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Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes

NCT06419777 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 430

Last updated 2024-11-21

No results posted yet for this study

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).

Conditions

  • Gestational Diabetes
  • Pregnancy Related

Interventions

DRUG

Insulin

Insulin will be used in gestational diabetics to control blood glucose levels

Sponsors & Collaborators

  • University of Rochester

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06419777 on ClinicalTrials.gov