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CGM Use in Preterm Infants

NCT05436925 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2025-09-24

No results posted yet for this study

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. 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.

Conditions

  • Very Low Birth Weight Infant
  • Very Preterm Maturity of Infant
  • Hyperglycemia

Interventions

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.

Sponsors & Collaborators

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-03
Primary Completion
2025-02-28
Completion
2025-08-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05436925 on ClinicalTrials.gov