Introduction
Gestational Diabetes (GDM) is a significant complication during pregnancy. It is associated with an increased risk of adverse outcomes including preeclampsia; macrosomia growth; caesarean section birth; shoulder dystocia and neonatal hypoglycaemia.(1) GDM is also a predictor for later development of type 2 diabetes mellitus (T2DM) in the mother.(2) The risk of adverse pregnancy outcomes can be reduced by treatment directed at reducing blood glucose concentrations.(3, 4)
The proportion of pregnancies affected by GDM vary according to the diagnostic criteria and the demographic characteristics of the studied population.(5) The International Association of the Diabetes and Pregnancy Study Groups (IADPSG) Consensus Panel’s assessment of the Hyperglycaemia and Adverse Pregnancy Outcome (HAPO) Study reported prevalence of 17.8%.(6) This is expected to further increase with the rise of obesity and increasing number of pregnancies at older maternal age.(7)
It is widely accepted that healthcare organisations should screen for GDM, since it is an asymptomatic condition in which appropriate interventions can improve pregnancy outcomes. However, there is disagreement on both the screening approach and the diagnostic cut-offs.(7) NICE recommend screening by assessing the risk factors, with higher risk women being offered 75g 2-hour OGTT with VPG measured at fasting and 2-hours.(8)
POC uses whole blood, rather than plasma for analysis of glucose concentrations. VPG measured by reference laboratory methods are 10 to 15 % higher than that of whole blood, due to the difference in the water content between red blood cells in comparison to plasma.(9) To avoid clinical misinterpretations, POC devices report glucose as plasma equivalent, rather than whole blood, by multiplying the measured concentration by a conversion factor to adjust for the haematocrit.(9)
POC is an effective tool in aiding management of glycaemic control diabetes. However, despite offering advantages over laboratory testing including: rapid turnaround time and lower cost, POC devices are not routinely recommended for screening/diagnosis of GDM due to insufficient accuracy and precision.(10, 11)
The Nova StatStrip® Glucose Hospital Meter (Nova Biomedical) is approved by the food and drug administration (FDA) for glucose monitoring in hospital/healthcare settings, including in those critically unwell,(12) and it is also acceptable for the diagnosis of T2DM.(13) Nova StatStrip® directly measures the haematocrit and uses a corrective algorithm for reporting glucose concentrations resulting in minimal interference from haematocrit between 20 to 70%, across a wide analytical range of glucose (3-33mmol/L).(14)
Our study objective was to assess the clinical utility of POC-StatStrip® meter in screening for GDM.