Continuous Glucose Monitoring in Infants

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04458649

Enrollment

200

Registered

2020-07-07

Start date

2020-10-01

Completion date

2024-12-31

Last updated

2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neonatal Hypoglycemia

Brief summary

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

Detailed description

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.

Interventions

DEVICEDexcom continuous glucose monitor

Measurement of interstitial glucose

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Hours to 2 Hours

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Time spent with glucose <40 mg/dL	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.

Countries

United States

Contacts

Primary ContactValentina Stanley, BS

vstanley@health.ucsd.edu(858) 249-5985

Backup ContactJane Kim, MD

(858) 966-4032

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026