Continous Glucose Monitoring in Neonates at Risk of Hypoglycaemia- a Feasibility Study (CSBS I)

January 21, 2026 updated by: Sykehuset Innlandet HF

Hypoglycemia and Continuous Glucose Monitoring in Neonates (Continuous Sweet Babies Study - CSBS I)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The overall aim of this study is to compare and evaluate the feasibility and effectiveness of CGM in clinical care of neonates and increase knowledge of hypoglycemia and neonatal glucose values.

Hypotheses: * CGM detects neonatal hypoglycemia by rapid response to changes in blood glucose levels more effectively than repeated capillary blood sampling

  • CGM accurately reflects blood glucose levels within the range relevant for newborn infants. * CGM is safe and easily applied to newborn infants and allows real-time monitoring of tissue glucose levels.

Objective: Examine the feasibility of CGM-device with blood glucose assessments in neonates at risk of hypoglycemia.

• Primary outcome: Hypoglycemic episodes (glucose < 2.6 mmol/L) and rapid changes in glucose values not detected by capillary blood sampling.

Recruitment

• ForCSBSI, recruitment of participants will be carried out at the maternity outpatient clinic at SIHF Lillehammer. In Innlandet Hospital Trust, the vast majority of pregnant women with risk factors of neonatal hypoglycemia are selected for delivery at Lillehammer hospital.

Due to only one sensor available we decided to include 25 neonates in order to test feasibility in a clinical setting.

The CGM-sensor will be applied on the lateral side of the upper thigh within 1 hour after birth. Doctors, midwives and nurses at the maternity ward will be trained in application of the devices and supervision will be offered throughout the entire project whenever requested. Capillary blood glucose measurements, enteral nutrition and other treatments and interventions will follow the standard guideline and procedure recommended by the Norwegian Neonatology Interest group. Exact time points for blood sampling will be registered by the nurse, midwife or parent in a registration form specially designed. Continuous glucose values will be sampled for up to 72 hours. Data will be downloaded from the CGM device storage solution and stored in a secure database. The sensor value will be blinded during sampling time. The neonates will be treated after existing guidelines and all treatment interventions based on standard capillary blood samples. Data from the CGM-devices and capillary blood samples will be analyzed and compared retrospectively.

Sampling and registration of data Capillary blood samples will be analyzed with radiometer technique. Validation will be secured through the ISO-recommendation. Sampling technique will be secured ahead of the project.

Due to the nature of the study and research ethics, the results will be unblinded and episodes of incidentally detected hypoglycemia will be treated according to national guidelines.

The neonate will be monitored for up to 72 hours. Variations in glucose, including rapid drops registered by the CGM-devices will be assessed. This will answer if CGM-sensors have clinically acceptable feasibility in neonates at risk of hypoglycemia, and if episodes of hypoglycemia can be detected earlier with CGM. The nurse or midwife responsible for the baby while admitted to the maternity ward or NICU will be asked to a few questions on clinical observations of symptoms. This will answer if the CGM-sensors are able to detect asymptomatic episodes of hypoglycemia in need of treatment. Number of neonates with registered hypoglycemias, total number of hypoglycemias as well as median and ranges of hypoglycemic values will be assessed. Frequencies of registered hypoglycemic episodes registered will be compared between CGM-devices and blood glucose by suitable statistical methods. Regression analyses will be used to calculate risks of developing hypoglycemia according to CGM or blood glucose testing adjusting for relevant background variables including birth weight, gender, gestational age, risk group for hypoglycemia. Agreement between CGM and blood glucose values will be evaluated.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Innlandet
      • Lillehammer, Innlandet, Norway, 2614
        • Innlandet hospital trust Lillehammer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Newborn babies first 72-100Hrs of life

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Aplication of CGM device on neonates upper tigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose profile
Time Frame: +100hrs
CGM values by sensor compared with Realtime golden standard bloodgas glucose values.
+100hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sykehuset Innlandet HF

Investigators

  • Study Chair: Dag Helge Froisland, MD, PhD, Inland Norway University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

November 12, 2025

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

January 21, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 29, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022101a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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