Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546943
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-11-08
Brief Title:
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations GeM-PEx
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GeM-PEx
Brief Summary:
The goal of this study is to investigate the prevalence of dysglycemia with continuous glucose monitoring CGM obtained during pulmonary exacerbations both outpatient and inpatient in youth with cystic fibrosis CF
Detailed Description:
This research is using continuous glucose monitoring CGM to study changes in blood sugar levels that may occur in youth with cystic fibrosis CF and cystic fibrosis related diabetes CFRD who experience a pulmonary exacerbation PEx whether admitted to the hospital or seen in clinic We hypothesize that 1 youth experiencing a PEx will have greater blood sugar changes during the PEx than at least 6 weeks after the PEx 2 that the changes in blood sugars will be greater during the PEx when compared to CGM data gathered at a baseline visit prior to the PEx when available 3 and that blood sugar changes during the PEx will compare with changes in short-term clinical outcomes collected using questionnaires about breathing problems and that this data will be predictive of the need for additional antibiotics This study aims to compare CGM measures of change during a PEx with those measured after recovery to compare CGM measures of change during the PEx to those taken at baseline and to examine the relationships between these changes and the changes in clinical findings including the need for additional antibiotics
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None