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Accuracy of Interstitial Continuous Glucose Sensors in Neonates

NCT07133906 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 114

Last updated 2025-08-21

No results posted yet for this study

Summary

Low blood sugar in newborns is common and if prolonged or untreated may place them at increased risk for later learning and behavior challenges. Currently, we measure newborn glucose with at least four painful heel sticks, missing one in four episodes of low blood sugar. The goal of this observational study is to develop a less invasive approach to glucose monitoring, developed for newborns, that provides more frequent glucose measurements. We will also measure how a pregnant woman's health impacts newborn glucose, and how newborn glucose is linked to brain oxygen saturation and development.

Conditions

  • Neonatal Hypoglycemia
  • Gestational Diabetes
  • Maternal Obesity Complicating Pregnancy
  • Small-for-gestational Age
  • Large-for-gestational Age

Interventions

DEVICE

Continuous glucose monitoring

A blinded Abbott Freestyle Libre 3 Pro will be placed on the newborn

DEVICE

Cerebral near-infrared spectroscopy

Blinded cerebral near infrared spectroscopy will be assessed

Sponsors & Collaborators

  • Women and Infants Hospital of Rhode Island

    lead OTHER

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07133906 on ClinicalTrials.gov