CGM Use in Preterm Infants

September 22, 2025 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

24

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

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

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

No older than 3 days (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Preterm infants (gestational age (GA) at birth <31 weeks) admitted to the University of Minnesota Masonic Children's Hospital

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

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
Dexcom G6 sensor Continuous Glucose Monitor (CGM)
All participants will be assigned to use the continuous glucose monitor
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
10 days post placement of CGM
Detection of hypo- and hyperglycemia - 60 mg/dL
Time Frame: 10 days post placement of CGM
% time below 60 mg/dL
10 days post placement of CGM
Detection of hypo- and hyperglycemia - 180 mg/dL
Time Frame: 10 days post placement of CGM
% time above 180 mg/dL
10 days post placement of CGM
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
10 days post placement of CGM

Collaborators and Investigators

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

Sponsor

University of Minnesota

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)

October 3, 2022

Primary Completion (Actual)

February 28, 2025

Study Completion (Actual)

August 14, 2025

Study Registration Dates

First Submitted

June 23, 2022

First Submitted That Met QC Criteria

June 23, 2022

First Posted (Actual)

June 29, 2022

Study Record Updates

Last Update Posted (Estimated)

September 24, 2025

Last Update Submitted That Met QC Criteria

September 22, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDS-2022-30647

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

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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