Insulin Use During Gestational and Pre-existing Diabetes in Pregnancy: A Systematic Review of Study Design.

IF 3.8 3区医学 Q2 Medicine

Diabetes Therapy Pub Date : 2024-05-01 Epub Date: 2024-03-18 DOI:10.1007/s13300-024-01541-6

Kristin Castorino, Beatrice Osumili, Theophilus Lakiang, Kushal Kumar Banerjee, Andrea Goldyn, Carolina Piras de Oliveira

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Abstract

Introduction: Insulin is the first-line pharmacologic therapy for women with diabetes in pregnancy. However, conducting well-designed randomized clinical trials (RCTs) and achieving recommended glycemic targets remains a challenge for this unique population. This systematic literature review (SLR) aimed to understand the evidence for insulin use in pregnancy and the outcome metrics most often used to characterize its effect on glycemic, maternal and fetal outcomes in gestational diabetes mellitus (GDM) and in pregnant women with diabetes.

Methods: An SLR was conducted using electronic databases in Medline, EMBASE via Ovid platform, evidence-based medicine reviews (2010-2020) and conference proceedings (2018-2019). Studies were included if they assessed the effect of insulin treatment on glycemic, maternal or fetal outcomes in women with diabetes in pregnancy. Studies on any type of diabetes other than gestational or pre-existing diabetes as well as non-human studies were excluded.

Results: In women diagnosed with GDM or pre-existing diabetes, most studies compared treatment of insulin with metformin (n = 35) followed by diet along with lifestyle intervention (n = 24) and glibenclamide (n = 12). Most studies reporting on glycemic outcomes compared insulin with metformin (n = 22) and glibenclamide (n = 4). Fasting blood glucose was the most reported clinical outcome of interest. Among the studies reporting maternal outcomes, method of delivery and delivery complications were most commonly reported. Large for gestational age, stillbirth and perinatal mortality were the most common fetal outcomes reported.

Conclusion: This SLR included a total of 108 clinical trials and observational studies with diverse populations and treatment arms. Outcomes varied across the studies, and a lack of consistent outcome measures to manage diabetes in pregnant women was observed. This elucidates a need for global consensus on study design and standardized clinical, maternal and fetal outcomes metrics.

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妊娠期使用胰岛素与妊娠前期糖尿病：研究设计的系统回顾。

简介胰岛素是治疗妊娠期糖尿病妇女的一线药物疗法。然而，对这一特殊人群而言，开展设计良好的随机临床试验（RCT）并实现推荐的血糖目标仍是一项挑战。本系统性文献综述（SLR）旨在了解妊娠期使用胰岛素的证据，以及最常用于描述胰岛素对妊娠期糖尿病（GDM）和糖尿病孕妇的血糖、母体和胎儿结局影响的结果指标：使用 Medline、EMBASE（通过 Ovid 平台）、循证医学综述（2010-2020 年）和会议论文集（2018-2019 年）中的电子数据库进行 SLR。如果研究评估了胰岛素治疗对妊娠期糖尿病妇女的血糖、母体或胎儿结局的影响，则纳入该研究。除妊娠期糖尿病或原有糖尿病外，其他类型糖尿病的研究以及非人类研究均被排除在外：在确诊为 GDM 或原有糖尿病的妇女中，大多数研究比较了胰岛素与二甲双胍（35 例）的治疗方法，其次是饮食与生活方式干预（24 例）和格列本脲（12 例）。大多数报告血糖结果的研究将胰岛素与二甲双胍（22 例）和格列本脲（4 例）进行了比较。报道最多的临床结果是空腹血糖。在报告产妇结局的研究中，分娩方式和分娩并发症是最常见的报道。胎龄过大、死胎和围产期死亡是最常见的胎儿结局报告：本 SLR 共包括 108 项临床试验和观察性研究，研究对象和治疗手段各不相同。各项研究的结果各不相同，而且在孕妇糖尿病管理方面缺乏一致的结果衡量标准。这说明有必要就研究设计和标准化临床、孕产妇和胎儿结果指标达成全球共识。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Diabetes Therapy Medicine-Endocrinology, Diabetes and Metabolism

CiteScore

6.90

自引率

7.90%

发文量

130

审稿时长

6 weeks

期刊介绍： Diabetes Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all areas of diabetes. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Diabetes Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.