Children's Hospital Colorado, University of Colorado Denver
Aurora, Colorado, 80045, United States
Location status: Recruiting
Location contact
Christine Hovater, BS
CONTACT
Christine L Chan, MD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06546943
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).
Interested in participating?
Request Info6 year–25 year
All sexes
Observational
Aurora, Colorado, 80045, United States
Location status: Recruiting
Christine Hovater, BS
CONTACT
Christine L Chan, MD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 14 days
Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)
Time frame: 14 days
CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)
Time frame: 14 days
CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)
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)
Time frame: up to 2 years
If initial Rx for antiobiotics proves unsuccessful and participant requires additional treatment
Time frame: up to 2 years
Questionnaire tracking exacerbation symptoms
Time frame: up to 2 years
Will be collected when available from clinical data
Time frame: up to 2 years
hsCRP (highly sensitive C-Reactive Protein) and cytokines (eg; Interleukin-6 [IL 6] & Interleukin-8 [IL8]) at visits
Time frame: up to 2 years
quality of life questionnaire
Contact information is provided by the study sponsor or research team.
University of Colorado, Denver
Other
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
Acronym: GeM-PEx
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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