← Back to Search

Other

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

Q: 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.

Q: 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.

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

Candidates between the age of 18 and 45 with a diagnosis of <a href="https://www.withpower.com/clinical-trials/diabetes">diabetes</a> mellitus may be eligible for this trial, which plans to recruit 828 participants.

Q: 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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after randomization 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Women and Infants Hospital of Rhode IslandOTHER

109 Previous Clinical Trials

37,772 Total Patients Enrolled

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,971 Previous Clinical Trials

2,676,624 Total Patients Enrolled

University of OklahomaOTHER

455 Previous Clinical Trials

95,004 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

Recent research and studies

clinicaltrials.govStudy

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Christina Scifres 2022. "Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05124808.