Continuous Glucose Monitoring in Infants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neonatal Hypoglycemia
- Sponsor
- University of California, San Diego
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Time spent with glucose <40 mg/dL
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
Detailed 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.
Investigators
Dr Jane Kim
Professor of Pediatrics
University of California, San Diego
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time spent with glucose <40 mg/dL
Time Frame: The device will be worn from about 2 hours after birth until hospital discharge, up to a maximum of 10 days. It will be removed sooner if required for medical care or if the parent requests removal.
The Dexcom continuous glucose monitors measure interstitial fluid glucose values every 5 minutes. Data obtained from the Dexcom tracings will allow us to quantify how much time both infants with no risk for hypoglycemia (defined here as \<40 mg/dL) and those with risk factors for hypoglycemia spend at a blood glucose of \<40 mg/dL.