Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management
Recruiting now · Phase 4
Conditions studied: Pregestational Diabetes, Pregnancy
In brief
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?
Key facts
- Study ID
- NCT07224893
- Run by
- Eastern Virginia Medical School
- People needed
- 200
- Starts
- 2026-05-18
- Expected to finish
- 2027-12-01
- Last updated by the study team
- 2026-05-15
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Sentara Norfolk General Hospital, Norfolk, Virginia 23507 — Norfolk, Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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