Evaluation of Blood Glucose Monitoring System in Screening for Neonatal Hypoglycemia: Tighter Accuracy Standard

J Diabetes Sci Technol. 2017 May;11(3):639-640. doi: 10.1177/1932296816668878. Epub 2016 Sep 14.

Abstract

Neonatal hypoglycemia may cause severe neurological damages; therefore, tight glycemic control is crucial to identify neonate at risk. Previous blood glucose monitoring system (BGMS) failed to perform well in neonates; there are calls for the tightening of accuracy requirements. It remains a need for accurate BGMS for effective bedside diabetes management in neonatal care within a hospital population. A total of 300 neonates were recruited from local hospitals. Accuracy performance of a commercially available BGMS was evaluated against reference instrument in screening for neonatal hypoglycemia, and assessment was made based on the ISO15197:2013 and a tighter standard. At blood glucose level < 47 mg/dl, BGMS assessed met the minimal accuracy requirement of ISO 15197:2013 and tighter standard at 100% and 97.2%, respectively.

Keywords: accuracy; blood glucose monitoring system; hematocrit; hypoglycemia; neonate.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Letter

MeSH terms

  • Blood Glucose / analysis*
  • Humans
  • Hypoglycemia / blood*
  • Hypoglycemia / diagnosis*
  • Infant, Newborn
  • Neonatal Screening / instrumentation*

Substances

  • Blood Glucose