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

Status: Terminated
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 day
Maximum Age: 3 months
Healthy Volunteers: t
View:

• Age: 0-90 days old

• Gestational Age: \> 28 weeks gestational age

• Diagnosis of hyperinsulinism based on critical sample and/or glucagon challenge

Locations
United States
California
Miller Children's Hospital
Long Beach
Time Frame
Start Date: 2023-06-01
Completion Date: 2025-09-22
Participants
Target number of participants: 1
Treatments
Neonates with hyperinsulinism
Neonates with a diagnosis of hyperinsulinism will wear a Dexcom G6 continuous glucose monitor placed for 10 days.
Sponsors
Collaborators: DexCom, Inc.
Leads: MemorialCare Health System

This content was sourced from clinicaltrials.gov