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Completed

NCT Number: NCT06744621

Glucose Frequent of A1GDM in Labor

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.

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Key information

Conditions

Gestational Diabetes, Controlled by Diet Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year–51 year

Sex eligibility

Female

Study type

Observational

Primary location

Mount Sinai West

New York, 10019, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fingerstick

Other

fingersticks during their labor process

Primary outcomes

  1. Neonatal glucose level

    Time frame: at 24 hours

Secondary outcomes

  1. Number of neonates requiring insulin

    Time frame: at 24 hours

  2. Number of NICU admissions

    Time frame: at 24 hours

  3. Number of glucose treatments

    Time frame: at 24 hours

  4. Number of neonatal with hyperbilirubinemia

    Time frame: at 24 hours

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Glucose Monitoring for A1GDM

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2024
Registry last updated
Jul 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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