Glucose Monitoring for A1GDM
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Neonatal glucose level
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 51 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Neonatal glucose level
Time Frame: at 24 hours
Secondary Outcomes
- Number of NICU admissions(at 24 hours)
- Number of glucose treatments(at 24 hours)
- Number of neonates requiring insulin(at 24 hours)
- Number of neonatal with hyperbilirubinemia(at 24 hours)
Investigators
Thomas Owens
Maternal Fetal Medicine Fellow
Icahn School of Medicine at Mount Sinai