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Small variations in fasting blood glucose have significant effects in diagnosis of gestational diabetes mellitus

Small variations in fasting blood glucose have significant effects in diagnosis of gestational diabetes mellitus
Small variations in fasting blood glucose have significant effects in diagnosis of gestational diabetes mellitus

Background: gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with onset during pregnancy. The correspondence between GDM cases ascertained in the first trimester (<12 weeks) using fasting blood glucose (FG) levels (FG >5.1 mmol/L) and third trimester (24-28 weeks) using Hyperglycemia Adverse Pregnancy Outcome (HAPO) study guidelines is not perfect and vary according to the cutoffs used. This retrospective observational study analyzed the variation in the prevalence of GDM for different cutoffs of FG in the first and third trimester. 

Methods: we analyzed registers of FG during early (<12 weeks; n=38,489) and late (24-28 weeks; n=60,432) stages of gestation. The estimated prevalence of GDM was calculated for both periods by selecting women with FG values between 5.0 to 5.3 mmol/L (90 to 95 mg/dL, HAPO study, odds ratio 1.5 to 2.0). The dispersion of the recommended cut-off by HAPO (OR 1.75) to GDM diagnosis, 5.1 mmol/L (92 mg/dL) was calculated based on the analytical (CVa 2%), biological (CVi 5.0%), and reference change value (RCV). 

Results: for early and late stages of pregnancies, the estimated GDM frequencies were 13.4% to 5.6% and 14.7% to 10.6%, respectively, with the FG cut-off varying from 5.0 to 5.3 mmol/L. The estimated variations of 5.1 mmol/L with (CVa 2% + CVi 5%), were 4.8 to 5.4 mmol/L. RCV, applied to a 5.1 mmol/L decision point showed a variation of 4.3 to 5.9 mmol/L. The 0.055 mmol/L (1 mg/dL) variation in fasting glycemia for the cut-off criterion of 5.1 mmol/L resulted in variations for estimated GDM of about 7% (+7% to -6%) of cases in late stages and about 15% (+19% to -15%) in the initial stages. 

Conclusions: fasting glycemia is linked to the diagnosis of GDM and presents a wide variation, mostly derived from intra-individual biological variability (CVi). Small variations of FG cut-off from an initial value (5.1 mmol/L) change the prevalence of GDM more expressively in early stages of pregnancy.

Analytical variation, Biological variation, Fasting glycemia, Gestational diabetes, Hyperglycemia Adverse Pregnancy Outcome (HAPO) diagnostic criteria
Volanski, Waldemar
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De Moraes Rego, Fabiane Gomes
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Do Prado, Ademir Luiz
246015ec-5be4-4c60-af63-5a5a4e55cb7f
Signorini, Liana
b1d8656c-534e-41cc-bb49-2668854c807a
Picheth, Guilherme Fadel
1bac7768-7a0e-41d6-b81e-b988986c8e02
Alves, Alexessander Couto
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Valdameri, Glaucio
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Picheth, Geraldo
83111b68-458e-49d9-ad5f-6096d4bf50f2
Volanski, Waldemar
5a9bec85-39a5-4280-84ac-dabc8b7b0c54
De Moraes Rego, Fabiane Gomes
4cbcd000-400e-40c7-9cff-21285bf8cc0e
Do Prado, Ademir Luiz
246015ec-5be4-4c60-af63-5a5a4e55cb7f
Signorini, Liana
b1d8656c-534e-41cc-bb49-2668854c807a
Picheth, Guilherme Fadel
1bac7768-7a0e-41d6-b81e-b988986c8e02
Alves, Alexessander Couto
87b9179e-abde-4ca5-abfc-4b7c5ac8b03b
Valdameri, Glaucio
9f6c0a40-999f-4aca-88b4-59548425262a
Picheth, Geraldo
83111b68-458e-49d9-ad5f-6096d4bf50f2

Volanski, Waldemar, De Moraes Rego, Fabiane Gomes, Do Prado, Ademir Luiz, Signorini, Liana, Picheth, Guilherme Fadel, Alves, Alexessander Couto, Valdameri, Glaucio and Picheth, Geraldo (2022) Small variations in fasting blood glucose have significant effects in diagnosis of gestational diabetes mellitus. Journal of Laboratory and Precision Medicine, 7, [6714]. (doi:10.21037/jlpm-21-57).

Record type: Article

Abstract

Background: gestational diabetes mellitus (GDM) is defined as any degree of glucose intolerance with onset during pregnancy. The correspondence between GDM cases ascertained in the first trimester (<12 weeks) using fasting blood glucose (FG) levels (FG >5.1 mmol/L) and third trimester (24-28 weeks) using Hyperglycemia Adverse Pregnancy Outcome (HAPO) study guidelines is not perfect and vary according to the cutoffs used. This retrospective observational study analyzed the variation in the prevalence of GDM for different cutoffs of FG in the first and third trimester. 

Methods: we analyzed registers of FG during early (<12 weeks; n=38,489) and late (24-28 weeks; n=60,432) stages of gestation. The estimated prevalence of GDM was calculated for both periods by selecting women with FG values between 5.0 to 5.3 mmol/L (90 to 95 mg/dL, HAPO study, odds ratio 1.5 to 2.0). The dispersion of the recommended cut-off by HAPO (OR 1.75) to GDM diagnosis, 5.1 mmol/L (92 mg/dL) was calculated based on the analytical (CVa 2%), biological (CVi 5.0%), and reference change value (RCV). 

Results: for early and late stages of pregnancies, the estimated GDM frequencies were 13.4% to 5.6% and 14.7% to 10.6%, respectively, with the FG cut-off varying from 5.0 to 5.3 mmol/L. The estimated variations of 5.1 mmol/L with (CVa 2% + CVi 5%), were 4.8 to 5.4 mmol/L. RCV, applied to a 5.1 mmol/L decision point showed a variation of 4.3 to 5.9 mmol/L. The 0.055 mmol/L (1 mg/dL) variation in fasting glycemia for the cut-off criterion of 5.1 mmol/L resulted in variations for estimated GDM of about 7% (+7% to -6%) of cases in late stages and about 15% (+19% to -15%) in the initial stages. 

Conclusions: fasting glycemia is linked to the diagnosis of GDM and presents a wide variation, mostly derived from intra-individual biological variability (CVi). Small variations of FG cut-off from an initial value (5.1 mmol/L) change the prevalence of GDM more expressively in early stages of pregnancy.

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6714-PB8-7097-R4 - Version of Record
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More information

Accepted/In Press date: 13 December 2021
Published date: 30 January 2022
Additional Information: Publisher Copyright: © 2021 Cohen J. S..
Keywords: Analytical variation, Biological variation, Fasting glycemia, Gestational diabetes, Hyperglycemia Adverse Pregnancy Outcome (HAPO) diagnostic criteria

Identifiers

Local EPrints ID: 509399
URI: http://eprints.soton.ac.uk/id/eprint/509399
PURE UUID: a84a82d0-e765-4433-a19c-e32686448536
ORCID for Alexessander Couto Alves: ORCID iD orcid.org/0000-0001-8519-7356

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Date deposited: 20 Feb 2026 17:36
Last modified: 21 Feb 2026 03:20

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Contributors

Author: Waldemar Volanski
Author: Fabiane Gomes De Moraes Rego
Author: Ademir Luiz Do Prado
Author: Liana Signorini
Author: Guilherme Fadel Picheth
Author: Alexessander Couto Alves ORCID iD
Author: Glaucio Valdameri
Author: Geraldo Picheth

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