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Big Week For GlucoWatch: APPROVED!!!The GlucoWatch, Cygnus' non-invasive, watch-like device that
provides "painless" Frequent access to blood sugar readings is likely to revolutionize diabetes treatment, as well as lead to major reductions in serious complications such as blindness, kidney disease and amputation. Dr. Steven Edelman, an San Diego endocrinologist who has diabetes and wore the GlucoWatch, was given a standing ovation when he presented his data and experiences before the FDA Advisory Panel. No one can remember any similar reaction by an FDA panel. The FDA did give a warning and placed three minor requirements on Cygnus before approval. The FDA warning says that 25 percent of the time readings from the GlucoWatch would differ as much as 30 percent from blood sugar tests. For instance a watch reading of 100 mg/dl might actually be 70 mg/dl or 130 mg/dl. The FDA also required Cygnus to come up with a comprehensive educational program for both health personnel and consumers for the prescription-only device, suggested labeling changes, and required ongoing study of how well the device detects low and high blood sugars. The GlucoWatch will not work when the user is sweating, but the user can set the watch to alarm before sweating due to hypoglycemia would cause inactivation. Cygnus estimates the price for its GlucoWatch will be between $225 and $250, with sensors that last up to 12 hours costing $4 apiece. Sales of the sensor are expected to be the major income producer for the company. Cygnus stock prices doubled overnight on FDA's approval. The GlucoWatch enlarges the skin's pores with small electrical currents so that fluid can be extracted from which glucose is measured. The GlucoWatch must be worn for three hours before enough fluid is available for testing, and a fingerstick test is then done to calibrate the watch. From that point, the new sensor is good for 12 hours of operation with readings automatically taken every 20 minutes. Blood sugar trends can then be picked up for correction with insulin dose adjustments with your doctor's help. Cygnus also says it has received its CE Certificate allowing sale of the GlucoWatch within the European Community. See our information on Cygnus and other new approaches to Semi-Invasive Monitors. FDA approval is expected to open the doors for other companies developing less invasive technologies, such as MiniMed which has a masked sensor already out, and SpectRx which uses a technology that allows 3 days continuous use. Progress is also being reported in the Non-invasive Field.
Easy Way To Increase LifespanWant to live six to nine years longer? Researcher Dr. Jeremiah Stamler and his colleagues at Northwestern University says 5 to 10 percent of the U.S. population is likely to do this just because they are at low risk for heart disease. This low risk population was defined as those having a cholesterol level of less than 200 mg/dl, blood pressure readings of 120/80 or lower, no history of smoking, and no history of diabetes. Their findings were reported in the Journal of the American Medical Association following the study of health data from more than 350,000 adults. An accompanying editorial in the journal suggested that Americans may be neglecting their most powerful tool for health, living a healthy life, in their race to new medications and fast food restaurants. The editorial made a point to encourage teaching healthy behaviors to kids at a young age regarding food, exercise and smoking.
Abbott Increases Financial Stake in SpectRx's MonitorAbbot Laboratories is upping its financial ante in SpectRx in its efforts toward finalizing development and production of an external continuous glucose sensor. After a recent purchase of $2.75 million in SpectRx preferred stock, Abbot says it plans to buy $2.5 million more by Jan. 3rd. SpectRx has developed a device which is applied to the surface of the skin and allows easy measurement of interstitial glucose levels through the skin every five minutes. In a preliminary study presented by SpectRx at the June, 1999, national ADA meeting, their continuous monitoring system showed a respectable correlation coefficient of 0.90 over a glucose range of 60 to 400 mg/dl compared to a finger stick method. See our information on SpectRx and other new approaches to Semi-Invasive Monitors. Under the revised agreement, Abbott has exclusive worldwide marketing rights to continuous monitoring as well as single-use monitoring applications of the technology. The new agreement includes revised milestones, and cooperative R&D focused on continuous monitoring. In return, SpectRx will receive a royalty on sales of disposables and have the option to manufacture continuous monitoring devices for Abbott.
Possible Key To Women And Autoimmune DiseaseA genetic malfunction found in mice may explain why autoimmune diseases, in particular Type 1 diabetes, are more common in women than in men. A new study by researchers at Massachusetts General Hospital and Harvard Medical School of mice with Type 1 diabetes found that a gene called Lmp2 does not function correctly. This malfunction seriously impacts nuclear factor kappa-B (NF-kB), a protein important for immune system health. NF-kB is produced in reduced amounts in male diabetic mice, but not at all in female mice. Autoimmune disease, like Type 1 diabetes, appears to be more likely when there is a total absence of this protein. The research by Harvard immunologist, Denise Faustman, M.D., Ph.D., and her post-doctoral fellow, Dr. Takuma Hayashi, may also explain why women develop autoimmune diseases like lupus, rheumatoid arthritis, and multiple sclerosis, up to ten times more often than do men. One in 20 Americans is affected by at least one of the more than 80 autoimmune diseases that have been identified. Their study appears in the December 1 issue of Molecular and Cellular Biology.
MRI Can Predict Heart Attacks"Soft" plaque in blood vessels which is likely to break off and cause a heart attack can now be noninvasively pictured by using magnetic resonance imaging (MRI). This recent advance in MRI can identify people at high risk of for heart attacks according to research presented at the Annual Meeting of the Radiological Society of North America (RSNA). Previous research has shown that "soft" plaque, which has a high lipid content, is more likely to break off of the walls and form a blood clot than firmer plaque. This can cause a heart attack. Zahi A. Fayad, Ph.D., assistant professor of radiology and director of cardiovascular imaging, physics and research at Mt. Sinai School of Medicine, New York and his team modified MRI so that it can image inside the coronary arteries. They tested 13 participants, 8 healthy and 5 with heart disease, with the modified MRI. They determined that plaque in the heart patients was 2 to 10 times thicker in 5 arteries specifically chosen for 40% or more blockage than in the healthy subjects. The MRI test was able to show that the plaque bulging in some places indicated soft plaque. The lipid core within a soft plaque contains free fatty acids. If the hard shell around this fatty core breaks open, FFAs are spilled into the blood vessel triggering clotting and closure. This puts patients at risk for heart attack and should be treated by diet, exercise, cholesterol drugs, angioplasty and bypass surgery. The statin class of cholesterol drugs is especially helpful in this situation because they reduce not only cholesterol but also the size of the fatty core. Why do some people form soft plaque? They are caused by fatty diets, genetics, and injury to the artery wall from smoking, hypertension, high cholesterol and diabetes. The result of the study appears in the December 1 issue of Molecular and Cellular Biology.
Transplant Extends Life For All Kidney PatientsAppropriate candidates for kidney transplantation should now include older patients, African-Americans, and patients with diabetes, since a new study shows that they all benefit from transplantation, not just young, healthy patients. The benefits are not just enhanced quality of life, but prolonged life as well. The results of the study analyzing death rates among nearly 230,000 patients undergoing dialysis are published in The New England Journal of Medicine for December 2. Dr. Robert A. Wolfe from the University of Michigan, Ann Arbor, and colleagues showed that of these patients over 46,000 qualified as potential candidates for kidney transplantation, while only 23,275 of them eventually received a transplant. Dialysis patients on the waiting list for transplantation were 38% to 58% less likely to die each year compared to dialysis patients not on the waiting list, partially because they tend to be healthier to begin with. In the first two weeks after a kidney transplantation, the death rate for kidney recipients goes up to 2.8 times that for people still waiting. But eventually the death rate is 68% lower for recipients of donor kidneys than for those still waiting. People who receive a kidney have an average of 20 more years of life compared to 10 for those left waiting. Although life was extended the most for younger, healthier patients, transplantation also extended the life of patients with diabetes by an average of 11 years, African-Americans by 6 years, and older patients by about 4 years, compared to those who did not receive a donor kidney.
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