Article Text
Abstract
Objective To validate a three-step protocol that assesses the clinical risk associated with using blood glucose monitoring systems (BGMS) in neonates for the management of dysglycaemia.
Method The three-step validation approach included confirmation of the accuracy of the reference method using National Institute of Standards and Technology (NIST) glucose standards, assessment of analytical risk performed on whole blood collected from paediatric patients routinely tested for glucose and a clinical risk assessment performed using heel stick capillary samples collected from 147 new-born babies and neonates admitted to intensive care. BGMS glucose measurements were compared with the NIST aligned laboratory reference method.
Results The accuracy of the laboratory reference method was confirmed with the NIST standards. Specificity studies demonstrated that the accuracy of one of the BGMS was affected, particularly, in the hypoglycaemic range, by known interference factors including haematocrit, ascorbic acid, lactose, galactose, N-acetylcysteine and glutathione. The accuracy of the other BGMS was unaffected. The clinical performance of this BGMS in neonates met the system accuracy criteria of Clinical and Laboratory Standards Institute (CLSI) POCT 12-A3 standard for evaluating hospital BGMS with 95.1% of glucose measurements within±0.67 mmol/L for samples ≤5.55 mmol/L and 95.6% within±12.5% for samples>5.55 mmol/L.
Conclusions This three-step validation protocol provides a challenging approach for determining the accuracy and reliability of BGMS for managing dysglycaemia in neonates. StatStrip BGMS achieved analytical and clinical performance criteria confirming its suitability for use in neonates. We advocate that this validation approach should be considered for performance evaluations of both BGMS and continuous glucose monitoring systems going forward.
- blood glucose monitoring
- neonates
- isotope dilution Liquid Chromatography Mass Spectrometry
- dysglycaemia
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Footnotes
YB and JX contributed equally.
Contributors CC was the lead investigator of the study devising the design of the study protocol and undertaking data collection and analysis, data interpretation, literature searches, preparation editing and submission of the manuscript. All authors contributed to the overall conception and final design of the study and to the interpretation of results and drafting of the manuscript. All authors read and approved the final manuscript. CC affirms that the manuscript is an honest, accurate and transparent account of the study being reported.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent Parental/guardian consent obtained.
Ethics approval Approved by the Ethics Committee of Children’s Hospital of Fudan University.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Supplemental data available.