NCT06546943

Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations

Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 6 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis Pulmonary Exacerbation

Timeline

• Start date: 2022-02-04
• Primary completion: 2025-04-30
• Completion: 2025-10-31
• First posted: 2024-08-09
• Last updated: 2024-08-09

Locations

1 site across 1 country: United States