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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

February 10, 2022

Primary Completion Date

January 31, 2026

Study Completion Date

March 31, 2026

Conditions
Diabetes Mellitus, Type 2Preterm BirthPregnancy, High RiskDiabetes, Gestational
Interventions
DRUG

Sliding Scale Insulin

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).

DRUG

Up-Titration of Home Insulin

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).

DRUG

Continuous Insulin Infusion

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.

DEVICE

Dexcom G6 Professional Continuous Glucose Monitor

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

Trial Locations (4)

29605

RECRUITING

University of South Carolina Greenville / Prisma Health-Upstate, Greenville

35223

RECRUITING

University of Alabama at Birmingham, Birmingham

77024

RECRUITING

University of Texas Health Science Center at Houston, Houston

97239

RECRUITING

Oregon Health and Science University, Portland

All Listed Sponsors
lead

University of Alabama at Birmingham

OTHER

NCT04542148 - Glycemic Control After Antenatal Corticosteroids in Women With Pregestational and Gestational Diabetes | Biotech Hunter | Biotech Hunter