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Glucose Frequent of A1GDM in Labor

Mount Sinai Health System logo

Mount Sinai Health System

Status

Completed

Conditions

Gestational Diabetes, Controlled by Diet

Treatments

Other: Fingerstick

Study type

Observational

Funder types

Other

Identifiers

NCT06744621
STUDY-24-01116

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

18 to 51 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Thomas Owens, MD

Data sourced from clinicaltrials.gov

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