An observational study in Neonatal Hypoglycemia, sponsored by University of California, San Diego. Recruiting at 1 site in United States. Open to participants aged 1 Hour to 2 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by University of California, San Diego · Observational
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
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.
640 studies on the registry are indexed under Hypoglycemia; 86 are open to participants now.
This study's planned enrollment of 200 is above the median of 75 across 132 observational studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →University of California, San Diego is the lead sponsor of 958 studies on the registry; 191 are open to participants now.
Of its 110 completed or terminated interventional studies of FDA-regulated products, 70 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.
Exclusion Criteria:
Infants born with no obvious risk factors for hypoglycemia in the neonatal period.
Device: 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%
Device: Dexcom continuous glucose monitor
Measurement of interstitial glucose
Time spent with glucose <40 mg/dL
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.
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.
Plan to share: No
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University of California, San Diego