Abstract:Background/Aims: Fast-acting insulin analogues (FAIAs) are being used more frequently during pregnancy. Previous studies comparing regular insulin (RI) and FAIA consist primarily of women enrolled with pre-existing diabetes; therefore, we compared pregnancy and neonatal outcomes in women with gestational diabetes. Methods: We retrospectively investigated 197 pregnant women with gestational diabetes mellitus (GDM) requiring insulin treatment for glycemic control. Individuals were divided into 2 groups: RI (n = … Show more
Metformin may be beneficial in treating gestational diabetes. However, even more studies are needed to provide more evidence for the future use of metformin.
Metformin may be beneficial in treating gestational diabetes. However, even more studies are needed to provide more evidence for the future use of metformin.
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.
Supplementary Information
The online version contains supplementary material available at 10.1007/s13300-024-01541-6.
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