Diabetes News October 17th, 1999

Heart Disease Prevention Study In Type 2 Begins
Depression and Stress Keep Blood Sugars High
Former Miss America Explains Diabetes Foot Care
Americans And MDs Ignore Obesity Hazards
SpectRx Gets CDC Grant For Non-Invasive Testing
HbA1c Blood Glucose Test Just Got Easier
Cheaper Blood Glucose Test Strips

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Nationwide Heart Disease Prevention Study Begins In Type 2

People often don't die from their diabetes. Rather, cardiovascular complications like heart attacks and strokes are the leading cause of illness and death among the nation's 16 million people with diabetes. For this reason, a new nationwide study called the Prevention of Cardiovascular Disease in Diabetes (PCDD) will attempt to find the best treatments for preventing heart disease among people with Type 2 diabetes. 

Principal investigators for the PCDD trial are Marc Thibonnier, M.D., and Saul Genuth, M.D., of the Department of Medicine at University Hospitals of Cleveland and Case Western Reserve University School of Medicine. They have been awarded $13.2 million by the National Heart, Lung, and Blood Institute at the National Institutes of Health to design and conduct a study that compares intensified with conventional blood sugar control, and assesses the effectiveness of several new drugs to lower blood sugar, blood pressure and cholesterol. 

Seven networks of hospitals and physicians will recruit 10,000 patients, who will be treated with free medications during the five-year trial and monitored for their effectiveness. The costs of medications for the average patient is upwards of $200 a month. Adults aged 50 to 75 with Type 2 diabetes who have not developed cardiac disease or had a heart attack will be eligible for the study. 

The PCDD study will focus on a wide range of cardiovascular risk factors, including obesity, smoking and physical inactivity as well as diabetes, high blood pressure and high cholesterol. 

Drs. Thibonnier and Genuth oversee a network of clinical sites in Ohio and Michigan that will recruit 1500 patients for the PCDD trial. This is just one of the seven networks assembled nationwide. Recruitment for the study will begin in the spring of 2000. Anyone interested in participating may call 216-368-6129, fax 216-368-5824, or e-mail mxt10@po.cwru.edu or smg15@cwru.edu.

Depression and Stress Keep Blood Sugars High

When depressed or anxious you may have more difficulty controlling your blood sugars according to a small study published in the October issue of the journal Applied Psychophysiology & Biofeedback. The study found that people with insulin-dependent diabetes who reported feeling depressed, anxious, or stressed-out were the least likely to succeed in lowering their blood sugar levels. This tendency for the stressed and depressed to remain high continued to be a problem even after the participants learned relaxation techniques to reduce stress.

In the 4-week study of 18 adults with insulin dependent diabetes at the Medical College of Ohio in Toledo, half the participants kept daily logs of their blood sugar levels and received standard medical care. In addition to this standard care, the other half also learned how to perform biofeedback-aided relaxation techniques that they were encouraged to practice at home. During biofeedback, a person is hooked up to a machine that measures the specific physical functions that he or she wants to control. Using feedback from the machine as guidance, people can learn how to control such functions, including stress hormone levels which affect blood sugars.

Although the researchers found that relaxation therapy benefited people who were not suffering from depression or anxiety, this benefit was not seen in the others. Of 12 people who were not depressed, relaxation techniques lowered their average blood sugar by 9%, while in nine people who were not classed as anxious, relaxation techniques lowered sugar levels by 12%.

Any small study like this raises many questions, including how effective the researchers were in teaching relaxation, whether the stressed or anxious participants actually able to carry out the relaxation techniques at home, and whether stress hormone levels dropped during the study. The authors suggest that some people with diabetes may benefit from relaxation, but that others may need antidepressant medication or therapy to see a benefit.

Hear Former Miss America Explain Good Diabetes Foot Care

Nicole Johnson traveled 20,000 miles a month in her year as Miss America. If she didn't know how a person with diabetes takes care of her feet before, she sure does now. And she shares how it's done in this streaming audio containing foot care advice.

Americans And Their Doctors Ignore Obesity Hazards

There's a growing epidemic of obesity in the U. S. and everyone is looking the other way, according to the results of research on overweight Americans sponsored by Shape Up America!, a national non-profit organization founded by former Surgeon General C. Everett Koop. The study shows that chances are if you are overweight (60 million Americans are), you understand the health risks of obesity contributing to heart disease and cancer, but you don't think it applies to you. And most likely your doctor has never discussed your weight with you. 

The national "Talk To Your Doctor" study, collected by Roper Starch Worldwide, surveyed 1,651 U.S. adults between the ages of 18 and 65. Focusing on 547 participants with Body Mass Index (BMI) scores of 27 or above, the survey polled significantly overweight Americans who are at high risk for obesity-related illnesses and premature death. The survey found that doctors of overweight Americans do not mention weight loss with their patients. If it is discussed, the patient usually brings it up, and the doctor fails to recommend a systematic treatment program of diet, exercise, behavioral modification, and medication.

This finding is particularly important in light of a study released last week of more than one million Americans published in the New England Journal of Medicine. The NEJM study conclusively shows that overweight people run a higher rate of premature death from all causes, but especially from heart disease and cancer. 

The major points of the study: 

• 7 out of 10 seriously overweight Americans believe their excess weight does not affect their health. 
• Less than half have discussed weight loss with their physician, and 2 out of 3 who have, brought the topic up first, rather than their doctor. 
• A large number of doctors (82%) did little more than suggest their patients get more exercise to manage their weight. Only 17% of participants indicated that their physicians recommended drug therapy to help them lose weight, 80% of the time without explaining the differences between FDA-approved prescription medications. 

Shape Up America!'s website has the latest diet, health and fitness information for weight loss and maintenance. Guidance for Treatment of Adult Obesity for physicians and other health care professionals, and Healthy Weight, Healthy Living for consumers can be downloaded for free from the website library, or ordered in paperback for $10 each.

SpectRx, Inc. Gets CDC Grant to Expand Non-Invasive Testing

The Centers for Disease Control and Prevention (CDC) awarded a $292,000 grant to SpectRx to enable adaption of its continuous glucose monitoring technology to monitor the blood sugar levels of children and elderly persons who have diabetes. This one-year study is part of the CDC's Innovative Technology Development Grant for the Detection and Monitoring of Diabetic Hypoglycemia by Non- or Minimally-Invasive Techniques.

The SpectRx continuous glucose monitoring system collects and measures interstitial fluid (ISF), the clear fluid under the skin through which glucose and other nutrients travel from the blood stream to the cells. It is collected through an array of micropores created with a laser in the stratum corneum, the dead outer layer of skin, and measured in a patch containing a glucose sensor. 

The grant is part of the CDC's ``Healthy People 2000'' initiative and is designed to stimulate the development and commercialization of innovative technology for monitoring people with diabetes who are at risk of developing hypoglycemia or low blood sugar. The condition may result in reduced alertness, temporary inability to communicate, loss of consciousness, seizures, coma injury or death.

The current SpectRx prototype consists of a disposable patch containing a glucose sensor connected by an umbilical to a beeper-sized meter. The prototype patch is placed over the array of micropores created on the skin by a hand held laser. By using a low-level of vacuum, a stream of interstitial fluid is drawn into the patch and sensor. The prototype meter may be worn on a belt or hidden under clothing. It is envisioned that in the final design, each patch could be used for up to three days before being replaced with a new patch.

HbA1c, Critical Test For Good Control, Just Got Easier 

The hemoglobin A1c or HbA1c test provides people with diabetes and their health care providers information about blood sugar control over the last 3 months. Now, with a prescription test kit, you can collect your own blood sample at home and send it in for a HbA1c analysis. The new test kit comes from BioSafe Diagnostic Products. 

How does the BioSafe HbA1c test kit work? A finger lancet is included to collect blood. Three drops of blood are placed on a collection card, the card is dropped into a specially sealed packet and mailed it in the prepaid envelope to BioSafe's laboratory for analysis. Results are sent to the person's physician, who interprets the results and alerts the person if their treatment needs adjusting. The new test kit will be available soon with a prescription at pharmacies. The price is $49.95 and is covered by most insurance plans under C.P.T. Code #83036. 

Miss America 1999, Nicole Johnson, who has Type 1 diabetes, is serving as a spokesperson for Bio-Safe's education program. To help with the education program, especially among children, BioSafe has worked with Tiger Electronics, Ltd/Hasbro, Inc. to create a ``doctor'' finger puppet based on Furby, one of the world's best selling toys. All patients with diabetes will receive a Furby finger puppet when they purchase a BioSafe HbA1c test kit. Those who have the recommended number of four tests a year will receive a complimentary electronic Furby(TM) toy.

Cheaper Blood Glucose Test Strips Available

Can-Am Care says their new Excel test strips are now available and priced to sell at about 30% less than other brand name strips. The strips are manufactured in Inverness Scotland, and can be used with the Glucometer Elite meters. They should be available at a pharmacy near you soon under the name Excel GE Test Strips. Call your local pharmacy for pricing details.

These electrochemically-based test strips are less expensive to produce than color-based strips used in older meters. It is not known if Bayer who manufactures the Glucometer will respond by reducing their strip prices to more closely match Can-Am.