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Insulin Glargine for Pregestational Diabetes in Pregnancy

This study is looking at whether taking insulin glargine (a long-acting insulin) twice a day instead of once a day helps manage pregestational diabetes (diabetes that existed before pregnancy) better in pregnant patients. You could be eligible if you are over 18, fluent in English, have Type II diabetes requiring insulin, and are between 24 and 28 weeks pregnant. Participants will be randomly assigned to receive insulin glargine either once or twice daily. The main goal is to see if taking insulin glargine twice a day leads to a better "time in range" (how long your blood sugar stays within a healthy target). The current recruitment status is unclear, and the study aims to enroll 200 participants.

Study design
This is an interventional study where participants will be randomly assigned to one of two groups: once-daily or twice-daily insulin glargine. It aims to enroll 200 women.
What's involved
Participants will have their blood sugar levels tracked using continuous glucose monitoring. The primary endpoint is measured from Day 7 to Day 14 after enrollment.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured between Day 7 and Day 14 after you join the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07224893

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

Recruiting
PHASE4Ages 18+InterventionalTreatment
Eastern Virginia Medical School
~200 participants
Updated 2026-05-15 on ClinicalTrials.gov
What's tested:Use of insulin glargine once dailyUse of insulin glargine twice daily

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Weekly Time in Range
Measured over From Day 7 to Day 14 after study enrollment

Conditions

Pregestational Diabetes
Pregnancy

Explore related trials

Pre-Gestational DiabetesPregnancyType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
Virginia1

Who to contact

Marwan Ma'ayeh, MD
[email protected]
7574467900
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Weekly Time in RangeFrom Day 7 to Day 14 after study enrollment

    The mean blood glucose time in range as measured by the continuous glucose monitor