Comparative study of i-SENS glucometers in neonates using capillary blood samples

Ha Nui Kim, Soo Young Yoon

Research output: Contribution to journalArticlepeer-review

2 Citations (Scopus)


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.

Original languageEnglish
Pages (from-to)1133-1141
Number of pages9
JournalClinical Chemistry and Laboratory Medicine
Issue number6
Publication statusPublished - 2021 May 1

Bibliographical note

Funding Information:
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.

Publisher Copyright:
© 2021 De Gruyter. All rights reserved.


  • Capillary blood glucose levels
  • Hypoglycemia
  • I-sens glucometers
  • Neonatal care
  • Neonates
  • Point-of care blood glucometers

ASJC Scopus subject areas

  • Clinical Biochemistry
  • Biochemistry, medical


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