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NCT Number: NCT07224893

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

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?

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sentara Norfolk General Hospital, Norfolk, Virginia 23507

Norfolk, Virginia, 23507, United States

Location status: Recruiting

Location contact

Marwan Ma'ayeh

CONTACT

[email protected]

7574467900

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Weekly Time in Range

    Time frame: From Day 7 to Day 14 after study enrollment

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

Secondary outcomes

  1. Hypertensive disorders of pregnancy

    Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment

    Development of hypertensive disorders of pregnancy

  2. Preterm birth <34 weeks

    Time frame: From time of enrollment to 34 weeks gestation

    Delivery at less than 34 weeks gestation

  3. Preterm birth <37 weeks

    Time frame: From time of enrollment until 37 weeks gestation

    Delivery prior to 37 weeks gestation

  4. Spontaneous or Indicated Delivery

    Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment

    Whether delivery was spontaneous or there was an indication for induction or cesarean delivery

  5. Operative vaginal delivery

    Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment

    Whether an operative vaginal delivery was indicated

  6. Cesarean Delivery

    Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment

    Whether a cesarean delivery was indicated

  7. Estimated blood loss

    Time frame: Duration of labor, up to 24 hours

    The estimated blood loss during delivery

  8. Quantitative blood loss

    Time frame: Duration of labor, up to 24 hours

    The quantified blood loss during delivery

  9. Blood transfusion

    Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)

    Whether a blood transfusion was necessary during or following delivery

  10. Endometritis

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)

    Incidence of endometritis (inflammation of uterine lining)

  11. Chorioamnionitis

    Time frame: From time of enrollment until time of hospital discharge (up to 42 days post-delivery)

    Incidence of chorioamnionitis (placental and amniotic membrane infection)

  12. Wound infection

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)

    Infection of wounds left by labor

  13. Venous thromboembolism

    Time frame: From time of enrollment to time of hospital discharge (up to 42 days post-delivery)

    Incidence of venous thromboembolism

  14. Massive transfusion and postpartum hemorrhage

    Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)

    Incidence of massive transfusion and postpartum hemorrhage

  15. ICU admission

    Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)

    Admission to the ICU

  16. Maternal death

    Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)

  17. Antepartum death

    Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment

    Fetal death

  18. Intrapartum death

    Time frame: Duration of labor, up to 24 hours

    Fetal death during labor and delivery

  19. Neonatal Intubation within 72 hours of birth

    Time frame: From time of delivery to 72 hours later

  20. Continuous positive airway pressure (CPAP) within 72 hours of birth

    Time frame: From time of delivery to 72 hours later

    Use of CPAP for neonate within 72 hours of birth

  21. High-flow nasal cannula (HFNC) within 72 hours of birth

    Time frame: From time of delivery to 72 hours later

  22. Cardiopulmonary resuscitation within 72 hours of birth

    Time frame: From time of delivery to 72 hours later

  23. Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

  24. Birthweight

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

    Infant birthweight

  25. Neonatal encephalopathy

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

  26. Seizures

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

    Incidence of neonatal seizures

  27. Shoulder dystocia

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

    Incidence of shoulder dystocia

  28. Birth trauma

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

    Incidence of neonatal birth trauma

  29. Intracranial hemorrhage

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

    Incidence of neonatal intracranial hemorrhage

  30. Hyperbilirubinemia requiring phototherapy or exchange transfusion

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

    Incidence of neonatal hyperbilirubinemia requiring phototherapy or exchange transfusion

  31. NICU admission

    Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery

    Admission of neonate to the neonatal intensive care unit

Study contacts

Contact information is provided by the study sponsor or research team.

Marwan Ma'ayeh, MD

CONTACT

[email protected]

7574467900

Sponsors and collaborators

Lead sponsor

Eastern Virginia Medical School

Other

Registry information

Official study title

Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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