Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.
The incidence of obesity and diabetes is rising worldwide even in younger populations. With a rise in maternal obesity also gestational diabetes mellitus (GDM) becomes more prevalent with a prevalence of up to 18% of pregnancies. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. The main purpose of this study is to prove that real time continuous glucose monitoring (rt-CGM) can effectively reduce the risk for adverse pregnancy and neonatal outcome in GDM. It is further hypothesized that rt-CGM can optimize maternal glycaemic control, increase patients satisfaction and adherence to management strategies of GDM. This is a open label randomized controlled trial with two parallel groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
302
Continuous glucose monitoring system
Standard Care
University Hospital of Bern, Inselspital
Bern, Switzerland
Composite adverse pregnancy and neonatal outcome
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.
Time frame: 2 years
Initiated Therapy
Need for antiglycemic therapy in example Insulin yes/no
Time frame: 10-14 weeks
Glycemic Outcomes 1
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 frame: 10-14 weeks
Glycemic Outcomes 2
Time in glucose target in %
Time frame: 10-14 weeks
Glycemic Outcomes 3
Duration and frequency postprandial hyperglycaemic excursions
Time frame: 10-14 weeks
Glycemic Outcomes 4
Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %
Time frame: 10-14 weeks
Pregnancy complications
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)
Time frame: 10-14 weeks
Mode of Delivery
Mode of delivery including cesarean delivery, induction of labor, need for operative vaginal delivery (forceps or vacuum-assisted vaginal delivery)
Time frame: 10-14 weeks
Need for induction of labor
Induction of labor yes/no
Time frame: 10-14 weeks
Obstetrical outcome
Obstetric injury yes/no
Time frame: 10-14 weeks
Maternal outcomes
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
Time frame: 10-14 weeks
Maternal weight gain
Weight gain after GDM diagnosis in kg
Time frame: 10-14 weeks
Maternal Compliance
Adherence to therapy yes/no
Time frame: 10-14 weeks
Maternal satisfaction questionnaire
Patient satisfaction after pregnancy evaluated through a questionnaire
Time frame: 10-14 weeks
Postpartum disorder
8 weeks postpartum oral glucose test values in mmol/L
Time frame: 10-14 weeks
Birth age
Gestational age at delivery in weeks
Time frame: 10-14 weeks
Preterm
Preterm delivery (delivery \< 37 weeks gestational age) yes/no
Time frame: 10-14 weeks
Neonatal weight
Birth weight in grams
Time frame: 10-14 weeks
Neonatal outcome
Small for gestational age (birth weight \< 10%) yes/no
Time frame: 10-14 weeks
Neonatal condition
Poor condition at birth (Apgar score at 5 minutes \<7, Arterial pH of \<7.0) yes/no
Time frame: 10-14 weeks
Neonatal Morbidity
Perinatal morbidity prior to hospital discharge.
Time frame: 10-14 weeks
Neonatal birth trauma
Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)
Time frame: 10-14 weeks
Resuscitation
Need for resuscitation yes/no
Time frame: 10-14 weeks
Neonatal Care
Admission to neonatal intensive care unit (NICU) with length of stay in days
Time frame: 10-14 weeks
Respiratory distress syndrome
Respiratory distress syndrome (need for supplemental oxygen \> 4 hours after birth) yes/no
Time frame: 10-14 weeks
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