HyperglycemiaCSBS INCT07375615
Continous Glucose Monitoring in Neonates at Risk of Hypoglycaemia- a Feasibility Study
An observational study of Hyperglycemia and Hypoglycemia, run by Sykehuset Innlandet HF at 1 site in Norway.
Trial summary
The study's main purpose is to test feasibility of Continous Glucose montoring in Neonates during the first 72 hrs. Read more about this study
- Who is it for?
- Ages 0 hours to 5 days
- Conditions the study is for
- Hyperglycemia, Hypoglycemia, Hypoglycemia Neonatal
- What is being tested?
- Continous glucose monitor
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- 1 Mar 2023to 12 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 hours to 5 days
- All sexes
- No healthy volunteers
- Child
Study population: Newborn babies first 72-100Hrs of life
Who may be able to join
- LGA, Maternal diabetes (TID and TIID and Gestational diabetes)
- GA>36+6
Who cannot join
- SGA, Prematurity, major congenital anomalies, multiple pregnancy and severe asphyxia (Apgar < 5 by 10 min. age).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hyperglycemia, Hypoglycemia, Hypoglycemia Neonatal
- Being tested
- Continous glucose monitor
- Keywords
- Neonate, glucose, hypoglycemia, Continous glucose measurement (CGM),newborn
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continous glucose monitorDevice
Aplication of CGM device on neonates upper tigh
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Continous glucose monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose profile
CGM values by sensor compared with Realtime golden standard bloodgas glucose values.
Measured: +100hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Mar 2023
- Primary completion30 Jun 2024
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Innlandet HF
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dag Helge Froisland, MD, PhD, Study chair, Inland Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375615
- Sponsor's protocol ID
- 2022101a
- Acronym
- CSBS I
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypoglycemia and Continuous Glucose Monitoring in Neonates (Continuous Sweet Babies Study - CSBS I)
- ClinicalTrials.gov ID
- NCT07375615
- Acronym / sponsor ID
- CSBS I / 2022101a
- Conditions
- Hyperglycemia, Hypoglycemia, Hypoglycemia Neonatal
- Keywords
- Neonate, glucose, hypoglycemia, Continous glucose measurement (CGM),newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Sykehuset Innlandet HFUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study's main purpose is to test feasibility of Continous Glucose montoring in Neonates during the first 72 hrs.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonates at risk of hypoglycemia after birth | – | Device: Continous glucose monitorCGM 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. |
Who may qualify
- Ages
- 0 hours to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Newborn babies first 72-100Hrs of life
Key inclusion criteria (2 listed)
- LGA, Maternal diabetes (TID and TIID and Gestational diabetes)
- GA>36+6
Key exclusion criteria (1 listed)
- SGA, Prematurity, major congenital anomalies, multiple pregnancy and severe asphyxia (Apgar < 5 by 10 min. age).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continous glucose monitorAplication of CGM device on neonates upper tigh | Device | Neonates at risk of hypoglycemia after birth |
Primary outcome
Glucose profile
Time frame: +100hrs
CGM values by sensor compared with Realtime golden standard bloodgas glucose values.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Helge Froisland, MD, PhD study chair
Inland Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperglycemia and Hypoglycemia, run by Sykehuset Innlandet HF at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose profile (time frame: +100hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.