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Diabetes Care. 2000 Aug;23(8):1149-53.

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

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  • 1Centre Hospitalier Universitaire de Québec, Hospital St. François d'Assise, Laval University, Québec City, Canada.

Abstract

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 neonates were included in the study. A capillary or arterial sample was analyzed for determination of glucose with the Glucometer Elite XL system by an attending trained nurse. Through the same sampling site, a specimen was collected and sent to the laboratory for measurement of plasma glucose, bilirubin, and hematocrit.

RESULTS:

The regression analysis between the results of the Glucometer Elite 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 plot indicated a mean bias of 0.04 mmol/l (95% CI -0.01 to 0.10). No relationship was found between meter glucose biases and hematocrit levels (r = 0.10, P = 0.14). Although a statistically significant correlation existed between 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.

PMID:
10937513
[PubMed - indexed for MEDLINE]
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