Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management
Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin
Eastern Virginia Medical School
200 participants
May 18, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria5
- 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.
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Interventions
Insulin glargine will be used once daily
Insulin glargine will be used twice daily
Locations(1)
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NCT07224893