ArticleContemporary clinical trials2023
GAP (gestational diabetes and pharmacotherapy) - study protocol for a randomized controlled, two-arm, single-site trial.
Article in Contemporary clinical trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.
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Who cites it
3 citing papers in PubMed, 3 citations in OpenAlex.
- Evaluation of fetal frontal lobe development and Evans index in pregnancies complicated by gestational diabetes mellitus: prospective comparative observational study.BMC pregnancy and childbirth · 2026Observational
- Barriers and facilitators to insulin management in pregnant people with gestational diabetes mellitus: A qualitative study.Pregnancy (Hoboken, N.J.) · 2026Article
- From Standard of Care to Emerging Innovations: Navigating the Evolution of Pharmacological Treatment of Gestational Diabetes.American journal of perinatology · 2025Review
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
Abstract
backgroundGestational diabetes (GDM) complicates 10% of pregnancies in the US. First-line treatment is medical nutrition therapy (MNT) and exercise. Second line is pharmacotherapy. The definition of what constitutes an unsuccessful trial of MNT and exercise has not been established. Tight glycemic control has been demonstrated to reduce GDM-related neonatal and maternal clinical complications. However, it could also increase rates of small-for-gestational age and carry negative effects on patient-reported outcomes such as anxiety and stress. We will study the effect of earlier and stricter pharmacotherapy in GDM on clinical and patient-reported outcomes.
methodsGDM and pharmacotherapy (GAP) study is a two-arm parallel, pragmatic randomized controlled trial, where 416 participants with GDM are randomized 1:1 to: 1) Intervention group - insulin initiation at 20% elevated glucose values on a weekly glucose log following MNT and exercise trial and insulin titration to keep elevated glucose values <20%; or 2) Active control group - insulin initiation at 40% elevated glucose values on a weekly log following MNT and exercise and insulin titration to keep elevated glucose values <40%. The primary outcome is a composite neonatal outcome of large-for-gestational-age, macrosomia, birth trauma, preterm birth, hypoglycemia, and hyperbilirubinemia. Secondary outcomes include preeclampsia, cesarean birth, small-for-gestational-age, maternal hypoglycemia, and patient-reported outcomes of anxiety, depression, perceived stress, and diabetes self-efficacy.
conclusionsThe GAP study will investigate the optimal glycemic threshold for pharmacotherapy addition to MNT and exercise in GDM. The GAP study will promote standardization in GDM management and will have direct relevance for clinical practice.
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