Diabetes News for
February 20, 2000

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New Animas Insulin Pump
Are Diabetes Eye Exams Needed Yearly?
AllRecipes.com Adds Diabetes Info And Recipes
Thyroid Problems/Heart Attacks In Older Women
Blacks Have 4X Greater Stroke Risk
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FDA Clears New Insulin Pump

Animas Corporation has received FDA clearance to market its new insulin infusion pump called the R-1000.

The R-1000 pump compares favorably with the two other main pump contenders on the market in offering an array of features for safety, performance, style and convenience. The R-1000 offers a menu-driven format, multiple basal rates and profiles, occlusion detection, accurate remaining insulin gauge, and precision basal delivery. The pump has an LED backlight and is water-tight.

Animas has partnered with Insulin Infusion Specialities (IIS), Inc to distribute the pump and supplies. IIS will exclusively distribute the pump in over one-third of the United States, and Animas will use a direct sale force in the rest of the country. Pricing and availability have not yet been announced.

Besides the R-1000 pump, Animas is developing improved infusion sets and a long-term implantable optical glucose monitor using near infrared technology. The ultimate goal is to combine the pump and glucose monitor to provide a closed-loop system for controlling blood sugars, thereby creating an artificial pancreas.

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Are Diabetes Eye Exams Needed Yearly?

Diabetes is the leading cause of blindness in the United States in adults ages between the ages of 20 and 74. To avoid this devastating complication, yearly eye exams are recommended by doctors for people over the age of forty who have diabetes. When someone has an eye exam, damaging changes in the blood vessels of the retina or an accumulation of hard exudate can be discovered at an early stage where laser surgery can repair them and usually avoid blindness. But new research suggests the annual eye exam may not be worth the cost and inconvenience for all people with Type 2 diabetes.

This study does not change the recommended annual eye exam for people with Type 1 diabetes.

Sandeep Vijan, the primary researcher who conducted the study at the Veterans Affairs Ann Arbor Healthcare System in Michigan, based his research on a computer analysis of the effect of staging exams from one to five years on a group of hypothetical people with diabetes. The results of the study comparing costs to benefits suggest that people who have good blood glucose control with no history of eye disease may need an exam only every two to three years. According to the study, the minimal benefit from annual exams for people who are well-controlled does not warrant the increased health care cost and patient inconvenience.

The two factors used to categorize risk of blindness were age and blood sugar control, measured by the level of HbA1c in the blood. The hypothetical high-risk person is 45 years old and has a HbA1c of 11 percent. The low-risk person is 65 years old and has a HbA1c of 7 percent. Using statistics but no retinal screening, the younger person in poor control would be expected to spend an average of 358 days blind in his lifetime, while the older, better controlled person would be expected to spend 20 days blind.

The research team concluded that the benefits of increasing screening frequency for all were marginal. However, as the risk of blindness increases, the researchers recommend increasing screening frequency.

The research, which was reported in the Journal of the American Medical Association (2000; v 283: pgs. 889-896), brought immediate reaction. The American Academy of Ophthalmology cautioned that changing the schedule of eye screenings for people with Type 2 diabetes from once a year to once every two or three years would increase the risk that individual patients might not receive follow-up care. 

According to the Academy, the JAMA study has several problems including basing the research on mathematical modeling instead of a clinical study comparing one screening frequency with another, using only the risk factors of age and HbA1c instead of duration of diabetes, racial identity, and presence of hypertension, high cholesterol and smoking, and ignoring patient education and counseling as well as the detection of other eye diseases as good reasons for having more frequent eye exams.

The Academy notes that only about 50% of people with Type 2 diabetes get an annual exam even though it is recommended, and they fear that the percentage of compliance will decrease even further if the recommendation is decreased. The Academy holds to its recommendation for annual dilated eye exams for people with Type 2 diabetes until clinical trials testing each exam frequency prove that annual exams are not necessary.

For more information on eye examination recommendations and diabetic retinopathy, visit the Academy's Web site.

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AllRecipes.com Adds Diabetes Info And Recipes

AllRecipes.com, the leading recipe web site, has joined with the Diabetes Forecast, the consumer magazine of the American Diabetes Association, to feature diabetes friendly recipes, diet tips and links to the ADA Web site. Nearly 16 million Americans have diabetes, but about one-third of them don't know they have it. As consumers check out healthy recipes, they will also be informed about diabetes, how to prevent it and spot it when it exists. This alliance will help spread the word about diabetes and alert people who have it but don't know it. 

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Thyroid Problems And Heart Attacks Linked In Older Women

About 10% of women in their 60s and 70s have a reduction in thyroid function but no obvious symptoms. Recent research, published in the Annals of Internal Medicine (2000: 132: pgs. 270-278), indicates that they are at increased risk of heart disease and heart attacks.

Subclinical hypothyroidism, or reduced thyroid function that shows up on blood tests but presents no obvious symptoms, was found in about 124 women in a study of 1,000 women with an average age of 69. This diagnosis was given when TSH (thyroid stimulating hormone) levels were above 4.0. These women were more likely to have plaque in the aorta, which clogs the arteries supplying the heart with blood and indicates heart disease, or to have had a heart attack. In fact subclinical hypothyroidism contributes to heart disease just slightly less than the other major risk factors of high cholesterol, smoking, high blood pressure, and diabetes.

The study, conducted by Dr. Jacqueline C.M. Witteman and colleagues at Erasmus University Medical School in Rotterdam, the Netherlands, indicates the need for screening older women for this disorder.

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Blacks Have 4X Greater Stroke Risk

Even though improvements in education and preventive health care have cut the risk of stoke in America by 70% over the last 50 years, middle-aged black Americans still have a four times greater risk of stroke compared with whites of similar age. This new finding comes from a study based on 1997 US death certificate data on fatal strokes among various racial groups, and was reported in Morbidity and Morality Weekly Report conducted by the Centers for Disease Control and Prevention (CDC) in Atlanta, Georgia.

Why does this higher stroke risk exist? The study did not provide clear conclusions, but the researchers believe that inadequate medical care and insurance, as well as lifestyle issues such as obesity, uncontrolled high blood pressure, poor nutrition, diabetes and smoking are to blame for the high stroke rate among this racial group. Genetic and environmental factors may also contribute to this higher risk. Other minority groups have relatively high stroke risk as well.

Interestingly, racial differences in stroke risk start to become similar with increased age. Over age 85, people of all races have no difference in stroke risk.

Stroke is the third leading cause of death in the United States. Public education campaigns and access to better health care for all Americans, especially minority groups, are considered essential for reversing this danger.

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