混合闭环胰岛素治疗与1型糖尿病孕妇标准治疗：随机对照试验的系统回顾和荟萃分析

IF 2.1 4区医学 Q2 OBSTETRICS & GYNECOLOGY

European journal of obstetrics, gynecology, and reproductive biology Pub Date : 2025-04-08 DOI:10.1016/j.ejogrb.2025.113969

Sohaira Tahir , Shafia Naeem , Izzah Nayyab , Aafia Batool , Sameer Emeish , Ilma Hasan , Arjun Dhir , Jawad Shahid , Muhammad Sheraz , Jaskaran Singh , Amandeep Kaur , Mohammad Umer , Antonio Simone Laganà

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引用次数: 0

摘要

目的：通过对随机对照试验（RCTs）的结果进行汇总，探讨混合闭环（HCL）系统与标准治疗（SC）相比对1型糖尿病（T1DM）孕妇的疗效和安全性。数据来源我们检索了PubMed， Cochrane, Embase, Web of Science, Clinicaltrials.gov等多个数据库，从成立到2024年9月，筛选后发现6项相关研究。研究入选标准我们纳入了以下研究：(1)随机对照试验；患者人群为(2)妊娠1型糖尿病患者；干预组接受(3)HCL，对照组接受(4)SC；同时报告(5)感兴趣的结果（终点）。我们汇总了与主要结果相关的结果；范围内时间（TIR）、夜间范围内时间（nTIR）和HbA1c；以及相关的次要结果。研究评价和综合方法我们使用Rob 2：一种改进的Cochrane随机试验风险偏倚工具对纳入的随机对照试验进行质量评估。我们采用dersimonan - laird随机效应模型，使用review manager 5.4对汇总估计和报告结果进行风险比分析；对于二分类结果；或平均差异；为了持续的结果。结果筛选了5个不同人群的rct （n = 274）进行分析。TIR （MD 4.95%; - 0.56 - 10.49）和HbA1c% (MD 0.09；- 0.44 - 0.63)无统计学意义，而nTIR的估计(MD为11.16%；7.15至15.15),% time <；63 mg/dL (MD -0.78；- 1.36至- 0.20)，%的时间<；54 mg/dL (MD -0.22；- 0.40 ~ - 0.03)，低血糖指数（LBGI） (MD -0.30；- 0.54 ~ - 0.06)，葡萄糖标准偏差(MD - 3.05；- 6.06 ~ - 0.04)， HCL优于SC。其他次要结局：140 mg/dL、180 mg/dL、平均血糖水平、严重不良事件发生率、剖宫产率和严重低血糖，组间无显著差异。结论shcl系统可以改善T1DM孕妇的血糖控制，但不良事件可容忍，但需要更多的研究来得出明确的结论。

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Hybrid closed loop insulin therapy versus standard therapy in pregnant women with type 1 diabetes: A systematic review and meta-analysis of randomized controlled trials

Objective

We aimed to explore the efficacy and safety of hybrid closed loop (HCL) systems compared to standard care (SC) in pregnant women with Type 1 Diabetes Mellitus (T1DM), pooling results from randomized controlled trials (RCTs).

Data sources

We searched through multiple databases like PubMed, Cochrane, Embase, Web of Science, and Clinicaltrials.gov etc. from inception to September 2024 and found six relevant studies after screening.

Study eligibility criteria

We included studies that were (1) RCTs; with patient population (2) pregnant patients with type 1 diabetes; intervention group receiving (3) HCL and control group receiving (4) SC; while reporting (5) outcomes of interest (endpoints). We pooled results pertaining to primary outcomes; time in range (TIR), nocturnal time in range (nTIR), and HbA1c; and relevant secondary outcomes.

Study appraisal and synthesis methods

We used Rob 2: A revised Cochrane risk-of-bias tool for randomized trials for quality assessment of the included RCTs. We employed the DerSimonian-Laird random effects model using review manager 5.4 to analyze the pooled estimates and reported results as risk ratio; for dichotomous outcomes; or mean difference; for continuous outcomes.

Results

Five RCTs (n = 274) with disparate populations were narrowed down for analysis. Pooled estimates for TIR (MD 4.95 %;−0.56 to 10.49)and HbA1c% (MD 0.09; −0.44 to 0.63) were statistically non-significant, while estimates for nTIR (MD 11.16 %; 7.15 to 15.15), % time < 63 mg/dL (MD –0.78; −1.36 to −0.20), % of time < 54 mg/dL (MD –0.22; −0.40 to −0.03), low blood glucose index (LBGI) (MD –0.30; −0.54 to −0.06), and glucose standard deviation (MD −3.05; −6.06 to −0.04) favored HCL over SC. No significant between-group differences were found in other secondary outcomes: % of time >140 mg/dL, % of time >180 mg/dL, mean glucose level, rate of serious adverse events, cesarian delivery, and severe hypoglycemia.

Conclusions

HCL systems can improve glycemic control in pregnant women with T1DM with a tolerable adverse event profile, however more research is needed to draw a definitive conclusion.

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来源期刊

European journal of obstetrics, gynecology, and reproductive biology 医学-妇产科学

CiteScore

4.60

自引率

3.80%

发文量

898

审稿时长

8.3 weeks

期刊介绍： The European Journal of Obstetrics & Gynecology and Reproductive Biology is the leading general clinical journal covering the continent. It publishes peer reviewed original research articles, as well as a wide range of news, book reviews, biographical, historical and educational articles and a lively correspondence section. Fields covered include obstetrics, prenatal diagnosis, maternal-fetal medicine, perinatology, general gynecology, gynecologic oncology, uro-gynecology, reproductive medicine, infertility, reproductive endocrinology, sexual medicine and reproductive ethics. The European Journal of Obstetrics & Gynecology and Reproductive Biology provides a forum for scientific and clinical professional communication in obstetrics and gynecology throughout Europe and the world.