Faculty Collaboration Database

GAP (gestational diabetes and pharmacotherapy) - study protocol for a randomized controlled, two-arm, single-site trial. Contemp Clin Trials 2023 Aug;131:107237

Date

05/29/2023

Pubmed ID

37245726

Pubmed Central ID

PMC10527045

DOI

10.1016/j.cct.2023.107237

Scopus ID

2-s2.0-85161020150 (requires institutional sign-in at Scopus site)   2 Citations

Abstract

BACKGROUND: 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.

METHODS: 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 <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.

CONCLUSIONS: The 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.

Author List

Palatnik A, Saffian E, Flynn KE, Pan AY, Yee LM, Basir MA, Cruz M

Authors

Mir Abdul Basir MD Professor in the Pediatrics department at Medical College of Wisconsin
Meredith Cruz MD Associate Professor in the Obstetrics and Gynecology department at Medical College of Wisconsin
Kathryn Eve Flynn PhD Vice Chair, Professor in the Medicine department at Medical College of Wisconsin
Anna Palatnik MD Associate Professor in the Obstetrics and Gynecology department at Medical College of Wisconsin
Amy Y. Pan PhD Associate Professor in the Pediatrics department at Medical College of Wisconsin

MESH terms used to index this publication - Major topics in bold

Blood Glucose
Diabetes, Gestational
Female
Glucose
Humans
Hypoglycemia
Infant, Newborn
Insulin
Pragmatic Clinical Trials as Topic
Pregnancy
Pregnancy Outcome
Premature Birth
Randomized Controlled Trials as Topic