Transcutaneous Analyte Measuring Methods (TAMM Phase 2)
Quarterly progress rept. no. 2
BIOTRONICS TECHNOLOGIES INC WAUKESHA WI
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The primary objectives of the second quarter of Phase 11 TAMM were the following 1. The design of a near infrared NIR-800 photodiode array spectrometer, two of which would be used in clinical testing starting in June of 1992. 2. The development of data acquisition and advanced pattern recognition software for analyzing the data collected with the spectrometer. 3. Completion of an ongoing, internal test program with the BI-102 Infrared Analyzer. 4. The establishment of a clinical test plan and protocol with the Naval Medical Research and Development Command in Bethesda, Maryland, and with The Blood Center of Southeast Wisconsin. The status of the major objectives outlined above is summarized below and detailed in the body of the report. 1. Delivery of the two instruments to be used in clinical testing has been delayed until June 1, 1992 due to difficulties in completing the experiments with the gallium arsenide InGaAs array, fiber-optic link and optrode. A revised schedule is included as Figure 1. 2. The development of the data acquisition and advanced pattern recognition software is proceeding on schedule. The data acquisition software has been completed. Many elements of the advanced pattern recognition software have been used experimentally in the analysis of the data collected with the BI- 102. 3. The internal BI-102 preclinical trials have been completed. One hundred and twenty sets of data were collected 80 reflective and 40 transmissive. The data were only analyzed for glucose because this analyte is easily measured with home glucose testing instruments and reagents. In general, the results confirm the feasibility of noninvasive NIR blood analysis.
- Medicine and Medical Research