Continuous Glucose Monitoring in Infants

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT04458649
Status
Recruiting
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Conditions

  • Neonatal Hypoglycemia

Eligibility Criteria

Sex
ALL
Age
1 Hour - 2 Hours
Healthy Volunteers
Accepted

Interventions

  • Dexcom continuous glucose monitor — DEVICE
    Measurement of interstitial glucose

Study Details

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

Key Dates

Start date
Oct 1, 2020
Status verified
Jul 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: No increased risk of hypoglycemia
    Infants born with no obvious risk factors for hypoglycemia in the neonatal period.
  • Arm: 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%

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

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Medical CenterLa JollaCalifornia92037
Valentina Stanley, BS
[email protected]
858-966-4032
Jane Kim, MD
858-966-4032

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By research site
UCSD Medical Center· La Jolla, CA

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