Recruiting

Glycemic Targets

Sponsor:

Indiana University

Code:

NCT05124808

Conditions

Gestational Diabetes

Pregnancy, High Risk

Overweight and Obesity

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Interventions

Intensive glycemic targets

Standard glycemic targets

Study Details

Brief summary:

This is a multicenter randomized clinical trial of 828 overweight and obese individuals with gestational diabetes designed to compare standard to intensive glycemic targets.

Conditions

Gestational Diabetes

Pregnancy, High Risk

Overweight and Obesity

Study ID

NCT05124808

Start date

Mar 1, 2022

Status verified date

Jun, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

828 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intensive glycemic targets

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.

active comparator: Standard glycemic targets

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.

Interventions

Intensive glycemic targets

Fasting blood glucose <90 mg/dL, 1 hour post-prandial blood glucose <120 mg/dL

Standard glycemic targets

Fasting blood glucose <95 mg/dL, 1 hour post-prandial blood glucose <140 mg/dL

Primary outcome measure

  • Number of participants with composite neonatal morbidity [ Time Frame: Within 7 days of delivery ]

Central Contacts and Locations

Central contacts

Sarah Oswalt

(317)944-7069seoswalt@iu.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Ashley Battarbee, MD, MSCR

anbattarbee@uambc.edu

Principal Investigator:

Ashley Battarbee, MD, MSCR

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Christina Scifres, MD

(317) 948-4103cmscifre@iu.edu

Sarah Oswalt, RN, BSN

(317) 944-7069seoswalt@iu.edu

Principal Investigator:

Christina Scifres, MD

University of Oklahoma

Recruiting

Norman, Oklahoma, United States, 73019

Contacts

Stephanie Pierce, MD

Stephanie-Pierce@ouhsc.edu

Principal Investigator:

Stephanie Pierce, MD

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15260

Contacts

Maisa Feghali, MD

feghalim@mwri.magee.edu

Principal Investigator:

Maisa Feghali, MD

Women and Infants Hospital of Rhode Island

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Methodius Tuuli, MD, MPH, MBA

MTuuli@Wihri.org

Principal Investigator:

Methodius Tuuli, MD, MPH, MBA

More Information

Sponsor

Indiana University

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Indiana University on 2026-06-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.