CGM Use in Preterm Infants

Active, not recruiting

• Conditions: Very Low Birth Weight Infant; Very Preterm Maturity of Infant; Hyperglycemia
• Interventions: Device: Dexcom G6 sensor Continuous Glucose Monitor (CGM)

• Registration Number: NCT05436925
• Lead Sponsor: University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-23
• Study First Submitted QC: 2022-06-23
• Study First Posted: 2022-06-29
• Study Start: 2022-10-03
• Primary Completion: 2025-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-17
• Study Completion: 2025-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexcom G6 sensor Continuous Glucose Monitor (CGM)	Dexcom G6 sensor Continuous Glucose Monitor (CGM)	All participants will be assigned to use the continuous glucose monitor

Primary Outcome Measures

Name	Time	Method
Detection of hypo- and hyperglycemia - CGM device	10 days post placement of CGM	Proportion of CGM device readings that match blood glucose readings
Detection of hypo- and hyperglycemia - 60 mg/dL	10 days post placement of CGM	% time below 60 mg/dL
Detection of hypo- and hyperglycemia - 180 mg/dL	10 days post placement of CGM	% time above 180 mg/dL
Detection of hypo- and hyperglycemia - AEs	10 days post placement of CGM	% of infants with adverse events secondary to CGM placement or wear

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States