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

Study Overview
=================
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.

Official Title
-----------------
Diabetes in Pregnancy Project Und Mobile Health in Gestational Diabetes: An Open Label Randomized Controlled Monocentric Trial on the Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care

Conditions
-----------------
Gestational Diabetes

Intervention / Treatment
-----------------
* Device: Dexcom G System
* Device: Self monitoring blood glucose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexcom G System<br>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. | Device: Dexcom G System<br>* Continuous glucose monitoring system<br>|
| Active Comparator: Standard care of gestational diabetes with self monitoring blood glucose (SMBG)<br>SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. | Device: Self monitoring blood glucose<br>* Standard Care<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiated Therapy | Need for antiglycemic therapy in example Insulin yes/no | 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). | 10-14 weeks | 
| Glycemic Outcomes 2 | Time in glucose target in % | 10-14 weeks | 
| Glycemic Outcomes 3 | Duration and frequency postprandial hyperglycaemic excursions | 10-14 weeks | 
| Glycemic Outcomes 4 | Hemoglobin A1c (HbA1c) values (at inclusion, birth and postpartum) in % | 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) | 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) | 10-14 weeks | 
| Need for induction of labor | Induction of labor yes/no | 10-14 weeks | 
| Obstetrical outcome | Obstetric injury yes/no | 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 | 10-14 weeks | 
| Maternal weight gain | Weight gain after GDM diagnosis in kg | 10-14 weeks | 
| Maternal Compliance | Adherence to therapy yes/no | 10-14 weeks | 
| Maternal satisfaction questionnaire | Patient satisfaction after pregnancy evaluated through a questionnaire | 10-14 weeks | 
| Postpartum disorder | 8 weeks postpartum oral glucose test values in mmol/L | 10-14 weeks | 
| Birth age | Gestational age at delivery in weeks | 10-14 weeks | 
| Preterm | Preterm delivery (delivery < 37 weeks gestational age) yes/no | 10-14 weeks | 
| Neonatal weight | Birth weight in grams | 10-14 weeks | 
| Neonatal outcome | Small for gestational age (birth weight < 10%) yes/no | 10-14 weeks | 
| Neonatal condition | Poor condition at birth (Apgar score at 5 minutes <7, Arterial pH of <7.0) yes/no | 10-14 weeks | 
| Neonatal Morbidity | Perinatal morbidity prior to hospital discharge. | 10-14 weeks | 
| Neonatal birth trauma | Birth trauma (brachial plexus injury, or clavicular, humeral, or skull fracture) | 10-14 weeks | 
| Resuscitation | Need for resuscitation yes/no | 10-14 weeks | 
| Neonatal Care | Admission to neonatal intensive care unit (NICU) with length of stay in days | 10-14 weeks | 
| Respiratory distress syndrome | Respiratory distress syndrome (need for supplemental oxygen > 4 hours after birth) yes/no | 10-14 weeks |