Glucose Frequent of A1GDM in Labor

Glucose Monitoring for A1GDM

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.

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes, Controlled by Diet
• Intervention / Treatment: Other: Fingerstick

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10019
      • Mount Sinai West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patient with A1GDM (diet controlled gestational diabetes)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infrequent; Patients will undergo one fingerstick on admission for their labor process.	Other: Fingerstick; fingersticks during their labor process
Frequent; Patients will undergo fingersticks every 4 hours in latent labor and 2 hour in active labor during their labor process.	Other: Fingerstick; fingersticks during their labor process

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Neonatal glucose level	at 24 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Thomas Owens, MD, Mount Sinai West

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Actual): July 15, 2025
• Last Update Submitted That Met QC Criteria: July 10, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: STUDY-24-01116

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No