Sentara Norfolk General Hospital, Norfolk, Virginia 23507
Norfolk, Virginia, 23507, United States
Location status: Recruiting
NCT Number: NCT07224893
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?
Interested in participating?
Request Info18 year and older
Female
Interventional
Phase 4
Norfolk, Virginia, 23507, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Insulin glargine will be used once daily
Insulin glargine will be used twice daily
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
Time frame: From time of enrollment until time of delivery, up to 20 weeks following enrollment
Development of hypertensive disorders of pregnancy
Time frame: From time of enrollment to 34 weeks gestation
Delivery at less than 34 weeks gestation
Time frame: From time of enrollment until 37 weeks gestation
Delivery prior to 37 weeks gestation
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
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Whether an operative vaginal delivery was indicated
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Whether a cesarean delivery was indicated
Time frame: Duration of labor, up to 24 hours
The estimated blood loss during delivery
Time frame: Duration of labor, up to 24 hours
The quantified blood loss during delivery
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
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Incidence of endometritis (inflammation of uterine lining)
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)
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Infection of wounds left by labor
Time frame: From time of enrollment to time of hospital discharge (up to 42 days post-delivery)
Incidence of venous thromboembolism
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Incidence of massive transfusion and postpartum hemorrhage
Time frame: From time of enrollment until hospital discharge (up to 42 days post-delivery)
Admission to the ICU
Time frame: From time of enrollment to hospital discharge (up to 42 days post-delivery)
Time frame: From time of enrollment to time of delivery, up to 20 weeks following enrollment
Fetal death
Time frame: Duration of labor, up to 24 hours
Fetal death during labor and delivery
Time frame: From time of delivery to 72 hours later
Time frame: From time of delivery to 72 hours later
Use of CPAP for neonate within 72 hours of birth
Time frame: From time of delivery to 72 hours later
Time frame: From time of delivery to 72 hours later
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Infant birthweight
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Incidence of neonatal seizures
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Incidence of shoulder dystocia
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Incidence of neonatal birth trauma
Time frame: From time of delivery to time of hospital discharge, up to 1 year following delivery
Incidence of neonatal intracranial hemorrhage
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
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
Contact information is provided by the study sponsor or research team.
Eastern Virginia Medical School
Other
Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin
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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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