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

NCT07462793 | Not Yet Recruiting

• 1 other identifier: 42/2025
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neonatal Hypoglycemia; Gestational Diabetes Mellitus (GDM)

Keywords

gestational diabetes mellitus; neonatal hypoglycemia; insulin-treated gestational diabetes; neurodevelopmental outcomes

Outcome Measures

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.

  From birth until 72 hours of life

Secondary Outcomes (6)

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

  From birth until 72 hours of life

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

  From birth until 72 hours of life

• Number of capillary blood glucose measurements per neonate

  From birth until 72 hours of life

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

  First 72 hours after birth

• Percentage of time with glucose <40 mg/dL

  From birth until 72 hours of life

Study Arms (2)

Continuous glucose monitoring

EXPERIMENTAL

Neonates undergo continuous glucose monitoring (CGM), with real-time glucose values visible to the clinical team. CGM data may be used to support the detection and clinical management of neonatal hypoglycaemia in accordance with the study protocol.

Device: Dexcom ONE Continuous Glucose Monitoring System

Blood glucose testing based on standard care procedures

ACTIVE COMPARATOR

Detection and management of neonatal hypoglycaemia are based on standard care procedures, as defined by the local protocol. Additionally, neonates undergo continuous glucose monitoring (CGM) in masked mode. CGM values are not visible to the clinical team and do not guide clinical decision-making.

Device: Dexcom ONE Continuous Glucose Monitoring System

Interventions

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).

Blood glucose testing based on standard care procedures; Continuous glucose monitoring

Eligibility Criteria

• Age: 1 Minute - 30 Minutes
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Maternal age of 18 years or older
• Singleton pregnancy
• Insulin-treated gestational diabetes mellitus

You may not qualify if:

• Multifetal pregnancy
• Congenital malformations or metabolic defects in the newborn
• Preterm birth (defined as birth \<37 weeks of gestation)
• Smoking during pregnancy
• Preeclampsia, fetal growth restriction
• Perinatal asphyxia
• Congenital infections in the newborn
• Adverse skin reactions (eczema, wounds) in the planned sensor insertion area

Sponsors & Collaborators

• Institute of Mother and Child, Warsaw, Poland: lead

Study Sites (1)

Institute of Mother and Child

Warsaw, 01-211, Poland

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: In the control group, CGM data are not visible to the clinical team and do not influence clinical management.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Physician in Neonatology

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)