
Non-Invasive Blood Glucose Measurement
The DREAM BEAM Analyzer
Recent News and Current Status
January 28, 2000
The Dream Beam Clinical Trials Are Progressing
Futrex announced that the calibration phase of the formal clinical trials of the Dream Beam non-invasive blood glucose meter is nearly completed. The initial data is now undergoing formal analysis. This analysis is to prove whether the Dream Beam Analyzer does satisfy the "Protocol" that was established between Futrex and the FDA. (The purpose of the formal clinical trials is to provide the scientific evidence required for submitting an application for FDA market clearance.)
The first half of the clinical trials involves calibrating the non-invasive Dream Beam instruments so that they then can be used for predictive purposes. Over 75 of approximately 140 Dream Beam units have completed calibration by individual volunteers in the privacy of their homes. They then returned the units to their designated principal investigator for calibration analysis.
Those Dream Beam units have now been returned to the volunteers and the predictive portion of the clinical trials (called a "validation phase") has commenced. It is expected that the validation phase will be completed in approximately 45 days.
In commenting on the initial results, Futrex stated that the Protocol requires proof that the Dream Beam Analyzer has accuracy at least as good as the finger stick meters used during the land-mark DCCT study. That study showed that performing four or more blood glucose tests per day could greatly diminish the dreaded complications of diabetes. .
The formal clinical trials are being conducted by three eminent independent principal investigators that are neither employees nor owners of any Futrex stock. Two of the Principal Investigators are diabetes researchers as well as medical doctors who treat a large number of diabetic patients. The third Principal Investigator is an internationally recognized expert in the field of utilizing near-infrared light to perform quantitative measurements.
Futrex is encouraged by the progress of the clinical trials. However, Futrex cautions that no definitive conclusion concerning the success of the formal clinical trials can be made until all the data is analyzed by the three independent Principal Investigators.
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| Date | Table of Contents |
|---|---|
| July 9, 2000 | Futrex to Describe its Proprietary Techniques |
| February 17, 2000 | Futrex Files Law Suit Against the FDA |
| January 28, 2000 | The Dream Beam Clinical Trials Are Progressing |
| March 1, 1997 | Comments on FDA Panel Meeting on Invasive and Non-invasive Home Glucose Meters |
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