Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363929
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-12-20
Brief Title:
Continuous Glucose Monitoring in Neonatal Hyperinsulinism
Sponsor:
MemorialCare Health System
Organization:
MemorialCare Health System
Study Overview
Official Title:
A Study to Evaluate the Accuracy of Continuous Glucose Monitors in Neonates With Hyperinsulinism
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Childrens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None