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孕前患有糖尿病的女性孕期血糖监测技术。

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, West Helen M

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. 2017 Jun 11;6(6):CD009613. doi: 10.1002/14651858.CD009613.pub3.


DOI:10.1002/14651858.CD009613.pub3
PMID:28602020
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6481528/
Abstract

BACKGROUND: Self-monitoring of blood glucose (SMBG) 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 (30 November 2016), searched reference lists of retrieved studies and contacted trial authors. SELECTION CRITERIA: Randomised controlled trials (RCTs) and quasi-RCTs comparing techniques of blood glucose monitoring including SMBG, 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. 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. The quality of the evidence was assessed using the GRADE approach. MAIN RESULTS: This review update includes at total of 10 trials (538) women (468 women with type 1 diabetes and 70 women with type 2 diabetes). The trials took place in Europe and the USA. Five of the 10 included studies were at moderate risk of bias, four studies were at low to moderate risk of bias, and one study was at high risk of bias. The trials are too small to show differences in important outcomes such as macrosomia, preterm birth, miscarriage or death of baby. Almost all the reported GRADE outcomes were assessed as being very low-quality evidence. This was due to design limitations in the studies, wide confidence intervals, small sample sizes, and few events. In addition, there was high heterogeneity for some outcomes.Various methods of glucose monitoring were compared in the trials. Neither pooled analyses nor individual trial analyses showed any clear advantages of one monitoring technique over another for primary and secondary outcomes. Many important outcomes were not reported.1. Self-monitoring versus standard care (two studies, 43 women): there was no clear difference for caesarean section (risk ratio (RR) 0.78, 95% confidence interval (CI) 0.40 to 1.49; one study, 28 women) or glycaemic control (both very low-quality), and not enough evidence to assess perinatal mortality and neonatal mortality and morbidity composite. Hypertensive disorders of pregnancy, large-for-gestational age, neurosensory disability, and preterm birth were not reported in either study.2. Self-monitoring versus hospitalisation (one study, 100 women): there was no clear difference for hypertensive disorders of pregnancy (pre-eclampsia and hypertension) (RR 4.26, 95% CI 0.52 to 35.16; very low-quality: RR 0.43, 95% CI 0.08 to 2.22; very low-quality). There was no clear difference in caesarean section or preterm birth less than 37 weeks' gestation (both very low quality), and the sample size was too small to assess perinatal mortality (very low-quality). Large-for-gestational age, mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.3. Pre-prandial versus post-prandial glucose monitoring (one study, 61 women): there was no clear difference between groups for caesarean section (RR 1.45, 95% CI 0.92 to 2.28; very low-quality), large-for-gestational age (RR 1.16, 95% CI 0.73 to 1.85; very low-quality) or glycaemic control (very low-quality). The results for hypertensive disorders of pregnancy: pre-eclampsia and perinatal mortality are not meaningful because these outcomes were too rare to show differences in a small sample (all very low-quality). The study did not report the outcomes mortality or morbidity composite, neurosensory disability or preterm birth.4. Automated telemedicine monitoring versus conventional system (three studies, 84 women): there was no clear difference for caesarean section (RR 0.96, 95% CI 0.62 to 1.48; one study, 32 women; very low-quality), and mortality or morbidity composite in the one study that reported these outcomes. There were no clear differences for glycaemic control (very low-quality). No studies reported hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), neurosensory disability or preterm birth.5.CGM versus intermittent monitoring (two studies, 225 women): there was no clear difference for pre-eclampsia (RR 1.37, 95% CI 0.52 to 3.59; low-quality), caesarean section (average RR 1.00, 95% CI 0.65 to 1.54; I² = 62%; very low-quality) and large-for-gestational age (average RR 0.89, 95% CI 0.41 to 1.92; I² = 82%; very low-quality). Glycaemic control indicated by mean maternal HbA1c was lower for women in the continuous monitoring group (mean difference (MD) -0.60 %, 95% CI -0.91 to -0.29; one study, 71 women; moderate-quality). There was not enough evidence to assess perinatal mortality and there were no clear differences for preterm birth less than 37 weeks' gestation (low-quality). Mortality or morbidity composite, neurosensory disability and preterm birth less than 34 weeks were not reported.6. Constant CGM versus intermittent CGM (one study, 25 women): there was no clear difference between groups for caesarean section (RR 0.77, 95% CI 0.33 to 1.79; very low-quality), glycaemic control (mean blood glucose in the 3rd trimester) (MD -0.14 mmol/L, 95% CI -2.00 to 1.72; very low-quality) or preterm birth less than 37 weeks' gestation (RR 1.08, 95% CI 0.08 to 15.46; very low-quality). Other primary (hypertensive disorders of pregnancy, large-for-gestational age, perinatal mortality (stillbirth and neonatal mortality), mortality or morbidity composite, and neurosensory disability) or GRADE outcomes (preterm birth less than 34 weeks' gestation) were not reported. 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(SMBG)被推荐作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(2016年11月30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。 入选标准:随机对照试验(RCT)和半随机对照试验,比较血糖监测技术,包括患有1型或2型糖尿病的孕妇的血糖自我监测、持续葡萄糖监测(CGM)或门诊监测。调查监测时间和频率的试验也包括在内。采用整群随机设计的RCT符合纳入标准,但未检索到相关研究。 数据收集与分析:两位综述作者独立评估研究的入选资格,提取数据并评估纳入研究的偏倚风险。检查数据的准确性。采用GRADE方法评估证据质量。 主要结果:本次综述更新共纳入10项试验(538名)女性(468名1型糖尿病女性和70名2型糖尿病女性)。试验在欧洲和美国进行。10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,一项研究存在高偏倚风险。这些试验规模太小,无法显示巨大儿、早产、流产或婴儿死亡等重要结局的差异。几乎所有报告的GRADE结局均被评估为极低质量的证据。这是由于研究中的设计局限性、宽置信区间、小样本量和少量事件。此外,一些结局存在高度异质性。试验中比较了各种血糖监测方法。汇总分析和单个试验分析均未显示一种监测技术在主要和次要结局方面优于另一种监测技术。许多重要结局未报告。1. 自我监测与标准护理(两项研究,43名女性):剖宫产(风险比(RR)0.78,95%置信区间(CI)0.40至1.49;一项研究,28名女性)或血糖控制(均为极低质量)无明显差异,且没有足够证据评估围产期死亡率、新生儿死亡率和发病率综合情况。两项研究均未报告妊娠高血压疾病、大于胎龄儿、神经感觉障碍和早产情况。2. 自我监测与住院治疗(一项研究,100名女性):妊娠高血压疾病(先兆子痫和高血压)(RR 4.26,95%CI 0.52至35.16;极低质量:RR 0.43,95%CI 0.08至2.22;极低质量)无明显差异。剖宫产或小于37周妊娠的早产无明显差异(均为极低质量),且样本量太小无法评估围产期死亡率(极低质量)。未报告大于胎龄儿、死亡率或发病率综合情况、神经感觉障碍和小于34周的早产情况。3. 餐前与餐后血糖监测(一项研究,61名女性):剖宫产(RR 1.45,95%CI 0.92至2.28;极低质量)、大于胎龄儿(RR 1.16,95%CI 0.73至1.85;极低质量)或血糖控制(极低质量)在两组之间无明显差异。妊娠高血压疾病(先兆子痫)和围产期死亡率的结果无意义,因为这些结局很少见,在小样本中无法显示差异(均为极低质量)。该研究未报告死亡率或发病率综合情况、神经感觉障碍或早产情况。4. 自动远程医疗监测与传统系统(三项研究,84名女性):剖宫产(RR 0.96,95%CI 0.62至1.48;一项研究,32名女性;极低质量)以及报告这些结局的一项研究中的死亡率或发病率综合情况无明显差异。血糖控制无明显差异(极低质量)。没有研究报告妊娠高血压疾病、大于胎龄儿、围产期死亡率(死产和新生儿死亡率)、神经感觉障碍或早产情况。5. 持续葡萄糖监测与间歇监测(两项研究,225名女性):先兆子痫(RR 1.37,95%CI 0.52至3.59;低质量)、剖宫产(平均RR 1.00,95%CI 0.65至1.54;I² = 62%;极低质量)和大于胎龄儿(平均RR 0.89,95%CI 0.41至1.92;I² = 82%;极低质量)无明显差异。持续监测组女性以平均母体糖化血红蛋白(HbA1c)表示的血糖控制较低(平均差异(MD)-0.60%,95%CI -0.91至-0.29;一项研究,71名女性;中等质量)。没有足够证据评估围产期死亡率,小于37周妊娠的早产无明显差异(低质量)。未报告死亡率或发病率综合情况、神经感觉障碍和小于34周的早产情况。6. 持续动态血糖监测与间歇动态血糖监测(一项研究,25名女性):剖宫产(RR,)、血糖控制(孕晚期平均血糖)(MD -0.14 mmol/L, 95% CI -2.00至1.72;极低质量)或小于37周妊娠的早产(RR 1.08,95%CI 0.08至15.46;极低质量)在两组之间无明显差异。未报告其他主要结局(妊娠高血压疾病、大于胎龄儿、围产期死亡率(死产和新生儿死亡率)、死亡率或发病率综合情况以及神经感觉障碍)或GRADE结局(小于34周妊娠的早产)。 作者结论:本综述未发现证据表明,对于患有1型或2型糖尿病的孕妇,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,以指导血糖监测技术的选择。

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本文引用的文献

[1]
CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.

BMC Pregnancy Childbirth. 2016-7-18

[2]
Different intensities of glycaemic control for pregnant women with pre-existing diabetes.

Cochrane Database Syst Rev. 2016-5-4

[3]
Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes.

Cochrane Database Syst Rev. 2014-4-30

[4]
Severe hypoglycemia in pregnant women with type 2 diabetes-A relevant clinical problem.

Diabetes Res Clin Pract. 2013-11

[5]
Real-time continuous glucose monitoring during labour and delivery in women with Type 1 diabetes - observations from a randomized controlled trial.

Diabet Med. 2013-7-26

[6]
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Diabetes Care. 2013-1-24

[7]
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BMC Pregnancy Childbirth. 2012-12-27

[8]
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Cochrane Database Syst Rev. 2012-1-18

[9]
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Cochrane Database Syst Rev. 2012-1-18

[10]
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