title: Evaluation of Blood Glucose Monitoring System in Screening for Neonatal Hypoglycemia: Tighter Accuracy Standard.
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.
authors.affiliation: 1 Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan.|2 School of Medical Laboratory Science and Biotechnology, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan.
authors.forename: Mei-Fen
authors.initials: MF
authors.lastname: Tsao
authors.affiliation: 1 Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan.|2 School of Medical Laboratory Science and Biotechnology, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan.
authors.forename: Hui-Wen
authors.initials: HW
authors.lastname: Chang
authors.affiliation: 1 Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan.|2 School of Medical Laboratory Science and Biotechnology, College of Medical Science and Technology, Taipei Medical University, Taipei, Taiwan.
authors.forename: Chien-Hsi
authors.initials: CH
authors.lastname: Chang
authors.affiliation: 1 Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan.
authors.forename: Chi-Hsuan
authors.initials: CH
authors.lastname: Cheng
authors.affiliation: 1 Department of Laboratory Medicine, Taipei Medical University Hospital, Taipei, Taiwan.|3 Department of Pediatrics, School of Medicine, College of Medicine, Taipei Medical University, Taipei, Taiwan.
authors.forename: Hsiu-Chen
authors.initials: HC
authors.lastname: Lin
mesh_terms: D001786:Blood Glucose / Q000032:analysis*; D006801:Humans; D007003:Hypoglycemia / Q000097:blood* / Q000175:diagnosis*; D007231:Infant, Newborn; D015997:Neonatal Screening / Q000295:instrumentation*
chemical_list: D001786:Blood Glucose
keywords: accuracy; blood glucose monitoring system; hematocrit; hypoglycemia; neonate