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

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

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.

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