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- Title
Multicenter evaluation of the Glucometer Elite XL meter, an instrument specifically designed for use with neonates.
- Authors
Girouard, Joel; Forest, Jean-Claude; Masse, Jacques; Leroux, Michael; Bradburn, Niceta C.; Noblet, Thomas C.; Joynes, Judy Ostrom; Baum, John; Girouard, J; Forest, J C; Massé, J; Leroux, M; Bradburn, N C; Noblet, T C; Joynes, J O; Baum, J
- Abstract
<bold>Objective: </bold>To evaluate the clinical performance of the Glucometer Elite XL Diabetes Care System in neonatal settings using a multicenter study<bold>Research Design and Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>The Glucometer Elite XL system showed a good performance when used in neonatal settings.
- Subjects
MEDICAL equipment; BLOOD sugar monitoring; DIABETES
- Publication
Diabetes Care, 2000, Vol 23, Issue 8, p1149
- ISSN
0149-5992
- Publication type
journal article
- DOI
10.2337/diacare.23.8.1149