Glucose Frequent of A1GDM in Labor

Recruiting

• Conditions: Gestational Diabetes, Controlled by Diet

• Registration Number: NCT06744621
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

This is a prospective double arm study in patients with Gestational Diabetes Mellitus (GDM) utilizing frequent (single fingerstick on admission) vs infrequent glucose monitoring in labor (q 4 hours in latent labor and every 2 hours in active labor). Primary Objective: The primary outcome is glucose value of the neonate at birth. Secondary Objectives: Determine rates of insulin requirements within different monitoring techniques. Determine if there is a difference in neonatal intensive care unit (NICU) admission within different monitoring techniques. Determine neonatal blood glucose concentrations at 24 hours of life, number of glucose treatments, and neonatal hyperbilirubinemia. Secondary characteristics to be viewed for each diagnosis; BMI, race, age, and parity.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study Start: 2024-12-05
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Study First Posted: 2024-12-20
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• All female patients of reproductive age (menarche-menopause: 18-51 years) who have the diagnosis diet controlled GDM

• Patient with singleton gestation presenting in labor or for induction

• Patients who had "good" glucose control and were A1GDM. Good Control;

  • • Patient with overall outpatient glucose average of less than 100
  • • No evidence of fetopathy, large for gestational age or polyhydramnios.
  • • Hgb A1c <5.7

Exclusion Criteria

• If patient's admission accu check is >120

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Neonatal glucose level	at 24 hours

Secondary Outcome Measures

Name	Time	Method
Number of neonates requiring insulin	at 24 hours
Number of NICU admissions	at 24 hours
Number of glucose treatments	at 24 hours
Number of neonatal with hyperbilirubinemia	at 24 hours

Trial Locations

Locations (1)

Mount Sinai West; 🇺🇸 New York, New York, United States