Continuous Glucose Monitoring in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2024-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Neonatal Hypoglycemia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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No increased risk of hypoglycemia

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

Dexcom continuous glucose monitor

Intervention Type DEVICE

Measurement of interstitial glucose

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%

Dexcom continuous glucose monitor

Intervention Type DEVICE

Measurement of interstitial glucose

Interventions

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Dexcom continuous glucose monitor

Measurement of interstitial glucose

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

1 Hour

Maximum Eligible Age

2 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes