Intensive Glycemic Targets for Gestational Diabetes in Overweight and Obese Women

This study is looking at how different blood sugar (glycemic) targets affect pregnant women who have gestational diabetes and are also overweight or obese. Researchers are comparing two approaches: an "intensive" target, aiming for fasting blood glucose below 90 mg/dL and 1-hour post-meal below 120 mg/dL, versus a "standard" target, aiming for fasting below 95 mg/dL and 1-hour post-meal below 140 mg/dL. The study wants to see if the intensive targets can reduce problems for newborns. You might be able to join if you are a pregnant woman between 18 and 45 years old, carrying one baby, are between 12 and 32 weeks pregnant, have gestational diabetes, and had a BMI of 25 or higher at your first prenatal visit. The study plans to enroll 828 participants, but its current status is unclear.

Study design
This is a randomized clinical trial, meaning participants will be randomly assigned to one of the two blood sugar target groups. It plans to include 828 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Newborns will be monitored for up to 7 days after delivery to assess for health problems.

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NCT05124808

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

Recruiting
NAAges 18–45InterventionalTreatment
Indiana University
~828 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:Intensive glycemic targetsStandard glycemic targets

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with composite neonatal morbidity
Measured over Within 7 days of delivery
Gestational Diabetes
Pregnancy, High Risk
Overweight and Obesity
5 sites across 5 states
Alabama1
Indiana1
Oklahoma1
Pennsylvania1
Rhode Island1
  • Christina Scifres, MD · PRINCIPAL_INVESTIGATOR · Indiana University

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Eligibility criteria

Inclusion

Pregnant women between the ages of 18-45
Singleton gestation
Gestational age between 12 0/7-32 6/7 weeks' gestation with gestational diabetes diagnosed during this time frame using either a 50g 1-hr GCT ≥200 mg/dL or two or more abnormal values on a 100g OGTT using the Carpenter-Coustan Criteria
Overweight or obese BMI at the first prenatal visit (BMI ≥25 kg/m2 or ≥23 kg/m2 in Asian Americans)

Exclusion

Inability or unwillingness to provide informed consent
Inability to communicate with members of the study team, despite the presence of an interpreter
Planned delivery at a non-study affiliated hospital
Known renal disease with a baseline creatinine \>1.5 mg/dL
Significant fetal anomalies diagnosed prior to study enrollment (these will include anomalies such as gastroschisis, spina bifida, complex congenital heart disease, or serious karyotypic anomalies that may lead to early delivery or increased risk of neonatal death)
Oral or IV/IM steroid use within 7 days of study enrollment
  • Number of participants with composite neonatal morbidityWithin 7 days of delivery

    Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome