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

OBJECTIVE: To assess the clinical utility of point-of-care (POC) capillary blood glucose (CBG) testing in the assessment of gestational diabetes mellitus (GDM) during oral glucose tolerance test (OGTT). DESIGN: Prospective cohort study. SETTING: Antenatal clinics at King's College Hospital. POPULATION: Women screened for GDM between March and June 2020. METHODS: The CBG was measured using the POC StatStrip® test and the venous plasma glucose (VPG) was measured by Roche analyser (Cobas 8000 c702). GDM was diagnosed based on the 2015 National Institute for Health and Clinical Excellence (NICE) Clinical Guideline criteria. The two methods were compared statistically using Analyse-It 5.40.2. MAIN OUTCOME MEASURES: Diagnostic sensitivity, specificity, positive and negative predictive values (PPV and NPV) for the POC StatStrip® test, compared with VPG measured by reference laboratory method. RESULTS: A total of 230 women were included. The number and percentage of women with glucose concentrations above the GDM threshold using the POC StatStrip® test versus laboratory VPG measurement was 15 (6.5%) versus eight (3.4%) at fasting and 105 (45.6%) versus 72 (31.1%) at 2 h, respectively. The sensitivity and specificity values (and 95% CIs) for the POC StatStrip® test were 88% (52%-99%) and 97% (93%-98%) at fasting and 97% (91%-99%) and 79% (71%-84%) at 2 h, respectively. However, the specificity and the NPV for the POC StatStrip® test for concentrations of ≤5.0 mmol/L at fasting or <7.5 mmol/L at 2 h were 100%, and the sensitivity and the PPV for concentrations of >9.5 mmol/L at 2 h were 100%. CONCLUSIONS: In our cohort the POC measurement of CBG cannot entirely replace the laboratory method for the OGTT; however, it can be used to rule out/rule in GDM for glucose concentrations of ≤5.0 mmol/L at fasting or <7.5/>9.5 mmol/L at 2 h.

Accuracy of capillary blood glucose for 50-g glucose challenge test for gestational diabetes screening.

Purpose: To assess the accuracy of capillary blood glucose (CBG) compared to conventional venous plasma glucose (VPG) testing for 50-g glucose challenge test (GCT) in gestational diabetes (GDM) screening. Methods: A total of 300 women were enrolled and 50-g GCT for GDM screening was offered. At 1 h after glucose loading, CBG was evaluated by CONTOUR® PLUS glucose meter by well-trained nurses immediately after venipuncture for VPG. Results of CBG were compared with those from VPG to evaluate its accuracy. Women with venous plasma glucose > 140 mg/dL were offered 100-g OGTT for GDM diagnosis. Results: The mean age was 30.2 years and the mean gestational age at testing was 21.8 weeks. GDM was diagnosed in 34 women (11.3%). The mean VPG was 142.1 ± 32.9 mg/dL and the mean CBG was 129.3 ± 33.5 mg/dL. Mean difference was -12.3 ± 12.5 mg/dL, corresponding to -8.8 ± 11.4%. CBG significantly correlated with VPG with correlation coefficient of 0.929, p < 0.001. In the detection of abnormal 50-g GCT results (VPG ≥ 140 mg/dL), at 126 mg/dL cutoff, CBG had sensitivity of 92.5%, specificity of 81.8%, and positive and negative predictive values of 82.8%and 92%. None of the GDM would have been missed if CBG was used. Conclusion: CBG by a certified glucose meter could be considered as an alternative to conventional VPG testing for 50-g GCT for GDM screening using 126 mg/dL cutoff value.

Use of capillary blood glucose for screening for gestational diabetes mellitus in resource-constrained settings.

AIMS: The aim of the study was to evaluate usefulness of capillary blood glucose (CBG) for diagnosis of gestational diabetes mellitus (GDM) in resource-constrained settings where venous plasma glucose (VPG) estimations may be impossible. METHODS: Consecutive pregnant women (n = 1031) attending antenatal clinics in southern India underwent 75-g oral glucose tolerance test (OGTT). Fasting, 1- and 2-h VPG (AU2700 Beckman, Fullerton, CA) and CBG (One Touch Ultra-II, LifeScan) were simultaneously measured. Sensitivity and specificity were estimated for different CBG cut points using the International Association of Diabetes in Pregnancy Study Groups (IADPSG) criteria for the diagnosis of GDM as gold standard. Bland-Altman plots were drawn to look at the agreement between CBG and VPG. Correlation and regression equation analysis were also derived for CBG values. RESULTS: Pearson's correlation between VPG and CBG for fasting was r = 0.433 [intraclass correlation coefficient (ICC) = 0.596, p < 0.001], for 1H, it was r = 0.653 (ICC = 0.776, p < 0.001), and for 2H, r = 0.784 (ICC = 0.834, p < 0.001). Comparing a single CBG 2-h cut point of 140 mg/dl (7.8 mmol/l) with the IADPSG criteria, the sensitivity and specificity were 62.3 and 80.7 %, respectively. If CBG cut points of 120 mg/dl (6.6 mmol/l) or 110 mg/dl (6.1 mmol/l) were used, the sensitivity improves to 78.3 and 92.5 %, respectively. CONCLUSIONS: In settings where VPG estimations are not possible, CBG can be used as an initial screening test for GDM, using lower 2H CBG cut points to maximize the sensitivity. Those who screen positive can be referred to higher centers for definitive testing, using VPG.

Comparison of periphery capillary whole blood glucose using BREEZE~(TM)blood glucose meter and venous plasma glucose using laboratory autoanalyzer / 中华内分泌代谢杂志

Objective To evaluate the precision of BREEZE~(TM) glucose monitor and correlation of glucose measurements between fingertip capillary whole blood glucose(CBG)using BREEZE~(TM) glucose monitor and venous plasma glucose(VPG)using autoanalyzer.Methods All samples of venous plasma and fingertip blood from 188 diabetes or non-diabetes patients were detected for glucose level at fasting,30,60 and 120 min postprandial.BREEZE~(TM) glucose monitor and autoanalyzer measured CBG and VPG respectively.Intra-and inter- coefficients of variations were determined using 10 BREEZE~(TM) glucose monitors with normal,slight high and high glucose levels for the three lots of strips.Results The correlation coefficients between CBG and VPG were all higher than 0.950 at fasting and different postprandial time.98.94% of all measurements were in the A zone when using error-grid analysis.The relevant differences between CBG and VPG were less than 5% at different blood glucose concentrations.The intra-and inter-coefficients of variations of blood glucose values at different blood glucose concentrations using different lots of strips were within 5%.Conclusion BREEZE~(TM) glucose monitor provides high accurate and precise glucose readings on fasting and different postprandial time points over a variety of blood glucose concentrations.