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

NACompletedINTERVENTIONAL
Enrollment

375

Participants

Timeline

Start Date

August 24, 2020

Primary Completion Date

August 24, 2024

Study Completion Date

February 28, 2025

Conditions
CgmGestational DiabetesPregnancy ComplicationsBlood GlucoseGDM
Interventions
DEVICE

Dexcom G6 Continuous Glucose Monitoring System

Users insert a tiny sensor wire just under their skin using an automatic applicator. The sensor can measure glucose readings in interstitial fluid throughout the day and night.

DEVICE

self-monitored blood glucose

Each participant in the control group will be assigned a study blood glucose meter to measure and store their blood glucose values during the study. Therefore, the Contour® Next One system (or a comparable device) will be used. The meter has CE Mark clearance and is commercially available in Europe. Participants will receive an ample supply of meter test materials based on quantities routinely used.

Trial Locations (1)

1090

Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna, Vienna

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

University Hospital, Basel, Switzerland

OTHER

collaborator

Charite University, Berlin, Germany

OTHER

collaborator

CNR Institute of Neurosceince, Padova, Italy

UNKNOWN

collaborator

Università Politecnica delle Marche

OTHER

collaborator

DexCom, Inc.

INDUSTRY

collaborator

Jena University Hospital

OTHER

collaborator

German Diabetes Center

OTHER

lead

Medical University of Vienna

OTHER