Logo 1 Logo 2

Clinical Trial Details

Trial ID: L1800
Source ID: NCT04542148
Associated Drug: Sliding Scale Insulin
Title: Glycemic Control After Antenatal Corticosteroids in Women with Pregestational and Gestational Diabetes
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2|Preterm Birth|Pregnancy, High Risk|Diabetes, Gestational
Interventions: DRUG: Sliding Scale Insulin|DRUG: Up-Titration of Home Insulin|DRUG: Continuous Insulin Infusion|DEVICE: Dexcom G6 Professional Continuous Glucose Monitor
Outcome Measures: Primary: 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: Time Above Range, Percent time glucose above range (\>140mg/dL) on CGM, During study intervention assessed for maximum of 5 days after ACS|Time Below Range, Percent time glucose below range (\<65mg/dL) on CGM, During study intervention assessed for maximum of 5 days after ACS|Additional insulin requirement, Percent increase in daily insulin requirements compared to home regimen, During study intervention assessed for maximum of 5 days after ACS|Glucose variability, Coefficient of variation (glucose standard deviation / mean glucose) on CGM, During study intervention assessed for maximum of 5 days after ACS|Patient satisfaction, Score on modified Diabetes Treatment Satisfaction Questionnaire (questions 1, 4, 5, 6, 7, 8) with score range from 0-36 with 0 being not satisfied and 36 being very satisfied, Upon completion of study intervention, on average 5 days after enrollment|Neonatal composite respiratory morbidity, Composite including need for continuous positive airway pressure or high-flow nasal cannula of \>=0.30 for \>=12 continuous hours, respiratory distress syndrome, or mechanical ventilation, Birth to hospital discharge, assessed up to 28 days|Initial neonatal glucose, Initial capillary neonatal glucose in mg/dL measured by heelstick, Birth to 2 hours of life|Umbilical cord blood C-peptide, C-peptide concentration (mcg/L) in the umbilical cord blood as measure of fetal insulin status, Delivery|Umbilical cord blood insulin, Insulin concentration (mcg/L) in the umbilical cord blood as measure of fetal insulin status, Delivery|Umbilical cord blood cortisol, Cortisol concentration (mcg/L) in the umbilical cord blood as measure of fetal HPA axis, Delivery|Umbilical cord blood surfactant protein A (SP-A), Fetal surfactant protein A, Delivery|Umbilical cord blood surfactant protein B (SP-B), Fetal surfactant protein B, Delivery|Umbilical cord blood surfactant protein C (SP-C), Fetal surfactant protein C, Delivery|Umbilical cord blood surfactant protein D (SP-D), Fetal surfactant protein D, Delivery
Sponsor/Collaborators: Sponsor: University of Alabama at Birmingham
Gender: ALL
Age: CHILD, ADULT
Phases: PHASE2
Enrollment: 120
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2022-02-10
Completion Date: 2025-11-30
Results First Posted:
Last Update Posted: 2024-10-08
Locations: University of Alabama at Birmingham, Birmingham, Alabama, 35223, United States|Oregon Health and Science University, Portland, Oregon, 97239, United States|University of South Carolina Greenville / Prisma Health-Upstate, Greenville, South Carolina, 29605, United States|University of Texas Health Science Center at Houston, Houston, Texas, 77024, United States
URL: https://clinicaltrials.gov/show/NCT04542148