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

NCT07224893 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Eastern Virginia Medical School

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-18
Primary Completion
2027-12-01
Completion
2027-12-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07224893 on ClinicalTrials.gov