Characterisation of a Population of Adults Suffering From Cystic Fibrosis in a Belgian Center of Reference and Evaluation of the Impact of Diabetes and CFTR Modulators on Respiratory Function, Nutritional Status and Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Comparison of quality of life between patients with cystic fibrosis according to the presence or absence of diabetes
Study Overview
Brief Summary
This research project aims to better understand the consequences of diabetes on the quality of life, respiratory function, and nutritional status of patients with cystic fibrosis followed at a Belgian reference center and to compare the quality of life of patients with cystic fibrosis depending on whether or not they have diabetes.
Detailed Description
This is a monocentric observational cohort study combining retrospective medical record review and cross-sectional assessment using quality-of-life questionnaires in patients with cystic fibrosis(CF) with or without cystic fibrosis-related diabetes.
This study aims to investigate and compare the characteristics of patients with cystic fibrosis according to the presence or absence of cystic fibrosis-related diabetes (CFRD), based on patients currently followed in one of the Belgian reference centers. The impact of diabetes, its early diagnosis, and its metabolic control will be assessed in relation to patients' nutritional and respiratory status, as well as their quality of life.
The influence of cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy on diabetes control will also be evaluated by comparing glycemic control parameters in patients receiving modulators with those not receiving them, and by examining these parameters before and after treatment initiation within the treated group. In addition, the impact of CFTR modulators on nutritional and respiratory status will be assessed in patients without CFRD.
Quality of life will be evaluated using the SF-36 questionnaire in patients with cystic fibrosis, with and without CFRD. The quality of life of patients with CFRD will also be compared with that of an age-matched sample of patients with type 1 diabetes followed at the same hospital. Additional diabetes-related outcomes will be assessed and compared between the two groups of diabetic patients, including hypoglycemia awareness, satisfaction with diabetes treatment, and satisfaction with blood glucose monitoring.
Previous studies suggest that patients with CFRD tend to report a lower overall quality of life, poorer acceptance of insulin therapy and glucose monitoring, but a better perception of hypoglycemia and a lower perceived impact of hypoglycemia on daily life.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adults ≥18 years Confirmed diagnosis of cystic fibrosis Followed at the participating CF reference center Ability to complete quality-of-life questionnaires Signed informed consent (if required by EC)
Exclusion Criteria
- •Refusal to participate Inability to complete questionnaires
Arms & Interventions
CF with CFRD group
Patients with cystic fibrosis and diabetes
CF without CFRD group
Patients with cystic fibrosis without diabetes
Type 1 diabetes group
Patients with type 1 diabetes as comparator group
Outcomes
Primary Outcomes
Comparison of quality of life between patients with cystic fibrosis according to the presence or absence of diabetes
Time Frame: cross-sectional assessment at study inclusion
Use the Short Form Haelth Survey SF-36, a questionnaire comprising 36 items to compare quality of life in patients with CF according to the presence or absence of CFRD. Score scale ranges from 0 to 100. A higher score means a better quality of life.
Comparison of ppFEV₁ between patients with cystic fibrosis according to the presence or absence of diabetes.
Time Frame: FEV₁ data will be collected retrospectively from medical records, using the value closest to the time of study inclusion
Predicted forced expiratory volume in 1 second (ppFEV1) FEV₁ values, obtained through pulmonary function testing, will be compared between cystic fibrosis patients according to the presence or absence of diabetes
Secondary Outcomes
- Comparison of BMI between patients with cystic fibrosis according to the presence or absence of diabetes(Data will be collected retrospectively from medical records, using the value closest to the time of study inclusion)
- Hypoglycemia awareness and treatment satisfaction will be assessed using validated questionnaires and compared between patients with CFTR-related disease and those with type 1 diabetes.(Cross-sectional assessment at study inclusion)
- Comparison of glycemic control parameters in patients with Cystic Fibrosis Related Diabetes before and after initiation of CFTR modulator therapy.(Glycemic parameters will be recorded retrospectively at the visit closest to the initiation of CFTR modulator treatment and at the visit closest to study inclusion)
Investigators
Agnes Burniat
University hospital professor
Erasme University Hospital