Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06546943

Conditions

Cystic Fibrosis Pulmonary Exacerbation

Eligibility Criteria

Sex: All

Age: 6 - 25

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06546943

Start date

Feb 4, 2022

Status verified date

Aug, 2024

Completion date

Oct 31, 2025

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • CGM standard deviation [ Time Frame: 14 days ]
  • CGM coefficient of variation [ Time Frame: 14 days ]
  • MAGE (mean amplitude of glycemic excursions) [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Christine Hovater

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

Christine Chan, MD

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

Locations

Children's Hospital Colorado, University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Christine Hovater, BS

720-777-3286christine.hovater@childrenscolorado.org

Principal Investigator:

Christine L Chan, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Aug 9, 2024

Last verified

Aug, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-08-09.