Recruiting

Continuous Glucose Monitoring

Sponsor:

UCLA

Code:

NCT04458649

Conditions

Neonatal Hypoglycemia

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

Interventions

Dexcom continuous glucose monitor

Study Details

Brief summary:

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

Conditions

Neonatal Hypoglycemia

Study ID

NCT04458649

Start date

Oct 1, 2020

Status verified date

Jul, 2024

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Dec 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

No increased risk of hypoglycemia

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

Increased risk of hypoglycemia

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%

Interventions

Dexcom continuous glucose monitor

Measurement of interstitial glucose

Primary outcome measure

  • 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. ]

Central Contacts and Locations

Central contacts

Valentina Stanley, BS

(858) 249-5985vstanley@health.ucsd.edu

Jane Kim, MD

(858) 966-4032

Locations

UCSD Medical Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Valentina Stanley, BS

858-966-4032vstanley@health.ucsd.edu

Jane Kim, MD

858-966-4032

More Information

Sponsor

University of California, San Diego

Last update posted

Jul 3, 2024

Last verified

Jul, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-07-03.