Accuracy of Interstitial Continuous Glucose Sensors in Neonates

Sponsor
Women and Infants Hospital of Rhode Island
Study ID
NCT07133906
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Continuous glucose monitoring — DEVICE
    A blinded Abbott Freestyle Libre 3 Pro will be placed on the newborn
  • Cerebral near-infrared spectroscopy — DEVICE
    Blinded cerebral near infrared spectroscopy will be assessed

Study Details

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.

Key Dates

First listed
Aug 21, 2025
Start date
Sep 30, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
114 participants (estimated)

Arms

  • Arm: Pregnant women >24 weeks gestation and their infants
    Pregnant women \>24 weeks gestation; infants of pregnant women \>24 weeks gestation, including 11 infants of women with gestational diabetes, 11 infants of women with type II diabetes, 11 infants of women with type I diabetes, 6 small-for-gestational age (SGA) infants, 6 large-for-gestational age (LGA) infants, and 12 control infants who are not considered at-risk for hypoglycemia.

Primary Outcome Measure

Point Accuracy: System agreement analysis [ Time Frame: From time of birth to discharge, an average of 3 days ]

Central Contacts

Related Studies