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RECRUITING
NCT06419777
NA

Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

Sponsor: Thomas Jefferson University

View on ClinicalTrials.gov

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

Interventions

DRUG

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