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.

Diabetics Who Adhere to Their Medication Have a 31% Associated Lower Risk of Hospitalization

Lifestyle-related diseases stemming from tobacco, alcohol and obesity, have taken over infectious diseases such as HIV and malaria to become the greatest killer of people worldwide, says a new World Health Organization report. Indeed, chronic illnesses like cancer, heart disease and diabetes have reached global epidemic proportions and now cause more deaths than all other diseases combined.

Evidence shows that a comprehensive focus on prevention and improved treatment leads to dramatic declines in mortality rates. Currently, the report points out, the main focus of health care for non-communicable diseases (NCDs) in many low- and middle-income countries is hospital-centered acute care. This is a very expensive approach that will not contribute to a significant reduction of the NCD burden. It also denies people the health benefits of taking care of their conditions at an early stage.

To contain the diabetes worldwide epidemic, WHO says at least three interventions for prevention and management of diabetes are shown to reduce costs while improving health. Blood pressure and glycemic control, and foot care are feasible and cost-effective interventions for people with diabetes, including in low- and middle-income countries.

WHO’s recommendations have been validated by a new study in the U.S. which shows that individuals with diabetes who adhere to their medication have lower risk of hospitalization by one-third when compared to patients who do not adhere to their medication.

The results of the study by Prime Therapeutics (Prime), a thought leader in pharmacy benefit management, are being presented the last week in April at the Academy of Managed Care Pharmacy's 23rd Annual Meeting and Showcase in Minneapolis earlier this week.

Nearly 300 million people worldwide have (mostly type 2) diabetes. In the U.S. alone, more than 23 million Americans have been diagnosed with diabetes mellitus (DM) and each year another 1.6 million people are diagnosed with the condition.

Poor medication adherence has been associated with worse medical outcomes and increased medical costs for patients with diabetes in a single employer or the elderly.

Until now, there has been little data quantifying the potential value of improved outcomes and costs possible with better medication adherence in a large commercially insured population. In this study, one of the largest of its kind, more than 15,000 commercially insured individuals with a diabetes diagnosis medical claim were followed for one year.

"Our research found adherent individuals had $1,010 lower medical costs during the year," said Patrick Gleason, PharmD, director of Clinical Outcomes Assessment at Prime, in a press release. "Besides the medical cost savings, patients that adhere to their medications are likely to have improved health and increased quality of life. Yet in this study, we found one-quarter of patients do not stick to their diabetes medication, so the medical community must find ways to increase adherence for those most at-risk."

Researchers from Prime and one of its Blue Cross and Blue Shield clients reviewed pharmacy and medical claims from a commercial medical plan with 1.3 million members. The study identified individuals continuously enrolled between 2007 and 2009.

Researchers then focused on members who had either two separate office visits for diabetes or a diabetes-related hospitalization in 2008 and with a DM medication supply or a diagnosis of diabetes with microvascular disease. All medical and pharmacy claim costs were added up to determine the total cost of care.

A total of 15,043 members were followed for one year. Of that group, 73.9 percent (11,108 members) were adherent to their medication and 26.1 percent (3,935 members) were non-adherent. While those individuals adherent to DM medication had higher pharmacy costs which led to an increase in the overall total cost of care ($572), those adhering to medications were found to have a 31 percent lower risk of hospitalization and significantly lower overall medical costs ($1,010) than the non-adherent group.

Earlier studies, too, have shown that non-adherence with medication regimens results in increased use of medical resources, such as physician visits, laboratory tests, unnecessary additional treatments, emergency department visits, and hospital or nursing home admissions. Non-adherence may also result in treatment failure.

In the context of disease, medication non-adherence can be termed an "epidemic." More than 10% of older adult hospital admissions may be due to non-adherence with medication regimens. In one study, one-third of older persons admitted to the hospital had a history of non-adherence. Nearly one-fourth of nursing home admissions may be due to older persons' inability to self-administer medications.

Problems with medication adherence were cited as a contributing factor in more than 20% of cases of preventable adverse drug events among older persons in the ambulatory setting. It is estimated that non-adherence costs the US health care system $100 billion per year. In addition, approximately 125,000 deaths occur annually in the U.S. due to non-adherence with cardiovascular medications.

Of all age groups, older persons with chronic diseases and conditions benefit the most from taking medications, and risk the most from failing to take them properly. Among older adults the consequences of medication non-adherence may be more serious, less easily detected, and less easily resolved than in younger age groups.

Improving adherence with medication regimens can make a difference. A recently published study found that for a number of chronic medical conditions - diabetes, hypertension, hypercholesterolemia, and congestive heart failure - higher rates of medication adherence were associated with lower rates of hospitalization (see diagram), and a reduction in total medical costs.

How To Manage Diabetes On A Budget Without Cutting Corners

IF you have diabetes, there is no getting around the fact that taking care of yourself can be expensive. The cost of medical care, diabetes medications and supplies, and healthy foods add up. And these expenses can be difficult to manage even in the best of times.

Even in less developed economies like India and other countries in Asia and Latin America where the spread of diabetes has assumed epidemic proportions, while seeing your doctor and a pharmacist every month might seem expensive.

Popular blogger Scott Strumello has calculated that in 2007, medical bills contributed to 62.1% of all bankruptcies in the U.S. Between 2001 and 2007, the proportion of all bankruptcies attributable to medical problems rose by about 50%.

Contrary to popular assumptions, chronic illnesses dominate the top 2 categories, and diabetes ranks second, following only nonstroke neurologic problems (i.e., multiple sclerosis).
According to a study published online in The American Journal of Medicine indicated that the health problems that left patients with the highest out-of-pocket medical expenses weren't dominated by catastrophic illnesses. The article reports that among common diagnoses, the health problems that left patients with the highest out-of-pocket expenses were ranked as follows:
#1) Neurologic (e.g., multiple sclerosis): $34,167
#2) Diabetes: $26,971
#3) Injuries: 25,096
#4) Stroke: $23,380
#5) Mental illnesses: $23,178
#6) Heart disease: $21,955

Also, it is important to keep in mind that among the other categories, diabetes is a leading contributor to the stroke and heart disease categories. These are some pretty astonishing figures!

Another interesting observation: hospital bills are, not surprisingly, the largest single out-of-pocket expense for 48.0% of patients who file for bankruptcy, but the second-largest category isn't doctor's bills, its for prescription drugs for 18.6%. Doctors' bills isn't far behind, accounting for 15.1%, and premiums accounting for 4.1%. The remainder cited expenses such as medical equipment and nursing homes.

As a person with type 1 diabetes myself, I must admit that while this disease is anything but cheap, even I was a bit surprised by some of these findings, especially considering that in February 2009, the American Diabetes Association and others were citing studies which showed many Americans with diabetes were skipping certain medical treatments, drugs etc. due to the cost.

In the context of rising costs for managing a chronic disease such as diabetes, a small study from Ohio shows that in the long run regular visits to the doctor saves patients and their families money in the long run when

Columbus-area pharmacist Allen Nichol looked at two groups of diabetic patients on Medicaid at one physician's office – 40 who kept monthly appointments and took their medications as prescribed and 120 who did not. He worked with Dr. Charles May, a primary-care doctor at Grandview Family Practice, and gathered the data in 2008.

During the monthly appointments, they evaluated patients' blood pressure, cholesterol and blood-sugar levels. If the numbers were good, the patient would continue with the same medications; if not, Nichol would suggest a medication change. "We'd have a plan, like a coach of a football team planning the first quarter," Nichol said.

The study found that patients not being managed were hospitalized more than those who regularly saw their doctor and pharmacist. This resulted in a net savings of $5,582 per patient for the year, Nichol said.

Health leaders acknowledge the benefits of having pharmacists work with patients, whether at a doctor's office or a pharmacy. For example, all Medicare prescription-drug plans are required to pay for meetings between beneficiaries and pharmacists. Private health insurers have found that when patients meet with pharmacists, costly emergency-room visits and hospital admissions can be reduced.

Here are a few tips from NFB to help you ensure that you do not miss out on manage your condition during hard times when many patients find it difficult pay their medical bills.

General Financial Management
Having a budget and sticking to it is important for everyone, even more so during hard times. You should evaluate your personal or family budget at least once a year, or more often if your income or expenses are changing. Involve the entire family in discussing the budget and brainstorming for ways to save money.

Here are a few questions to consider:

• What is your monthly income?

• What are your monthly expenses for essentials (home, utilities, phone, food, transportation, medicine)?

• When are your bills due? Avoid late fees by paying bills on time.

• Do you have expenses that come once or twice a year (such as taxes and insurance)?

• Where does the money go from your wallet? Keep a diary of your spending.

• Identify non-essential expenses (entertainment, shopping as “stress management,” eating out).

Paying cash helps you stay within your limits. Use a credit card only in emergencies. If you have several cards, cancel most of them, and keep one and two. Pay off your credit card bill each month, so you aren’t paying high interest for carrying charges. If you have credit card debt, call your creditors to discuss options to deal with it, and try to negotiate a lower interest rate. If you feel you cannot do this, or if your debt load is overwhelming, seek consumer credit counseling from your bank or card issuer.

Healthy Eating on a Budget
Many people have the misconception healthy meals are always more expensive. Actually, healthy eating can save money through using smaller portion sizes and fewer high-calorie, high-priced foods.

Here is a list of tips to help you keep your food prices down:

• Plan a menu each week based on sales in grocery stores near you.

• Check what you already have to keep from buying what you do not need.

• Take a shopping list with you, and buy only what is on that list.

• Avoid going to the store if you are hungry, to make it easier to stick to your list.

• Store brand or generics are often just as good as name brand, and usually less expensive.

• Cook enough to have leftovers. Take the leftovers to work instead of buying lunch, or freeze the leftovers for a busy time.

• Add vegetables to casseroles, stews, or soups. This is a good way to increase your vegetables and stretch a meal.

If you manage your personal finances well, you’ll never find it difficult to skimp on managing expenses related to your medical condition.

A Cure for Diabetes By Implanting Insulin-Producing Islets in Abdomen

Trials on Primates Have Shown Promising Results

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DOCTORS from Hackensack University Medical Center (HUMC) in New Jersey hope to find a cure for diabetes as they embark on a partnership with one of the world's leading researchers for the disease.

The hospital will be the first to try a procedure on humans with diabetes that is currently being tested on monkeys in Florida — a collaborative effort with Dr. Camillo Ricordi, a pioneer in the field and the scientific director and chief academy officer of the University of Miami Diabetes Research Institute.

"Dr. Ricordi wants to find a cure for diabetes, and he doesn't care how many people are involved in the process or share in the credit," said Dr. Michael Shapiro, Hackensack’s chief of organ transplantation and leader of the diabetes partnership. "This collaboration will do great things for diabetes research."

“Forty percent of transplant patients have diabetes. And we know the DRI is committed to linking everyone worldwide to find a cure,” he said.

Diabetes occurs when the body cannot produce or properly use insulin, a hormone that helps the body metabolize glucose into energy and control blood sugar levels.

With Type 1 diabetes, earlier called juvenile diabetes and the most serious form of the disease, the body's immune system destroys the cells from the pancreas that make insulin, called islets. People with Type 2 diabetes make insulin, but their body doesn't utilize it correctly and production of it typically declines as they age. More than 25 million Americans have diabetes, and about 3 million of those suffer with Type 1.

Typical treatment for diabetic patients includes insulin pumps, injections and oral medications. Transplanting islets from deceased donors is sometimes effective, but it frequently triggers other complications because the islets need to be implanted in the liver. The number of organ donors also falls way short of the number of diabetics who would benefit from a transplant.

NewTechnique

Dr. Ricordi's technique includes loading islets — the cells that make insulin and are destroyed by Type 1 diabetes — on a disc and implanting them in the abdomen. In the past, islets have been transplanted in the liver with little success.

Dr Camillo Ricordi

"The challenge is we're dealing with an autoimmune disease so we have to replace or get cells to regenerate that were destroyed," Ricordi told dozens of HUMC executives, physicians and health care workers last week. "And the key is to do this without a lifelong regimen of autoimmune rejection drugs."

But successfully transplanting the islets will only be part one of the cure. Researchers need to figure out how to create islets in the lab so there will be enough to treat all diabetic patients who need them. Still, the partnership has hospital executives determined and diabetic patients hopeful. "I'm absolutely sure we'll find a cure," said Robert Garrett, president and chief executive of HUMC.

Because of promising results with the monkeys, Shapiro hopes to have four patients undergo the procedure in early 2012. The ideal patients will be those who aren't responding to other treatments.

Past Success

Physicians attending the announcement highlighted Ricordi's expertise and advances in treatment of the disease.

His creation, the Ricordi Chamber, is so well-known in the field that it was mentioned in a recent episode of the medical drama "Grey's Anatomy." Critical for a transplant, it is able to efficiently separate islets from the pancreas.

Stephanie Stone, who was diagnosed with diabetes at 10 and is now 18, attended the announcement with her Franklin Lakes family. "I'm optimistic for the future," Stephanie said. "If this isn't a cure, it sounds like it's a better treatment before a cure is found."

Earlier in January, the Molly and Lindsey Diabetes Research Foundation at Hackensack University Medical Center (HUMC) and the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine had announced the formation of the Hackensack-Miami DRI Federation Project.

The project is aimed to provide a unique opportunity for funding agencies, financial institutions, and corporate entities to collaborate with the scientists and their project teams in order to provide the core competencies and infrastructure needed to move projects forward in the safest, fastest, and most efficient way possible.

“This collaboration represents an exceptional opportunity to overcome current limitations of research progress within traditional academic institutions,” said Robert C. Garrett,

“Hackensack University Medical Center is going to take the lead in diabetes research in the tri-state area,” said Dr. Shapiro. “Forty percent of transplant patients have diabetes. And we know the DRI is committed to linking everyone worldwide to find a cure.”

One of the group’s first objectives is to expand collaborative alliances with other leading research centers and to foster dynamic multidisciplinary research teams.

“There are few other collaborative projects that fully integrate basic, pre-clinical and clinical scientists to increase the rate of progress at which therapeutic solutions for type 1 diabetes can be safely and effectively brought from the bench to the bedside and eventually to a cure,” said Dr. Ricordi.

The impossible becomes possible when you bring the right people and the right resources together – especially when there is a common goal. The Molly and Lindsey Diabetes Research Foundation is the brainchild of two families who know what it means to have a child living with diabetes.

Nick Miniccuci and his wife, Susan, made a pledge more than two decades ago when they were told their nine-year-old daughter Molly had diabetes. “I vowed to do everything in my power to find a cure” explains Mr. Miniccuci, one of the philanthropists behind the alliance. “That was a promise I intend to keep.”

“When Lindsey was diagnosed at the age of 11, we searched the world for a place that focused on curing the disease – not simply on learning to live with it – and found theDRI,” said Bonnie Inserra, co-founder of the Foundation. “There’s nobody like them worldwide. TheDRI team doesn’t keep research to themselves; they are experts who believe in worldwide collaborative science. I want to see diabetes cured.”

In recognition of the endless efforts of Susan and Nick Minicucci and Bonnie and Larry Inserra, the HUMC Foundation’s Executive Vice President and Chief Operating Officer Robert L. Torre, presented a $500,000 check to the Miami-Hackensack project during a dinner held in January at the Stony Hill Inn Hackensack. More than 50 people came together to celebrate a turning point in the history of diabetes thanks to the Minicucci and Inserra families. “We want to celebrate this new partnership – together we will find a cure,” Torre said.

About HUMC

HUMC is a nationally recognized healthcare organization offering patients the most comprehensive services, state-of-the-art technologies, and facilities. A leader in providing the highest quality patient-centered care, the medical center has been recognized for performance excellence encompassing the entire spectrum of hospital quality and service initiatives. These honors include being named one of America’s 50 Best Hospitals by HealthGrades® for four years in a row.

HUMC is the only hospital in New Jersey, New York, and New England to receive this honor. The medical center has also been ranked by U.S. News and World Report's "America's Best Hospitals 2010-11" in Geriatrics and Heart and Heart Surgery. NJBIZ, New Jersey’s premiere business news publication, honored HUMC as the 2010 Hospital of the Year, recognized for its excellence, innovation, and efforts which are making a significant impact on the quality of healthcare in New Jersey.

Hospital Newspaper, the leading provider of local hospitals and healthcare community news and information for hospital executives, also named HUMC Hospital of the Year in its December 2010 edition. Additionally, HUMC was named to The Leapfrog Group’s annual class of top hospitals and health systems and is one of only two hospitals in New Jersey to receive this national designation. HUMC is the hometown hospital of the New York Giants and Nets Basketball.

About the DRI

The Diabetes Research Institute, a Center of Excellence at the University of Miami Miller School of Medicine, is a recognized world leader in cure-focused research. Since its inception in the early 1970s, the DRI has made significant contributions to the field of diabetes research, pioneering many of the techniques used in islet transplantation.

The DRI is now building upon these achievements by bridging cell-based therapies with emerging technologies to restore insulin production. For the millions of families already affected by diabetes, the Diabetes Research Institute is the best hope for a cure. Visit DiabetesResearch.org or call 800-321-3437 for more information.

Benchmark Cambridge Trial In Quest For Ambulatory Artificial Pancreas

I had reported earlier that once perfected and approved by regulators, safe and robust ambulatory artificial pancreas ‒ or to use the scientific term ‘closed loop insulin delivery system’ ‒ has the potential to greatly improve the health and lives of people with type 1 diabetes. The idea itself is not new but the old generation closed loop insulin delivery systems were cumbersome and unsuitable for long term or outpatient use.

Artificial pancreas concept

The newer systems link a continuous glucose monitor and a subcutaneous insulin infusion pump via a control algorithm, which retrieves continuous glucose monitoring data in real time (for example, every five minutes) and uses a mathematical formula to compute insulin delivery rates that are then transmitted to the insulin pump.

However, artificial pancreas that can be worn by diabetics on their person as they go about their daily lives is still in development, with the first in-clinic studies now being reported. Preliminary results have been promising ‒ the most notable improvement is in overnight control of type 1 diabetes, with improvements in safety and a reduction in nocturnal hypoglycemia being reported.

These improvements result from the fine adjustment of insulin delivery provided by closed loop control overnight being superior to a generally fixed basal rate and less likely to cause hypoglycemia. The first application of closed loop control is therefore likely to be in glucose regulation overnight, a step that has the potential to improve dramatically the safety of insulin delivery during crucial, generally unsupervised, periods.

Now a University of Cambridge research tem led by Roman Hovorka has demonstrated the safety and efficacy of overnight closed loop insulin delivery with conventional insulin pump therapy in adults with type 1 diabetes.

Artificial Pancreas Best Hope For Diabetics In Near Term

The trial group consisted of 24 adults (10 men and 14 women) aged 18-65, who had used insulin pump therapy for at least three months and the research team used two protocols ‒ a medium sized meal (60 g carbohydrate) and a large size meal (100 g carbohydrate + alcohol) ‒ to see whether artificial pancreas were effective in overcoming nocturnal hypoglycemia.

As in previous studies carried out by Boris Kovatchev and others in the U.S. and France, the Cambridge closed loop system significantly increased the time that plasma glucose was in the target range (70-144 mg/dl), reduced incidence of hypoglycemia, and better overnight control.

But what makes the Cambridge study important is that the randomized crossover trial design is virtually unique in the field of closed loop control. Because this design is the gold standard for clinical research, the results set a benchmark for future studies.

The only other randomized controlled trial of closed loop control was recently presented by the University of Virginia research team led by Kovatchev at the 4th International Conference on Advanced Technologies and Treatments for Diabetes. This study recruited 24 adults and adolescents with type 1 diabetes in the United States and in France and achieved results similar to those reported by Hovorka and colleagues ‒ more time within the target range of 70-180 mg/dl and a threefold reduction in hypoglycemia.

Dr Roman Hovorka

Moreover, the control algorithm used by Hovorka and colleagues belongs to an advanced class of closed loop control technologies known as “model predictive control”. Algorithm designs for artificial pancreas have generally used either “proportional-integral-derivative control” or “model predictive control”.

Proportional-integral-derivative control algorithms are reactive, responding to changes in glucose levels with adjustment in insulin delivery. Model predictive control algorithms are built over a model of the human metabolic system and are therefore proactive, delivering insulin in anticipation of changes in glucose concentrations.

This compensates partially for the time delays inherent in subcutaneous glucose control (the time delay in insulin action, which can amount to 60 minutes or more). For this reason, model predictive control has become the approach of choice more recently.

The algorithm developed by Hovorka and colleagues has certain distinct features, such as real time adaptation of the underlying model to changing patient parameters implemented as a selection from several predefined models. However, this potential advantage remains to be evaluated.

Most importantly, this is one of the first studies to test realistic meal scenarios and challenge the participants with a large dinner that included alcohol. As such, the study is a clear advance in the quest for an artificial pancreas that can be used by a diabetic while performing normal daily activity.

However, as the authors admit, one limitation is the exclusivelymanual control of the artificial pancreas used relied on study personnel to transmit data manually from the continuous glucose monitor (CGM) to the computer running the closed loop control, and to transmit insulin injection recommendations from the computer to the insulin pump because of technological and regulatory barriers

In fully automated systems ‒ which is what researchers and medical device makers are hoping to make a reality for diabetics ‒ these processes are handled by data transmission and pump control devices, respectively. However, Cambridge method limited the investigation to testing only the control algorithm, not the artificial pancreas as a whole. The testing of other key components, such as sensor-pump communication and error mitigation, would require much more effort and thorough system validation.

Studies using fully automated systems have already been reported by the Artificial Pancreas Project and offer hope for the future of ambulatory systems i.e. devices that be worn by diabetics on their person in their daily lives.

Lastly, despite the sophistication of the control algorithm and the significant reduction in nocturnal hypoglycemia, four episodes of severe hypoglycemia (<70 mg/dl) occurred, three of which the authors thought were attributable to the preceding prandial insulin dose and could not be prevented by the artificial pancreas suspending insulin delivery.

This finding reinforces the recently proposed idea that a dedicated hypoglycemia safety system ‒ a separate algorithm responsible solely for the assessment and mitigation of the risk of hypoglycemia ‒ may need to accompany closed loop control. Such safety systems already exist, and have proved useful.

Based on ‘Boris Kovatchev: Closed Loop Control For Type 1 Diabetes (BMJ 2011; 342:d1911)

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