RECRUITING

Continuous Glucose Monitoring in Neonatal Hyperinsulinism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit. The participants will wear the device for 10 days on their lateral thigh. Whenever blood sugars are checked by glucometer, the investigators will also record the continuous glucose monitor sugar. Additionally, if the continuous glucose monitor alarms for a low sugar or an impending low sugar, the investigators will check the blood sugar by glucometer and, if verified to be low, treat the low blood sugar accordingly.

Official Title

A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism.

Quick Facts

Study Start:2023-06-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06363929

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:24 Hours to 3 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Age: 0-90 days old
  2. * Gestational Age: \> 28 weeks gestational age
  3. * Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge
  1. * Diffuse skin disease such that placement of a Dexcom G6 sensor would be difficult to secure
  2. * Infants colonized or infected with multi-drug resistant organisms (i.e. MRSA, VRE, ESBL producing bacteria)
  3. * Infants on hypothermic protocols
  4. * Infants expected to remain in the NICU \<24 hours
  5. * Infants enrolled in a competing clinical trial
  6. * Family/team have decided to limit or redirect from aggressive NICU technological support
  7. * Ward of the state

Contacts and Locations

Study Contact

Erin Okawa, MD
CONTACT
310-825-6244
eokawa@mednet.ucla.edu

Study Locations (Sites)

Miller Children's Hospital
Long Beach, California, 90806
United States

Collaborators and Investigators

Sponsor: MemorialCare Health System

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2025-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Hyperinsulinism
  • Hypoglycemia Neonatal