Abstract
Objectives
The accuracy of point-of-care blood glucometers in the detection and evaluation of neonatal hypoglycemia is a concern. This study compared the performance of three i-SENS glucometers with that of the YSI 2300 STAT Plus Analyzer, which was used as a reference.
Methods
The leftover neonatal capillary blood samples of 319 patients were used in this study. The evaluation process and accuracy performance criteria were based on the International Organization for Standardization 15197:2013 guidelines. The evaluation involved three i-SENS glucometers (BAROzen H Expert plus, CareSens PRO, and CareSens H Beat) and the ACCU-CHEK® Inform II glucometer.
Results
The accuracy evaluation yielded acceptable results as follows: a) 100 and 100% for BAROzen H Expert plus; 99.8 and 100% for CareSens PRO; 98.7%, and 97.2% for CareSens H Beat glucometers were within the range of ±0.8 mmol/L (15 mg/dL) and ±15% of the average reference values at glucose concentrations <5.55 mmol/L (100 mg/dL) and ≥5.55 mmol/L (100 mg/dL), respectively, and b) all estimated glucose values (100%) were within the zones A and B of Consensus Error Grid for all three i-SENS glucometers. There was good correlation between the glucose values estimated by the glucometers and the reference values (R>0.990).
Conclusions
This study demonstrated that i-SENS glucometers exhibit acceptable performance and can be used as effective point-of-care devices in neonates.
Funding source: Korean Health Technology R&D Project
Funding source: Ministry of Health & Welfare, Republic of Korea
Award Identifier / Grant number: H15C1512
Funding source: i-SENS, Inc.
Funding source: Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea
Award Identifier / Grant number: HR20C0021
Acknowledgments
We would like to thank Editage (www.editage.co.kr) for the English language editing and also i-SENS, Inc., for providing reagents with technical support.
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Research funding: This study was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grant number: HR20C0021) and the Korean Health Technology R&D Project, Ministry of Health & Welfare, Republic of Korea (H15C1512) and i-SENS, Inc.
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Author contributions: HK and SY reviewed the literature and conceived the study. SY was involved in protocol development, obtaining ethical approval, patient recruitment and data analysis. HK wrote the first draft of the manuscript. All authors reviewed and edited the manuscript and approved the final version of the manuscript.
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Competing interests: Authors state no conflict of interest.
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Informed consent: Informed consent was obtained from all individuals included in this study.
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Ethical approval: The research related to human use has been complied with all the relevant national regulations, institutional policies and in accordance the tenets of the Helsinki Declaration, and has been approved by Institutional Review Board of Korea University Guro Hospital (IRB No: 2019GR0016).
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