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COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus
Sponsor: Institute of Mother and Child, Warsaw, Poland
Summary
The purpose of this study is to determine whether continuous glucose monitoring (CGM) improves the detection and management of neonatal hypoglycaemia in newborns of mothers with insulin-treated gestational diabetes.
Official title: COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus (COMET-GDM): a Randomised Controlled Trial
Key Details
Gender
All
Age Range
1 Minute - 30 Minutes
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2026-03
Completion Date
2027-12
Last Updated
2026-03-10
Healthy Volunteers
Yes
Interventions
Dexcom ONE Continuous Glucose Monitoring System
The Dexcom ONE continuous glucose monitoring system is applied to all participants. Following randomisation, CGM data are either available in real time to the clinical team (intervention group) or recorded in masked mode and not available to the clinical team, and therefore do not influence clinical management (control group).
Locations (1)
Institute of Mother and Child
Warsaw, Poland