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Validation of Time in Range as an Outcome Measure for Diabetes Clinical Trials.验证时间在范围内作为糖尿病临床试验的结果测量。
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新型血糖生化标志物预测 1 型糖尿病女性妊娠结局

Novel Biochemical Markers of Glycemia to Predict Pregnancy Outcomes in Women With Type 1 Diabetes.

机构信息

Wellcome-MRC Institute of Metabolic Science, University of Cambridge, Cambridge, U.K.

Cambridge Universities NHS Foundation Trust, Cambridge, U.K.

出版信息

Diabetes Care. 2021 Mar;44(3):681-689. doi: 10.2337/dc20-2360. Epub 2021 Jan 25.

DOI:10.2337/dc20-2360
PMID:33495292
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8051277/
Abstract

OBJECTIVE

The optimal method of monitoring glycemia in pregnant women with type 1 diabetes remains controversial. This study aimed to assess the predictive performance of HbA, continuous glucose monitoring (CGM) metrics, and alternative biochemical markers of glycemia to predict obstetric and neonatal outcomes.

RESEARCH DESIGN AND METHODS

One hundred fifty-seven women from the Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT) were included in this prespecified secondary analysis. HbA, CGM data, and alternative biochemical markers (glycated CD59, 1,5-anhydroglucitol, fructosamine, glycated albumin) were compared at ∼12, 24, and 34 weeks' gestation using logistic regression and receiver operating characteristic (ROC) curves to predict pregnancy complications (preeclampsia, preterm delivery, large for gestational age, neonatal hypoglycemia, admission to neonatal intensive care unit).

RESULTS

HbA, CGM metrics, and alternative laboratory markers were all significantly associated with obstetric and neonatal outcomes at 24 weeks' gestation. More outcomes were associated with CGM metrics during the first trimester and with laboratory markers (area under the ROC curve generally <0.7) during the third trimester. Time in range (TIR) (63-140 mg/dL [3.5-7.8 mmol/L]) and time above range (TAR) (>140 mg/dL [>7.8 mmol/L]) were the most consistently predictive CGM metrics. HbA was also a consistent predictor of suboptimal pregnancy outcomes. Some alternative laboratory markers showed promise, but overall, they had lower predictive ability than HbA.

CONCLUSIONS

HbA is still an important biomarker for obstetric and neonatal outcomes in type 1 diabetes pregnancy. Alternative biochemical markers of glycemia and other CGM metrics did not substantially increase the prediction of pregnancy outcomes compared with widely available HbA and increasingly available CGM metrics (TIR and TAR).

摘要

目的

对于 1 型糖尿病孕妇而言,血糖监测的最佳方法仍存在争议。本研究旨在评估 HbA、连续血糖监测(CGM)指标和其他血糖生化标志物预测产科和新生儿结局的预测性能。

研究设计和方法

本研究为 CONCEPTT 试验的一项预设二次分析,共纳入 157 例来自 CONCEPTT 试验的女性。使用逻辑回归和受试者工作特征(ROC)曲线比较了 HbA、CGM 数据和其他生化标志物(糖化 CD59、1,5-脱水葡萄糖醇、果糖胺、糖化白蛋白)在大约 12、24 和 34 孕周时的预测价值,以评估妊娠并发症(子痫前期、早产、大于胎龄儿、新生儿低血糖、新生儿重症监护病房入院)。

结果

HbA、CGM 指标和其他实验室标志物在 24 孕周时均与产科和新生儿结局显著相关。CGM 指标在孕早期与更多的结局相关,而实验室标志物(ROC 曲线下面积通常<0.7)在孕晚期与更多的结局相关。血糖达标时间(TIR,63-140mg/dL[3.5-7.8mmol/L])和血糖超标时间(TAR,>140mg/dL[>7.8mmol/L])是最一致的预测 CGM 指标。HbA 也是预测不良妊娠结局的一个始终不变的指标。一些替代的实验室标志物显示出一定的潜力,但总体而言,它们的预测能力低于 HbA。

结论

HbA 仍是 1 型糖尿病妊娠母婴结局的重要生物标志物。与广泛可用的 HbA 和越来越多的 CGM 指标(TIR 和 TAR)相比,血糖的其他生化标志物和其他 CGM 指标并不能显著提高对妊娠结局的预测能力。