Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes (iGDM)

June 22, 2026 updated by: Christina Scifres, Indiana University

Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes Mellitus: A Multicenter Randomized Trial

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
828

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Ashley Battarbee, MD, MSCR
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Sarah Oswalt, RN, BSN
          • Phone Number: (317) 944-7069
          • Email: seoswalt@iu.edu
        • Principal Investigator:
          • Christina Scifres, MD
        • Contact:
          • Christina Scifres, MD
          • Phone Number: (317) 948-4103
          • Email: cmscifre@iu.edu
    • Oklahoma
      • Norman, Oklahoma, United States, 73019
        • Recruiting
        • University of Oklahoma
        • Contact:
        • Principal Investigator:
          • Stephanie Pierce, MD
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Recruiting
        • University of Pittsburgh
        • Principal Investigator:
          • Maisa Feghali, MD
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Recruiting
        • Women and Infants Hospital of Rhode Island
        • Contact:
        • Principal Investigator:
          • Methodius Tuuli, MD, MPH, MBA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Intensive glycemic targets
Fasting blood glucose <90 mg/dL, 1 hour post-prandial blood glucose <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.
Other: Standard glycemic targets
Fasting blood glucose <95 mg/dL, 1 hour post-prandial blood glucose <140 mg/dL

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of participants with composite neonatal morbidity
Time Frame: Within 7 days of delivery
Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome
Within 7 days of delivery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with large for gestational age birth weight
Time Frame: Birth
≥90th percentile birth weight for gestational age, based on US birth weight normograms
Birth
Number of participants with neonatal hypoglycemia
Time Frame: Within 24 hours of delivery
Blood glucose <40 mg/dL in the 1st 24 hours of life
Within 24 hours of delivery
Number of participants with neonatal jaundice
Time Frame: Within 7 days of delivery
Documentation of need for phototherapy
Within 7 days of delivery
Number of participants with respiratory distress syndrome
Time Frame: Within 7 days of delivery
Signs of respiratory distress (tachypnea, grunting, nasal flaring, cyanosis) with an oxygen requirement within the first 24 hours of life and the presence of radiologic chest findings of hypoaeration and reticulogranular infiltrates or those needing immediate intubation for respiratory distress syndrome
Within 7 days of delivery
Maternal hyperglycemia
Time Frame: From randomization to delivery
Percent of maternal glucose values ≥120 and ≥140 mg/dL from randomization through delivery
From randomization to delivery
Episodes of maternal hypoglycemia
Time Frame: From randomization to delivery
Percent of all glucose values <60 mg/dL
From randomization to delivery
Number of episodes of symptomatic maternal hypoglycemia
Time Frame: From randomization to delivery
Number of episodes of symptomatic hypoglycemia, episodes of symptomatic hypoglycemia requiring assistance
From randomization to delivery
Number of participants with small for gestational age birth weight
Time Frame: Birth
≤10th percentile birth weight for gestational age, based on US birth weight normograms
Birth
Number of participants with preterm birth <37 weeks
Time Frame: Delivery
Gestational age at delivery <37 0/7 weeks (spontaneous or indicated)
Delivery
Number of participants with shoulder dystocia
Time Frame: Delivery
Documentation in the medical record of failure to deliver the fetal shoulder with gentle downward traction on the fetal head, requiring additional obstetric maneuvers to effect delivery, as documented by the delivery physician
Delivery
Number of participants with NICU admission
Time Frame: Within 7 days of delivery
Admission to the neonatal intensive care unit for any indication in the first 7 days of life
Within 7 days of delivery
Early maternal glycemic levels
Time Frame: 7 days after randomization
Mean fasting and post-prandial values in the 7 days after randomization
7 days after randomization
Pre-delivery maternal glycemic levels
Time Frame: 14 days prior to delivery
Mean fasting and post-prandial values in the 14 days prior to delivery
14 days prior to delivery
Glycemic levels during study enrollment
Time Frame: Up to 29 weeks
Mean fasting and post-prandial glucose values from study enrollment until delivery
Up to 29 weeks
Number of participants with hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia)
Time Frame: From randomization up to 30 days after delivery

Gestational hypertension

• Requires systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg on two occasions at least for hours apart after 20 weeks of gestational in a woman with a previously normal blood pressure

Pre-eclampsia

  • Requires systolic blood pressure ≥140 or diastolic blood pressure ≥90 mm Hg on two occasions at least for hours apart after 20 weeks of gestational in a women with a previously normal blood pressure and at least one of the following:69
  • Proteinuria (≥300 mg/24 hour timed collection, protein/creatinine ratio >0.3, or 2+ proteinuria on dipstick)
  • Thrombocytopenia (platelets<100,000)
  • Elevated blood concentrations of liver transaminases to twice normal concentration
  • Creatinine >1.1 mg/dL or a doubling of the serum creatinine concentration
  • Headache, blurry vision, or epigastric/RUQ pain
  • Pulmonary edema

OR Systolic blood pressure of 160 mm Hg or diastolic blood pressure of 110 mg Hg or more
From randomization up to 30 days after delivery
Number of participants with cesarean delivery
Time Frame: Delivery
Cesarean delivery for any indication
Delivery
Infant adiposity
Time Frame: Within 72 hours of delivery
Calculated using a flank skinfold
Within 72 hours of delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Indiana University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Alabama at Birmingham
University of Pittsburgh
University of Oklahoma
Women and Infants Hospital of Rhode Island

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christina Scifres, MD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 11435
  • R01HD101476 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the study is completed and the investigators have published the main manuscripts regarding the outcomes of the trial, de-identified data will be made available by request. All requests will require review and approval by the investigators and the institutional regulatory committees.

IPD Sharing Time Frame

Data will be available one year after study completion.

IPD Sharing Access Criteria

Data access will be possible after approval of the request for data by the primary study team and after appropriate regulatory documents are in place.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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