Accuracy of five plasma calibrated glucometers to screen for and diagnose gestational diabetes mellitus in a low resource clinic setting

Dickson, Lynnsay M.; Buchmann, Eckhart; Rensburg, Charl Janse van; Norris, Shane A.

doi:10.1016/j.jcte.2018.12.003

Cited by 10 publications

(12 citation statements)

References 18 publications

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“…[32] The reliable use of selected plasma calibrated glucometers to measure FPG in a universal GDM screening programme in a low-resource SA setting was recently reported. [22] Maternal obesity was strongly associated with a positive GDM diagnosis in this study. SA has a high prevalence of obesity, which is associated with an increased risk of insulin resistance and dysglycaemia.…”

Section: Discussionsupporting

confidence: 55%

“…This analysis was part of a research study to assess the feasibility of implementing a universal screening, diagnosis and GDM lifestyle intervention programme in a low-resource urban setting. [22,23] We intended to identify 100 GDM-positive women for the purpose of participating in the GDM lifestyle intervention. Based on an estimated 16% global prevalence, 625 consecutive participants would need to be recruited.…”

Section: Sample Sizementioning

confidence: 99%

“…This original research article forms part of LMD's PhD thesis. [22,23] Acknowledgements. The Johannesburg District Department of Health granted permission to conduct this study at the CHC in Soweto.…”

Section: Research Highlightsmentioning

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: 55%

Section: Sample Sizementioning

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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“…Una de sus limitantes en la utilización de GM es el costo de las tiras reactivas (TR), según recomendación de la Asociación Americana de Diabetes (ADA) deben utilizarse de tres a cuatro veces al día para la diabetes tipo 1, y una al día para diabetes tipo 2 tratada farmacológicamente 14 . Un reporte reciente del uso de GM en muestras de gestantes, reporta inexactitud de todos los GM, incluso con previa calibración 15 . El presente estudio tuvo como objeto determinar la utilidad de glucómetros en relación al método de laboratorio estándar (MEL) en muestras sanguíneas: saludables, diabéticas, eritrociticas y anémicas.…”

Section: J Selva Andina Res Soc __________________________________unclassified

Determinación de glucosa

Gygliola-Ormachea¹,

Tarquino-Flores²,

Chambi-Gutierrez³

et al. 2020

J. Selva Andina Res. Soc.

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El objetivo de este estudio fue determinar la utilidad de glucómetros en relación al método de laboratorio estándar (MEL) en muestras sanguíneas: saludables, diabéticas, eritrociticas y anémicas. Los glucómetros (GM) evaluados fueron ACCU CHEK Active en sus dos procedimientos (ACCU I y ACCU II), ONE TOUCH Ultra (ONETu) y TRUEread fácil (TRUEf). Se utilizó el análisis de varianza ANOVA, p<0.005. De 54 muestras saludables con hematocrito 49±4, ONETu no expuso diferencia significativa con MEL, ACCU I, ACCU II y TRUEf expusieron diferencias significativas, siendo TRUEf el que reveló mayor diferencia con valores sobreestimados en más de 30 mg/dL. De 60 muestras diabéticas con hematocrito 48±8, no hubo diferencias significativas entre los GM y MEL, sin embargo se detectaron resultados incongruentes de 2 a 3 veces sobreestimados (13%) y de 2 a 3 veces infravalorados (12%) con los GM ONETu y TRUEf; ACCU I y ACCU II expusieron incongruencias leves. De 54 muestras eritrociticas con hematocrito 66±6, se detectaron valores infravalorados en 20 mg/dL con ONETu y TRUEf (10%), ACCU I (18%); ACCU II reporto valores sobreestimados entre 15-25 mg/dL (40%) con diferencia estadística significativa. De 40 muestras anémicas con hematocrito 29±9, se reportó valores sobreestimados, 20% (ONETu), 35% (TRUEf), 45% (ACCU II) y 55% (ACCU I), con una diferencia mayor a 20 mg/dL. Los GM evaluados presentan diferentes grados de interferencia por muestras diabéticas, anémicas y eritrociticas, en el caso de muestras eritrociticas se observan valores infravalorados, en muestras anémicas valores sobrevalorados, estos datos deben ser considerados para un mejor uso de los GM.

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“…This analysis is part of a study that investigated the utility of plasma-calibrated glucometers to universally screen for GDM in a low resource, routine clinical setting 21–23 . In this study both the HK and GOx laboratory methods were used as reference tests against the glucometers in all women tested.…”

Section: Study Subjects Methods and Materialsmentioning

confidence: 99%

The impact of differences in plasma glucose between glucose oxidase and hexokinase methods on estimated gestational diabetes mellitus prevalence

Dickson

Buchmann

Rensburg

et al. 2019

Sci Rep

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We evaluated the extent of measurement discordance between glucose oxidase and hexokinase laboratory methods and the effect of this on estimated gestational diabetes mellitus (GDM) prevalence in a routine clinical setting. 592 consecutive urban African women were screened for GDM. Paired venous specimens were submitted to two independent calibrated laboratories that used either method to measure plasma glucose concentrations. World Health Organisation diagnostic criteria were applied. GDM prevalence determined by the glucose oxidase and hexokinase methods was 6.9% and 5.1% respectively. The overall GDM prevalence was 9%. Only 34% of GDM positive diagnoses were common to both laboratory methods. Bland Altman plots identified a bias of 0.2 mmol/l between laboratory methods. Plasma glucose concentrations measured by the glucose oxidase method were more platykurtic in distribution. Low diagnostic agreement between laboratory methods was further indicated by a Cohen’s kappa of 0.48 (p < 0.001). Reports of GDM prevalence using either the glucose oxidase or hexokinase laboratory methods may not be truly interchangeable or directly comparable.

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Accuracy of five plasma calibrated glucometers to screen for and diagnose gestational diabetes mellitus in a low resource clinic setting

Abstract: HighlightsAn elevated fasting glucose defined 80% of laboratory GDM positive diagnoses.Selected glucometers fulfilled ISO 15197:2013 recommended accuracy at fasting of OGTT.All glucometers evaluated were inaccurate at one and two hours of OGTT.

Cited by 10 publications

References 18 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

Determinación de glucosa

The impact of differences in plasma glucose between glucose oxidase and hexokinase methods on estimated gestational diabetes mellitus prevalence

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