Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes

NCT ID: NCT05124808

Last Updated: 2025-08-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 828 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-01
• Study Completion Date: 2026-04-08

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.

Detailed Description

The prevalence of both obesity and gestational diabetes mellitus (GDM) have increased, and each is associated with adverse perinatal outcomes including fetal overgrowth, neonatal morbidity, hypertensive disorders of pregnancy, and cesarean delivery. Women with GDM who are also overweight and obese have higher rates of pregnancy complications when compared to normal weight women with GDM, which may occur in part due to suboptimal glycemic control. The current recommendations for glycemic targets in pregnant women with diabetes are not rigorously defined, and they far exceed the mean fasting (70.9 ±7.8 mg/dL) and 1 hour post- prandial (108.9 ± 12.9 mg/dL) glucose values in pregnant women without GDM. Our prior work demonstrated that use of intensive (fasting <90, 1 hr post-prandial <120 mg/dL) compared to standard (fasting <95 mg/dL, 1 hr post-prandial <140 mg/dL) glycemic targets resulted in improved glycemic control without increasing the risk for hypoglycemia. The Intensive Glycemic Targets in Overweight and Obese Women with Gestational Diabetes Mellitus: A Multicenter Randomized Trial (iGDM Trial) is a large, pragmatic randomized clinical trial designed to investigate the impact of intensive versus standard glycemic targets on perinatal outcomes in women with GDM who are overweight and obese. During the 5-year project period, a multidisciplinary team of investigators from 4 medical centers representing regions of the U.S. with high rates of obesity will randomize 828 overweight and obese women with GDM to either intensive or standard glycemic targets. The specific aims of this project are: 1) Determine the effectiveness of intensive glycemic targets in reducing the risk for neonatal composite morbidity and large for gestational age birthweight in overweight and obese women with GDM, 2) Assess the safety of intensive glycemic targets as measured by the frequency of maternal hypoglycemia in overweight and obese women with GDM, and 3) Evaluate the cost-effectiveness of intensive glycemic control compared with standard glycemic control as measured by the incremental cost per case of neonatal morbidity and LGA birth weight prevented and per Quality-adjusted Life-year. The expected outcome of this study is high-quality evidence on the effectiveness, safety, and cost-effectiveness of intensive glycemic targets in reducing adverse perinatal outcomes among overweight and obese women with GDM. If proven effective, use of intensive glycemic targets in overweight and obese women with GDM will have an important positive impact on the health of these high risk women and their infants.

Conditions

Gestational Diabetes; Pregnancy, High Risk; Overweight and Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Intensive glycemic targets

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Standard glycemic targets

Intervention Type: OTHER

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

Interventions

Intensive glycemic targets

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

Intervention Type: OTHER

Standard glycemic targets

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: collaborator

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

NIH

Sponsor Role: collaborator

Women and Infants Hospital of Rhode Island

OTHER

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Christina Scifres

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christina Scifres, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status: RECRUITING

Indiana University

Indianapolis, Indiana, United States

Site Status: RECRUITING

University of Oklahoma

Norman, Oklahoma, United States

Site Status: RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Oswalt

Role: CONTACT

seoswalt@iu.edu

(317)944-7069

Facility Contacts

Ashley Battarbee, MD, MSCR

Role: primary

anbattarbee@uambc.edu

Christina Scifres, MD

Role: primary

cmscifre@iu.edu

317-948-4103

Sarah Oswalt, RN, BSN

Role: backup

seoswalt@iu.edu

(317) 944-7069

Stephanie Pierce, MD

Role: primary

Stephanie-Pierce@ouhsc.edu

Maisa Feghali, MD

Role: primary

feghalim@mwri.magee.edu

Methodius Tuuli, MD, MPH, MBA

Role: primary

MTuuli@Wihri.org

References

Scifres CM, Battarbee AN, Feghali MN, Pierce S, Edwards RK, Smith EM, Guise D, Bhamidipalli S, Daggy J, Tuuli MG. Intensive glycaemic targets in overweight and obese individuals with gestational diabetes mellitus: clinical trial protocol for the iGDM study. BMJ Open. 2024 Feb 29;14(2):e082126. doi: 10.1136/bmjopen-2023-082126.

Reference Type: DERIVED

PMID: 38423770 (View on PubMed)

Other Identifiers

R01HD101476

Identifier Type: NIH

Identifier Source: secondary_id

View Link

11435

Identifier Type: -

Identifier Source: org_study_id