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NCT07224893PHASE4Recruiting

Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management

Eastern Virginia Medical School

Start Date

5/18/2026

Completion Date

12/1/2027

Summary

The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients older than 18 years of age; * The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study; * Type II diabetes mellitus requiring insulin; * The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists. * Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management Exclusion Criteria: * Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated; * Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance; * Known or suspected fetal anomaly or aneuploidy; * Prisoners; * Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.

Interventions

DRUG

Use of insulin glargine once daily

DRUG

Use of insulin glargine twice daily

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Conditions

Pregestational DiabetesPregnancy

Locations

Sentara Norfolk General Hospital, Norfolk, Virginia 23507

Norfolk, Virginia 23507

United States