CGM Use in Preterm Infants

NCT05436925 | Completed FDA Device

• 1 other identifier: PEDS-2022-30647
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Continuous glucose monitor; Neonates; Hyperglycemia; Hypoglycemia; Very low birth weight

Outcome Measures

Primary Outcomes (4)

• Detection of hypo- and hyperglycemia - CGM device

  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 below 60 mg/dL

  10 days post placement of CGM

• Detection of hypo- and hyperglycemia - 180 mg/dL

  % time above 180 mg/dL

  10 days post placement of CGM

• Detection of hypo- and hyperglycemia - AEs

  % of infants with adverse events secondary to CGM placement or wear

  10 days post placement of CGM

Study Arms (1)

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)

Interventions

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.

Dexcom G6 sensor Continuous Glucose Monitor (CGM)

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Hyperglycemia; Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: October 3, 2022
• Primary Completion: February 28, 2025
• Study Completion: August 14, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

US (1)