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Use of Glucose Meters for Critically Ill Patients, 1st Edition

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CLSI POCT17

Use of Glucose Meters for Critically Ill Patients, 1st Edition

This free white paper includes an overview of glucose meter limitations with practical advice for use of glucose meters in critically ill patients. 

This reaffirmed document has been reviewed and confirmed as suitable to remain published without revision to content, as of September 2023. The document’s next scheduled review is generally five years after the reaffirmation date.

This document is available in electronic format only.

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Details

Chairholder: James H. Nichols, PhD, DABCC, FACB

Date of Publication: March 29, 2016

Order Code PDF: CLSI POCT17Ed1E
ISBN Number: 1-56238-929-7

Order Code Print: print not available

Edition: First

Pages: 20

CLSI POCT17 Abstract

Glucose meters, used for self-monitoring and in a myriad of healthcare settings, provide for frequent and rapid measurement of glucose levels using a capillary fingerstick blood sample. However, due to their limitations, self-monitoring glucose meters based on strip technology were never intended for use in acute care settings. Hematocrit, oxygen therapy, drugs, and metabolites can falsely increase or decrease glucose test results in hospitalized patients. Problems observed during the use of glucose meters in critically ill patients has raised awareness of their safety for professional use in hospitalized patients. Hospital laboratories should note the limitations of their glucose meter methodology and recognize conditions for intended and off-label use of the test system. Originally, all glucose meters were cleared as over-the-counter (OTC) products. By definition, the OTC labeling made these devices waived for use in hospitals based on the Clinical Laboratory Improvement Amendments of 1988 (CLIA). In the United States, off-label use of glucose meters changes the meter classification from CLIA-waived to CLIA high complexity. This shift to high complexity classification may limit the staff who can perform testing and necessitates additional resources to meet CLIA compliance. These consequences must be considered for glucose meter testing in the critically ill and for other patient conditions for which the manufacturer may not have thoroughly evaluated the analytical performance of a meter in all patient care settings.

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