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Corticosteroid

Insulin Management Strategies for Diabetes during Pregnancy

Phase 2
Recruiting
Led By Ashley N Battarbee, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Maternal age 18-50
Gestational or pregestational type 2 diabetes mellitus treated with daily insulin injection(s) or oral hypoglycemic agents such as metformin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up delivery
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the best way to manage diabetes during pregnancy after a woman has been given a steroid to help her baby's development.

Who is the study for?
This trial is for pregnant women aged 18-50 with gestational or pregestational type 2 diabetes, treated with insulin injections or medications like metformin. They must be hospitalized for corticosteroid administration due to the risk of premature birth between weeks 23 and almost 37 of pregnancy.
What is being tested?
The study tests three strategies to control blood sugar after receiving corticosteroids: adding sliding scale insulin, increasing usual home insulin doses, and giving continuous insulin infusions. It also uses a Dexcom G6 monitor to track glucose levels.
What are the potential side effects?
Potential side effects include variations in blood sugar levels that may require close monitoring and adjustments in treatment. Continuous infusion might lead to discomfort at the infusion site and increased healthcare interactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged between 18 and 50.
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I have type 2 diabetes during or before pregnancy and am on insulin or metformin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during study intervention assessed for maximum of 5 days after acs
This trial's timeline: 3 weeks for screening, Varies for treatment, and during study intervention assessed for maximum of 5 days after acs for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time In Range
Secondary study objectives
Additional insulin requirement
Glucose variability
Initial neonatal glucose
+11 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Up-Titration of Home InsulinExperimental Treatment2 Interventions
Increase in home insulin regimen based on standardized algorithm for maximum of 5 days after antenatal corticosteroids
Group II: Sliding Scale InsulinExperimental Treatment2 Interventions
Addition of supplemental sliding scale insulin to home insulin regimen for maximum of 5 days after antenatal corticosteroids
Group III: Continuous Insulin InfusionExperimental Treatment2 Interventions
Discontinuation of home insulin regimen and receipt of continuous insulin infusion for maximum of 5 days after antenatal corticosteroids

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,646 Previous Clinical Trials
2,342,264 Total Patients Enrolled
Ashley N Battarbee, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Antenatal Corticosteroids (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04542148 — Phase 2
Type 2 Diabetes Research Study Groups: Sliding Scale Insulin, Continuous Insulin Infusion, Up-Titration of Home Insulin
Type 2 Diabetes Clinical Trial 2023: Antenatal Corticosteroids Highlights & Side Effects. Trial Name: NCT04542148 — Phase 2
Antenatal Corticosteroids (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04542148 — Phase 2
~30 spots leftby Oct 2025
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