Multicenter evaluation of the Glucometer Elite XL Meter, an instrument specifically designed for use with neonates

OBJECTIVE - To evaluate the clinical performance of the Glucometer Elite XL Diabetes Care System in neonatal settings using a multicenter study. RESEARCH DESIGN AND METHODS - A total of 388 blood specimens from 333 neona tes were included in the study. A capillary or arterial sample was analyzed for determination of glucose with the Glucometer Elite XL system by an att ending trained nurse. Through the same sampling site, a specimen was collec ted and sent to the laboratory for measurement of plasma glucose, bilirubin , and hematocrit. RESULTS - The regression analysis between the results of the Glucometer Eli te XL system and comparative methods resulted in the following. Glucometer Elite XL meter = 1.01 X laboratory method + 0.02 mmol/l (n = 388). For the 1.1-4.0 mmol/l plasma glucose range, the regression was Glucometer Elite XL meter = 1.07 X laboratory method + 0.12 mmol/l (n = 150). A difference plo t indicated a mean bias of 0.04 mmol/l (95% CI -0.01 to 0.10). No relations hip was found between meter glucose biases and hematocrit levels (r = 0.10, P = 0.14). Although a statistically significant correlation existed betwee n bilirubin levels and the glucose meter biases (r = 0.14, P = 0.005), the predicted mean biases were of little clinical significance. CONCLUSIONS - The Glucometer Elite XL system showed a good performance when used in neonatal settings.