Transcutaneous Analyte Measuring Methods
Abstract
The major objective of this quarter was to complete all patient data collection at Froedtert Lutheran Memorial Hospital (Medical College of Wisconsin), finalize all TAMM algorithms, integrate the new diagnostic software into the NIR-800 Array Analyzer and deliver the instrument to the Naval Health Research Center (NHRC) in San Diego, California. All of the above work activities were completed, and the NIR-800 was shipped to NHRC on March 9, 1993. Prior to shipment, test set runs on all 9 of the analytes were completed with the results shown in Table 1. All of the electrolytes recorded average errors of less than 6% of mean value with all except bicarbonate less than 4%. The reliable operating range of the system for each analyte is also indicated in Table 1. This limited range results from the lack of sufficient extreme values for all analytes except glucose. Even glucose by these standards is marginal because only a few values over 150 mg/dl were obtained during preclinical testing. Extension of this range to include abnormal values for each analyte will require additional data collection in an Intensive Care Unit (ICU) where extreme analyte concentration values are common. Data on 531 patients have been collected of which 514 were acceptable. Best results were obtained using the final 73 patients for whom data collection instrumentation and procedures were optimized. Project emphasis for the next quarter and the remainder of the Phase 11 contract ending in August of 1993 is on the development and delivery of the field instrument. A description of the preliminary field instrument design is included in this report.
Document Details
- Document Type
- Technical Report
- Publication Date
- Apr 02, 1993
- Accession Number
- ADA262861
Entities
People
- Kenneth J. Schlager