Capillary glucose concentration during oral glucose tolerance test for the diagnosis of gestational diabetes

Abstract

Objective To assess concordance between two point‐of‐care testing (POCT) devices and the standard laboratory method in screening for gestational diabetes mellitus (GDM) in Huesca. Methods Pregnant women who met criteria for an oral glucose tolerance test (OGTT) and attended the laboratory between October 2017 and November 2018 were recruited in this prospective observational study. Glucose was measured in venous (laboratory) and capillary blood (Accu‐Chek or Contour Next glucometers). GDM was diagnosed attending to NDDG criteria for venous samples or capillary‐specific cut‐off. Linear regression, Passing–Bablok, Bland–Altman, and the kappa coefficient were used to study concordance between POCT and laboratory method. Results Data from 109 women were analyzed (57 for Accu‐Chek, 52 for Contour Next). Statistical analyses showed good agreement between both POCT and laboratory method. There were no statistical differences in fasting glucose measurements between capillary and venous samples and both POCT devices meet the ISO 15197 standard. Accu‐Chek showed good agreement (k=0.629) regarding the laboratory method in classifying GDM, with an acceptable inter‐evaluator bias of 3.5% (P<0.001). Conclusion POCT can be used to obtain fasting values and reduce overall waiting times for patients. Additionally, Accu‐Chek can be used to diagnose GDM in remote areas applying specific cut‐off values.

Clinical utility of point of care glucose in the assessment of gestational diabetes: Prospective cohort study.

“…(20)(21)(22) So the discrepancy in diagnostic performance might be partly attributed to the negative bias with lab methods rather than positive bias with POC. Generally, studies that compared POC without strict measures to control in-vitro glycolysis, like our study, have reported positive analytical bias, (23,24) high sensitivity and NPV (25)(26)(27)(28)(29) for POC with potential for over-diagnosis. While some studies that religiously applied NACB guidelines have reported negative analytical bias and potential for misdiagnosis.…”

“…In total 230 pregnant women were included. The age and gestation were 34 (30-37) years and 28 (20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35) weeks respectively. Our hospital serves a large ethnically diverse catchment area.…”

Comparison of Venous and Capillary Sampling in Oral Glucose Testing for the Diagnosis of Gestational Diabetes Mellitus: A Diagnostic Accuracy Cross-Sectional Study Using Accu-Chek Inform II

“…A recent Swedish study supported continuous use of POCT with the Hemocue device in GDM diagnostics [26]. Another recent study suggested that POCT using Accu-Chek can be used to obtain fasting values and to reduce overall waiting times for patients [27].…”

Association between Gestational Diabetes and Proinflammatory Cytokine(IL-1β)

“…14 It was consider the "gold standard" in the diagnosis of GDM. 15 The thresholds Cont... Some authors do not find statistically marked differences throughout the whole period of pregnancy 25 , other authors find decreases 26,27 , and still others find increases in the third trimester.…”