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Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management Phase 4 200 Pregnancy

Not yet recruiting
Clinical Trial NCT07224893 is designed to study Treatment for Pregestational Diabetes, Pregnancy. This Phase 4 interventional study is not yet recruiting. Enrollment is planned to begin on 1 December 2025 until the study accrues 200 participants. Led by Eastern Virginia Medical School, this study is expected to complete by 1 December 2027. The latest data from ClinicalTrials.gov was last updated on 5 November 2025.
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 st...Show More
Official Title

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

Conditions
Pregestational DiabetesPregnancy
Publications
Scientific articles and research papers published about this clinical trial:
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Other Study IDs
  • 25-09-FB-0214
NCT ID Number
NCT07224893
Start Date (Actual)
2025-12-01
Last Update Posted
2025-11-05
Completion Date (Estimated)
2027-12-01
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 4
Status
Not yet recruiting
Keywords
continuous glucose monitoring
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
Active ComparatorOnce-Daily Insulin Glargine
Participants randomized to this arm will take insulin glargine once daily
Use of insulin glargine once daily
Insulin glargine will be used once daily
ExperimentalTwice-Daily Insulin Glargine
Participants randomized to this arm will take insulin glargine twice daily
Use of insulin glargine twice daily
Insulin glargine will be used twice daily
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Weekly Time in Range
The mean blood glucose time in range as measured by the continuous glucose monitor
From Day 7 to Day 14 after study enrollment
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Hypertensive disorders of pregnancy
Development of hypertensive disorders of pregnancy
From time of enrollment until time of delivery, up to 20 weeks following enrollment
Preterm birth <34 weeks
Delivery at less than 34 weeks gestation
From time of enrollment to 34 weeks gestation
Preterm birth <37 weeks
Delivery prior to 37 weeks gestation
From time of enrollment until 37 weeks gestation
Spontaneous or Indicated Delivery
Whether delivery was spontaneous or there was an indication for induction or cesarean delivery
From time of enrollment until time of delivery, up to 20 weeks following enrollment
Operative vaginal delivery
Whether an operative vaginal delivery was indicated
From time of enrollment to time of delivery, up to 20 weeks following enrollment
Cesarean Delivery
Whether a cesarean delivery was indicated
From time of enrollment to time of delivery, up to 20 weeks following enrollment
Estimated blood loss
The estimated blood loss during delivery
Duration of labor, up to 24 hours
Quantitative blood loss
The quantified blood loss during delivery
Duration of labor, up to 24 hours
Blood transfusion
Whether a blood transfusion was necessary during or following delivery
From time of enrollment until hospital discharge (up to 42 days post-delivery)
Endometritis
Incidence of endometritis (inflammation of uterine lining)
From time of enrollment to hospital discharge (up to 42 days post-delivery)
Chorioamnionitis
Incidence of chorioamnionitis (placental and amniotic membrane infection)
From time of enrollment until time of hospital discharge (up to 42 days post-delivery)
Wound infection
Infection of wounds left by labor
From time of enrollment to hospital discharge (up to 42 days post-delivery)
Venous thromboembolism
Incidence of venous thromboembolism
From time of enrollment to time of hospital discharge (up to 42 days post-delivery)
Massive transfusion and postpartum hemorrhage
Incidence of massive transfusion and postpartum hemorrhage
From time of enrollment until hospital discharge (up to 42 days post-delivery)
ICU admission
Admission to the ICU
From time of enrollment until hospital discharge (up to 42 days post-delivery)
Maternal death
From time of enrollment to hospital discharge (up to 42 days post-delivery)
Antepartum death
Fetal death
From time of enrollment to time of delivery, up to 20 weeks following enrollment
Intrapartum death
Fetal death during labor and delivery
Duration of labor, up to 24 hours
Neonatal Intubation within 72 hours of birth
From time of delivery to 72 hours later
Continuous positive airway pressure (CPAP) within 72 hours of birth
Use of CPAP for neonate within 72 hours of birth
From time of delivery to 72 hours later
High-flow nasal cannula (HFNC) within 72 hours of birth
From time of delivery to 72 hours later
Cardiopulmonary resuscitation within 72 hours of birth
From time of delivery to 72 hours later
Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy
From time of delivery to time of hospital discharge, up to 1 year following delivery
Birthweight
Infant birthweight
From time of delivery to time of hospital discharge, up to 1 year following delivery
Neonatal encephalopathy
From time of delivery to time of hospital discharge, up to 1 year following delivery
Seizures
Incidence of neonatal seizures
From time of delivery to time of hospital discharge, up to 1 year following delivery
Shoulder dystocia
Incidence of shoulder dystocia
From time of delivery to time of hospital discharge, up to 1 year following delivery
Birth trauma
Incidence of neonatal birth trauma
From time of delivery to time of hospital discharge, up to 1 year following delivery
Intracranial hemorrhage
Incidence of neonatal intracranial hemorrhage
From time of delivery to time of hospital discharge, up to 1 year following delivery
Hyperbilirubinemia requiring phototherapy or exchange transfusion
Incidence of neonatal hyperbilirubinemia requiring phototherapy or exchange transfusion
From time of delivery to time of hospital discharge, up to 1 year following delivery
NICU admission
Admission of neonate to the neonatal intensive care unit
From time of delivery to time of hospital discharge, up to 1 year following delivery
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  • 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

  • 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;
  • Concomitant use of other anti-diabetic medication (such as metformin); use of a short-acting insulin will not be considered an exclusion;
  • Known or suspected fetal anomaly or aneuploidy;
  • Prisoners;
  • Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.
Eastern Virginia Medical School logoEastern Virginia Medical School
Study Responsible Party
Marwan Ma'ayeh, Principal Investigator, Assistant Professor, Eastern Virginia Medical School
Study Central Contact
Contact: Marwan Ma'ayeh, MD, 7574467900, [email protected]
1 Study Locations in 1 Countries

Virginia

Sentara Norfolk General Hospital, Norfolk, Virginia 23507, Norfolk, Virginia, 23507, United States
Marwan Ma'ayeh, Contact, 7574467900, [email protected]