Continuous Glucose Monitoring in Infants

Recruiting

• Conditions: Neonatal Hypoglycemia
• Interventions: Device: Dexcom continuous glucose monitor

• Registration Number: NCT04458649
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-02
• Study First Posted: 2020-07-07
• Study Start: 2020-10-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No increased risk of hypoglycemia	Dexcom continuous glucose monitor	Infants born with no obvious risk factors for hypoglycemia in the neonatal period.
Increased risk of hypoglycemia	Dexcom continuous glucose monitor	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%

Primary Outcome Measures

Name	Time	Method
Time spent with glucose <40 mg/dL	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.

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 La Jolla, California, United States