It is proposed to develop two tests as improvements on and replacement for the currently used, time averaged glycohemoglobin test. The improvements deal with resolving the retrospective report into time segments to give more information regarding periods (episodes) of hypoglycemia, hyperglycemia and normal periods, all of which are now averaged into one batch hemolysate. The two tests differ in complexity and in their actual time resolution. The concept of time series analysis form a single sample is proprietary to Chronomed, Inc. The technology is applicable to markets well beyond diabetes, including diagnostics and monitoring devioces in fields of hematology, alcoholism, drug therapy compliance and measurement of control in other metabolic diseases (e.g. galactosemia). Long term objectives are to bring products to market exploiting the Time Series Analysis concept, both for diabetes and other fields. The specific goal of this Phase I project is to complete the design of feasibility models of both high and low resolution methods and to provide a preliminary demonstration of improved clinical test results with their use. Density gradient and fluorescence cytometry methods will be used. Simplification of procedures for actual clinical use is part of the task.
