Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes (DiP GlucoMo)
Gestational Diabetes
About this trial
This is an interventional treatment trial for Gestational Diabetes
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
Sites / Locations
- University Hospital of Bern, InselspitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Dexcom G System
Standard care of gestational diabetes with self monitoring blood glucose (SMBG)
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.
SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.