NCT07375615

Brief Summary

The study's main purpose is to test feasibility of Continous Glucose montoring in Neonates during the first 72 hrs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 21, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

January 29, 2026

Status Verified

January 1, 2026

Enrollment Period

1.3 years

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

HyperglycemiaHypoglycemiaHypoglycemia Neonatal

Keywords

Neonate, glucose, hypoglycemia, Continous glucose measurement (CGM),newborn

Outcome Measures

Primary Outcomes (1)

  • Glucose profile

    CGM values by sensor compared with Realtime golden standard bloodgas glucose values.

    +100hrs

Study Arms (1)

Neonates at risk of hypoglycemia after birth

CGM sensor placed on infant as soon as possible after birth, taken off after 72 hrs, 2 bloodspecimens drawn from babies at different timepoints to compare with CGM values. CGM used to describe glucose profile variation.

Device: Continous glucose monitor

Interventions

Continous glucose monitorDEVICE

Aplication of CGM device on neonates upper tigh

Neonates at risk of hypoglycemia after birth

Eligibility Criteria

Age0 Hours - 5 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Newborn babies first 72-100Hrs of life

You may qualify if:

  • LGA, Maternal diabetes (TID and TIID and Gestational diabetes)
  • GA\>36+6

You may not qualify if:

  • SGA, Prematurity, major congenital anomalies, multiple pregnancy and severe asphyxia (Apgar \< 5 by 10 min. age).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Innlandet hospital trust Lillehammer

Lillehammer, Innlandet, 2614, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Bloodsamples analyzed in bloodgasmachine for glucose values.

MeSH Terms

Conditions

HyperglycemiaHypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Dag Helge Froisland, MD, PhD

    Inland Norway University of Applied Sciences

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 29, 2026

Study Start

March 1, 2023

Primary Completion

June 30, 2024

Study Completion

November 12, 2025

Last Updated

January 29, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Regional Ethical board of Norway prohibit sharing individual data on participants in clininical studies this is similar for all studies bot anonymized data and de-identificed data.

Locations

NO(1)