Benaiges David, Flores-Le Roux Juana A, Marcelo Irene, Mañé Laura, Rodríguez Marta, Navarro Xavier, Chillarón Juan J, Llauradó Gemma, Gortazar Lucia, Pedro-Botet Juan, Payà Antonio
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.
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.
Diabetes Res Clin Pract. 2017 Nov;133:85-91. doi: 10.1016/j.diabres.2017.08.019. Epub 2017 Aug 30.
To evaluate the usefulness and efficacy of first-trimester HbA1c in the diagnosis of gestational diabetes (GDM).
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.
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.
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.
评估孕早期糖化血红蛋白(HbA1c)在妊娠期糖尿病(GDM)诊断中的实用性和有效性。
对连续的孕妇进行前瞻性观察。所有孕妇在孕早期测定HbA1c,并在妊娠24 - 28周时采用两步法进行GDM筛查。绘制受试者工作特征(ROC)曲线以确定HbA1c检测GDM的敏感性和特异性,并提出纳入-排除诊断算法。计算所提出算法的成本。
1195名女性中有152名(13.1%)被诊断为GDM。HbA1c检测GDM的ROC曲线下面积为0.679(95%可信区间0.631 - 0.727)。HbA1c排除阈值为4.8%(29mmol/mol)时,敏感性为96.7%(95%可信区间93.9 - 99.5),特异性为10.1%(95%可信区间8.3 - 12.0),阴性预测值为95.3%(95%可信区间91.3 - 99.3)。纳入值为5.6%(38mmol/mol)时,阳性预测值为31.6%(95%可信区间24.4 - 38.9),特异性为89.3%(95%可信区间87.4 - 91.2),敏感性为32.9%(95%可信区间25.4 - 40.4)。纳入阈值的低阳性预测值使其无法用于GDM诊断,但可用于识别GDM高危女性,对于这些女性可采用一步法进行诊断。所提出算法的总体成本节约将占标准策略总成本的6.5%。
孕早期HbA1c诊断GDM的敏感性或特异性不足,尽管使用较高和较低阈值可通过减少口服葡萄糖耐量试验次数、相关成本和患者不便来简化诊断过程。