CGM Use in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2025-08-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Very Low Birth Weight Infant Very Preterm Maturity of Infant Hyperglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dexcom G6 sensor Continuous Glucose Monitor (CGM)

All participants will be assigned to use the continuous glucose monitor

Dexcom G6 sensor Continuous Glucose Monitor (CGM)

Intervention Type DEVICE

The device used as part of the study is to obtain results for glucose testing for research only and not for diagnostic purposes.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Maximum Eligible Age

72 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No