Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis Pulmonary Exacerbation. Basic parameters: 6 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Glucose Monitoring in Youth With Cystic Fibrosis During Pulmonary Exacerbations (GeM-PEx)
Overview
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.
Primary outcome measures
- CGM standard deviation [Time frame: 14 days]
- CGM coefficient of variation [Time frame: 14 days]
- MAGE (mean amplitude of glycemic excursions) [Time frame: 14 days]
Secondary outcome measures (6)
- Forced expiratory volume at one second (FEV1) at each visit [Time frame: up to 2 years]
- Need for additional antibiotics within 28 days following initial treatment [Time frame: up to 2 years]
- Chronic Respiratory Infection Symptom Score questionnaire [Time frame: up to 2 years]
- sputum culture as available from clinical data [Time frame: up to 2 years]
- markers of inflammation when available [Time frame: up to 2 years]
- Cystic Fibrosis Questionnaire Revised (CFQR) questionnaire [Time frame: up to 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Children's Hospital Colorado, University of Colorado Denver — Aurora
Identifiers
NCT: NCT06546943 · 21-3666