Continuous Glucose Monitoring in Infants

University of California San Diego

Status: Enrolling

Conditions: Neonatal Hypoglycemia

Treatments: Device: Dexcom continuous glucose monitor

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04458649

191263

Details and patient eligibility

About

The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.

Full description

We will place a continuous glucose monitor on the infant within 2 hours of birth and record blood glucose values every 5 minutes via the monitor; in addition, the infant will receive blood glucose checks via heel stick according to the standard hospital glucose monitoring protocol.

Enrollment: 200 estimated patients

Sex: All

Ages: 1 to 2 hours old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Mother at least 18 years of age
• Infants born either appropriate for gestational age (AGA) or large for gestational age (LGA)
• Skin fold over superior gluteus area at least 1 inch in thickness as measured by skin calipers

Exclusion criteria

• Infants born small for gestational age (SGA)
• Infant birth weight <2.5 kg
• Infant BMI <10th percentile on Olsen chart
• Infants born <38 weeks gestation
• Infants with concern for intrauterine growth restriction (IUGR) and short femur length based on ultrasound
• Mother is non-English speaking

Trial design

200 participants in 2 patient groups

No increased risk of hypoglycemia

Description:

Infants born with no obvious risk factors for hypoglycemia in the neonatal period.

Treatment:

Device: Dexcom continuous glucose monitor

Increased risk of hypoglycemia

Description:

Infants considered at increased risk for hypoglycemia after birth including the following criteria: * Infant born to a diabetic mother * Very large for gestational age (VLGA) infant with weight \>97%

Treatment:

Device: Dexcom continuous glucose monitor