Diabetes Prevention Today

/ April 14th, 2011/ Posted in Diabetes / No Comments »

State effort targets diabetes

Insurers and the Centers for Disease Control and Prevention aren’t willing to wait for Georgians to get a diabetes diagnosis before they change their lifestyles.

A leading cause of kidney failure and heart disease, diabetes costs the U.S. more than $170 billion annually, according to the CDC. Insurers across the country are experimenting with ways to prevent the chronic disease in those most at risk — hoping to curb the ballooning cost of care.

In Georgia, insurance giant UnitedHealth Group is partnering with the YMCA, the CDC and local pharmacists — a sometimes underutilized resource — to help its members lower their risk of developing Type 2 diabetes: by eating healthy, exercising and losing weight.

It’s part of a larger effort by the CDC to lay the groundwork for a nationwide diabetes prevention system it hopes other insurers and nonprofits eventually will join. Even those not at risk of diabetes could see a benefit if the effort lowers escalating health care costs for everyone.

“Lifestyle changes — even those that are modest — can make a dent,” said Dr. Catherine Palmier, chief medical director for UnitedHealthcare’s Southeast region. “As little as 10 pounds can make a difference.”

Nationwide, 25.8 million people — 7 million of them undiagnosed — suffer from the disease, and one-third of Americans could have it by 2050, according to the CDC.

When the new health care law goes into full effect in 2014, insurers will have to cover more people with chronic illnesses, giving them more of a stake in curbing the epidemic, experts say.

Insurers such as Aetna offer diabetes management programs, and Blue Cross Blue Shield of Georgia has bumped up its diabetes prevention efforts, which include health coaches, in recent years.

The cost involved in treating diabetes is unsustainable for society and is a natural area for health care organizations to build partnerships, said Rick Elliott, CEO of UnitedHealthcare of Georgia. “We’ve got to get people to live healthier.”

The disease is especially prevalent in the Southeast; 9.7 percent of Georgians had diagnosed diabetes in 2009, CDC data show.

UnitedHealth, which has 1.4 million Georgia members, is encouraging those most at risk of developing the disease to join the 16-week YMCA program, which is free to the insurer’s members. It will pay the nonprofit and Walgreens pharmacists for members they help. Delta Air Lines already has signed on to the program, which UnitedHealth also is working on in other states.

The effort is based on a prevention program tested by the National Institutes of Health and the CDC that showed people who lost 5 to 7 percent of their body weight could prevent or delay the onset of Type 2 diabetes — which is less severe than Type 1 — by 58 percent.

Pharmacists track blood work, cholesterol and other indicators, said Amy Elkareh, a local Walgreens pharmacist. “We also talk with patients about what they’re struggling with and what areas they feel like they need help with controlling.”

UnitedHealth also is tapping Walgreens pharmacists to counsel patients who already have diabetes on how to better manage it by properly using medications, monitoring blood glucose levels and other methods.

Insurers are increasingly focused on controlling chronic illnesses in part because employers are demanding it, said Tony Holmes, a partner in global consulting firm Mercer’s Atlanta office.

A survey by the firm showed companies that put a heavy focus on health management activities, such as wellness programs, had a 2 percent lower increase in year-over-year health care costs than those that didn’t, Holmes said.

UnitedHealth, which has 75 million members worldwide, has launched its diabetes programs in 10 states so far.

The CDC hopes bringing other insurers on board will help give 15 million Americans access to diabetes prevention programs by 2020, said Dr. Ann Albright, who heads the Division of Diabetes Translation.

The agency has invested $3 million in the project to get it started, but a sustainable funding source from third parties will be key to its success, Albright said. Other insurers and health care providers can contract with UnitedHealth or develop their own programs, she said. So far, Minnesota-based insurer Medica has signed on through an agreement with UnitedHealth.

It’s a complicated problem, she said. “It’s going to take a lot of us to do this.”


A YMCA program is a key element of UnitedHealth Group’s partnership with the Centers for Disease Control and Prevention. Here’s how it works:

— Participants meet one hour a week for 16 weeks, followed by monthly check-ins for a year. The program trains people to eat healthier and find ways to incorporate exercise into their day, such as taking the stairs instead of the elevator, said Kristin McEwen, Metro Atlanta YMCA group vice president. “We run through the day, and if it’s not scheduled, we can’t find time for it.”

— The program is free to UnitedHealth members. Non-UnitedHealth members can participate at a cost of $142 for YMCA members and $299 for nonmembers with financial assistance available.

Data Showing Use Of Tethys’ PreDx(R) Diabetes Risk Score Improves Medical Management And Outcomes In Patients At High Risk For Type 2 Diabetes

Data were presented today showing that utilization of the PreDx® Diabetes Risk Score (DRS) to accurately assess a patient’s risk of developing type 2 diabetes within five years results in more aggressive treatment and follow-up for diabetes prevention among patients whose test scores indicate high risk levels, as well as statistically significant improvements in their cardiometabolic risk factors, compared to patients with lower test scores and those not tested with PreDx DRS. The strong correlation among accurate risk assessment, risk reduction and improved medical outcomes suggests that utilization of PreDx DRS contributes to more careful diabetes risk monitoring and more effective preventive and therapeutic intervention than reliance upon traditional risk assessments.

The data were presented at the Fourth International Congress on Prediabetes and the Metabolic Syndrome, held in Madrid, Spain, in a presentation titled, “A Comparative Study of the Use of the Diabetes Risk Score (DRS) in Primary Care: How Are Medical Management and Patient Outcomes Affected?” authored by S. E. Conard, et al.

PreDx Diabetes Risk Score (DRS) is a multi-marker fasting blood test that assesses markers of inflammation, fat cell function, and glucose metabolism. The DRS categorizes individuals as low, moderate, or high risk for diabetes conversion within 5 years, and has been shown to be significantly more accurate than HbA1c or fasting glucose. Medical Edge Healthcare Group in Dallas, Texas, conducted the retrospective observational study using electronic medical records in order to evaluate the impact of PreDx DRS on clinical practice and patient care in a natural primary care practice setting.

“Today we face several challenges in diabetes prevention. Use of evidence-based interventions before disease diagnosis has been traditionally low, and with 79 million Americans already considered pre-diabetic, we have too many patients to treat effectively. This study provides strong evidence that PreDx DRS is not only a powerful risk assessment tool, but also an important prevention tool, enabling physicians to more effectively direct resources to patients with the greatest need for intervention, and motivating physicians and patients to employ preventive measures,” said Mickey S. Urdea, PhD, chairman and chief executive officer of Tethys.

“Careful monitoring of risk factors is essential to patient behavioral change and effective medical management,” said Scott Conard, MD, chief medical officer of Medical Edge. “PreDx DRS captures essential information about the physiology of our patients, and provides an easy-to-understand diabetes risk score which can contribute to enhanced monitoring of diabetes risk and the use of more appropriate preventive therapy for higher-risk individuals. The evidence showing that patients with high diabetes risk scores were more aggressively treated for risk factor control strongly suggests that these patients and physicians were more engaged in reducing risk factors when this test was applied.”

About the Observational Study and Results

The Tethys sponsored study included data on 696 patients age 30 or older who received the PreDx DRS test between June and December 2010 with valid test results and no prior diagnosis of diabetes. A total of 35 physicians ordered the PreDx test for at least one patient during this period. A control un-tested group was randomly selected in a 3:1 ratio to DRS-tested patients to match gender and age distributions from those who had at least one measurement of LDL, blood pressure, and weight in the 18 months prior to the reference date, and had no record of visiting a physician known to be ordering PreDx DRS tests. Biometric, diagnosis, and prescription records of all selected patients were extracted for the 18 months prior to the reference date of October 1, 2010 and all dates afterwards (mean follow-up 4 months).

Biometric measures included blood pressure, LDL, HDL, weight, HbA1c, triglycerides, fasting glucose, and HbA1c. Per-patient means were computed for the periods before and after the reference date. Diagnoses examined were hypercholesterolemia and hypertension. Prescriptions for anti-hypertensives, lipid-lowering agents, anti-diabetic agents, and aspirin written after the reference date were compiled. Differences in intensity of care between controls, and low, moderate, and high scoring DRS patients were evaluated by subsequent risk factor monitoring rates, use of pharmacological agents, and improvement in risk-factor control. P-values were computed using a two-tailed chi-square test.

Results showed:

– Patients who received the PreDx DRS test were more likely to have follow-up monitoring of biometric risk factors by a physician relative to similar patients who did not receive the test, including measurements of lipid and glucose control (p<0.001).

– Patients with high PreDx DRS diabetes risk scores were more aggressively treated for risk factor control than those with lower PreDx scores or no test, including use of aspirin, antihypertensive agents, lipid lowering therapies and other agents (p<0.01)

– There was significant improvement of risk-factors in patients who received the PreDx test, including weight, blood pressure, and cholesterol measures (p<0.001).

About Type 2 Diabetes

Type 2 diabetes mellitus is a major public health epidemic. According to the United States Centers for Disease Control and Prevention, diabetes affects nearly 26 million people in the United States or 8.3% of the population. Diabetes is the seventh leading cause of mortality in the US, a major cause of heart disease and stroke, and the leading cause of kidney failure, nontraumatic lower-limb amputations and new cases of blindness among adults in the US. The direct and indirect costs of diabetes in the U.S. exceeded $174 billion in 2007, including $58 billion in indirect costs (disability, work loss, premature mortality). Medical expenditures for people with diabetes are more than two times higher than for people without diabetes. Worldwide, in 2000, diabetes affected an estimated 171 million people and this figure is projected to rise to 366 million by 2030, propelled by increases in age, obesity, and urbanization of the world’s population.

In 2005-2008, based on fasting glucose or A1c levels, 35% of US adults aged 20 years or older had prediabetes (50% of those aged 65 years or older), In 2010, it is estimated that 79 million Americans aged 20 years or older had prediabetes. The Diabetes Prevention Program (DPP), a large prevention study of people at high risk for diabetes, showed that lifestyle intervention to lose weight and increase physical activity reduced the development of type 2 diabetes by 58% during a 3-year period. The reduction was even greater, 71%, among adults aged 60 years or older.

About PreDx® Diabetes Risk Score

The PreDx Diabetes Risk Score (DRS) provides enhanced risk stratification through the measurement of multiple biomarkers linked to pathways of diabetes progression. PreDx DRS was developed using a unique approach to quantifying biomarkers suspected of playing roles in diabetes development. Tethys methodology enabled evaluation of many biomarkers utilizing very small amounts of blood from select and well-characterized large study cohorts with known diabetes outcomes. The company then determined the combination of these biomarkers with an algorithm that best identified an individual’s risk of developing type 2 diabetes within five years. PreDx DRS has been validated by the Tethys Clinical Laboratory (TCL) in several large populations. The test uses standard immunoassay and clinical chemistry formats, sample collection and shipment methods. Currently performed exclusively by the CLIA-certified TCL, the test generates a Diabetes Risk Score between 1 and 10 that corresponds to an absolute percentage risk of developing disease within five years.

Tethys Snags U.S. Air Force Support for Big Diabetes Prevention Study

Tethys Bioscience is making a big bet as a company that it can help prevent people from getting diabetes. Now it has got some critical support to help it prove that idea.

Emeryville, CA-based Tethys is announcing today it has secured a partnership with the U.S. Air Force to see if the company’s PreDx test can help people avoid getting full-blown diabetes that can lead to a range of complications like blindness, heart attacks, and limb amputations. Air Force physicians, led by Lt. Col. Mark True, plan to enroll 600 pre-diabetic patients at six domestic Air Force bases. Half of the patients will get information on their diabetes risk at the beginning of a 12-week study, while the other half won’t. Researchers want to see whether this trial supports the idea that the Tethys test essentially scares patients into really changing their behavior, and improving their diet and exercise habits as a way of staving off diabetes.

The company isn’t disclosing the budget for the study, and isn’t saying when it expects to have results—although the study will require patients be followed for six months. It’s safe to say, though, that if this confirms some of the anecdotal reports that suggest Tethys is helping motivate some patients, then the findings could be a powerful new tool for Tethys, as it seeks to convince insurers that the test’s list price of $585 is justified.

Tethys has had some success already in the marketplace, based on data that says its test can identify who among the nation’s 79 million “pre-diabetics” who are likely to worsen over five years, and join the much riskier group of 25 million people with diabetes. Anything to reduce the number of diabetics could have huge implications for the U.S. health system. The total cost of diabetes in the U.S. is estimated at about $3.4 trillion in the 10 years through 2020, according to UnitedHealth, the nation’s largest health insurer.

Tethys, as I described in a feature earlier this month, has already had some success in its early days, selling about 27,000 of its tests in its first year and a half on the market. Last week, the company said it has sold 35,000 tests, meaning it sold about 8,000 tests in the first two and a half months of this year. We’ll see how big that number can go if Tethys can present hard evidence to insurers that its test changes behavior and can prevent a chronic, expensive ailment like diabetes.

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