Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes

The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight >90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.

Need for antiglycemic therapy in example Insulin yes/no

Glycemic variability including number and duration of hypoglycemic and hyperglycemic events, mean interstitial glucose in mmol/L and its standard deviation (SD) A hypoglycemic event was defined for two separate analyses as excursions of at least 15 min below the target range (<3.5 mmol/L), and a hyperglycemic event was defined for two separate analyses as excursions of at least 15 min above the target range (>7.8 mmol/L).

Time in glucose target in %

Duration and frequency postprandial hyperglycaemic excursions

Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %

Pregnancy Complications such as

• Placenta insufficiency (Estimated fetal weight < 10th centile and blood flow changes),
• Gestational hypertension (systolic blood pressure ≥ 140 mm Hg or diastolic blood pressure ≥ 90 mg Hg on two occasions at least 4 hours apart)
• Preeclampsia (international Society for the Study of Hypertension in Pregnancy (ISSHP) definition)

Mode of delivery including cesarean delivery, induction of labor, need for operative vaginal delivery (forceps or vacuum-assisted vaginal delivery)

Induction of labor yes/no

Obstetric injury yes/no

Body mass index (BMI) (pre-pregnancy and at the time of delivery) weight and height will be combined to report BMI in kg/m^2

Weight gain after GDM diagnosis in kg

Adherence to therapy yes/no

Patient satisfaction after pregnancy evaluated through a questionnaire

8 weeks postpartum oral glucose test values in mmol/L

Gestational age at delivery in weeks

Preterm delivery (delivery < 37 weeks gestational age) yes/no

Birth weight in grams

Small for gestational age (birth weight < 10%) yes/no

Poor condition at birth (Apgar score at 5 minutes <7, Arterial pH of <7.0) yes/no

Perinatal morbidity prior to hospital discharge.

Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)

Need for resuscitation yes/no

Admission to neonatal intensive care unit (NICU) with length of stay in days

Respiratory distress syndrome (need for supplemental oxygen > 4 hours after birth) yes/no