabetes Drug Development: Identification and Validation of Markers that Predict Long-Term Beta Cell Function and Mass” ‒ is being managed by the Metabolic Disorders Steering Committee (MDSC) of the FNIH Biomarkers Consortium.

It is a three-year, $5.1 million clinical study to standardize tests for measuring beta cell function in the clinical setting that aims to improve methods for the early prediction of the long-term response to an intervention and for identification of patients at risk for rapid beta cell function deterioration, thereby enabling future clinical studies that examine diabetes progression.

A biomarker is a biochemical feature or facet that can be used to measure the progress of disease or the effects of treatment. So the validation of biomarkers to measure the progression of diabetes will greatly facilitate the development of better medicines to treat and potentially prevent this disease and its often disabling complications.

Experts believe biomarkers will become one of the major driving forces of pharmaceutical research and drug development in the coming years.

Currently, diabetes researchers are working without the benefit of agreed-upon standards for gauging beta cell function and this initiative will give researchers practical tools that can be used to measure beta cell function over time and stimulate research to maintain and improve that function.

The project was developed through a rigorous consensus-building process by a team of experts from across the entire scientific community. The pharmaceutical industry, academic, and government representatives contributed their clinical trials expertise and scientific support to the design and execution of the studies.

Utilizing a collaborative approach, the FNIH Biomarkers Consortium has brought together diabetes experts from the National Institutes of Health (NIH), Food and Drug Administration (FDA), leading academic institutions, the pharmaceutical industry, and non-profit sector to develop the project.

Biomarkers play an integral part in conducting clinical trials and treating patients. In most instances, they help medical practitioners, researchers, and regulatory officials make well-informed, scientifically sound decisions.

However, in clinical studies, there is often uncertainty in how much weight to place on biomarker results versus clinical outcomes. This uncertainty emanates from opposing goals of the drug approval process. On one hand, the process must ensure that all therapeutics tested are safe and that the benefits outweigh the risks. On the other hand, the process should allow therapies to be accessible to patients as quickly as reasonably possible.

Judicious use of biomarkers in the drug development process can bring these goals into alignment. More efficient discovery and use of biomarkers in the development of anti-diabetes drugs will depend on advancing current understanding of the pathogenesis of diabetes and especially its macrovascular (pertaining to the larger blood vessels) complications.

The idea of using biomarkers to predict diabetes is not entirely new. Glycated hemoglobin (HbA1C) values are now routinely being monitored to screen for at-risk patients. A study published in PLoS One last year shows that several new biomarkers in the blood may further our understanding of exactly who’s at risk for diabetes, and increase our knowledge of the etiology of the disease.

Veikko Salomaa and colleagues from the Department of Chronic Disease Prevention at the National Institute for Health and Welfare in Helsinki, Finland, tested nearly 13,000 people and found almost 600 cases of diabetes during routine follow-up exams.

According to the study, low levels of adiponectin, and high levels of apoB, C-reactive protein (CRP), and insulin, increase the chance that a woman will develop diabetes. When these factors were measured, proper diabetes prediction increased by 14% compared to when doctors only use classic risk factors, such as BMI and blood glucose levels, to predict disease.

The biomarkers that best predicted diabetes in men were low adiponectin, and high levels of CRP, interleukin-1 receptor antagonist (IL-1RA), and ferritin. Accounting for these biomarkers led to a 25% increase in correct diabetes detection in the cohort. Adiponectin is a hormone found in the body that modulates a number of metabolic processes, including glucose regulation and fatty acid catabolism.

The use of adiponectin, a hormone derived from fat cells, which is abundant in plasma and easy to measure through commercially available kits, was also confirmed as a robust biomarker predictive of glycemic efficacy in Type 2 diabetes and healthy subjects, after treatment with peroxisome proliferator-activated receptor-agonists (PPAR), but not after treatment with non-PPAR drugs such as metformin by the first project to be completed by the Biomarkers Consortium.

The project conducted a statistical analysis of pooled and blinded pre-existing data from Phase II clinical trials contributed by four pharmaceutical companies and analyzed under the direction of a diverse team of scientists from industry, the National Institutes of Health (NIH), U.S. Food & Drug Administration (FDA), and academic research institutions.

Source: FNIH Biomarker Consortium

mHealth: How Cell Phones Can Deliver Better Diabetes Care

AT long last, technology is coming to the rescue of diabetics, trying to make diabetes management easier. In fact, just in the past few years, there finally has been marvelous progress in diabetes care. This isn’t just with insulin pumps and home blood glucose monitoring systems. The technologies available now and those at the cusp of development are really encouraging and exciting.

It is heartening to see the advantages of the wireless world finally being brought to use beyond socializing. For diabetics, they’re being used as a means of communicating critical information about our health and the status of the conditions that can be mortally devastating and an expensive burden.

For example, after a year-long study researchers have demonstrated how a mHealth ‒ mobile-phone-based remote patient monitoring ‒ system helped patients in Canada with type 2 diabetes and uncontrolled hypertension get their blood pressure (BP) under control. The study findings were presented at a press briefing in Tampa, Florida at the American Telemedicine Association’s (ATA) 16th Annual International Meeting last week and discussed later in this report.

Telehealth: The New Frontier
Telemedicine is the use of medical information exchanged from one site to another via electronic communications to improve patients' health status. Closely associated with telemedicine is the term "telehealth," which is often used to encompass a broader definition of remote healthcare that does not always involve clinical services. Videoconferencing, transmission of still images, e-health including patient portals, remote monitoring of vital signs, continuing medical education and nursing call centers are all considered part of telemedicine and telehealth.

Telemedicine is not a separate medical specialty. Products and services related to telemedicine are often part of a larger investment by health care institutions in either information technology or the delivery of clinical care. Even in the reimbursement fee structure, there is usually no distinction made between services provided on site and those provided through telemedicine and often no separate coding required for billing of remote services.

Of course, nothing replaces weight loss and proper diet. But communications technology can be used as a means to inform, monitor and support patients and health care providers and medical companies are quickly learning how to leverage emerging communication and electronic technologies to make diabetes management more efficient, reducing hospitalizations and ultimately decreasing the cost of the disease to individuals and on society.

Mobile Health: The New Hot Topic
Dale C. Alverson, MD, ATA president and medical director of the Center for Telehealth at the University of New Mexico Health Sciences Center in Albuquerque, said "mobile health, or mHealth, is the hot topic in telemedicine technology. These are applications for remote monitoring of patients with chronic disease, such as diabetes and chronic congestive heart failure, through a mobile phone-based system."

This technology is "becoming ubiquitous," he added, "and in our program, we are seeing the providers and the patients adopting this technology in ways we may never have dreamed of. It adds that mobility and that sense of connection between patient and provider."

Killer Apps That Are Revolutionizing Diabetes Care

This was ably demonstrated by Joseph Cafazzo, PhD, PEng, senior director of eHealth Innovation at the University Health Network, in Toronto, Ontario, Canada, and his colleagues who developed and tested an mHealth intervention to automate capture of BP readings through a mobile-phone-based system that provides "actionable messages to patients and critical alerts to physicians."

Their study involved 110 men and women with type 2 diabetes and uncontrolled systolic hypertension. Study subjects had a mean age of 62 years and a mean weight of 90.2 kg (198.4 lbs).

Over the course of 1 year, half of the subjects monitored their BP at home with a standard home BP monitoring system (the control group). The other half used a Bluetooth-enabled BP monitor that transmitted readings through a mobile-phone-based remote patient monitoring system to their family physician (the intervention group). These patients were also given automated reminders after 3 days of not taking their measurements.

The ChroniCare system

At baseline, patients' mean daytime BP was 142.7/77.1 mm Hg. After 1 year, Dr. Cafazzo reported, the intervention group had a 9.1 mm Hg dip in systolic BP (P < .0001) and a 4.6 mm Hg dip in diastolic BP (P < .0001). In contrast, there was virtually no change in the control group. According to the investigators, "50% of patients in the telemonitoring group had their BP under good control (130/80 mm Hg)," compared with only 29% in the control group (P < .05).

Self-awareness: Gateway to Better Self-care
"The family doctors caring for these patients really had nothing to do with the improvements. This was really a self-care tool and the patients were performing better self-care because they were more self-aware, more accountable," Dr. Cafazzo said.

By contrast, study patients who merely checked their BP at home, without reporting it to their physician through the remote system, had no marked change in BP during the study. "The act of just giving a patient a [BP] home monitor had no effect; it had to have the telemonitoring component," Dr Cafazzo pointed out.

"We believe that patients become far more self-aware and more accountable to their care provider knowing that the data are going back to their care provider and that the care provider will be acting on it," he explained.

During the briefing, Dr. Cafazzo also shared similarly promising findings from a recently completed study in which a mobile-phone-based system significantly improved uncontrolled BP in a group of chronic heart failure patients.

For the heart failure patient, he explained, "we have a decision support engine that looks at the data and only sends relevant data to the clinician when the algorithm determines that the patient is deteriorating at home." This is a "first of its kind," he added, in terms of using a mobile-phone-based system to monitor multiple parameters.

Next Target: Adolescents With Diabetes
Dr. Cafazzo also presented preliminary findings from the first clinical trial of an iPhone application called "Bant," which has a fully integrated glucometer and targets adolescents 12 to 16 years of age with type 1 diabetes. The study currently has 28 adolescents enrolled.

"This is a very difficult population," he said. "They are transitioning from being totally dependent on their parent's care to asserting their independence, and unfortunately their HbA1c often starts to increase. We knew this population would be amenable to the iPhone, but that their attention span would be very short."

To entice these young people, the researchers incorporated a social networking application. "There is essentially a microblogging chat room where these kids can exchange their experiences; so far, kids are using it and usually they talk about music, the iPhone, anything but their diabetes," Dr. Cafazzo reported.

There is also a redeemable point system that rewards participants with iTunes for taking and reporting their blood sugar levels regularly. "The rewards mechanism appears to be working very well," Dr. Cafazzo said.

Not surprisingly, it is because of studies like these that the health care market is seeing a large influx of companies who are putting technology to use in a growing field of healthcare communications and health-record management. At a basic level, this means using technology to manage health records and share information with a patient’s physician or other approved health care providers and caregivers ‒ including family members. At an advanced level, the possibilities are endless.

Sources: American Telemedicine Association, Medscape News, PubMed

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Mobile phone-based remote patient monitoring system for management of hypertension in diabetic patients

“Normal” Blood Sugar Levels May Still Mean You Have Prediabetes

FPG between 91 and 99 mg/dl is a strong independent predictor of type 2 diabetes, claims new study

Type 2 diabetes is a lifestyle disease in which the body no longer responds appropriately to the hormone insulin, which helps ferry sugar from the blood into our cells after a meal. When fasting blood sugar levels reach 126 mg/dl or more, doctors will diagnose diabetes.

Prediabetes means that your blood sugar level is higher than normal, but it's not yet increased enough to be classified as type 2 diabetes. Still, without intervention, prediabetes is likely to become type 2 diabetes in 10 years or less. (Scroll to end for Prediabetes FAQs)

Traditionally, blood sugar levels below 100 mg/dl have been considered “safe”, whereas levels between 100 and 126 signal a “higher risk” of diabetes (prediabetes). But according to the new study by Dr. Paolo Brambilla and colleagues at the University Milano Bicocca in Italy, the currently accepted "normal" blood sugar range might be too wide.

“FPG (Fasting Plasma Glucose) between 91 and 99 mg/dl is a strong independent predictor of type 2 diabetes and should be used to identify people to be further investigated and aided with preventive measures,” the researchers say. The conclusion significantly expands the "prediabetes" label.

To back their claim, the researchers report that in the course of their study they discovered people at the high end of what's considered the "normal" blood sugar range are twice as likely to get the disease as are those in the low end. The findings are in line with an earlier study from Oregon, and the Italian researchers say they can help identify the people who need extra medical attention.

The researchers looked at data for nearly 14,000 men and women who'd had blood drawn several times at their clinic. The patients were between 40 and 69 years old and all of them had normal blood sugar levels at first. Over the next seven to eight years, on average, about two percent of the women and nearly three percent of the men developed diabetes.

Less than one percent of those who started out with fasting blood sugar levels between 51 and 82 mg/dl wound up with the disease, while more than three percent did so if they had values between 91 and 99. After controlling for other factors that might influence the likelihood of getting diabetes, that corresponded to a two-fold difference in risk of developing the disease.

Research has shown that if you have prediabetes, the long-term damage of diabetes — especially to your heart and circulatory system — may already be starting. If your blood sugar tests over 100 mg/dl fasting more than once, your fasting blood sugar is likely to go over the 125 mg/dl level used to diagnose full diabetes within 3 years.

More importantly, if your blood sugar is at 100 mg/dl fasting, it is very likely that your post-meal blood sugar is heading towards the diabetic range, which is over 200 mg/dl which is why your fasting blood sugar is deteriorating. High post-meal blood sugars kill beta cells. If you can bring down those post-meal highs, you may be able to prevent the beta cell death that is destroying your fasting control!

While opinion is divided on the question whether doctors should treat these people any different, as the researchers suggest, everyone agrees that people should strive to manage their weight and be physically active irrespective of what their blood sugar level is.

The bald reality is that, according to the American Diabetes Association, in the US alone there are three times as many prediabetics as people with diabetes (79:27 million). And It is estimated that there will be 418 million people worldwide with prediabetes by 2025.

How to Tell if You Have Prediabetes
The American Diabetes Association says while diabetes and prediabetes occur in people of all ages and races, some groups have a higher risk for developing the disease than others and warns that Diabetes is more common in African Americans, Latinos, Native Americans, and Asian Americans/Pacific Islanders, as well as the aged population. This means they are also at increased risk for developing prediabetes.

There are three different tests your doctor can use to determine whether you have prediabetes:

• The A1C test

• The fasting plasma glucose test (FPG)

• The oral glucose tolerance test (OGTT).

The blood glucose levels measured after these tests determine whether you have a normal metabolism, or whether you have prediabetes or diabetes.

If your blood glucose level is abnormal following the FPG, you have impaired fasting glucose (IFG); if your blood glucose level is abnormal following the OGTT, you have impaired glucose tolerance (IGT). Both are also known as prediabetes.

The American Diabetes Association Risk Test for Diabetes can help you determine if you are at increased risk for diabetes or prediabetes. A high score may indicate that you have prediabetes or at risk for prediabetes. Take the test and find out for sure.

ADA Prediabetes FAQs

What is prediabetes and how is it different from diabetes?
Prediabetes is the state that occurs when a person's blood glucose levels are higher than normal but not high enough for a diagnosis of diabetes. About 11 percent of people with prediabetes in the Diabetes Prevention Program standard or control group developed type 2 diabetes each year during the average 3 years of follow-up. Other studies show that many people with prediabetes develop type 2 diabetes in 10 years.

What are the symptoms of prediabetes?
The reason why so many people suffer from prediabetes and are completely unaware of it is because it is quite possible for no symptoms to manifest themselves. Both diabetes and prediabetes develop at a gradual rate.

How do I know if I have prediabetes?
Doctors can use either the fasting plasma glucose test (FPG) or the oral glucose tolerance test (OGTT) to detect prediabetes. Both require a person to fast overnight. In the FPG test, a person's blood glucose is measured first thing in the morning before eating. In the OGTT, a person's blood glucose is checked after fasting and again 2 hours after drinking a glucose-rich drink.

How do I stop prediabetes developing into Type 2 diabetes?

The good news may be that, if you have become aware of the disease early, your condition can still be cured. The two principle factors for consideration are the changing of diet and the addition of appropriate physical exercise to your lifestyle. By making these changes, it may be possible to return blood sugar levels to normal. Prediabetes is a serious medical condition that can be treated.

The recently completed Diabetes Prevention Program study conclusively showed that people with prediabetes can prevent the development of type 2 diabetes by making changes in their diet and increasing their level of physical activity. They may even be able to return their blood glucose levels to the normal range. But for a comprehensive and individual plan you should see your doctor.

Is prediabetes the same as Impaired Glucose Tolerance or Impaired Fasting Glucose?
Yes. Doctors sometimes refer to this state of elevated blood glucose levels as Impaired Glucose Tolerance or Impaired Fasting Glucose (IGT/IFG), depending on which test was used to detect it.

Why do we need to give it a new name? Has the condition changed?
The condition has not changed, but what we know about it has. We are giving IGT/IFG a new name for several reasons. prediabetes is a clearer way of explaining what it means to have higher than normal blood glucose levels. It means you are likely to develop diabetes and may already be experiencing the adverse health effects of this serious condition. People with prediabetes are at higher risk of cardiovascular disease. People with prediabetes have a 1.5-fold risk of cardiovascular disease compared to people with normal blood glucose. People with diabetes have a 2- to 4-fold increased risk of cardiovascular disease. We now know that people with prediabetes can delay or prevent the onset of type 2 diabetes through lifestyle changes.

How does the FPG test define diabetes and prediabetes?
Normal fasting blood glucose is below 100 mg/dl. A person with prediabetes has a fasting blood glucose level between 100 and 125 mg/dl. If the blood glucose level rises to 126 mg/dl or above, a person has diabetes.

How does the OGTT define diabetes and prediabetes?
In the OGTT, a person's blood glucose is measured after a fast and 2 hours after drinking a glucose-rich beverage. Normal blood glucose is below 140 mg/dl 2 hours after the drink. In prediabetes, the 2-hour blood glucose is 140 to 199 mg/dl. If the 2-hour blood glucose rises to 200 mg/dl or above, a person has diabetes.

Which test is better?
According to the expert panel, either test is appropriate to identify prediabetes.

Why do I need to know if I have prediabetes?
If you have prediabetes, you can and should do something about it. Studies have shown that people with prediabetes can prevent or delay the development of type 2 diabetes by up to 58 percent through changes to their lifestyle that include modest weight loss and regular exercise. The expert panel recommends that people with prediabetes reduce their weight by 5-10 percent and participate in some type of modest physical activity for 30 minutes daily. For some people with prediabetes, intervening early can actually turn back the clock and return elevated blood glucose levels to the normal range.

What is the treatment for prediabetes?
Treatment consists of losing a modest amount of weight (5-10 percent of total body weight) through diet and moderate exercise, such as walking, 30 minutes a day, 5 days a week. Don't worry if you can't get to your ideal body weight. A loss of just 10 to 15 pounds can make a huge difference. If you have prediabetes, you are at a 50 percent increased risk for heart disease or stroke, so your doctor may wish to treat or counsel you about cardiovascular risk factors, such as tobacco use, high blood pressure, and high cholesterol.

Who should get tested for prediabetes?
If you are overweight and age 45 or older, you should be checked for prediabetes during your next routine medical office visit. If your weight is normal and you're over age 45, you should ask your doctor during a routine office visit if testing is appropriate. For adults younger than 45 and overweight, your doctor may recommend testing if you have any other risk factors for diabetes or prediabetes. These include high blood pressure, low HDL cholesterol and high triglycerides, a family history of diabetes, a history of gestational diabetes or giving birth to a baby weighing more than 9 pounds, or belonging to an ethnic or minority group at high risk for diabetes.

How often should I be tested?
If your blood glucose levels are in the normal range, it is reasonable to be checked every 3 years. If you have prediabetes, you should be checked for type 2 diabetes every 1-2 years after your diagnosis.

Could I have prediabetes and not know it?
Absolutely. People with prediabetes don't often have symptoms. In fact, millions of people have diabetes and don't know it because symptoms develop so gradually, people often don't recognize them. Some people have no symptoms at all. Symptoms of diabetes include unusual thirst, a frequent desire to urinate, blurred vision, or a feeling of being tired most of the time for no apparent reason.

Sources: American Diabetes Association, Diabetes Care, Diabetes UK

Group Visits To Doctor Can Help Diabetics Get High-Value, High-Quality Health Care At Reduced Cost

THE American Association of Clinical Endocrinology (AACE) at its 20th Annual Meeting and Clinical Congress in San Diego last month issued new clinical practice guidelines for developing comprehensive care plans for patients with type 1 and type 2 diabetes. The guidelines emphasize a personalized approach to controlling diabetes and achieving blood glucose targets with care plans that take into account patients’ risk factors for complications, comorbid conditions, and psychological, social, and economic status.

While it is recognized that every individual patient’s needs are unique, there are times when simple group visits also work wonders for diabetics manage their condition. It's a small but slowly growing trend that promises to get more attention with the tight supply of primary care physicians, who find it hard to squeeze in time to teach their patients how to deal with a complex chronic illness like diabetes.

Group visit programs are rapidly proliferating in group practice and managed care organizations throughout the United States in an effort to leverage existing resources and to provide high-value, high-quality health care in this era of increasing purchaser and patient demands for enhanced services at reduced cost.

Group visits typically include group education, shared problem-solving, focused private or semi-private medical evaluations that allow individualized medication adjustment, and ordering of preventive services and referrals. Sessions may last from 60 minutes to several hours and typically include 3 to 20 patients. The draw for patients lies in the potential for group visits to provide better access and to improve counseling, between-patient learning, and self-efficacy.

What's in it for the doctor? Dr. Ray Dorsey, a neurologist, studied the pros and cons of group appointments and found he learned more about how his Parkinson's patients were faring by watching them interact with others than when he had them one-on-one. Indeed, group visits gave him the opportunity to observe his patients for a longer period of time and appreciate problems he may not readily have appreciated during a routine office visit.

"I can see if you're getting worse over the course of the visit, your ability to eat, to walk, to converse and to think," says Dorsey, who led a pilot study of group checkups for Parkinson's patients at the University of Rochester Medical Center, adding, "This is a new way of delivering health care. People are thirsting for better ways." Dorsey reported his findings last week in the journal Neurology.

"Many heads are better than one. They think of questions you wouldn't normally think of by yourself," says Jim Euken, a retired judge and Parkinson's patient from Belmont, NY. He began exercising on a bicycle after one of Dorsey's group visits discussed research showing some patients can still cycle when they can barely walk, for unknown reasons. “I still think I learned more and I think the process was better doing it in a group format," he confirmed.

Research has shown patients often enjoy interacting in a group environment that can provide encouragement and tips that they may not receive in a short clinical visit. On the other hand, physicians may benefit from the change of pace and a chance to creatively and more thoroughly address the issues presented by chronic conditions common in primary care.

Peer pressure among patients helps, family physician Dr. George Whiddon of Quincy, Florida, told Associated Press. He has about 40 diabetic patients divided into groups for shared checkups at Tallahassee Memorial Family Medicine Quincy, and he wants to add more.

One woman with uncontrolled diabetes for years confessed to fellow patients that she'd ignored Whiddon's eat-better-take-your-meds advice for too long. "Now I only have one toe left. I should have listened," Whiddon recalled her saying. "That had more impact than anything I said all day."

The use of group visits is an innovative approach now receiving attention for its potential to improve the care of established patients with chronic conditions, such as diabetes, while using available resources more efficiently. The terminology of group visits includes “group visits,” “shared medical appointments,” “cluster visits,” and “problem-solving DIGMA (drop-in group medical appointments).”

Of course, group appointments don't replace the patient's annual in-depth physical. But many people with chronic illnesses, especially if they're not well-controlled, are supposed to have additional follow-up visits about every three months — an opportunity for shared checkups that stress patient education.

But how well do these group visits work? Evidence is mixed. An Italian study published last year found that diabetics who took part in them lowered their blood sugar, blood pressure and cholesterol more than similar patients who got regular individual office visits.

A separate study at two Veterans Affairs Medical Centers, in North Carolina and Virginia, tracked people with poorly controlled diabetes and blood pressure and also concluded shared appointments can improve care for some people. Those in group visits significantly improved their blood pressure and needed less emergency care, but there was no difference in diabetes improvement between patients who had shared checkups or regular ones.

Shared check-ups aim to help patients who are battling certain chronic diseases, and they're far from the typical 15-minute office visit. They're stretched over 90 minutes or even two hours, offering more time to quiz the doctor about concerns, learn about managing the disease — and get tips from fellow patients.

What needs to be stressed, though, is that group and individual visits work well together and complement each other: the strengths of one model are often the weaknesses of the other, and vice versa.

Edward B. Noffsinger, a pioneer in the field of group medical visits, sounds a note of caution. “While a carefully thought-out group visit program can maximize benefits to patients, physicians, purchasers, insurers, and health care organizations alike, it is very important that any potential for abuse also be thoroughly examined and scrupulously prevented if these benefits are to be fully realized,” he says.

He points out that in today's challenging, competitive health care environment, group visits can be abused in two basic ways: 1) by putting fewer resources into group visits than adequately supported, properly run programs require, or 2) by attempting to extract more from group visits than is commensurate with good care.

“If we wait until some abuse of group visits actually occurs and receives negative publicity, we could incur a public relations black eye, which could seriously undermine the credibility of all such programs in the future ‒ a predictable, preventable, and completely unnecessary injury to the image of group visit programs,” he says.

Moreover, should third-party insurers, upon recognizing the multiple economic and patient care benefits which group visits can offer, over-incentivize them relative to individual visits, abuse could result which would reduce the voluntary nature of group visits for physicians and patients alike.

“Despite all of these concerns surrounding potential abuses, group visits will undoubtedly continue to grow in importance and be ever more frequently used during the coming years. Without question, group visits have an important role to play in the future of health care,” Noffsinger concludes.

Sources: Associated Press, Neurology, American Academy of Family Physicians, NIH

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Analysis Shows Value of Structured Exercise Programs in Diabetes Care

Insurance Benefits for Exercise Programs Can Cut Health Costs

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FOR the person with type 2 diabetes, or the high-risk individual who is trying to prevent the development of diabetes, there is an enormous body of research literature documenting the benefits of exercise. Indeed, research shows that just six weeks of exercise is enough to change both brain chemistry and body chemistry for the better; diets alone don’t have the same effect. But some questions still remain ‒ how much exercise is needed, and what kind?

A host of studies have linked exercise programs with improved health measures related to blood pressure, lipid levels — including cholesterol and triglycerides — cardiovascular events, cognition, physical performance, premature death and quality of life. Analyses of interventions to promote physical exercise in adults have found that compared with no intervention, exercise programs are cost-effective and have the potential to improve survival rates and health-related quality of life.

A recent systematic review and meta-analysis ‒ undertaken by scientists led by Daniel Umpierre of the Hospital de Clinica de Porto Alegre in Brazil ‒ compares the association between physical activity advice and structured exercise programs, respectively, and markers of diabetes. It reveals that implementing structured exercise training — including aerobic, resistance or both — is associated with a greater reduction in HbA1c levels for patients with diabetes compared to patients in control groups. Results of the study are published in the May 4 issue of the Journal of the American Medical Association (JAMA).

A structured exercise is a task, activity, or question posed by a leader that pushes everyone to reflect, focus, offer ideas and insights, and become engaged in learning. Structured exercises offer group leaders a variety of options for encouraging group participation and discussion, practicing skills, and involving adults who have a range of learning styles and capabilities.

After analyzing the results of 47 randomized clinical trials, the researchers also found that exercising for longer periods of time was better at bringing blood sugar levels down than exercising more intensively. Longer weekly exercise duration was also associated with a greater decrease in these levels, according to results of the analysis of previous studies.

The meta-analysis shows that greatest reductions in HbA1c occurred in patients exercising for more than 150 minutes in total per week. Exercise intensity did not appear to matter. Exercising a minimum of 150 minutes a week (usually broken down to 30 minutes of exercise five days a week) is recommended by such institutions as the American College of Sports Medicine.

"People with type 2 diabetes should engage in regular exercise training, preferentially supervised exercise training," says Beatriz Schaan, the study's senior author. "If these patients can perform training for more than 150 minutes per week, this would be more beneficial concerning their glucose control. However, if they cannot reach this amount of weekly exercise, lower exercise amounts are also beneficial."

The Importance of Exercise in Diabetes Management

A recent joint statement from the American Diabetes Association (ADA) and the American College of Sports Medicine (ACSM) has already underscored the importance of physical exercise to prevent and manage insulin resistance, type 2 diabetes mellitus, gestational diabetes mellitus, and the complications of diabetes.

“Current guidelines recommend that patients with type 2 diabetes should perform at least 150 minutes per week of moderate-intensity aerobic exercise and should perform resistance exercise three times per week,” the authors of the Brazil study wrote. “Regular exercise improves glucose control in diabetes, but the association of different exercise training interventions on glucose control is unclear.”

Indeed, although some clinical trial evidence suggests that aerobic exercise and resistance training can each improve glucose control in patients with type 2 diabetes mellitus, not all clinical trials are consistent with regard to this finding.

However, differences in results of clinical trials about the ability of aerobic exercise and resistance training to improve glucose control are primarily due to differences in trial design, including modality, intensity, exercise program duration, adherence to the programs, sample size, and patient populations.

In the Brazilian study, the authors analyzed 47 randomized controlled trials (RCTs) into the effect of exercise on HbA1c, with a total of 8538 patients. In 23 of these RCTs, patients took part in structured exercise training, and in the other 24 they were simply given advice on physical activity.

Across all studies analyzed, engaging in structured exercise was associated with decreased HbA1c levels compared with controls, whether this was structured resistance training (fall in HbA1c of 0.57%), structured aerobic exercise (fall of 0.75%), or a combination of both (0.51% fall).

A longer total time spent in structured exercise was associated with better glycemic control. If total weekly time in structured exercise exceeded 150 minutes, the average drop in HbA1c was 0.89%, against 0.36% for a time of 150 minutes or less.

Physical activity advice was only associated with a decline in HbA1c if it was combined with dietary advice.

The authors said: “This systematic review and meta-analysis of RCTs demonstrates important findings regarding the prescription of structured exercise training. First, aerobic, resistance, and combined training are each associated with HbA1c decreases, and the magnitude of this reduction is similar across the three exercise modalities.

“Second … structured exercise of more than 150 minutes per week is associated with greater declines in HbA1c than structured exercise of 150 minutes or less per week in patients with type 2 diabetes. This finding is important because the current guideline-recommended exercise duration is at least 150 minutes per week.

They added: “Although high-intensity exercise has been previously shown to have an association with HbA1c reduction, our findings did not demonstrate that more intensive exercise was associated with greater declines in HbA1c.”

In an accompanying editorial, Marco Pahor, director of the University of Florida Institute on Aging, argues that “the meta-analysis … and cumulative evidence from a large number of randomized controlled trials conducted over the past few decades in the area of physical activity and exercise provide solid evidence for public policy makers to consider structured exercise and physical activity programs as worthy of insurance reimbursement to promote health, especially in high-risk populations.”

Insurance Benefits for Exercise Programs Can Cut Health Costs
With respect to type 2 diabetes, Medicare reimburses for approved self-management education and medical nutrition therapy programs. But no specific reimbursement is given for any physical activity or exercise program, despite evidence that such programs can help improve health and cut costs.

Questions remain as to what format reimbursable exercise and physical activity programs should take, what population group should be targeted, and at what stage of life or health status would a lifestyle intervention be most cost-effective to implement.

Some insurance providers already include a fitness benefit for members, such as monthly membership at certain fitness centers or access to personal trainers or exercise classes at reduced cost. Indeed, use of such health plan-sponsored club benefits by older adults has been linked to slower increases in total health care costs.

In one study, older adults who visited a health club two or more times a week over two years incurred $1,252 less in health-care costs in the second year than those who visited a health club less than once a week. Programs among people with lower incomes can also pay off, because people in that group are otherwise more likely to forego health-promoting physical activity because of economic constraints or safety concerns.

“People are willing to invest in improved health, but if you have a fixed amount of resources then you want to choose where you get the most health for the dollar,” said Erik Groessl, an assistant professor of family and preventive medicine at the University of California, San Diego, and director of the UCSD Health Services Research Center. Groessl was not involved in the current analysis.

Group training or walking programs, for example, can be cost-effective, sustainable forms of physical activity that don’t require expensive health care professionals or equipment. But more costly interventions that yield dramatic results might also be worth the expense.

“There is a lot of evidence that physical activity works, and I think it’s time to start putting it into practice more widely,” Groessl said.

Sources: JAMA, University of Florida News, Medpage Today

Poor Sleep Quality In People With Diabetes Leads To Poor Blood Sugar Control

• Do you have difficulty falling or staying asleep?

• Are you excessively sleepy during the day or fall asleep when you don't want to?

• Do you snore or have you been told that you snore loudly?

• Do you gasp for air or have you been told that you stop breathing during sleep?

• Do you experience uncomfortable sensations in the legs in the evening that are relieved by movement?

• Are you a restless sleeper or have you been told that you kick during sleep?

SLEEP disturbances are common and can be detrimental to the health, mood, and quality of life of people with diabetes. Sleep-disordered breathing, pain, restless legs syndrome, primary insomnia, and lifestyle factors all contribute to a high rate of sleep complaints in this population.

Because the etiology of poor sleep quality is often multifactorial and may shift over time, a careful evaluation for insomnia, sleep-disordered breathing, and restless legs syndrome should be an integral part of the routine care of patients with diabetes, say experts.

Generally, people with diabetes have poorer sleep than non-diabetics. Also, poor sleep has been proposed as a risk factor for developing the disease. Sleep disorders, such as obstructive sleep apnea, are more prevalent in people with type 2 diabetes. Therefore, it is not surprising that up to 71% of this population complain of poor sleep quality and high rates of hypnotic use.

Diabetes is worse when combined with insomnia symptoms. In fact, insomnia makes most medical diseases much worse in ways that are only just being found out and can chemically disrupt the body’s insulin balance enough to even be a root cause for certain types of diabetes, say experts.

Insomnia-Insulin Resistance Link

In the largest study of its kind to establish a link between sleep and diabetes ‒ published in the June issue of Diabetes Care ‒ researchers have found that people with diabetes who sleep poorly have higher insulin resistance, and a harder time controlling the disease.

"Poor sleep quality in people with diabetes was associated with worse control of their blood glucose levels," says Kristen Knutson, PhD, assistant professor of medicine at the University of Chicago Medical Center and lead author of the study.

"People who have a hard time controlling their blood glucose levels have a greater risk of complications. They have a reduced quality of life. And, they have a reduced life expectancy," she explains in apress statement.

Multiple factors contribute to insomnia complaints in patients with diabetes, say Phyllis C Zee, and Erik Naylor in their expert columnin Medscape. In type 1 diabetes, rapid changes in glucose levels during sleep have been postulated to cause awakenings. For individuals with type 2 diabetes, sleep disturbances may be related to obesity or obesity-associated sleep disorders, such as sleep apnea.

Sleep-disordered breathing correlates highly with obesity in the diabetic population. A strong association also exists between obesity, impaired glucose tolerance, insulin resistance, and sleep-disordered breathing.

Furthermore, the severity of sleep-disordered breathing, as measured by the apnea-hypopnea index, correlates with the severity of glucose intolerance, insulin resistance, and diabetes. Although obstructive sleep apnea is the most common type of sleep-disordered breathing, central-type apneas and periodic breathing have been reported in patients with autonomic diabetic neuropathy.

The Chemistry of the Sleep-Wake Cycle 

Since diabetics are sensitive to blood glucose levels and chemical balances in the body, it’s illustrative to explore just how detrimental disruptions in the sleep cycle can be. Studies have shown that diabetes worsens when adult sufferers sleep less than 6 hours per night or more than 9.

The loss of normal sleep hours or addition of sleep hours seems to undo the body’s chemistry and completely throw off-balance the blood glucose levels. Doctors don’t know for sure the exact chemistry behind this phenomenon outside of the observation. This underscores the importance of the sleep cycle chemistry.

In Knutson’s study, for example, among the diabetics, poor sleepers had 23% higher blood glucose levels in the morning, and 48% higher blood insulin levels. Using these numbers to estimate a person's insulin resistance, the researchers found that poor sleepers with diabetes had 82% higher insulin resistance than normal sleepers with diabetes.

Other studies have shown that chronic insomnia in healthy people can also instigate diabetes. Loss of sleep interrupts insulin balance—leads to insulin resistance—which in turn can lead to more severe medical problems and Type 2 diabetes.

Diabetes Management

Much of the challenge for diabetics is proper and long-term management of their diabetes. When the sleep-wake cycle is also mismanaged, so too is the diabetes. Like many other medical diseases and conditions, diabetes is sensitive to sleep disturbances. But insomnia, as a set of symptoms, is usually secondary to something else.

Insomnia is characterized in a number of ways: you could have problems going to sleep (sleep onset insomnia), problems waking up and going back to sleep (middle of the night insomnia), or waking up in the early dawn unable to return to sleep that night (terminal or late insomnia). Doctors can often associate particular patterns of insomnia such as these to particular medical problems.

Insomnia is rarely treated as a primary affliction. In most medical sectors it’s important to identify and diagnose insomnia for its implication in other problems, including depression, a common secondary illness to diabetes. As patients get older, the risk for depression escalates. Loss of a loved one, stress, anxiety and a range of other social disturbances can set in motion the symptoms for chronic insomnia. Loss of sleep makes for haywire blood sugar.

The Way Forward

Knutson says the next step for researchers is to see if treating poor sleep can improve long-term outcomes and quality of life for diabetics. "For someone who already has diabetes, adding a sleep treatment intervention, whether it's treating sleep apnea or treating insomnia, may be an additional help for them to control their disease," she points out.

In fact, restoring a healthy amount of sleep may be as powerful an intervention as the drugs currently used to treat type 2 diabetes. "This suggests that improving sleep quality in diabetics would have a similar beneficial effect as the most commonly used anti-diabetes drugs," says Eve Van Cauter, PhD, professor of medicine and co-author of the study.

"For someone who already has diabetes, adding a sleep treatment intervention, whether it's treating sleep apnea or treating insomnia, may be an additional help for them to control their disease," feels Knutson.

Further investigation into which leads to the other – the chronic poor sleep or chronic insulin resistance – could improve the quality of life for people with type 2 diabetes. "Anything that we can do to help people improve their ability to control their glucose will help their lives in the long run," Knutson concludes.

Type 2 Diabetics Also At Increased Risk Of Hypothyroidism

THYROID is an important endocrine gland of human body and plays vital role in the normal functioning of the body. It has important effects on glucose metabolism along with lipids and proteins and conversely can be affected by abnormal glucose metabolism.

Recently new research has found a strong link between type 2 diabetes and an increased risk of hypothyroidism, the most common type of thyroid disorder. It is the situation where the thyroid fails to make enough thyroid hormone to regulate the body's metabolism. The findings were presented at the American Association of Clinical Endocrinologists (AACE) 20th Annual Meeting and Clinical Congress in San Diego last month.

Symptoms of underactive thyroid gland functioning, no matter what the cause, include fatigue, dry, coarse skin and hair, inability to tolerate cold weather, weight gain, hoarse voice, and heavy or irregular menstrual periods. The symptoms develop so slowly that sometimes people just think they are growing old prematurely.

Thyroid disorders (hypothyroidism or hyperthyroidism) and diabetes mellitus are quite common endocrinopathies (diseases of endocrine glands) seen in general population. Thyroid disorder in the general population is estimated to be 6.6%, while the prevalence in diabetic population has been estimated at 10.8%. The prevalence of sub-clinical (early stage) hypothyroidism is 5.4% and clinical hypothyroidism is 4.1%, while the prevalence of sub clinical hyperthyroidism is 5.8% and the clinical hyperthyroidism is 5.1%, the researchers noted.

The cross-sectional study comparing 1,848 adult patients with type 2 diabetes with 3,313 individuals without diabetes, showed the prevalence of hypothyroidism on the study group to be 5.7% compared with 1.8% in the control group (P ≤.0001).

Citing the Whickham survey, the researchers said thyroid function affected 6.6% of adults. A higher prevalence of abnormal TSH concentration in Type 2 diabetic patients (31%) was reported by Celani et al, they pointed out. In their study, sub-clinical hypothyroidism was detected in 11.66% of evaluated diabetic patients and hypothyroidism was evident in 35% of diabetic patients, which is a quite high ratio as compared to other reported data. “This may be because of only concentrating diabetes mellitus and its complications rather than thinking other diagnosis partly or misreporting by patients,” they noted.

“Although there is a recognized association between thyroid disease and diabetes, this association has been perceived mostly for type 1 diabetes. However, in type 2 diabetes, there is no consensus as to whether screening for hypothyroidism is necessary. We were surprised that the results showed an association that was this high,” said lead author Hector Eloy Tamez-Perez, MD, Autonomous University of Nuevo Leon, Monterrey, Mexico.

The study included patients who were enrolled in a private outpatient clinic in 2009, had a diagnosis of type 2 diabetes, and were treated with levothyroxine (Levothroid, Levoxyl, Synthroid, Tirosint, Unithroid), although patients with thyroid neoplasia (the process of abnormal and uncontrolled growth of cells. The product of neoplasia is a neoplasm, i.e. a tumor), panhypopituitarism (a deficiency involving all the hormonal functions of the pituitary gland), or have surgical complications of a multinodular goiter or a thyroid nodule were excluded.

It was found that around 10 per cent to 31 per cent of patients with type 2 diabetes had thyroid dysfunction, and that those with subclinical (early stage) hypothyroidism were the most common thyroid condition.

“So it is important to evaluate diabetic population regarding hypothyroidism whether clinical or sub-clinical, as one condition can worsen the other if left untreated by causing worsening control of diabetes mellitus, worsening dyslipidemias and causing diverse complications. Therefore, it is imperative to screen diabetic population regarding hypothyroidism. Moreover further studies on large scale should be planned to evaluate the magnitude of the disorder,” they concluded.

Popular Health Central columnist Dr Bill Quick, a physician living with diabetes, writes:

Treatment for hypothyroidism is straight-forward: give the patient thyroid hormone replacement. How much thyroid hormone to give is about the only question: give too little, and the symptoms continue; give too much and the patient can become hyperthyroid. Physicians adjust the dose of thyroid hormone replacement by rechecking the TSH (thyroid stimulating hormone) level rather than judging by symptom levels: when the TSH is in the normal range, it can be assumed that the amount of thyroid hormone replacement therapy is appropriate.

Testing for hypothyroidism is easy to do, thyroid disease is common in the age group that has T2DM, treatment for hypothyroidism is easy and rewarding in relieving symptoms and decreasing the risk of future disease.

 Lab tests for hypothyroidism are done using a standard blood sample, and include measurement of the TSH levels, thyroid hormone levels (called T3 and T4), and sometimes thyroid antibodies. In a patient with the symptoms, an elevated TSH level with simultaneous low levels of T3 and T4 are conclusive evidence that the thyroid gland is underactive. Indeed, a high level of TSH with normal levels of T3 and T4 are considered very suggestive evidence of impending hypothyroidism and worthy of treatment.

By the way, note the paradox: the TSH level is high in most underactive thyroid disorders. This is easy to understand when it is understood that TSH is made elsewhere, in the pituitary gland, and if the thyroid is failing to make its thyroid hormone, then the pituitary gland attempts to stimulate the thyroid to make more thyroid hormone, hence the TSH level goes up. For people without symptoms of hypothyroidism, measurement of the TSH level can be used as a screening test to look for early thyroid gland problems; sometime, it's also recommended that thyroid antibodies be part of the screening process.

The American Diabetes Association suggests for patients with T1DM that "TSH concentrations should be measured after metabolic control has been established. If normal, they should be re-checked every 1-2 years, or if the patient develops symptoms of thyroid dysfunction..." But there's no ADA recommendation for people with T2DM. The authors of the (Monterrey study) abstract (cited above) advised testing "similar to what occurs in type 1 diabetes."

If you have diabetes, whether T1DM or T2DM, it seems reasonable that you should have your TSH level checked every year or two.