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.