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Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)
Sponsor: Thomas Jefferson University
Summary
The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.
Official title: Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Continuous Glucose Monitoring Use - A Randomized Control Trial (START 2 Trial)
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
430
Start Date
2024-09-01
Completion Date
2026-05
Last Updated
2024-11-22
Healthy Volunteers
Yes
Conditions
Interventions
Insulin
Insulin will be used in gestational diabetics to control blood glucose levels
Locations (2)
University of Rochester Medical Center
Rochester, New York, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States