Pregestational Diabetes, Pregnancy
Conditions
Keywords
continuous glucose monitoring
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 study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?
Interventions
DRUGUse of insulin glargine once daily
Insulin glargine will be used once daily
DRUGUse of insulin glargine twice daily
Insulin glargine will be used twice daily
Sponsors
Eastern Virginia Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Time in Range | From Day 7 to Day 14 after study enrollment | The mean blood glucose time in range as measured by the continuous glucose monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neonatal encephalopathy | From time of delivery to time of hospital discharge, up to 1 year following delivery | — |
| Seizures | From time of delivery to time of hospital discharge, up to 1 year following delivery | Incidence of neonatal seizures |
| Shoulder dystocia | From time of delivery to time of hospital discharge, up to 1 year following delivery | Incidence of shoulder dystocia |
| Birth trauma | From time of delivery to time of hospital discharge, up to 1 year following delivery | Incidence of neonatal birth trauma |
| Intracranial hemorrhage | From time of delivery to time of hospital discharge, up to 1 year following delivery | Incidence of neonatal intracranial hemorrhage |
| Hyperbilirubinemia requiring phototherapy or exchange transfusion | From time of delivery to time of hospital discharge, up to 1 year following delivery | Incidence of neonatal hyperbilirubinemia requiring phototherapy or exchange transfusion |
| NICU admission | From time of delivery to time of hospital discharge, up to 1 year following delivery | Admission of neonate to the neonatal intensive care unit |
| Massive transfusion and postpartum hemorrhage | From time of enrollment until hospital discharge (up to 42 days post-delivery) | Incidence of massive transfusion and postpartum hemorrhage |
| ICU admission | From time of enrollment until hospital discharge (up to 42 days post-delivery) | Admission to the ICU |
| Maternal death | From time of enrollment to hospital discharge (up to 42 days post-delivery) | — |
| Antepartum death | From time of enrollment to time of delivery, up to 20 weeks following enrollment | Fetal death |
| Intrapartum death | Duration of labor, up to 24 hours | Fetal death during labor and delivery |
| 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 | From time of delivery to 72 hours later | Use of CPAP for neonate within 72 hours of birth |
| 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 | — |
| Venous thromboembolism | From time of enrollment to time of hospital discharge (up to 42 days post-delivery) | Incidence of venous thromboembolism |
| Hypertensive disorders of pregnancy | From time of enrollment until time of delivery, up to 20 weeks following enrollment | Development of hypertensive disorders of pregnancy |
| Preterm birth <34 weeks | From time of enrollment to 34 weeks gestation | Delivery at less than 34 weeks gestation |
| Preterm birth <37 weeks | From time of enrollment until 37 weeks gestation | Delivery prior to 37 weeks gestation |
| Spontaneous or Indicated Delivery | 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 |
| Operative vaginal delivery | From time of enrollment to time of delivery, up to 20 weeks following enrollment | Whether an operative vaginal delivery was indicated |
| Cesarean Delivery | From time of enrollment to time of delivery, up to 20 weeks following enrollment | Whether a cesarean delivery was indicated |
| Estimated blood loss | Duration of labor, up to 24 hours | The estimated blood loss during delivery |
| Quantitative blood loss | Duration of labor, up to 24 hours | The quantified blood loss during delivery |
| Blood transfusion | From time of enrollment until hospital discharge (up to 42 days post-delivery) | Whether a blood transfusion was necessary during or following delivery |
| Endometritis | From time of enrollment to hospital discharge (up to 42 days post-delivery) | Incidence of endometritis (inflammation of uterine lining) |
| Chorioamnionitis | From time of enrollment until time of hospital discharge (up to 42 days post-delivery) | Incidence of chorioamnionitis (placental and amniotic membrane infection) |
| Birthweight | From time of delivery to time of hospital discharge, up to 1 year following delivery | Infant birthweight |
| Wound infection | From time of enrollment to hospital discharge (up to 42 days post-delivery) | Infection of wounds left by labor |
Countries
United States
Contacts
CONTACTMarwan Ma'ayeh, MD
Outcome results
None listed