Cystic Fibrosis Pulmonary Exacerbation
Conditions
Keywords
cystic fibrosis related diabetes, continuous glucose monitoring, cystic fibrosis pulmonary exacerbation
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.
Interventions
None listed
Sponsors
Cystic Fibrosis Foundation
Baylor College of Medicine
University of Colorado, Denver
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 25 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| MAGE (mean amplitude of glycemic excursions) | 14 days | CGM measures of glycemic variability (MAGE) during the exacerbation (CGM-PEx) with recovery measures (CGM-post) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire | up to 2 years | quality of life questionnaire |
| 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 |
| 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 |
| Chronic Respiratory Infection Symptom Score questionnaire | up to 2 years | Questionnaire tracking exacerbation symptoms |
Countries
United States
Contacts
Primary ContactChristine Hovater
Backup ContactChristine Chan, MD
Outcome results
None listed