Improving blood sugar control in pregnant women with diabetes receiving corticosteroids
Glycemic Control After Antenatal Corticosteroids in Women with Pregestational and Gestational Diabetes (Close the GAP)
This study is testing different insulin management strategies to see if they can help pregnant women with diabetes better control their blood sugar after receiving corticosteroids.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | N/A to 50 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 4 sites (Birmingham, Alabama and 3 other locations) |
| Trial ID | NCT04542148 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of antenatal corticosteroids on glycemic control in women with pregestational and gestational diabetes who are at risk of preterm birth. Eligible participants will be randomized into three groups to receive different insulin management strategies while using a continuous glucose monitor for 10 days. The goal is to optimize maternal blood sugar levels after corticosteroid administration, which is crucial for evaluating neonatal benefits. The study aims to fill a significant gap in existing research regarding the impact of corticosteroids on diabetic pregnancies.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-50 with gestational or pregestational type 2 diabetes who are hospitalized for antenatal corticosteroid administration.
Not a fit: Patients who are scheduled for delivery within 72 hours of receiving corticosteroids or have major fetal anomalies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved maternal and neonatal outcomes for women with diabetes at risk of preterm birth.
How similar studies have performed: While there have been numerous studies on corticosteroids in non-diabetic populations, this approach specifically targeting women with diabetes is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational or pregestational type 2 diabetes mellitus treated with daily insulin injection(s) or oral hypoglycemic agents such as metformin * Hospitalized for antenatal corticosteroid administration in anticipation of preterm birth * Gestational age 23 0/7 weeks - 36 5/7 weeks * Maternal age 18-50 Exclusion Criteria: * Planned delivery \< 72 hours after 1st dose of antenatal corticosteroids * More than 16 hours after 1st dose of antenatal corticosteroids * Major fetal anomaly * Triplet or higher order multiple gestation
Where this trial is running
Birmingham, Alabama and 3 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Oregon Health and Science University — Portland, Oregon, United States (Recruiting)
- University of South Carolina Greenville / Prisma Health-Upstate — Greenville, South Carolina, United States (Recruiting)
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ashley N Battarbee, MD — University of Alabama at Birmingham
- Study coordinator: Ashley N Battarbee, MD
- Email: anbattarbee@uabmc.edu
- Phone: 205-975-2361
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.