Clinical utility of point of care glucose in the assessment of
gestational diabetes: Prospective cohort study.
Abstract
Objective: To assess the clinical utility of point of care (POC)
capillary blood glucose (CBG) in the assessment of gestational diabetes
(GDM) during oral glucose tolerance test (OGTT). Design: Prospective
cohort study. Setting: Antenatal clinics at King’s Collage Hospital.
Population: Women screening for GDM between March and June 2020.
Methods: CBG was measured using POC-StatStrip® (Nova) and venous plasma
glucose (VPG) was measured by Roche (Cobas 8000 c702) analyser. GDM was
diagnosed based on NICE-2015 criteria. The two methods were compared
statistically using Analyse-It (v 5.40.2) Main outcome measures:
Diagnostic sensitivity, specificity, positive and negative predictive
values (PPV and NPV) for POC-StatStrip® compared to reference laboratory
method. Results: 230 women were included. The number and the percentage
of women with glucose concentration above the GDM thresholds using
POC-StatStrip® vs. Lab-VPG measurement was 15 (6.5%) vs. 8 (3.4%) at
fasting and 105 (45%.6) vs. 72 (31.1%) at 2-hour respectively.
Sensitivity and specificity for POC-StatStrip® were 88% and 97% at
fasting and 97% and 79% at 2-hour respectively. However, the
specificity and the NPV for POC-StatStrip® concentrations ≤5.0 mmol/L at
fasting or <7.5mmol/L at 2-hour were 100% and the sensitivity
and the PPV for concentration >9.5mmol/L at 2-hour was 100
%. Conclusion: In our cohort POC-CBG measurement cannot entirely
replace laboratory method in OGTT, however, it can be used to rule
out/rule in GDM when the glucose concentrations are ≤5.0mmol/L at
fasting or <7.5/>9.5mmol/L at 2-hour. Funding:
not applicable. Key Words: Gestational Diabetes Mellitus (GDM), point of
care (POC).