NCT07224893

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Eastern Virginia Medical School · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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?

Conditions

• Pregestational Diabetes
• Pregnancy

Interventions

Type	Name	Description
DRUG	Use of insulin glargine once daily	Insulin glargine will be used once daily
DRUG	Use of insulin glargine twice daily	Insulin glargine will be used twice daily

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-01
• Completion: 2027-12-01
• First posted: 2025-11-05
• Last updated: 2025-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study