Continuous Glucose Monitoring in Infants
ConditionNeonatal Hypoglycemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-2
SponsorUniversity of California, San Diego
About this trial
The purpose of this study is to employ continuous glucose monitoring to measure glucose profiles in newborn infants.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Mother/infant dyads will be admitted at UCSD Jacobs Medical Center for antepartum and postpartum care.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Dexcom continuous glucose monitor
DeviceMeasurement of interstitial glucose
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: No increased risk of hypoglycemia1 intervention
Group B: Increased risk of hypoglycemia1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Diego
Lead sponsor
DexCom, Inc.
Collaborator
Source ClinicalTrials.gov