Evaluating the utility of a point‐of‐care glucometer for the diagnosis of gestational diabetes

Adam, Sheryl; Rheeder, Paul

doi:10.1002/ijgo.12399

Cited by 15 publications

(18 citation statements)

References 26 publications

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“…Importantly, 87.8% of GDM-positive diagnoses in this study population were based on an elevated FPG. This confirms the RESEARCH findings of Macauley et al [3] and Adam and Rheeder [24] that the majority of GDM diagnoses in SA women screened were based on an elevated FPG. The use of FPG alone to screen for GDM is attractive as it is less expensive than a complete OGTT, avoids the need for multiple punctures, reduces laboratory workload, and avoids exposing pregnant women to the sometimes emesis-inducing oral glucose load.…”

Section: Discussionsupporting

confidence: 88%

“…Macauley et al [3] reported a 9.1% GDM prevalence in a tertiary hospital setting, using a research laboratory (glucose oxidase method), and their participants had a higher risk profile for GDM than participants at the CHC where this study was conducted. [3] A study by Adam and Rheeder [24] possibly overestimated the GDM prevalence at 25.8%, and one reason for this is that the laboratory bias of 3.65%, which is not within the ≤2.2% recommended by the NACB, [20] would adversely affect the quality of plasma glucose measures. Importantly, 87.8% of GDM-positive diagnoses in this study population were based on an elevated FPG.…”

Section: Discussionmentioning

confidence: 99%

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Fasting plasma glucose and risk factor assessment: Comparing sensitivity and specificity in identifying gestational diabetes in urban black African women

et al. 2019

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Background. Identifying women with gestational diabetes mellitus (GDM) allows interventions to improve perinatal outcomes. A fasting plasma glucose (FPG) level ≥5.1 mmol/L is 100% specific for a diagnosis of GDM. The International Association of Diabetes and Pregnancy Study Groups acknowledges that FPG <4.5 mmol/L is associated with a low probability of GDM. Objectives. The validity of selective screening based on the presence of risk factors was compared with the universal application of FPG ≥4.5 mmol/L to identify women with GDM. FPG ≥4.5 mmol/L or the presence of one or more risk factors was assumed to indicate an intermediate to high risk of GDM and therefore the need for an oral glucose tolerance test (OGTT). Methods. Consecutive black South African (SA) women were recruited to a 2-hour 75 g OGTT at 24 -28 weeks' gestation in an urban community health clinic. Of 969 women recruited, 666 underwent an OGTT, and of these 589 were eligible for analysis. The glucose oxidase laboratory method was used to measure plasma glucose concentrations. The World Health Organization GDM diagnostic criteria were applied. All participants underwent a risk factor assessment. The χ 2 test was used to determine associations between risk factors and a positive diagnosis of GDM. The sensitivity and specificity of a positive diagnosis of GDM were calculated for FPG ≥4.5 mmol/L, FPG ≥5.1 mmol/L, and the presence of one or more risk factors. Results. The prevalence of overt diabetes mellitus and GDM was 0.5% and 7.0%, respectively. Risk factor-based selective screening indicated that 204/589 (34.6%) of participants needed an OGTT, but 18/41 (43.9%) of positive GDM diagnoses were missed. Universal screening using the FPG threshold of ≥4.5 mmol/L indicated that 152/589 (25.8%) of participants needed an OGTT, and 1/41 (2.4%) of positive diagnoses were missed. An FPG of ≥5.1 mmol/L identified 36/41 (87.8%) of GDM-positive participants. The sensitivity and specificity of the presence of one or more risk factors were 56% and 67%, respectively. The sensitivity and specificity of FPG ≥4.5 mmol/L were 98% and 80%, respectively. Conclusions. Universal screening using FPG ≥4.5 mmol/L had greater sensitivity and specificity in identifying GDM-affected women and required fewer women to undergo a resource-intensive diagnostic OGTT than risk factor-based selective screening. A universal screening strategy using FPG ≥4.5 mmol/L may be more efficient and cost-effective than risk factor-based selective screening for GDM in black SA women.

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Section: Discussionsupporting

confidence: 88%

Section: Discussionmentioning

confidence: 99%

Fasting plasma glucose and risk factor assessment: Comparing sensitivity and specificity in identifying gestational diabetes in urban black African women

et al. 2019

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“…Compared with gold standard laboratory glucose determination for the diagnosis of GDM, POCT revealed discordant results in other South Africa studies. Adam and Rheeder [16], concluded that the POCT device, cannot be recommended because the diagnostic sensitivity of POCT compared with the laboratory method was poor (26%). However, in another South Africa study that utilized the same device, good correlations between the POCT and laboratory values were documented in women with GDM, but that study had limited patient numbers [29].…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies in South Africa have examined the ability of POCT to diagnose GDM, with conflicting results [15,16], but confounders that may influence glucose evaluation during gestation are absent in the post-partum period. Previous studies in South Africa have examined the ability of POCT to diagnose GDM, with conflicting results [15,16], but confounders that may influence glucose evaluation during gestation are absent in the post-partum period.…”

Section: Introductionmentioning

confidence: 99%

“…Compared with laboratory glucose testing, point-of-care testing (POCT) is an attractive option at the early postpartum visit when considering cost, convenience and the immediate availability of results. Previous studies in South Africa have examined the ability of POCT to diagnose GDM, with conflicting results [15,16], but confounders that may influence glucose evaluation during gestation are absent in the post-partum period. [17,18].…”

Section: Introductionmentioning

confidence: 99%

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A comparison between point‐of‐care testing and venous glucose determination for the diagnosis of diabetes mellitus 6–12 weeks after gestational diabetes

et al. 2019

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Aim To evaluate point-of-care-testing (POCT) for the diagnosis of Type 2 diabetes mellitus 6-12 weeks post-partum in women with gestational diabetes (GDM).Methods Post-partum glucose assessment (75-mg oral glucose tolerance test, OGTT) was performed prospectively in 122 women with GDM (1 November 2015 to 1 November 2017) at Tygerberg Hospital, Cape Town, South Africa. Individuals with known pre-existing diabetes were excluded. The accuracy and clinical utility of POCT (capillary fingerprick) were compared with laboratory plasma glucose (hexokinase and glucokinase methods). The OGTT consisted of two time points (fasting and 2 h) during which concurrent glucose samples (POCT and laboratory) were obtained. Bland-Altman plots and paired analysis were used to assess the analytical accuracy of POCT, whereas its diagnostic performance was determined using positive and negative predictive values to calculate specificity and sensitivity.Results Spearman's ranked correlation analysis indicated a strong association between POCT and laboratory glucose values at both OGTT time points (fasting, r = 0.95, P < 0.0001; 2 h, r = 0.88, P < 0.0001). Thirty-six women were diagnosed with Type 2 diabetes based on gold standard laboratory glucose levels (fasting > 7 mmol/l; 2 h > 11.1 mmol/ l). POCT correctly identified Type 2 diabetes in 78% of women (28 of 36) with a positive predictive value of 89.3% and a negative predictive value of 96.7% at the fasting time point. The sensitivity and specificity of POCT to diagnose Type 2 diabetes were 89% (fasting), 85.7% (2 h) and 96.7% (fasting), 98.5% (2 h) respectively. POCT proved less sensitive to diagnose pre-diabetes (69%) but displayed satisfactory specificity (92%) at both time points assessed.Conclusion POCT accurately identifies women with Type 2 diabetes 6-12 weeks after GDM.

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

García-Claver

Ramos-Corral

Laviña-Fañanás

et al. 2020

Intl J Gynecology & Obste

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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.

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Evaluating the utility of a point‐of‐care glucometer for the diagnosis of gestational diabetes

Abstract: Use of the Roche Accuchek Active glucometer for the diagnosis of GDM cannot be recommended.

Cited by 15 publications

References 26 publications

Fasting plasma glucose and risk factor assessment: Comparing sensitivity and specificity in identifying gestational diabetes in urban black African women

Fasting plasma glucose and risk factor assessment: Comparing sensitivity and specificity in identifying gestational diabetes in urban black African women

A comparison between point‐of‐care testing and venous glucose determination for the diagnosis of diabetes mellitus 6–12 weeks after gestational diabetes

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

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