GAP (gestational diabetes and pharmacotherapy) – study protocol for a randomized controlled, two-arm, single-site trial

• Published in: Contemporary clinical trials 2023-08, Vol.131, p.107237-107237, Article 107237
• Main Authors: Palatnik, Anna, Saffian, Eleanor, Flynn, Kathryn E., Pan, Amy Y., Yee, Lynn M., Basir, Mir Abdul, Cruz, Meredith
• Format: Article
• Language: English
• Subjects: Blood Glucose; Diabetes, Gestational - drug therapy; Female; Gestational diabetes; Glucose - therapeutic use; Humans; Hypoglycemia; Infant, Newborn; Insulin; Insulin - therapeutic use; Medical nutrition therapy; Neonatal outcomes; Patientreported outcomes; Pharmacotherapy; Pregnancy; Pregnancy Outcome; Premature Birth - drug therapy; Randomized Controlled Trials as Topic
• ISSN: 1551-7144; 1559-2030; 1559-2030
• DOI: 10.1016/j.cct.2023.107237

Gestational 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. GDM 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