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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

Who can join

Ages 18 and older · Women

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.

About the study

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?

What is being tested

• Use of insulin glargine once daily (drug)
• Use of insulin glargine twice daily (drug)

Sponsor: Eastern Virginia Medical School · Participants: 200 · Started: May 18, 2026

Contact the study team

• Marwan Ma'ayeh, MD · Phone: 7574467900

Official record on ClinicalTrials.gov — NCT07224893

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.