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| |  ADA: Short-Term Blood Glucose Control Yields Dramatic Quality Of Life Improvement SAN ANTONIO, TX -- June 15, 2000 -- Even a short-term improvement in blood glucose control yields dramatic improvements in the daily quality of life of people with diabetes, according to a report presented here today at the American Diabetes Association's 60th Annual Scientific Sessions. "A renewed vitality and zest for life -- with more energy and fewer sick days -- can be the immediate payoff for people who improve their control of type 2 diabetes," reported Donald C. Simonson, MD, associate professor at the Harvard Medical School, in a recent interview. This is the first demonstration that an association between improved control and enhanced quality of life is consistent, stable, and durable across cultural and linguistic boundaries. The study involved nearly 700 men and women at 62 sites in nine countries around the world. More than 16 million Americans have diabetes, a group of serious diseases characterized by high blood sugar levels that result from defects in the body's ability to produce and/or use insulin. Diabetes can lead to severely debilitating or fatal complications, such as blindness, kidney disease, heart disease and amputations. It is the sixth-leading cause of death by disease in the U.S. The study focused on people who had type 2 diabetes (formerly called non- insulin-dependent or adult-onset diabetes). The disorder usually arises because of insulin resistance, in which the body fails to use insulin properly, combined with relative (rather than absolute) insulin deficiency. It typically occurs in those over 45 and overweight, although increasing numbers of children and teenagers around the world are developing the disease due to overweight and sedentary lifestyles. The researchers "piggybacked" the psychological study onto a phase III randomized, double-blind, placebo-controlled clinical trial designed to evaluate the impact of various doses of an investigational drug, nateglinide, in reducing blood glucose levels. A total of 694 men and women, average age 58, who had type 2 diabetes were enrolled in nine countries -- the United States, Canada, France, Germany, Norway, Finland, Poland, Switzerland, and Russia. Participants were primarily Caucasian (87 percent), married (71 percent), employed (54 percent) and college educated (54 percent). Glucose levels were checked with HbA1c blood tests, an indicator of diabetes control over the prior two to three months. At the outset, the average HbA1c was 8.1 percent -- higher than ideal. After six months, the average HbA1c was down to 7.3 -- 7.6 percent for those taking any dose of the active drug, compared to placebo. "Participants reported significant improvements in their quality of life in many areas, and the degree of improvement was positively correlated with the degree of change in glycemic control," Dr. Simonson said. The pattern of association was consistent across dosage groups, country, and language. "Although we have seen similar results with other drugs in U.S. trials, this clearly demonstrates that, around the world, something physiological about improved diabetes control helps people to feel better -- to have less anxiety about their lives, less depression, less worry about their health -- and that such benefits are directly correlated with the degree of control they attain," said Dr. Simonson. The most highly correlated improvements were seen in: Health care utilization (based on hospital or clinic visits and calls the physician) were also lower for those taking active medication compared to those on placebo.
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