title: Clinical impact of improved point-of-care glucose monitoring in neonatal intensive care using Nova StatStrip: Evidence for improved accuracy, better sensitivity, and reduced test utilization.
abstract: OBJECTIVE
  Studies have demonstrated improved analytical performance of the Nova StatStrip glucose meter, but limited data is available on its clinical performance in critically ill neonates in the neonatal intensive care unit (NICU).
  
  
  METHODS
  A retrospective charge review was conducted on 651 neonates admitted to the NICU over 2 years. Demographics, sample collection information, and clinical details were recorded. Glucose measurements were performed at the bedside using either the Nova StraStrip or LifeScan SureStep Flexx meters as well as corresponding measurements of laboratory venous plasma glucose. Performance was analyzed by receiver operator characteristic (ROC) curves for detecting hypoglycemia and critical glucose levels.
  
  
  RESULTS
  Linear regression analysis comparing StatStrip and laboratory venous plasma glucose samples demonstrated significantly tighter agreement (r(2)=0.7994) and accuracy (mean bias=0.13mmol/L) than SureStep (r(2)=0.6845 and mean bias=0.53mmol/L). StatStrip also showed improved sensitivity for detecting critical low glucose values ≤3.0mmol/L (80.9 vs 68.9%, p<0.05). ROC curve analysis further demonstrated excellent performance of StatStrip at this cutoff with an AUC of 0.98. Overall, neonates were also tested significantly less frequently with the StatStrip meter by 24% compared to SureStep.
  
  
  CONCLUSIONS
  Implementation of StatStrip led to better agreement with venous plasma glucose, improved detection of critical low glucose results, and more efficient test utilization. This study demonstrates the importance of accurate and sensitive glucose monitoring in the NICU.
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Joshua E
authors.initials: JE
authors.lastname: Raizman
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Shea
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Caitlin H
authors.initials: CH
authors.lastname: Daly
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Kimiya
authors.initials: K
authors.lastname: Karbasy
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Petra
authors.initials: P
authors.lastname: Ariadne
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Yunqi
authors.initials: Y
authors.lastname: Chen
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Tina
authors.initials: T
authors.lastname: Henderson
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Sarah
authors.initials: S
authors.lastname: Redmond
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Sarah
authors.initials: S
authors.lastname: Silverman
authors.affiliation: Division of Neonatology, Department of Pediatrics, The Hospital for Sick Children, Toronto, Ontario, Canada.
authors.forename: Aideen M
authors.initials: AM
authors.lastname: Moore
authors.affiliation: Clinical Biochemistry and Neonatology Divisions, Division of Clinical Biochemistry, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. Electronic address: khosrow.adeli@sickkids.ca.
authors.forename: Khosrow
authors.initials: K
authors.lastname: Adeli
mesh_terms: D015415:Biomarkers / Q000097:blood*; D001786:Blood Glucose / Q000032:analysis*; D005260:Female; D005500:Follow-Up Studies; D006403:Hematologic Tests; D006801:Humans; D006943:Hyperglycemia / Q000097:blood / Q000175:diagnosis*; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis*; D007231:Infant, Newborn; D015931:Intensive Care, Neonatal / Q000592:standards*; D016014:Linear Models; D008297:Male; D008991:Monitoring, Physiologic / Q000295:instrumentation; D019095:Point-of-Care Systems / Q000592:standards*; D017410:Practice Guidelines as Topic; D011379:Prognosis; D012372:ROC Curve; D011934:Reagent Strips; D015203:Reproducibility of Results; D012189:Retrospective Studies
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D011934:Reagent Strips
keywords: Critical results; Hypoglycemia; NICU; Nova StatStrip; Point-of-care testing