Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations

NCT ID: NCT06546943

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-04

Study Completion Date

2025-10-31

Brief Summary

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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

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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

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Cystic Fibrosis Pulmonary Exacerbation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Children's Hospital Colorado, University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Hovater

Role: CONTACT

720-777-6128 ext. 3286

Christine Chan, MD

Role: CONTACT

720-777-6128 ext. 0990

Facility Contacts

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Christine Hovater, BS

Role: primary

720-777-3286

Other Identifiers

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21-3666

Identifier Type: -

Identifier Source: org_study_id

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