David Benaiges1, Juana A Flores-Le Roux2, Irene Marcelo3, Laura Mañé4, Marta Rodríguez3, Xavier Navarro5, Juan J Chillarón2, Gemma Llauradó2, Lucia Gortazar4, Juan Pedro-Botet2, Antonio Payà6. 1. Department of Endocrinology and Nutrition, Hospital del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain; Department of Medicine, Universitat Pompeu Fabra, Campus del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain; Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Passeig Marítim, 25-29, 08003 Barcelona, Spain. Electronic address: 96002@parcdesalutmar.cat. 2. Department of Endocrinology and Nutrition, Hospital del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain; Department of Medicine, Universitat Pompeu Fabra, Campus del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain; Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Passeig Marítim, 25-29, 08003 Barcelona, Spain. 3. Department of Medicine, Universitat Pompeu Fabra, Campus del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain. 4. Department of Endocrinology and Nutrition, Hospital del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain; Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Passeig Marítim, 25-29, 08003 Barcelona, Spain. 5. Laboratori de Referència de Catalunya, Carrer de la Selva, 10, 08820 Prat de Llobregat, Spain. 6. Department of Medicine, Universitat Pompeu Fabra, Campus del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain; Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Passeig Marítim, 25-29, 08003 Barcelona, Spain; Department of Gynecology and Obstetrics, Hospital del Mar, Passeig Marítim, 25-29, 08003 Barcelona, Spain.
Abstract
AIMS: To evaluate the usefulness and efficacy of first-trimester HbA1c in the diagnosis of gestational diabetes (GDM). METHODS: Prospective observational of consecutive pregnant women. All women had a first-trimester HbA1c determination and GDM screening at 24-28weeks of pregnancy using a two-step approach. A ROC curve was drawn to determine the sensitivity and specificity of HbA1c in detecting GDM and a rule-in rule-out diagnostic algorithm was proposed. The cost of the proposed algorithm was calculated. RESULTS: 152 (13.1%) of 1195 women were diagnosed of GDM. The area under the ROC curve for HbA1c to detect GDM was 0.679 (95%CI 0.631-0.727). A rule-out threshold for HbA1c of 4.8% (29mmol/mol) had 96.7% sensitivity (95%CI 93.9-99.5), 10.1% specificity (95%CI 8.3-12.0) and a negative predictive value of 95.3% (95%CI 91.3-99.3). A rule-in value of 5.6% (38mmol/mol) had a positive predictive value of 31.6% (95%CI 24.4-38.9), 89.3% specificity (95%CI 87.4-91.2) and 32.9% sensitivity (95%CI 25.4-40.4). The low positive predictive value of the rule-in threshold precludes its use for GDM diagnosis, but could be used to identify women at high risk of GDM in whom the diagnosis can be established using a one-step approach. The overall saving of the proposed algorithm would be 6.5% of the total cost with the standard strategy. CONCLUSIONS: A first-trimester HbA1c does not have sufficient sensitivity or specificity to diagnose GDM, although the use of a higher and lower threshold could simplify the diagnostic process by reducing the number of oral glucose tolerance test, associated costs and patient inconvenience.
AIMS: To evaluate the usefulness and efficacy of first-trimester HbA1c in the diagnosis of gestational diabetes (GDM). METHODS: Prospective observational of consecutive pregnant women. All women had a first-trimester HbA1c determination and GDM screening at 24-28weeks of pregnancy using a two-step approach. A ROC curve was drawn to determine the sensitivity and specificity of HbA1c in detecting GDM and a rule-in rule-out diagnostic algorithm was proposed. The cost of the proposed algorithm was calculated. RESULTS: 152 (13.1%) of 1195 women were diagnosed of GDM. The area under the ROC curve for HbA1c to detect GDM was 0.679 (95%CI 0.631-0.727). A rule-out threshold for HbA1c of 4.8% (29mmol/mol) had 96.7% sensitivity (95%CI 93.9-99.5), 10.1% specificity (95%CI 8.3-12.0) and a negative predictive value of 95.3% (95%CI 91.3-99.3). A rule-in value of 5.6% (38mmol/mol) had a positive predictive value of 31.6% (95%CI 24.4-38.9), 89.3% specificity (95%CI 87.4-91.2) and 32.9% sensitivity (95%CI 25.4-40.4). The low positive predictive value of the rule-in threshold precludes its use for GDM diagnosis, but could be used to identify women at high risk of GDM in whom the diagnosis can be established using a one-step approach. The overall saving of the proposed algorithm would be 6.5% of the total cost with the standard strategy. CONCLUSIONS: A first-trimester HbA1c does not have sufficient sensitivity or specificity to diagnose GDM, although the use of a higher and lower threshold could simplify the diagnostic process by reducing the number of oral glucose tolerance test, associated costs and patient inconvenience.
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