Clinical trial NCT06546943: Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations
Official title: Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cystic Fibrosis Pulmonary Exacerbation
Keywords: cystic fibrosis related diabetes
continuous glucose monitoring
cystic fibrosis pulmonary exacerbation
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: Baylor College of Medicine
First posted: 2024-08-09
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: CGM standard deviation
timeFrame: 14 days
measure: CGM coefficient of variation
timeFrame: 14 days
measure: MAGE (mean amplitude of glycemic excursions)
timeFrame: 14 days
Secondary outcomes:
measure: Forced expiratory volume at one second (FEV1) at each visit
timeFrame: up to 2 years
measure: Need for additional antibiotics within 28 days following initial treatment
timeFrame: up to 2 years
measure: Chronic Respiratory Infection Symptom Score questionnaire
timeFrame: up to 2 years
measure: sputum culture as available from clinical data
timeFrame: up to 2 years
measure: markers of inflammation when available
timeFrame: up to 2 years
measure: Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado, University of Colorado Denver
state: Colorado
Study officials:
References: