CGM Use in Preterm Infants

University of Minnesota (UMN)

Status

Active, not recruiting

Conditions

Very Low Birth Weight Infant

Hyperglycemia

Very Preterm Maturity of Infant

Treatments

Device: Dexcom G6 sensor Continuous Glucose Monitor (CGM)

Study type

Observational

Funder types

Other

Identifiers

NCT05436925

PEDS-2022-30647

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

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