Very Low Birth Weight InfantNCT05436925
CGM Use in Preterm Infants
An observational study of Very Low Birth Weight Infant and Very Preterm Maturity of Infant, run by University of Minnesota at 1 site in United States.
Trial summary
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. Read more about this study
- Who is it for?
- Ages Up to 72 hours
- Conditions the study is for
- Very Low Birth Weight Infant, Very Preterm Maturity of Infant, Hyperglycemia
- What is being tested?
- Dexcom G6 sensor Continuous Glucose Monitor (CGM)
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Oct 2022to 14 Aug 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 Up to 72 hours
- All sexes
- No healthy volunteers
- Child
Study population: Preterm infants (gestational age (GA) at birth <31 weeks) admitted to the University of Minnesota Masonic Children's Hospital
Who may be able to join
- preterm infants (gestational age (GA) at birth < 31 weeks)
- admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
- written informed consent can be secured from a parent within 96 hours of birth.
Who cannot join
- Infants born at ≥31 weeks GA
- infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development
- children experiencing severe birth asphyxia,
- children enrolled in another nutritional study,
- children likely to be transferred out of the NICU
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.
- Being tested
- Dexcom G6 sensor Continuous Glucose Monitor (CGM)
- Keywords
- Continuous glucose monitor, Neonates, Hyperglycemia, Hypoglycemia, Very low birth weight
- Medical subject headings
- Hyperglycemia, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexcom G6 sensor Continuous Glucose Monitor (CGM)Device
The device used as part of the study is to obtain results for glucose testing for research only and not for diagnostic purposes.
| Study group | Role | What they receive |
|---|---|---|
| Dexcom G6 sensor Continuous Glucose Monitor (CGM) | All participants will be assigned to use the continuous glucose monitor Receives: Device: Dexcom G6 sensor Continuous Glucose Monitor (CGM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of hypo- and hyperglycemia - CGM device
Proportion of CGM device readings that match blood glucose readings
Measured: 10 days post placement of CGM
Detection of hypo- and hyperglycemia - 60 mg/dL
% time below 60 mg/dL
Measured: 10 days post placement of CGM
Detection of hypo- and hyperglycemia - 180 mg/dL
% time above 180 mg/dL
Measured: 10 days post placement of CGM
Detection of hypo- and hyperglycemia - AEs
% of infants with adverse events secondary to CGM placement or wear
Measured: 10 days post placement of CGM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start3 Oct 2022
- Primary completion28 Feb 2025
- Study completion14 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Very Low Birth Weight InfantStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436925
- Sponsor's protocol ID
- PEDS-2022-30647
- Status last verified
- Sep 2025
- First submitted
- 23 Jun 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia
- ClinicalTrials.gov ID
- NCT05436925
- Acronym / sponsor ID
- PEDS-2022-30647
- Keywords
- Continuous glucose monitor, Neonates, Hyperglycemia, Hypoglycemia, Very low birth weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 3 Oct 2022 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 14 Aug 2025 (actual)
- First posted
- 29 Jun 2022 (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.
Preterm infants (gestational age (GA) at birth < 31 weeks) admitted to the University of Minnesota Masonic Children's Hospital NICU will have a Dexcom G6 sensor Continuous Glucose Monitor (CGM) placed shortly after consent and wear the device for up to 10 days. The low alarm threshold will be set at 60 mg/dL or 80mg/dL (depending on whether they are receiving continuous insulin) to detect the potential for hypoglycemia. A suggestion will be made to the clinical team to draw a blood glucose to correlate with CGM values ≤60 mg/dL and the infant will be treated according to Neonatal Intensive Care Unit (NICU) protocol for corroborating blood glucose levels. Infants will also be monitored per current NICU protocol (blood glucose checks every 1-2 hours while on insulin) and treated accordingly. Clinical data and long-term growth, body composition and neurodevelopmental outcomes will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dexcom G6 sensor Continuous Glucose Monitor (CGM) | – | Device: Dexcom G6 sensor Continuous Glucose Monitor (CGM)All participants will be assigned to use the continuous glucose monitor |
Who may qualify
- Ages
- Up to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Preterm infants (gestational age (GA) at birth <31 weeks) admitted to the University of Minnesota Masonic Children's Hospital
Key inclusion criteria (3 listed)
- preterm infants (gestational age (GA) at birth < 31 weeks)
- admitted to the University of Minnesota Masonic Children's Hospital Neonatal Intensive Care Unit
- written informed consent can be secured from a parent within 96 hours of birth.
Key exclusion criteria (5 listed)
- Infants born at ≥31 weeks GA
- infants with a prenatally diagnosed clinical or genetic condition (other than prematurity) that is known to affect growth rate, adiposity, or neurocognitive development
- children experiencing severe birth asphyxia,
- children enrolled in another nutritional study,
- children likely to be transferred out of the NICU
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 |
|---|---|---|
| Dexcom G6 sensor Continuous Glucose Monitor (CGM)The device used as part of the study is to obtain results for glucose testing for research only and not for diagnostic purposes. | Device | Dexcom G6 sensor Continuous Glucose Monitor (CGM) |
Primary outcome
Detection of hypo- and hyperglycemia - CGM device
Time frame: 10 days post placement of CGM
Proportion of CGM device readings that match blood glucose readings
Detection of hypo- and hyperglycemia - 60 mg/dL
Time frame: 10 days post placement of CGM
% time below 60 mg/dL
Detection of hypo- and hyperglycemia - 180 mg/dL
Time frame: 10 days post placement of CGM
% time above 180 mg/dL
Detection of hypo- and hyperglycemia - AEs
Time frame: 10 days post placement of CGM
% of infants with adverse events secondary to CGM placement or wear
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 24 Sep 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Very Low Birth Weight Infant and Very Preterm Maturity of Infant, run by University of Minnesota at 1 site in United States.
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 3 inclusion and 5 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 24 Sep 2025. 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 United States. 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?
Detection of hypo- and hyperglycemia - CGM device (time frame: 10 days post placement of CGM). The study lists 4 primary outcomes in all. 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 24 Sep 2025; AzTrials last refreshed its copy on 26 Oct 2026.