Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes
- Conditions
- Gestational Diabetes
- Interventions
- Device: Dexcom G SystemDevice: Self monitoring blood glucose
- Registration Number
- NCT05037526
- Lead Sponsor
- Insel Gruppe AG, University Hospital Bern
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 302
- Informed Consent as documented by signature
- GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
- Maternal age of 18 to 45 years,
- Singleton gestation
- Gestational age ≥ 24 0/7 weeks and <32 0/7 weeks at enrollment.
- Known hypersensitivity or allergy to the sensor
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
- Participation in another study with investigational drug or product within the 30 days preceding and during the present study
- Maternal age < 18 years,
- Multi-fetal gestations,
- Known fetal structural or chromosomal anomalies
- Chronic use of medications associated with hyperglycemia (steroids)
- Planned preterm delivery
- Overt diabetes mellitus type 1 or 2
- HbA1c by study entry > 6.5%
- History of bariatric surgery or other surgeries that induce malabsorption
- Fetal growth restriction by study entry
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dexcom G System Dexcom G System The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app. Standard care of gestational diabetes with self monitoring blood glucose (SMBG) Self monitoring blood glucose SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.
- Primary Outcome Measures
Name Time Method Composite adverse pregnancy and neonatal outcome 2 years 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.
- Secondary Outcome Measures
Name Time Method Neonatal outcome 10-14 weeks Small for gestational age (birth weight \< 10%) yes/no
Initiated Therapy 10-14 weeks Need for antiglycemic therapy in example Insulin yes/no
Glycemic Outcomes 1 10-14 weeks 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).
Glycemic Outcomes 2 10-14 weeks Time in glucose target in %
Glycemic Outcomes 3 10-14 weeks Duration and frequency postprandial hyperglycaemic excursions
Glycemic Outcomes 4 10-14 weeks Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in %
Pregnancy complications 10-14 weeks 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 10-14 weeks Mode of delivery including cesarean delivery, induction of labor, need for operative vaginal delivery (forceps or vacuum-assisted vaginal delivery)
Need for induction of labor 10-14 weeks Induction of labor yes/no
Obstetrical outcome 10-14 weeks Obstetric injury yes/no
Maternal outcomes 10-14 weeks 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
Maternal weight gain 10-14 weeks Weight gain after GDM diagnosis in kg
Maternal Compliance 10-14 weeks Adherence to therapy yes/no
Maternal satisfaction questionnaire 10-14 weeks Patient satisfaction after pregnancy evaluated through a questionnaire
Postpartum disorder 10-14 weeks 8 weeks postpartum oral glucose test values in mmol/L
Birth age 10-14 weeks Gestational age at delivery in weeks
Preterm 10-14 weeks Preterm delivery (delivery \< 37 weeks gestational age) yes/no
Neonatal weight 10-14 weeks Birth weight in grams
Neonatal condition 10-14 weeks Poor condition at birth (Apgar score at 5 minutes \<7, Arterial pH of \<7.0) yes/no
Neonatal Morbidity 10-14 weeks Perinatal morbidity prior to hospital discharge.
Neonatal birth trauma 10-14 weeks Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture)
Resuscitation 10-14 weeks Need for resuscitation yes/no
Neonatal Care 10-14 weeks Admission to neonatal intensive care unit (NICU) with length of stay in days
Respiratory distress syndrome 10-14 weeks Respiratory distress syndrome (need for supplemental oxygen \> 4 hours after birth) yes/no
Trial Locations
- Locations (1)
University Hospital of Bern, Inselspital
🇨🇭Bern, Switzerland