Clinical Evaluation of a Novel On-Strip Calibration Method for Blood Glucose Measurement

Background:This study evaluated a novel technology for improving accuracy of self-monitoring of blood glucose (SMBG). The technology calibrates each and every test by measuring the response from a predetermined amount of glucose present in the sample chamber of each test strip.Method: SMBG test strips were modified to include a lid coated with a fast dissolving formulation containing glucose. These test strips were characterized for hematocrit (Hct) and temperature induced error response to develop a calibration algorithm. The modified test strips were used in a clinical evaluation involving fingerstick blood samples from 160 subjects.Results:Experiments involving Hct and temperature induced errors show that the technology generates a signal characteristic of the error conditions in any particular test, but independent of glucose concentration, allowing a correction algorithm to be derived. The approach substantially reduced Hct and temperature derived errors. Clinical evaluation using fingerstick blood d...