Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations

NCT06546943 | Recruiting DMC

• 1 other identifier: 21-3666
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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).

Conditions

Cystic Fibrosis Pulmonary Exacerbation

Keywords

cystic fibrosis related diabetes; continuous glucose monitoring; cystic fibrosis pulmonary exacerbation

Outcome Measures

Primary Outcomes (3)

• CGM standard deviation

  Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)

  14 days

• CGM coefficient of variation

  CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)

  14 days

• MAGE (mean amplitude of glycemic excursions)

  CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)

  14 days

Secondary Outcomes (6)

• Forced expiratory volume at one second (FEV1) at each visit

  up to 2 years

• Need for additional antibiotics within 28 days following initial treatment

  up to 2 years

• Chronic Respiratory Infection Symptom Score questionnaire

  up to 2 years

• sputum culture as available from clinical data

  up to 2 years

• markers of inflammation when available

  up to 2 years

Eligibility Criteria

• Age: 6 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with CF ages 6 y- 25 years will be eligible to enroll. Participants will be enrolled at baseline health during a routine CF clinic visit or upon diagnosis of a pulmonary exacerbation (PEx). A PEx will be defined by treatment with either oral or IV antibiotics for an increase in respiratory symptoms as defined by a pediatric pulmonologist at our CF Center. Oral antibiotics are typically prescribed for two weeks based on clinical care guidelines developed at our center which standardize antibiotic selection based on prior respiratory culture results.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Cystic Fibrosis Foundation: collaborator
• Baylor College of Medicine: collaborator

Study Sites (1)

Children's Hospital Colorado, University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

optional blood sampling to run inflammatory markers at end of study

Central Study Contacts

Christine Hovater

CONTACT

720-777-6128; christine.hovater@childrenscolorado.org

Christine Chan, MD

CONTACT

720-777-6128; christinel.chan@childrenscolorado.org

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: August 9, 2024
• Study Start: February 4, 2022
• Primary Completion: April 30, 2025
• Study Completion: October 31, 2025
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

US (1)