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Comparison of Four Point-of-Care Glucometers for Neonatal Glucose Testing-A Diagnostic Study
Avinash Sundar1, Arnepalli Navya2, Usha Devi3
1Department of Pediatrics, Chettinad Hospital and Research Institute, Kelambakkam, Tamil Nadu, India.
Clinical Therapeutics
|July 23, 2026
Summary
Four newer glucometers showed good precision for neonatal glucose monitoring, meeting International Organization for Standardization (ISO) standards, especially for lower glucose levels. However, none met United Nations Children
Area of Science:
- Neonatal Medicine
- Clinical Diagnostics
- Biomedical Engineering
Background:
- Point-of-care (POC) glucometers, originally designed for adults, face challenges in neonatal glucose monitoring due to factors like high hematocrit and oxygen therapy.
- Newer glucometer generations aim to minimize errors, but their diagnostic performance in neonates requires thorough evaluation against established standards.
Purpose of the Study:
- To assess the accuracy and precision of four newer-generation glucometers for neonatal glucose screening.
- To evaluate the influence of neonatal-specific factors (hematocrit, oxygen therapy) on glucometer measurement accuracy.
- To compare glucometer performance against International Organization for Standardization (ISO) 15197:2013, CLSI POCT12-A3, and United Nations Children's Fund (UNICEF) standards.
Main Methods:
- A prospective diagnostic accuracy study involving 199 neonates requiring glucose monitoring.
- Comparison of four glucometers (Contour Plus, Accu-Chek Instant, OneTouch Select Plus, FreeStyle Optium Neo) against laboratory plasma glucose estimation.
- Assessment of agreement using Bland-Altman plots and evaluation against ISO, CLSI, and UNICEF criteria.
Main Results:
- All tested glucometers demonstrated good precision for neonatal glucose measurement, particularly for values below 100 mg/dL, meeting ISO 15197:2013 criteria.
- Accu-Chek Instant and Contour Plus also met CLSI standards for glucose values below 100 mg/dL.
- None of the glucometers met the stricter UNICEF performance benchmarks; hematocrit and oxygen therapy showed negligible impact on measurement accuracy.
Conclusions:
- Newer-generation glucometers show acceptable performance for neonatal glucose screening, aligning with ISO standards, especially for lower glucose concentrations.
- Current glucometers do not meet the stringent UNICEF performance benchmarks for neonatal use.
- There is a need for neonatal-specific validation standards for point-of-care glucose monitoring devices to ensure optimal accuracy in this vulnerable population.
