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Review
. 2024 May;15(5):929-1045.
doi: 10.1007/s13300-024-01541-6. Epub 2024 Mar 18.

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

Kristin Castorino  1 , Beatrice Osumili  2 , Theophilus Lakiang  3 , Kushal Kumar Banerjee  3 , Andrea Goldyn  4 , Carolina Piras de Oliveira  4
Affiliations
Review

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

Kristin Castorino et al. Diabetes Ther. 2024 May.

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.

Keywords: Gestational diabetes mellitus; Insulin use in pregnancy; Pregnancy; Systematic review; Type 1 diabetes mellitus; Type 2 diabetes mellitus.

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Conflict of interest statement

Beatrice Osumili, Kushal Kumar Banerjee, Andrea Goldyn, and Carolina Piras De Oliveira are full-time employees and shareholders of Eli Lilly and Company. Theophilus Lakiang was an employee of Eli Lilly and Company at the time this research was conducted and is currently an employee of GE Healthcare. Kristin Castorino receives research support provided to her institution from Dexcom, Abbott, Medtronic, Novonordisk, Ely Lilly, and Insulet and consulting fees from Dexcom. Theophilus Lakiang: Author affiliation has changed since the time this research was conducted. Assigned affiliation is the institution of employment at the time this research was conducted.

Figures

Fig. 1
Fig. 1
PRISMA flow diagram presenting number of studies included and excluded at each stage of screening
See this image and copyright information in PMC

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