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NCT Number: NCT04458649

Continuous Glucose Monitoring in Infants

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

Recruiting

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Key information

Conditions

Neonatal Hypoglycemia

Age range

1 hour–2 hour

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom continuous glucose monitor

Device

Measurement of interstitial glucose

Primary outcomes

  1. 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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jane Kim, MD

CONTACT

(858) 966-4032

Valentina Stanley, BS

CONTACT

[email protected]

(858) 249-5985

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • DexCom, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 7, 2020
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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