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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
| Baylor College of Medicine | OTHER |
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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| CGM standard deviation | Measures of glycemic variability from CGM during the exacerbation (CGM-PEx) compared measure derived from recovery period (CGM-post) | 14 days |
| CGM coefficient of variation | CGM measure of glycemic variability during the exacerbation (CGM-PEx) with recovery measure (CGM-post) | 14 days |
| MAGE (mean amplitude of glycemic excursions) | CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post) | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Hovater | Contact | 720-777-6128 | 3286 | christine.hovater@childrenscolorado.org |
| Christine Chan, MD | Contact | 720-777-6128 | 0990 | christinel.chan@childrenscolorado.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Colorado, University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States |
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optional blood sampling to run inflammatory markers at end of study
| up to 2 years |
| Need for additional antibiotics within 28 days following initial treatment | If initial Rx for antiobiotics proves unsuccessful and participant requires additional treatment | up to 2 years |
| Chronic Respiratory Infection Symptom Score questionnaire | Questionnaire tracking exacerbation symptoms | up to 2 years |
| sputum culture as available from clinical data | Will be collected when available from clinical data | up to 2 years |
| markers of inflammation when available | hsCRP (highly sensitive C-Reactive Protein) and cytokines (eg; Interleukin-6 [IL 6] & Interleukin-8 [IL8]) at visits | up to 2 years |
| Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire | quality of life questionnaire | up to 2 years |