Gestational DiabetesiGDMNCT05124808
Intensive Glycemic Targets in Overweight and Obese Women With Gestational Diabetes
A study testing Intensive glycemic targets and Standard glycemic targets in people with Gestational Diabetes and Pregnancy, High Risk, run by Indiana University at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes, Pregnancy, High Risk, Overweight and Obesity
- What is being tested?
- Intensive glycemic targets and Standard glycemic targets
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 828 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Mar 2022to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Ashley Battarbee, MD, MSCR, anbattarbee@uambc.edu
Ashley Battarbee, MD, MSCR
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Christina Scifres, MD, (317) 948-4103, cmscifre@iu.edu
Rasika Sadolikar, MBBS, MPH, (317) 278-8040, rsadolik@iu.edu
- Recruiting
University of Oklahoma
Norman, Oklahoma, 73019
Stephanie Pierce, MD, Stephanie-Pierce@ouhsc.edu
Stephanie Pierce, MD
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Maisa Feghali, MD, feghalim@mwri.magee.edu
Maisa Feghali, MD
- Recruiting
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Methodius Tuuli, MD, MPH, MBA, MTuuli@Wihri.org
Methodius Tuuli, MD, MPH, MBA
About this study
Official title: 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.
Read the 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.
- Being tested
- Intensive glycemic targets, Standard glycemic targets
- Medical subject headings
- Diabetes, Gestational, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive glycemic targetsOther
Fasting blood glucose <90 mg/dL, 1 hour post-prandial blood glucose <120 mg/dL
Standard glycemic targetsOther
Fasting blood glucose <95 mg/dL, 1 hour post-prandial blood glucose <140 mg/dL
| Study group | Role | What they receive |
|---|---|---|
| Intensive glycemic targets | Experimental | 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. Receives: Other: Intensive glycemic targets |
| Standard glycemic targets | Active comparator | 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. Receives: Other: Standard glycemic targets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with composite neonatal morbidity
Composite of large for gestational age birth weight, neonatal hypoglycemia, neonatal jaundice, and neonatal respiratory distress syndrome
Measured: Within 7 days of delivery
Secondary outcomes (17)
Number of participants with large for gestational age birth weight
≥90th percentile birth weight for gestational age, based on US birth weight normograms
Measured: Birth
Number of participants with neonatal hypoglycemia
Blood glucose <40 mg/dL in the 1st 24 hours of life
Measured: Within 24 hours of delivery
Number of participants with neonatal jaundice
Documentation of need for phototherapy
Measured: Within 7 days of delivery
Number of participants with respiratory distress syndrome
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
Measured: Within 7 days of delivery
Maternal hyperglycemia
Percent of maternal glucose values ≥120 and ≥140 mg/dL from randomization through delivery
Measured: From randomization to delivery
Early maternal glycemic levels
Mean fasting and post-prandial values in the 7 days after randomization
Measured: 7 days after randomization
Pre-delivery maternal glycemic levels
Mean fasting and post-prandial values in the 14 days prior to delivery
Measured: 14 days prior to delivery
Glycemic levels during study enrollment
Mean fasting and post-prandial glucose values from study enrollment until delivery
Measured: Up to 29 weeks
Episodes of maternal hypoglycemia
Percent of all glucose values <60 mg/dL
Measured: From randomization to delivery
Number of episodes of symptomatic maternal hypoglycemia
Number of episodes of symptomatic hypoglycemia, episodes of symptomatic hypoglycemia requiring assistance
Measured: From randomization to delivery
Number of participants with hypertensive disorders of pregnancy (gestational hypertension and pre-eclampsia)
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
Measured: From randomization up to 30 days after delivery
Number of participants with small for gestational age birth weight
≤10th percentile birth weight for gestational age, based on US birth weight normograms
Measured: Birth
Number of participants with cesarean delivery
Cesarean delivery for any indication
Measured: Delivery
Number of participants with preterm birth <37 weeks
Gestational age at delivery <37 0/7 weeks (spontaneous or indicated)
Measured: Delivery
Number of participants with shoulder dystocia
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
Measured: Delivery
Number of participants with NICU admission
Admission to the neonatal intensive care unit for any indication in the first 7 days of life
Measured: Within 7 days of delivery
Infant adiposity
Calculated using a flank skinfold
Measured: Within 72 hours of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Mar 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 828 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh, University of Alabama at Birmingham, University of Oklahoma, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Women and Infants Hospital of Rhode Island
- Responsible party
- Principal investigator, Christina Scifres, Indiana University
- Investigators
- Christina Scifres, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124808
- Sponsor's protocol ID
- 11435
- Other IDs
- R01HD101476
- Acronym
- iGDM
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2021
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 38423770