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NCT Number: NCT06546943

Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations

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).

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Key information

Age range

6 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Colorado, University of Colorado Denver

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Christine Hovater, BS

CONTACT

[email protected]

720-777-3286

Christine L Chan, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. CGM standard deviation

    Time frame: 14 days

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

  2. CGM coefficient of variation

    Time frame: 14 days

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

  3. MAGE (mean amplitude of glycemic excursions)

    Time frame: 14 days

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

Secondary outcomes

  1. Forced expiratory volume at one second (FEV1) at each visit

    Time frame: up to 2 years

    Collected clinically at baseline during routine visits, and at the start of a pulmonary exacerbation (PEx) for those admitted inpatient and in clinic, and at next in person routine clinic visit; b)by home spirometer during routine clinic visits, and in the hone setting (if not in person) once for the baseline visit, and at the onset of exacerbation and twice/week for 14 days, and once upon recovery (at least 6 weeks after PEx)

  2. Need for additional antibiotics within 28 days following initial treatment

    Time frame: up to 2 years

    If initial Rx for antiobiotics proves unsuccessful and participant requires additional treatment

  3. Chronic Respiratory Infection Symptom Score questionnaire

    Time frame: up to 2 years

    Questionnaire tracking exacerbation symptoms

  4. sputum culture as available from clinical data

    Time frame: up to 2 years

    Will be collected when available from clinical data

  5. markers of inflammation when available

    Time frame: up to 2 years

    hsCRP (highly sensitive C-Reactive Protein) and cytokines (eg; Interleukin-6 [IL 6] & Interleukin-8 [IL8]) at visits

  6. Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire

    Time frame: up to 2 years

    quality of life questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Chan, MD

CONTACT

[email protected]

720-777-6128 ext. 0990

Christine Hovater

CONTACT

[email protected]

720-777-6128 ext. 3286

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Baylor College of Medicine
  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Acronym: GeM-PEx

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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