Radar des Essais Cliniques

Time in Range (TIR) at 34 weeks gestation

Percentage of time spent within target range (63-140mg/dL) on Continuous Glucose Monitoring at 34 weeks gestation

33 to 35 weeks gestation

Composite Neonatal Morbidity

Composite morbidity of the neonate including one or more of preterm birth (delivery less than 37 weeks for any indication), birth trauma (shoulder dystocia with nerve injury, clavicular or humeral fracture or 3 or more maneuvers to resolve), hypoglycemia (requiring treatment with dextrose gel or IV within 24 hours of birth), hyperbilirubinemia (requiring phototherapy within 72 hours of birth), large-for-gestational-age infant (birthweight greater than the 90th percentile for gestational age), and miscarriage, stillbirth or neonatal death prior to hospital discharge.

From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

Preterm birth

Delivery less than 37 weeks gestation

Delivery

Birth trauma

Shoulder dystocia with nerve injury, clavicular or humeral fracture or 3 or more maneuvers to relieve

Delivery

Neonatal hypoglycemia

Low neonatal glucose requiring treatment with dextrose gel or IV within 24 hours of life

Delivery to 24 hours of life

Hyperbilirubinemia

Elevated bilirubin requiring phototherapy within 72 hours of life

Delivery to 72 hours of life

Large-for-gestational-age (LGA) neonate

Birthweight greater than the 90th percentile for gestational age

Delivery

Small-for-gestational-age (SGA) neonate

Birthweight less than the 10th percentile for gestational age

Delivery

Fetal glucose

Concentration of umbilical cord blood glucose (mg/dL)

Delivery

Fetal insulin

Concentration of umbilical cord blood insulin (uU/mL)

Delivery

Fetal C-peptide

Concentration of umbilical cord blood C-peptide (ng/mL)

Delivery

Fetal leptin

Concentration of umbilical cord blood leptin (ng/mL)

Delivery

Fetal ghrelin

Concentration of umbilical cord blood ghrelin (uU/L)

Delivery

Fetal surfactant protein D

Concentration of umbilical cord blood surfactant protein D (ng/mL)

Delivery

Time Above Range (TAR) at 34 weeks

Percentage of time spent above range greater than 140mg/dL on Continuous Glucose Monitoring (CGM) at 34 weeks

33 to 35 weeks

Time Below Range (TBR) at 34 weeks

Percentage of time spent below range less than 63mg/dL on Continuous Glucose Monitoring at 34 weeks

33 to 35 weeks

Mean glucose at 34 weeks

Average glucose in mg/dL using Continuous Glucose Monitoring data at 34 weeks

33 to 35 weeks

Glucose Management Indicator (GMI)

Glucose management indicator as an estimate of hemoglobin A1c calculated using mean glucose on CGM at 34 weeks

33 to 35 weeks

Glucose variability at 34 weeks

Coefficient of variation calculated as the mean glucose divided by standard deviation using Continuous Glucose Monitoring data at 34 weeks

33 to 35 weeks

Mean fasting glucose at 34 weeks

Average glucose at 6-7am on Continuous Glucose Monitoring at 34 weeks

33 to 35 weeks

Hemoglobin A1c at Delivery

Hemoglobin A1c (%) at delivery

Delivery

Insulin total daily dose at delivery

Total number of units of insulin taken per day at time of delivery

Delivery

Cesarean delivery

First cesarean delivery or cesarean delivery after a history of prior cesarean

Delivery

Glucose Monitoring Satisfaction

Score on glucose monitoring satisfaction survey at delivery

Delivery

Fetal or neonatal death

Miscarriage (pregnancy loss less than 20 weeks), stillbirth (fetal death at 20 weeks or more), or neonatal death (death after birth up to 28 days of life)

From the date of randomization to the date of neonatal hospital discharge, assessed up to 12 months of life

Neonatal Intensive Care Unit (NICU) Admission

Admission to the neonatal intensive care unit with length of stay greater than 24 hours

From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

Neonatal length of stay

Duration of neonatal hospitalization after delivery

From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

Neonatal mechanical ventilation

Neonate requiring intubation and mechanical ventilation for respiratory support

From the date of delivery to the date of neonatal hospital discharge, assessed up to 12 months of life

Insulin increase during pregnancy

Percentage change in total daily dose of insulin at delivery compared to enrollment

From the date of randomization to the date of delivery, assessed up to 9 months

Preeclampsia

Elevated blood pressure greater than 140/90 mmHg after 20 weeks gestation with proteinuria or other severe features by ACOG criteria (may be superimposed on chronic hypertension or not)

From the date of randomization to the date of maternal hospital discharge after delivery, assessed up to 9 months

Postpartum infection

Developing one or more of endometritis, wound infection or other wound complication such as seroma, hematoma or dehiscence)

From the date of delivery through 6 weeks' postpartum

Glucose Monitoring Adherence

Defined as percentage of expected self-monitoring of blood glucose (SMBG) values completed based on recommended 4 values per day for participants in the SMBG arm and percentage of time Continuous Glucose Monitoring (CGM) in use in the CGM arm

From the date of randomization to the date of delivery, assessed up to 9 months