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Biotech / Medical : BICO & VITK -- Ignore unavailable to you. Want to Upgrade?

To: LINEMOVER who wrote (2132)	8/28/1998 5:09:00 PM
From: Tom R. Jones	Read Replies (1) \| Respond to of 2395

I found this on the Yahoo site: Current Intended Use of the Diasensor 1000 Due to current limitations in this brand new technology, the Diasensor 1000 is not for everyone. At this time, averages of blood glucose test results obtained at clinically relevant times of the day over two to four-week periods are intended to be used by physicians together with other laboratory tests, such as glycosylated hemoglobin (HbA1c) and fructosamine, patient-reported acute complications such as low blood glucose (hypoglycemia), changes in weight and changes in lifestyle, to adjust their patients' diabetes therapy. Individual test results from the Diasensor 1000 are not intended to be used by the patient to make daily adjustments to their insulin therapy, and the Diasensor 1000 should not be used to detect or monitor for hypoglycemia. Despite these current limitations, there is a significant number of people with diabetes for whom the Diasensor 1000 offers the opportunity to increase the frequency of their self-monitoring of blood glucose. More frequent blood glucose monitoring can provide their physicians with the additional information that could lead to improved overall control of their blood glucose levels. Improved blood glucose control has been demonstrated by the National Institutes of Health (NIH) - sponsored Diabetes Control and Complications Trial (DCCT) to be correlated to significant reduction in the risk of the long-term complications of diabetes, which include blindness, kidney disease and nerve damage leading to amputations and other disorders. It is Biocontrol's goal to continue the evolution of this new noninvasive technology to the point where noninvasive devices will become a direct replacement to the current invasive home-use blood glucose meters. Calibration The Diasensor 1000 must be calibrated for each individual who would use it. This is necessary due to the significant person-to-person variation in skin morphology and chemistry. The current calibration process requires a user to perform two tests per day for at least 60 days using both the Diasensor 1000 and a HemoCue blood glucose meter which is supplied with the Diasensor 1000 system. These tests are performed at times at which the user would normally test his or her blood glucose (for example, in the morning before breakfast and then again before the evening meal). This means that the user does not perform any more fingerstick procedures for the Diasensor 1000 calibration than he or she usually would. The data from these tests is returned to Biocontrol's Computational Analysis Department, which calculates the algorithm that relates the measured response of the Diasensor 1000 to blood glucose concentration. This algorithm is then transferred to a memory card which is returned to the user. The user then performs two tests per day, again using both the Diasensor 1000 and the HemoCue meter, for at least 30 days to evaluate the performance of the Diasensor 1000. If the user or the user's physician is not satisfied with the Diasensor 1000 performance as demonstrated during the evaluation, then the user returns the Diasensor 1000 and receives a refund. In the near future, Biocontrol expects to reduce the calibration procedure from 60 days to 30 days and the evaluation procedure from 30 days to 2 weeks.