A Phase 4 interventional study of Use of insulin glargine once daily and Use of insulin glargine twice daily in Pregestational Diabetes and Pregnancy, sponsored by Eastern Virginia Medical School. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.
Sponsored by Eastern Virginia Medical School · Phase 4, Interventional, and Treatment
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?
Eastern Virginia Medical School is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants randomized to this arm will take insulin glargine once daily
Drug: Use of insulin glargine once daily
Participants randomized to this arm will take insulin glargine twice daily
Drug: Use of insulin glargine twice daily
Insulin glargine will be used once daily
Insulin glargine will be used twice daily
Weekly Time in Range
The mean blood glucose time in range as measured by the continuous glucose monitor
Time frame: From Day 7 to Day 14 after study enrollment
Hypertensive disorders of pregnancy
Development of hypertensive disorders of pregnancy
Time frame: 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
Time frame: From time of enrollment to 34 weeks gestation
Preterm birth <37 weeks
Delivery prior to 37 weeks gestation
Time frame: 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
Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment
Operative vaginal delivery
Whether an operative vaginal delivery was indicated
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Cesarean Delivery
Whether a cesarean delivery was indicated
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Estimated blood loss
The estimated blood loss during delivery
Time frame: Duration of labor, up to 24 hours
Quantitative blood loss
The quantified blood loss during delivery
Time frame: Duration of labor, up to 24 hours
Blood transfusion
Whether a blood transfusion was necessary during or following delivery
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Endometritis
Incidence of endometritis (inflammation of uterine lining)
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Chorioamnionitis
Incidence of chorioamnionitis (placental and amniotic membrane infection)
Time frame: From time of enrollment until time of hospital discharge (up to 42 days post-delivery)
Wound infection
Infection of wounds left by labor
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Venous thromboembolism
Incidence of venous thromboembolism
Time frame: 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
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
ICU admission
Admission to the ICU
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Maternal death
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Antepartum death
Fetal death
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Intrapartum death
Fetal death during labor and delivery
Time frame: Duration of labor, up to 24 hours
Neonatal Intubation within 72 hours of birth
Time frame: 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
Time frame: From time of delivery to 72 hours later
High-flow nasal cannula (HFNC) within 72 hours of birth
Time frame: From time of delivery to 72 hours later
Cardiopulmonary resuscitation within 72 hours of birth
Time frame: From time of delivery to 72 hours later
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
Birthweight
Infant birthweight
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Neonatal encephalopathy
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Seizures
Incidence of neonatal seizures
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Shoulder dystocia
Incidence of shoulder dystocia
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Birth trauma
Incidence of neonatal birth trauma
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Intracranial hemorrhage
Incidence of neonatal intracranial hemorrhage
Time frame: 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
Time frame: 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
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Eastern Virginia Medical School