Accuracy of Interstitial Continuous Glucose Sensors in Neonates

NCT07133906 | Not Yet Recruiting FDA Device

• 1 other identifier: 2177993
• Study Type: observational
• Target: 114
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Point Accuracy: System agreement analysis

  Number and percent of glucose monitoring (GM) sensor results within the intervals +/- 20% of glucose reference throughout the system measuring range

  From time of birth to discharge, an average of 3 days

Secondary Outcomes (3)

• Episodes of neonatal hypoglycemia (NH) by risk factors

  Between birth to 72 hours after birth

• NNNS scores

  From time of birth to 72 hours after birth, at an average of 48 hours of age

• ASQ scores

  6 months and 12 months

Study Arms (1)

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.

Device: Continuous glucose monitoring; Device: Cerebral near-infrared spectroscopy

Interventions

Continuous glucose monitoring DEVICE

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

Pregnant women >24 weeks gestation and their infants

Cerebral near-infrared spectroscopy DEVICE

Blinded cerebral near infrared spectroscopy will be assessed

Pregnant women >24 weeks gestation and their infants

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Antenatal floor, labor and delivery unit (L\&D), neonatal intensive care unit (NICU), mother baby unit (MBU), and obstetrics and diabetes clinics at Women and Infants Hospital

You may qualify if:

• women aged 18 years or older
• speaks English, Spanish, Portuguese, or Haitian Creole
• pregnant \>24 weeks gestation with singleton pregnancy

You may not qualify if:

• known concomitant maternal or fetal condition which, in the opinion of the investigator, could present a risk to the safety or welfare of the subject or study staff
• plans to deliver at a hospital other than Women and Infants Hospital of Rhode Island

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Maternal dried blood spots and cord serum.

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Sarbattama Sen, MD

CONTACT

401-274-1122; ssen@carene.org

Isabella Lawandy

CONTACT

401-274-1100; ilawandy@wihri.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair Pediatric Clinical Research

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 21, 2025

Record last verified: 2025-08