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

ConditionsNeonatal HypoglycemiaGestational Diabetes Mellitus (GDM)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-30
SponsorInstitute of Mother and Child, Warsaw, Poland

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Maternal age of 18 years or older

Singleton pregnancy

Insulin-treated gestational diabetes mellitus

Disqualifiers

Multifetal pregnancy

Congenital malformations or metabolic defects in the newborn

Preterm birth (defined as birth <37 weeks of gestation)

Smoking during pregnancy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexcom ONE Continuous Glucose Monitoring System

    Device

    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).

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Continuous glucose monitoringExperimental treatment 1 intervention
Group B: Blood glucose testing based on standard care proceduresActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Neonatal hypoglycaemia

Number of hypoglycaemic episodes per neonate, defined as the number of CGM-recorded glucose values \<40mg/dl (2.2 mmol/L) occuring within the first 72 hours after birth.

Time frame
From birth until 72 hours of life

Secondary outcomes

1

Total cumulative duration of hypoglycaemia per neonate within the first 72 hours of life

Total cumulative duration of hypoglycaemia per neonate within the first 72 hours of life, defined as the sum of all time periods during which CGM-measured glucose concentration is \<40 mg/dL (2.2 mmol/L), expressed in minutes.

Time frame
From birth until 72 hours of life
2

Number of hypoglycaemia-related clinical interventions per neonate during the monitoring period

Number of clinical interventions (feeding, oral glucose, intravenous glucose administration) per neonate during the monitoring period due to hypoglycaemia

Time frame
From birth until 72 hours of life
3

Number of capillary blood glucose measurements per neonate

Number of capillary blood glucose measurements per neonate during the monitoring period in the control group.

Time frame
From birth until 72 hours of life
4

Measures of glucose variability per neonate within the first 72 hours of life

Glucose variability metrics derived from CGM data, including: * standard deviation (SD) of glucose concentration, and * coefficient of variation (CV), calculated as SD divided by mean glucose and expressed as a percentage.

Time frame
First 72 hours after birth

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Mother and Child, Warsaw, Poland

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: