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Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes
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 threshold is defined as two abnormal values or more over a one-week period (two fasting values elevated, two of the same post prandial values elevated, or 1 fasting and 1 post prandial value elevated), whereas the permissive threshold is defined as 50% of values elevated over 1 week (50% of overall fasting values, 50% of postprandial values, or 50% of overall values).
Official title: Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)
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
2024-11-21
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