The Effectiveness of Rt-CGM to Improve Glycemic Control and Pregnancy Outcome in Patients With GDM
Cgm, Gestational Diabetes, Pregnancy Complications
About this trial
This is an interventional treatment trial for Cgm
Eligibility Criteria
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
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
Sites / Locations
- Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of ViennaRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
self-monitored blood glucose
Continuous glucose monitoring
The control group participants will perform self-monitored blood glucose testing with a study-provided blood glucose meter, including testing supplies. They will perform capillary blood glucose monitoring as routinely used for patients with GDM i.e. at least four capillary blood glucose values daily including measurements at fasting as well as 1h after starting each meal by using a routinely available blood glucose measurement device.
Patients randomized to the intervention group will be equipped with a real-time CGM sensor (Dexcom G6 sensor, a small flexible device that records interstitial glucose levels every five minutes). The sensor will be inserted into the subcutaneous tissue of the anterior abdomen wall. Additionally, patients will be advised to record capillary blood glucose values if glucose alerts or readings do not match with symptoms or expectations. Participants will be educated how to exchange the sensor (has to be exchanged every ten days) and will be equipped with a real-time CGM monitor and instructed in its use. The monitor provides the user with information about current glucose levels and notifies the patient before she reaches her upper or lower glucose threshold and when glucose levels change rapidly. All patients in the intervention group will specifically trained how to use the system.