RecruitingNot ApplicableNCT06419777

Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

Strict Versus Permissive Threshold for Initiation of Pharmacotherapy in Gestational Diabetes Mellitus (GDM) With Glucometer Use - A Randomized Control Trial (START1)


Sponsor

Thomas Jefferson University

Enrollment

430 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Insulin for people with gestational diabetes and pregnancy related. The study is currently recruiting participants at 2 locations. People eligible for this study include women aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInsulin

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

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NCT06419777


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