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

Part of paid clinical trials in Norfolk, Virginia.

Sponsor
Eastern Virginia Medical School
Study ID
NCT07224893
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Pregestational Diabetes
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Use of insulin glargine once daily — DRUG
    Insulin glargine will be used once daily
  • Use of insulin glargine twice daily — DRUG
    Insulin glargine will be used twice daily

Study Details

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 Dates

Start date
May 18, 2026
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Once-Daily Insulin Glargine
    Participants randomized to this arm will take insulin glargine once daily
  • Experimental: Twice-Daily Insulin Glargine
    Participants randomized to this arm will take insulin glargine twice daily

Primary Outcome Measure

Weekly Time in Range [ Time Frame: From Day 7 to Day 14 after study enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sentara Norfolk General Hospital, Norfolk, Virginia 23507NorfolkVirginia23507
Marwan Ma'ayeh
[email protected]
7574467900

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By research site
Sentara Norfolk General Hospital, Norfolk, Virginia 23507· Norfolk, VA

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