Ann Lab Med.  2019 Nov;39(6):524-529. 10.3343/alm.2019.39.6.524.

Screening for Gestational Diabetes Mellitus by Measuring Glycated Hemoglobin Can Reduce the Use of the Glucose Challenge Test

• Maesa JM
• Fernandez-Riejos P
• Gonzalez-Rodriguez C
• Sanchez-Margalet V

• KMID: 2450946
• DOI: http://doi.org/10.3343/alm.2019.39.6.524

Abstract

BACKGROUND
Physiological changes during pregnancy, such as dilutional anemia and a reduced half-life of red blood cells, have prevented the use of glycated Hb (HbA1c) as a biomarker for gestational diabetes mellitus (GDM). Nevertheless, increasing evidence supports the use of HbA1c in GDM diagnostic strategies.We studied HbA1c as a biomarker of GDM and its possible use as a screening test to avoid the use of the glucose challenge test (GCT).
METHODS
This case-control study involved 607 pregnant women between the 24th and 28th week of gestation. HbA1c level was determined, and GDM was diagnosed according to the National Diabetes Data Group criteria. The area under the ROC curve (AUC) was determined; two low and two high cut-off points were established to rule out GDM and classify high-risk pregnant women, respectively. For each cut-off, sensitivity (S), specificity (SP), and total number and percentage of GCTs avoided were determined.
RESULTS
The AUC for HbA1c diagnostic performance was 0.68 (95% confidence interval 0.57-0.79). Using 4.6% HbA1c (27 mmol/mol) as the lower cut-off (S=100%), 14% of participants could avoid the GCT. Using 5.5% HbA1c (36 mmol/mol) as the upper cut-off (SP =94.5%), 6% of participants would be considered at high risk.
CONCLUSIONS
HbA1c can be used as a screening test prior to the GCT, thereby reducing the need for the GCT among pregnant women at a low risk of GDM.

Keyword

Gestational diabetes mellitus; Glycated Hb; Glucose challenge test; Screening

MeSH Terms

Anemia
Area Under Curve
Case-Control Studies
Diabetes, Gestational*
Erythrocytes
Female
Glucose*
Half-Life
Hemoglobin A, Glycosylated*
Humans
Mass Screening*
Pregnancy
Pregnant Women
ROC Curve
Sensitivity and Specificity
Glucose

Reference

1. International Association of Diabetes and Pregnancy Study Groups Consensus Panel. Metzger BE, Gabbe SG, Persson B, Buchanan TA, Catalano PA, et al. International association of diabetes and pregnancy study groups recommendations on the diagnosis and classification of hyperglycemia in pregnancy. Diabetes Care. 2010; 33:676–682. PMID: 20190296.

2. HAPO Study Cooperative Research Group. Metzger BE, Lowe LP, Dyer AR, Trimble ER, Chaovarindr U. Hyperglycemia and adverse pegnancyoutcomes. N Engl J Med. 2008; 358:1991–2002. PMID: 18463375.

3. Farrar D, Duley L, Medley N, Lawlor DA. Different strategies for diagnosing gestational diabetes to improve maternal and infant health. Cochrane Database Syst Rev. 2015; 1:CD007122. PMID: 25604891.

4. American Diabetes Association. Management of diabetes in pregnancy: standards of medical care in diabetes - 2019. Diabetes Care. 2019; 42(Suppl 1):S165–S172. PMID: 30559240.

5. Committee on Practice Bulletins--Obstetrics.Practice Bulletin No. 137: Gestational diabetes mellitus. Obstet Gynecol. 2013; 122:406–416. PMID: 23969827.

6. Donovan L, Hartling L, Muise M, Guthrie A, Vandermeer B, Dryden DM. Screening tests for gestational diabetes: a systematic review for the US Preventive Services Task Force. Ann Intern Med. 2013; 159:115–122. PMID: 23712349.

7. Bonongwe P, Lindow SW, Coetzee EJ. Reproducibility of a 75G oral glucose tolerance test in pregnant women. J Perinat Med. 2015; 43:333–338. PMID: 25405716.

8. Maesa JM, Fernández-Riejos P, Mora CS, de Toro M, Valladares PM, González-Rodriguez C. Evaluation of Bio-Rad D-100 HbA1c analyzer against Tosoh G8 and Menarini HA-8180V. Pract Lab Med. 2016; 5:57–64. PMID: 28856205.

9. WHO. Use of glycated haemoglobin (HbA1c) in diagnosis of diabetes mellitus: abbreviated report of a WHO consultation. 2011. p. 1–25.

10. International Expert Committee. International expert committee report on the role of the A1C assay in the diagnosis of diabetes. Diabetes Care. 2009; 32:1327–1334. PMID: 19502545.

11. Lowe LP, Metzger BE, Dyer AR, Lowe J, McCance DR, Lappin TR, et al. Hyperglycemia and adverse pregnancy outcome (HAPO) Study: associations of maternal A1C and glucose with pregnancy outcomes. Diabetes Care. 2012; 35:574–580. PMID: 22301123.

12. Maesa JM, Fernandez-Riejos P, Sanchez-Mora C, Toro-Crespo M, Gonzalez-Rodriguez C. Application of six sigma model to evaluate the analytical quality of four HbA1c analyzers. Clin Lab. 2017; 63:79–83. PMID: 28164511.

13. GrupoEspañol Diabetes y Embarazo. Asistencia a la gestante con diabetes. Guía de práctica clínica actualizada en 2014. Diabetologia. 2015; 31:45–59.

14. National Diabetes Data Group. Classification and diagnosis of diabetes mellitus and other categories of glucose intolerance. Diabetes. 1979; 28:1039–1057. PMID: 510803.

15. Renz PB, Cavagnolli G, Weinert LS, Silveiro SP, Camargo JL. HbA1c test as a tool in the diagnosis of gestational diabetes mellitus. PLoS One. 2015; 10:e0135989. PMID: 26292213.

16. Agarwal MM, Hughes PF, Punnose J, Ezimokhai M, Thomas L. Gestational diabetes screening of a multiethnic, high-risk population using glycated proteins. Diabetes Res Clin Pract. 2001; 51:67–73. PMID: 11137184.

17. Plan integral de diabetes en Andalucía. Análisissituación 2013. Updated on 2013. https://www.juntadeandalucia.es/export/drupaljda/salud_5af065335c108_pidma3.pdf.

18. Benhalima K, Damm P, Van Assche A, Mathieu C, Devlieger R, Mahmood T, et al. Screening for gestational diabetes in Europe: where do we stand and how to move forward?: A scientific paper commissioned by the European Board & College of Obstetrics and Gynaecology (EBCOG). Eur J Obstet Gynecol Reprod Biol. 2016; 201:192–196. PMID: 27105781.

19. National Institute for Health and Care Excellence. Diabetes in pregnancy: management of diabetes and its complications from preconception to the postnatal period. 2015. p. 2–65.

20. Aceituno Velasco L, Aguado Maldonado J, Arribas Mir L, Caño Aguilar A, Corona Páez I, Martín López J, et al. Procesoasistencialintegradoembarazo, parto y puerperio. 3. Junta Andalucía ConserjeríaIgualdad, Salud u PolíticasSoc;2014. p. 1–73.

21. Carpenter MW, Coustan DR. Criteria for screening tests for gestational diabetes. Am J Obstet Gynecol. 1982; 144:768–773. PMID: 7148898.

22. Kwon SS, Kwon JY, Park YW, Kim YH, Lim JB. HbA1c for diagnosis and prognosis of gestational diabetes mellitus. Diabetes Res Clin Pract. 2015; 110:38–43. PMID: 26344325.

23. Khalafallah A, Phuah E, Al-Barazan AM, Nikakis I, Radford A, Clarkson W, et al. Glycosylated haemoglobin for screening and diagnosis of gestational diabetes mellitus. BMJ Open. 2016; 6:e011059.

24. Ye M, Liu Y, Cao X, Yao F, Liu B, Li Y, et al. The utility of HbA1c for screening gestational diabetes mellitus and its relationship with adverse pregnancy outcomes. Diabetes Res Clin Pract. 2016; 114:43–49. PMID: 27103368.

25. Wolffenbuttel BH, Herman WH, Gross JL, Dharmalingam M, Honghua HJ, Hardin DS. Ethnic differences in glycemic markers in patients with type 2 diabetes. Diabetes Care. 2013; 36:2931–2936. PMID: 23757434.