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Intensive Glycemic Control for Gestational Diabetes in Overweight/Obese Women (iGDM Trial)

N/A
Recruiting
Led By Christina Scifres, MD
Research Sponsored by Indiana University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)
Pregnant women between the ages of 18-45 with singleton gestation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 24 hours of delivery
Awards & highlights

iGDM Trial Summary

This trial is testing whether a more intensive glycemic target is better for overweight and obese individuals with gestational diabetes.

Who is the study for?
This trial is for overweight or obese pregnant women aged 18-45 with gestational diabetes. They should have a BMI of at least 25 kg/m2 (or ≥23 kg/m2 in Asian Americans) and be between 12 to almost 33 weeks into their pregnancy. Women with significant fetal anomalies, communication barriers, non-study hospital delivery plans, inability to consent, kidney disease with high creatinine levels, or recent steroid use can't participate.Check my eligibility
What is being tested?
The study compares two approaches to managing blood sugar in participants: one group will follow intensive glycemic targets while the other follows standard ones. It's a multicenter trial where participants are randomly assigned to either group.See study design
What are the potential side effects?
Potential side effects may include low blood sugar episodes more frequently in the intensive treatment group due to tighter glucose control. Other risks could relate to the methods used for maintaining these targets but are not specified here.

iGDM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI was 25 or higher (23 if I'm Asian American) at my first prenatal visit.
Select...
I am pregnant, aged 18-45, and expecting one baby.

iGDM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 72 hours of delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 72 hours of delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with composite neonatal morbidity
Secondary outcome measures
Early maternal glycemic levels
Episodes of maternal hypoglycemia
Glycemic levels during study enrollment
+14 more

iGDM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive glycemic targetsExperimental Treatment1 Intervention
Participants in this arm will target a fasting blood glucose of <90 mg/dL and 1 hour post-prandial blood glucose values <120 mg/dL.
Group II: Standard glycemic targetsActive Control1 Intervention
Participants in this arm will target a fasting blood glucose of <95 mg/dL and 1 hour post-prandial blood glucose values <140 mg/dL.

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandOTHER
110 Previous Clinical Trials
37,985 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,977 Previous Clinical Trials
2,679,965 Total Patients Enrolled
University of OklahomaOTHER
455 Previous Clinical Trials
94,828 Total Patients Enrolled

Media Library

Intensive glycemic targets (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05124808 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research protocol include individuals aged 80 or above?

"This clinical trial has an age range requirement of 18 to 45, as specified in the entry requirements."

Answered by AI

How many participants are currently taking part in this clinical trial?

"Indeed, the data hosted on clinicaltrials.gov confirms that this medical study is actively seeking participants. This trial was first posted on March 1st 2022 and has been most recently updated on March 15th of the same year. 828 individuals are required to be recruited from a single site in order for the trial to move forward."

Answered by AI

What criteria must be met by prospective participants in this clinical experiment?

"Candidates between the age of 18 and 45 with a diagnosis of diabetes mellitus may be eligible for this trial, which plans to recruit 828 participants."

Answered by AI

Are there any current opportunities to enroll in this trial?

"Affirmative, the findings on clinicaltrials.gov demonstrate that this trial is currently recruiting suitable participants. It was first announced on March 1st 2022 and updated for a final time two weeks later. A total of 828 individuals are required from one facility to complete the study."

Answered by AI
~372 spots leftby Apr 2026