Once-daily vs twice-daily insulin glargine in pregnant people with pregestational diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional Phase 4 trial randomizes adult pregnant participants with pregestational diabetes to receive either once-daily or twice-daily insulin glargine. Continuous glucose monitoring is used to track glucose levels and determine time in range. The goal is to see if split dosing improves glycemic control during the second and third trimesters. The study compares two regimens to identify potential differences in fetal and maternal glucose management.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sentara Norfolk General Hospital, Norfolk, Virginia 23507
  Norfolk, Virginia, United States Recruiting

Study contacts

• Study coordinator: Marwan Ma'ayeh, MD
• Email: maayehmg@odu.edu
• Phone: 7574467900

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pregnant Women Living with HIV on Bictegravir/Emtricitabine/Tenofovir Alafenamide

  This study looks at how B/F/TAF is used in pregnant women with HIV and whether it helps maintain viral suppression from before conception through delivery.

  Recruiting Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida · Paris · NCT07921472

• Pelvic Floor Training and a Modified Lumbopelvic Belt for Symphysis Pubis Pain in Pregnancy

  This study tests whether pelvic floor muscle training plus a modified lumbopelvic belt can reduce pain and improve function for pregnant women with symphysis pubis pain.

  Recruiting Kahramanmaras Sutcu Imam University · Kahramanmaraş · NCT07919548

• Effective Communication in VBAC Counseling

  This study tests how clearly doctors and midwives explain VBAC options during prenatal visits and whether patients feel understood.

  Recruiting IRCCS San Raffaele · Milan, MI · NCT07919145

• Innovative Multidisciplinary and Virtual Care for IBD in Pregnancy

  This study tests a dedicated IBD pregnancy care model, including a new virtual approach, to see if it improves access and quality of care for pregnant people with Crohn's disease or ulcerative colitis.

  Recruiting at 5 sites Austin Health · Hobart and 6 other locations · NCT07916727

• Compare spinal-epidural versus general anesthesia for babies after cesarean delivery

  This trial tests whether the type of anesthesia used for cesarean delivery affects newborn hearing in babies.

  Recruiting Second Affiliated Hospital of Wenzhou Medical University · Wenzhou · NCT07852624

• Pregnant women weight-management support via an app and care model

  Aims to try a smartphone-based weight-management program plus professional support for pregnant women to see if it helps manage gestational weight and promote healthy behaviors.

  Recruiting Mackay Medical College · Taipei · NCT07814885

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.