Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations

Recruiting

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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
MAGE (mean amplitude of glycemic excursions)	14 days	CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post)
CGM standard deviation	14 days	Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post)
CGM coefficient of variation	14 days	CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post)

Secondary Outcome Measures

Name	Time	Method
Need for additional antibiotics within 28 days following initial treatment	up to 2 years	If initial Rx for antiobiotics proves unsuccessful and participant requires additional treatment
Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire	up to 2 years	quality of life questionnaire
sputum culture as available from clinical data	up to 2 years	Will be collected when available from clinical data
Forced expiratory volume at one second (FEV1) at each visit	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)
Chronic Respiratory Infection Symptom Score questionnaire	up to 2 years	Questionnaire tracking exacerbation symptoms
markers of inflammation when available	up to 2 years	hsCRP (highly sensitive C-Reactive Protein) and cytokines (eg; Interleukin-6 \[IL 6\] \& Interleukin-8 \[IL8\]) at visits

Locations (1): Children's Hospital Colorado, University of Colorado Denver
🇺🇸
Aurora, Colorado, United States

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