Real-time Continuous Glucose Monitoring for Reduced Adverse Complications and Events in Women With Gestational Diabetes (GRACE): a Multicentre International Randomized Controlled Trial

Inclusion Criteria: * female patients between 18 and 55 years * gestational diabetes mellitus in accordance with the IADPSG criteria between 24 and 31+6 weeks of gestation by a 2h 75g OGTT * If the GDM diagnosis is made before 24+0 weeks of gestation in accordance with the local guideline (i.e. when IADPSG cut-offs for fasting and post-load glucose are exceeded) patients can be included if no insulin treatment was started until 24+0 Exclusion Criteria: * Overt diabetes (i.e. pregestationally known type 1 or type 2 diabetes or fasting plasma glucose during the OGTT ≥126 mg/dl \[7.0 mmol/l\] or HbA1c ≥6.5% \[44 mmol/l\] or 2h post-load OGTT levels ≥200 mg/dl \[11.1 mmol/l\] assessed before 24+0 weeks of gestation * history of bariatric surgery or other surgeries that induce malabsorption * long-term use (\>2 weeks) of systemic steroids prior to enrolment * multiple pregnancy * Patients already using glucose lowering medications (metformin or insulin) before study entry * fetal growth restriction due to placental dysfunction at study entry - Inpatient psychiatric treatment up to 1 year before enrolment * Participation in this study in previous pregnancy