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Cited by 54Gestational Diabetes Research and ManagementDiabetes Management and ResearchDiabetes, Cardiovascular Risks, and Lipoproteins

Diagnostic accuracy of glycated hemoglobin for gestational diabetes mellitus: a systematic review and meta-analysis

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Renz, Paula B., Chume, Fernando C., Timm, João R.T., Pimentel, Ana L., Camargo, Joíza L.·2019·Clinical Chemistry and Laboratory Medicine (CCLM)
DOI 10.1515/cclm-2018-1191
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Abstract

Background: We conducted a systematic review and meta-analysis to establish the overall accuracy of glycated hemoglobin (HbA 1c) in the diagnosis of gestational diabetes mellitus (GDM) diagnosis. Methods: We searched MEDLINE, EMBASE, SCOPUS and ClinicalTrials.gov up to October 2018, using keywords related to GDM, HbA 1c and diagnosis. Studies were included that were carried out with pregnant women without previous diabetes that assessed the performance of HbA 1c (index test) compared to the 75 g oral glucose tolerance test (OGTT) (reference test) for the diagnosis of GDM, that measured HbA 1c by standardized methods and presented data necessary for drawing 2 × 2 tables. Results: This meta-analysis included eight studies, totaling 6406 pregnant women, of those 1044 had GDM. The diagnostic accuracy of HbA 1c was reported at different thresholds ranging from 5.4% (36 mmol/mol) to 6.0% (42 mmol/mol), and the area under the curve (AUC) was 0.825 (95% confidence interval [CI] 0.751–0.899), indicating a good level of overall accuracy. The pooled sensitivities and specificities were 50.3% (95% CI 24.8%–75.7%) and 83.7% (67.5%–92.7%); 24.7% (10.3%–48.5%) and 95.5% (85.7%–98.7%); 10.8% (5.7%–19.41%) and 98.7% (96.2%–99.5%); 12.9% (5.5%–27.5%) and 98.7% (97.6%–99.3%), for the cut-offs of 5.4% (36 mmol/mol), 5.7% (39 mmol/mol), 5.8% (40 mmol/mol) and 6.0% (42 mmol/mol), respectively. Conclusions: We observed a high heterogeneity among the studies. The effect of ethnicities, different criteria for OGTT interpretation and the individual performance of HbA 1c methods may have contributed to this heterogeneity. The HbA 1c test presents high specificity but low sensitivity regardless of the threshold used to diagnose GDM. These findings point to the usefulness of HbA 1c as a rule-in test. HbA 1c should be used in association with other standard diagnostic tests for GDM diagnosis.

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  • Early pregnancy HbA1c at thresholds of 6.0-6.4% (42-47 mmol/mol) is highly specific for gestational diabetes mellitus diagnosed on POGTT, but its positive predictive value is limited in many populations.

    “Although HbA1c at these thresholds is highly specific for gestational diabetes mellitus diagnosed on POGTT, the positive predictive value is limited in many populations. 48”

    From Australasian Diabetes in Pregnancy Society ( <scp>ADIPS</scp> ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [48]

    The ‘Effect of the HbA1c threshold on diagnostic accuracy’ section (page not provided) reports 98.7% pooled specificity at ≥6.0% (42 mmol/mol). ‘Applicability of findings to the review question’ reports a 69% probability of GDM after a positive result, assuming 18% prevalence, which supports a limitation on predictive value. The review does not evaluate a 6.0–6.4% range or establish that this predictive value applies to early pregnancy or many populations. (LLM, conf=0.88)

    Experimental — accuracy not yet measured

  • HbA1c has poor sensitivity for screening for gestational diabetes mellitus in later pregnancy, because the physiological fall in HbA1c by the second trimester leads to underestimation of HbA1c.

    “In later pregnancy, HbA1c is not recommended for gestational diabetes mellitus screening due to poor sensitivity, arising from the physiological fall of HbA1c by the second trimester, leading to the underestimation of HbA1c. 48”

    From Australasian Diabetes in Pregnancy Society ( <scp>ADIPS</scp> ) 2025 consensus recommendations for the screening, diagnosis and classification of gestational diabetes (2025) · cites this paper as [48]

    The Study selection section says the included studies tested women in the second or third trimester, and the Conclusions report low sensitivity and many false negatives, supporting the concern about using HbA1c alone for GDM screening in later pregnancy. The Introduction says HbA1c is lower during pregnancy and significantly lower in the first trimesters, but the paper does not establish that a fall by the second trimester causes the poor sensitivity or leads to underestimation in later pregnancy. Page numbers are unavailable in our copy. (LLM, conf=0.87)

    Experimental — accuracy not yet measured

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Cites

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Cited by

Sorted by citations

Authors
Renz, P. B., Chume, F. C., Timm, J. R. T., Pimentel, A. L., & Camargo, J. L.
Affiliations
Universidade Federal do Rio Grande do Sul (BR)
Corresponding author
Camargo, Joíza L.
ORCID
Camargo, Joíza L.
Venue
Clinical Chemistry and Laboratory Medicine (CCLM)
Publisher
Walter de Gruyter GmbH
Published
2019-03-20
Volume
57
Issue
10
Pages
1435-1449
ISSN
  • 1434-6621 (ISSN-L)
  • 1437-4331
DOI
10.1515/cclm-2018-1191
OpenAlex
W2923183749
Cited by
54
References
11
Citations by year
2026: 1 · 2025: 6 · 2024: 9 · 2023: 3 · 2022: 11 · 2021: 16 · 2020: 7
FWCI
1.35
Type
journal article
Language
en
Open access
Locations
  • Clinical Chemistry and Laboratory Medicine (CCLM) (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Obstetrics and Gynecology › Gestational Diabetes Research and Management
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
  • Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes, Cardiovascular Risks, and Lipoproteins
Keywords
HbA1c, gestational diabetes mellitus, diagnostic accuracy, oral glucose tolerance test, HbA1c thresholds, sensitivity and specificity, pregnant women, diagnostic performance, ethnic differences, study heterogeneity, area under the curve, glycemic control in pregnancy, glycemic load, glycemic variability
MeSH terms
Adult, Blood Glucose, Female, Glucose Tolerance Test, Glycated Hemoglobin, Humans, Pregnancy, ROC Curve, Sensitivity and Specificity, Diabetes, Gestational, Area Under Curve

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