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Glucose Monitoring for Gestational Diabetes

N/A
Recruiting
Led By Thomas Owens, MD
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
All female patients of reproductive age who have the diagnosis GDM
Be older than 18 years old
Must not have
Patients below the age of 18
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study at 6 months

Summary

This trial aims to compare different protocols for monitoring blood sugar levels in pregnant women with Gestational Diabetes Mellitus during labor. The study will randomly assign patients to either regular or less frequent blood sugar monitoring,

Who is the study for?
This trial is for pregnant individuals with Gestational Diabetes Mellitus (GDM). It's designed to see if the frequency of checking blood sugar levels during labor affects their newborns' risk of low blood sugar. Participants will be randomly assigned to either 'frequent' or 'infrequent' glucose monitoring groups.
What is being tested?
The study tests two different approaches to monitor blood sugar in laboring mothers with GDM: one group will have their glucose checked frequently, while the other less so. The main goal is to observe how these methods impact the baby's blood sugar level at birth.
What are the potential side effects?
Since this trial involves fingerstick testing for glucose levels, potential side effects are minimal and may include discomfort or bruising at the site of the finger prick.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am of childbearing age and have been diagnosed with gestational diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am under 18 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study at 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study at 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Neonatal Hypoglycemia

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Infrequent testingExperimental Treatment1 Intervention
Finger sticks every 4 hours in latent labor (less than 5cm cervical dilation) and every 2 hours in active labor (6cm and greater)
Group II: Frequent testingPlacebo Group1 Intervention
Finger sticks every 2 hours in latent labor (less than 5cm cervical dilation) and every 1 hours in active labor (6cm and greater)

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,661 Total Patients Enrolled
Thomas Owens, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
~0 spots leftby Nov 2024
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