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OpenTrials
Completed

NCT Number: NCT05436925

CGM Use in Preterm Infants

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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Key information

Conditions

Very Low Birth Weight Infant Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Very Preterm Maturity of Infant

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Detection of hypo- and hyperglycemia - 60 mg/dL

    Time frame: 10 days post placement of CGM

    % time below 60 mg/dL

  3. Detection of hypo- and hyperglycemia - 180 mg/dL

    Time frame: 10 days post placement of CGM

    % time above 180 mg/dL

  4. 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

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Improving Growth and Neurodevelopmental Outcomes in Preterm Infants Experiencing Hyperglycemia

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 29, 2022
Registry last updated
Sep 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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