Assessment of the performance of blood glucose monitoring systems for monitoring dysglycaemia in neonatal patients

Abstract

ObjectiveTo 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.MethodThe 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.ResultsThe 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.ConclusionsThis 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.

Impact of High-Dose Intravenous Vitamin C for Treatment of Sepsis on Point-of-Care Blood Glucose Readings

“…There has also been recent evidence published that the POC BGM employed by our institution and used in this study (Accu-Chek® Inform II) showed analytical interference with ascorbic acid, lactose, galactose, N -acetylcysteine and glutathione in neonatal patients. 40 Further studies should be conducted with both this BGM and others to assess interference of ascorbic acid as well as other chemicals on blood glucose accuracy. Additionally, this study was a retrospective case series; thus, all data collected were highly dependent on the accuracy of documentation.…”

Differences in the system accuracy acceptability of four types of blood glucose monitoring systems against five different standards

“…Previous studies have shown that better clinical outcomes are associated with improved glycemic control [16][17][18]. However, there is increasing concern about the accuracy and reliability of glucose meters [1,13,19]. A feasible method to assess the system accuracy of glucose meters is to compare the glucose measurement values obtained from the BGMS with the reference glucose values from the biochemical analyzer of the central laboratory.…”

Nurse workload, missed nursing care, and the contributing factors in the Neonatal Intensive Care Unit in a limited resource setting: A case from Indonesia

“…37 An extreme level of low blood glucose can cause several life-threatening conditions in neonates, such as apnea, irritability, lethargy, seizures, and even brain damage. 38 Failure to do bedside glucose monitoring as ordered can result in a dangerous situation to the neonates and hence, it is really important to increase the awareness of the consequences of omission 39 and to provide better bedside glucose monitoring devices 40,41 to reduce the morbidity caused by missed nursing care. Conversely, the top three least frequent missed nursing care could be related to the fact that they are too obvious to be missed and are routinely audited by the nursing units.…”