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Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study
INTRODUCTION: There is a need for continuous glucose monitoring in critically ill patients. The objective of this trial was to determine the point accuracy and reliability of a device designed for continuous monitoring of interstitial glucose levels in intensive care unit patients. METHODS: We evalu...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4382831/ https://www.ncbi.nlm.nih.gov/pubmed/25652770 http://dx.doi.org/10.1186/s13054-015-0757-4 |
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author | van Hooijdonk, Roosmarijn TM Leopold, Jan Hendrik Winters, Tineke Binnekade, Jan M Juffermans, Nicole P Horn, Janneke Fischer, Johan C van Dongen-Lases, Edmée C Schultz, Marcus J |
author_facet | van Hooijdonk, Roosmarijn TM Leopold, Jan Hendrik Winters, Tineke Binnekade, Jan M Juffermans, Nicole P Horn, Janneke Fischer, Johan C van Dongen-Lases, Edmée C Schultz, Marcus J |
author_sort | van Hooijdonk, Roosmarijn TM |
collection | PubMed |
description | INTRODUCTION: There is a need for continuous glucose monitoring in critically ill patients. The objective of this trial was to determine the point accuracy and reliability of a device designed for continuous monitoring of interstitial glucose levels in intensive care unit patients. METHODS: We evaluated point accuracy by comparing device readings with glucose measurements in arterial blood by using blood gas analyzers. Analytical and clinical accuracy was expressed in Bland-Altman plots, glucose prediction errors, and Clarke error grids. We used a linear mixed model to determine which factors affect the point accuracy. In addition, we determined the reliability, including duration of device start-up and calibration, skips in data acquisition, and premature disconnections of sensors. RESULTS: We included 50 patients in whom we used 105 sensors. Five patients from whom we could not collect the predefined minimum number of four consecutive comparative blood draws were excluded from the point accuracy analysis. Therefore, we had 929 comparative samples from 100 sensors in 45 patients (11 (7 to 28) samples per patient) during 4,639 hours (46 (27 to 134) hours per patient and 46 (21 to 69) hours per sensor) for the accuracy analysis. Point accuracy did not meet the International Organization for Standardization (ISO) 14971 standard for insulin dosing accuracy but did improve with increasing numbers of calibrations and was better in patients who did not have a history of diabetes. Out of 105 sensors, 60 were removed prematurely for a variety of reasons. The device start-up time was 49 (43 to 58) minutes. The number of skips in data acquisition was low, resulting in availability of real-time data during 95% (89% to 98%) of the connection time per sensor. CONCLUSIONS: The point accuracy of a device designed for continuous real-time monitoring of interstitial glucose levels was relatively low in critically ill patients. The device had few downtimes, but one third of the sensors were removed prematurely because of unresolved sensor- or device-related problems. TRIAL REGISTRATION: Netherlands Trial Registry number: NTR3827. Registered 30 January 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-015-0757-4) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4382831 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-43828312015-04-03 Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study van Hooijdonk, Roosmarijn TM Leopold, Jan Hendrik Winters, Tineke Binnekade, Jan M Juffermans, Nicole P Horn, Janneke Fischer, Johan C van Dongen-Lases, Edmée C Schultz, Marcus J Crit Care Research INTRODUCTION: There is a need for continuous glucose monitoring in critically ill patients. The objective of this trial was to determine the point accuracy and reliability of a device designed for continuous monitoring of interstitial glucose levels in intensive care unit patients. METHODS: We evaluated point accuracy by comparing device readings with glucose measurements in arterial blood by using blood gas analyzers. Analytical and clinical accuracy was expressed in Bland-Altman plots, glucose prediction errors, and Clarke error grids. We used a linear mixed model to determine which factors affect the point accuracy. In addition, we determined the reliability, including duration of device start-up and calibration, skips in data acquisition, and premature disconnections of sensors. RESULTS: We included 50 patients in whom we used 105 sensors. Five patients from whom we could not collect the predefined minimum number of four consecutive comparative blood draws were excluded from the point accuracy analysis. Therefore, we had 929 comparative samples from 100 sensors in 45 patients (11 (7 to 28) samples per patient) during 4,639 hours (46 (27 to 134) hours per patient and 46 (21 to 69) hours per sensor) for the accuracy analysis. Point accuracy did not meet the International Organization for Standardization (ISO) 14971 standard for insulin dosing accuracy but did improve with increasing numbers of calibrations and was better in patients who did not have a history of diabetes. Out of 105 sensors, 60 were removed prematurely for a variety of reasons. The device start-up time was 49 (43 to 58) minutes. The number of skips in data acquisition was low, resulting in availability of real-time data during 95% (89% to 98%) of the connection time per sensor. CONCLUSIONS: The point accuracy of a device designed for continuous real-time monitoring of interstitial glucose levels was relatively low in critically ill patients. The device had few downtimes, but one third of the sensors were removed prematurely because of unresolved sensor- or device-related problems. TRIAL REGISTRATION: Netherlands Trial Registry number: NTR3827. Registered 30 January 2013. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s13054-015-0757-4) contains supplementary material, which is available to authorized users. BioMed Central 2015-02-05 2015 /pmc/articles/PMC4382831/ /pubmed/25652770 http://dx.doi.org/10.1186/s13054-015-0757-4 Text en © van Hooijdonk et al.; licensee BioMed Central. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research van Hooijdonk, Roosmarijn TM Leopold, Jan Hendrik Winters, Tineke Binnekade, Jan M Juffermans, Nicole P Horn, Janneke Fischer, Johan C van Dongen-Lases, Edmée C Schultz, Marcus J Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study |
title | Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study |
title_full | Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study |
title_fullStr | Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study |
title_full_unstemmed | Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study |
title_short | Point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study |
title_sort | point accuracy and reliability of an interstitial continuous glucose-monitoring device in critically ill patients: a prospective study |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4382831/ https://www.ncbi.nlm.nih.gov/pubmed/25652770 http://dx.doi.org/10.1186/s13054-015-0757-4 |
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