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NOT YET RECRUITING
NCT07462793
NA

COntinuous Glucose Monitoring in nEwborns of Mothers With Insulin-Treated Gestational Diabetes Mellitus

Sponsor: Institute of Mother and Child, Warsaw, Poland

View on ClinicalTrials.gov

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

DEVICE

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