Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes

NCT04542148 | Active Not Recruiting Phase 2 DMC FDA Device

• 1 other identifier: 300005848
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Diabetes Mellitus, Type 2; Preterm Birth; Pregnancy, High Risk; Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• Time In Range

  Percent time glucose in range (65-140mg/dL) on CGM

  During study intervention assessed for maximum of 5 days after ACS

Secondary Outcomes (14)

• Time Above Range

  During study intervention assessed for maximum of 5 days after ACS

• Time Below Range

  During study intervention assessed for maximum of 5 days after ACS

• Additional insulin requirement

  During study intervention assessed for maximum of 5 days after ACS

• Glucose variability

  During study intervention assessed for maximum of 5 days after ACS

• Patient satisfaction

  Upon completion of study intervention, on average 5 days after enrollment

Study Arms (3)

Sliding Scale Insulin

EXPERIMENTAL

Addition of supplemental sliding scale insulin to home insulin regimen for maximum of 5 days after antenatal corticosteroids

Drug: Sliding Scale Insulin; Device: Dexcom G6 Professional Continuous Glucose Monitor

Up-Titration of Home Insulin

EXPERIMENTAL

Increase in home insulin regimen based on standardized algorithm for maximum of 5 days after antenatal corticosteroids

Drug: Up-Titration of Home Insulin; Device: Dexcom G6 Professional Continuous Glucose Monitor

Continuous Insulin Infusion

EXPERIMENTAL

Discontinuation of home insulin regimen and receipt of continuous insulin infusion for maximum of 5 days after antenatal corticosteroids

Drug: Continuous Insulin Infusion; Device: Dexcom G6 Professional Continuous Glucose Monitor

Interventions

Sliding Scale Insulin DRUG

After antenatal corticosteroid administration, women will continue to receive long- and short-acting subcutaneous insulin injections as prescribed at home. In addition, they will receive supplemental short-acting insulin using a sliding scale based on postprandial glucose values. Capillary blood glucose values will be measured with fingersticks 4 times daily (fasting and 1-hour postprandial).

Also known as: Aspart, Lispro

Sliding Scale Insulin

Up-Titration of Home Insulin DRUG

After antenatal corticosteroid administration, women will receive long- and short-acting subcutaneous insulin injections at increased dosages compared to that prescribed at home. Insulin will be increased by 30% on the day that they receive their 1st dose of antenatal corticosteroids (day 1), 50% on day 2, 50% on day 3, 30% on day 4, and 15% increase on day 5. On day 6 they will return to their home insulin regimen. Capillary blood glucose values will be measured with fingersticks 4 times daily (fasting and 1-hour postprandial).

Also known as: Glargine, NPH, Aspart, Lispro, Regular insulin

Up-Titration of Home Insulin

Continuous Insulin Infusion DRUG

After antenatal corticosteroid administration, women will discontinue their home insulin regimen and be placed on a continuous insulin infusion with insulin boluses and titration of infusion rate per institutional L\&D protocol. Capillary blood glucose values will be measured with fingersticks every hour.

Also known as: Regular insulin

Continuous Insulin Infusion

Dexcom G6 Professional Continuous Glucose Monitor DEVICE

Masked Dexcom G6 Pro devices will be worn for 10 days.

Also known as: G6 Pro

Continuous Insulin Infusion; Sliding Scale Insulin; Up-Titration of Home Insulin

Eligibility Criteria

• Age: Up to 50 Years
• Gender Eligibility Details: The primary aim of the study is an intervention unique to pregnancy. Male and female neonates will be included.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35223, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of South Carolina Greenville / Prisma Health-Upstate

Greenville, South Carolina, 29605, United States

Location

University of Texas Health Science Center at Houston

Houston, Texas, 77024, United States

Location

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Premature Birth; Diabetes, Gestational

Interventions

Insulin Aspart; Insulin Lispro; Insulin Glargine; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Proinsulin

Study Officials

• Ashley N Battarbee, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: September 9, 2020
• Study Start: February 10, 2022
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)