Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-25
SponsorUniversity of Colorado, Denver
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
known type 1 or type 2 diabetes, monogenic diabetes
critical illness requiring admission to the ICU
pregnancy
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
CGM standard deviation
Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)
Time frame
14 days2
CGM coefficient of variation
CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)
Time frame
14 days3
MAGE (mean amplitude of glycemic excursions)
CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)
Time frame
14 daysSecondary outcomes
1
Forced expiratory volume at one second (FEV1) at each visit
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)
Time frame
up to 2 years2
Need for additional antibiotics within 28 days following initial treatment
If initial Rx for antiobiotics proves unsuccessful and participant requires additional treatment
Time frame
up to 2 years3
Chronic Respiratory Infection Symptom Score questionnaire
Questionnaire tracking exacerbation symptoms
Time frame
up to 2 years4
sputum culture as available from clinical data
Will be collected when available from clinical data
Time frame
up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
Cystic Fibrosis Foundation
Collaborator
Baylor College of Medicine
Collaborator
Source ClinicalTrials.gov