Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes (Close the GAP)

Who is this study for? Women with pregestational and gestational diabetes
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

There is a fundamental gap in understanding the maternal and neonatal effects of antenatal corticosteroid (ACS) administration in women with threatened preterm birth (PTB) who have diabetes. Since the initial discovery of ACS for neonatal benefit in 1972, more than 40 randomized controlled trials have been performed evaluating its efficacy. However, none of these trials have included women with T2DM, and there is limited data among women with gestational diabetes. While ACS have been shown to reduce neonatal morbidity associated with PTB in non-diabetic women, the side effects of ACS (maternal hyperglycemia and fetal hyperinsulinemia) may mitigate the neonatal benefit of ACS in women with diabetes. Before neonatal benefit of ACS can be evaluated in this population, the first step is to optimize maternal glycemic control after ACS. Previous studies evaluating maternal hyperglycemia after ACS have been limited by small sample size, retrospective study design, or insufficient glucose data. Use of continuous glucose monitoring (CGM) in a randomized clinical trial provides a unique opportunity to overcome these challenges. Our long-term goal is to improve maternal and child health among women with diabetes as an independently funded clinical researcher. The research objectives of this proposal are to test the efficacy of three treatment strategies at achieving maternal glycemic control after ACS and evaluate the association between maternal glycemic control and neonatal outcomes. Our central hypothesis is that treatment with a continuous insulin infusion will improve maternal glycemic control, which is key to improving neonatal outcomes, but at the cost of less patient satisfaction and more health resource utilization. This hypothesis will be tested by pursuing the following specific aims: 1) Test the efficacy of three treatment strategies (addition of sliding scale insulin, up-titration of home insulin, and continuous insulin infusion) at achieving maternal glycemic control after ACS and 2) Quantify the association between maternal glycemic control after ACS and neonatal morbidity. Completion of these aims will determine the optimal strategy to achieve maternal glycemic control after ACS and inform a larger, multicenter trial to improve neonatal outcomes among women with diabetes and threatened PTB.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
United States
Alabama
University of Alabama at Birmingham
RECRUITING
Birmingham
Oregon
Oregon Health and Science University
RECRUITING
Portland
South Carolina
University of South Carolina Greenville / Prisma Health-Upstate
RECRUITING
Greenville
Texas
University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Ashley N Battarbee, MD
anbattarbee@uabmc.edu
205-975-2361
Time Frame
Start Date: 2022-02-10
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 120
Treatments
Experimental: Sliding Scale Insulin
Addition of supplemental sliding scale insulin to home insulin regimen for maximum of 5 days after antenatal corticosteroids
Experimental: Up-Titration of Home Insulin
Increase in home insulin regimen based on standardized algorithm for maximum of 5 days after antenatal corticosteroids
Experimental: Continuous Insulin Infusion
Discontinuation of home insulin regimen and receipt of continuous insulin infusion for maximum of 5 days after antenatal corticosteroids
Sponsors
Leads: University of Alabama at Birmingham

This content was sourced from clinicaltrials.gov