Recruiting

Insulin Glargine

Sponsor:

Eastern Virginia Medical School

Code:

NCT07224893

Conditions

Pregestational Diabetes

Pregnancy

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Use of insulin glargine once daily

Use of insulin glargine twice daily

Study Details

Brief 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

Study ID

NCT07224893

Start date

May 18, 2026

Status verified date

May, 2026

Completion date

Dec 1, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Use of insulin glargine once daily

Insulin glargine will be used once daily

Use of insulin glargine twice daily

Insulin glargine will be used twice daily

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Marwan Ma'ayeh, MD

7574467900maayehmg@odu.edu

Locations

Sentara Norfolk General Hospital, Norfolk, Virginia 23507

Recruiting

Norfolk, Virginia, United States, 23507

Contacts

Marwan Ma'ayeh

7574467900maayehmg@odu.edu

More Information

Sponsor

Eastern Virginia Medical School

Last update posted

May 15, 2026

Last verified

May, 2026

Keywords

  • continuous glucose monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eastern Virginia Medical School on 2026-05-15.