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

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Cystic Fibrosis Pulmonary Exacerbation

Study type: Observational

Funder types: Other

Identifiers

NCT06546943

21-3666

Details and patient eligibility

About

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).

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 6 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 6- 25 years old
• Confirmed diagnosis of cystic fibrosis (based on sweat chloride and/or two known disease causing CF mutations)
• access to a smart phone and/or internet connection and the ability to complete remote telehealth visits

Exclusion criteria

• known type 1 or type 2 diabetes, monogenic diabetes
• critical illness requiring admission to the ICU
• pregnancy