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对患有糖尿病的孕妇进行孕期血糖监测的技术。

Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes.

作者信息

Moy Foong Ming, Ray Amita, Buckley Brian S

机构信息

Julius Centre University of Malaya, Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50603.

出版信息

Cochrane Database Syst Rev. 2014 Apr 30(4):CD009613. doi: 10.1002/14651858.CD009613.pub2.

Abstract

BACKGROUND

Self-monitoring of blood glucose is recommended as a key component of the management plan for diabetes therapy during pregnancy. No existing systematic reviews consider the benefits/effectiveness of various techniques of blood glucose monitoring on maternal and infant outcomes among pregnant women with pre-existing diabetes. The effectiveness of the various monitoring techniques is unclear.

OBJECTIVES

To compare techniques of blood glucose monitoring and their impact on maternal and infant outcomes among pregnant women with pre-existing diabetes.

SEARCH METHODS

We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (6 August 2013), searched reference lists of retrieved studies and contacted trial authors.

SELECTION CRITERIA

Randomised controlled trials (RCTs) comparing techniques of blood glucose monitoring including self blood glucose monitoring, continuous glucose monitoring (CGM) or clinic monitoring among pregnant women with pre-existing diabetes mellitus (Type 1 or Type 2). Trials investigating timing and frequency of monitoring were also included. Quasi-RCTs and RCTs using a cluster-randomised design were eligible for inclusion but none were identified.

DATA COLLECTION AND ANALYSIS

Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies. Data were checked for accuracy.

MAIN RESULTS

The search of the Pregnancy and Childbirth Group's Trials Register identified 21 trial reports. Following application of eligibility criteria, nine trials were included in this review. The included trials involved a total of 506 women (436 women with Type 1 diabetes and 70 women with Type 2 diabetes). All trials originated from European countries and the USA. None of the studies included women with gestational diabetes. Five of the nine included studies were at moderate risk of bias and four studies were at low to moderate risk of bias. Primary outcomes were maternal glycaemic control (fasting blood glucose and HbA1c) and infant birthweight or macrosomia.Various methods of glucose monitoring were compared in the trials. The following comparisons were included in the review: (1) self-monitoring versus standard care, (2) self-monitoring versus hospitalisation, (3) pre-prandial versus post-prandial glucose monitoring, (4) automated telemedicine monitoring versus conventional system, (5) CGM versus intermittent monitoring and (6) constant CGM versus intermittent CGM.Neither pooled analyses nor individual trial analyses showed any significant advantages of one monitoring technique over another for primary outcomes (maternal glycaemic control and infant birthweight) and secondary outcomes such as gestational age at birth or preterm birth, frequency of neonatal hypoglycaemia, death of baby including stillbirth, and neonatal intensive care admission. Primary outcome data on macrosomia were reported by one trial but at a different cut-off value than that pre-specified for the review. Secondary outcomes such as shoulder dystocia, major and minor anomalies were not reported by any of the trials.

AUTHORS' CONCLUSIONS: This review found no evidence that any glucose monitoring technique is superior to any other technique among pregnant women with pre-existing Type 1 or Type 2 diabetes. The evidence base for the effectiveness of monitoring techniques is weak and additional evidence from large well-designed randomised trials is required to inform choices of glucose monitoring techniques.

摘要

背景

血糖自我监测被推荐为孕期糖尿病治疗管理计划的关键组成部分。目前尚无系统评价探讨各种血糖监测技术对患有糖尿病的孕妇母婴结局的益处/有效性。各种监测技术的有效性尚不清楚。

目的

比较血糖监测技术及其对患有糖尿病的孕妇母婴结局的影响。

检索方法

我们检索了Cochrane妊娠与分娩组试验注册库(2013年8月6日),检索了检索到的研究的参考文献列表并联系了试验作者。

选择标准

随机对照试验(RCT),比较血糖监测技术,包括自我血糖监测、持续葡萄糖监测(CGM)或患有糖尿病(1型或2型)的孕妇的门诊监测。研究监测时间和频率的试验也包括在内。准随机对照试验和采用整群随机设计的随机对照试验符合纳入条件,但未检索到。

数据收集与分析

两位综述作者独立评估研究的纳入资格,提取数据并评估纳入研究的偏倚风险。检查数据的准确性。

主要结果

检索妊娠与分娩组试验注册库识别出21篇试验报告。应用纳入标准后,本综述纳入了9项试验。纳入的试验共涉及506名女性(436名1型糖尿病女性和70名2型糖尿病女性)。所有试验均来自欧洲国家和美国。没有一项研究纳入妊娠期糖尿病女性。9项纳入研究中有5项存在中度偏倚风险,4项研究存在低至中度偏倚风险。主要结局为母体血糖控制(空腹血糖和糖化血红蛋白)和婴儿出生体重或巨大儿。试验中比较了各种血糖监测方法。本综述纳入了以下比较:(1)自我监测与标准护理,(2)自我监测与住院治疗,(3)餐前与餐后血糖监测,(4)自动远程医疗监测与传统系统,(5)持续葡萄糖监测与间歇性监测,以及(6)持续动态血糖监测与间歇性动态血糖监测。汇总分析和单项试验分析均未显示一种监测技术在主要结局(母体血糖控制和婴儿出生体重)以及次要结局如出生时孕周或早产、新生儿低血糖发生频率、包括死胎在内的婴儿死亡以及新生儿重症监护病房入住方面比另一种监测技术有任何显著优势。一项试验报告了关于巨大儿的主要结局数据,但截断值与本综述预先设定的不同。任何试验均未报告次要结局如肩难产、重大和轻微异常。

作者结论

本综述未发现证据表明在患有1型或2型糖尿病的孕妇中,任何血糖监测技术优于其他技术。监测技术有效性的证据基础薄弱,需要来自大型精心设计的随机试验的更多证据来指导血糖监测技术的选择。

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