An observational study in Quality of Lifte, Cystic Fibrosis (CF) and Diabetes, sponsored by Erasme University Hospital. Enrolling by invitation at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-02.
Sponsored by Erasme University Hospital · Observational
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's planned enrollment of 162 is above the median of 85 across 482 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Erasme University Hospital is the lead sponsor of 178 studies on the registry; 34 are open to participants now.
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Adult patients with cystic fibrosis followed at a Belgian CF reference center, with or without cystic fibrosis-related diabetes. An additional age-matched cohort of adults with type 1 diabetes followed at the same hospital will be included for comparative analyses
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)
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Exclusion Criteria:
Refusal to participate Inability to complete questionnaires
Patients with cystic fibrosis and diabetes
Patients with cystic fibrosis without diabetes
Patients with type 1 diabetes as comparator group
Comparison of quality of life between patients with cystic fibrosis according to the presence or absence of diabetes
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.
Time frame: cross-sectional assessment at study inclusion
Comparison of ppFEV₁ between patients with cystic fibrosis according to the presence or absence of diabetes.
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
Time frame: FEV₁ data will be collected retrospectively from medical records, using the value closest to the time of study inclusion
Comparison of BMI between patients with cystic fibrosis according to the presence or absence of diabetes
Body mass index (kg/m2) will be compared between patients with cystic fibrosis with and without diabetes.
Time frame: 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.
Standardized and widely used questionnaires for the assessment of insulin-treated patients with diabetes will be. Questionnaires used: 1/ Clarke questionnaire: 8 items with a total score of 7 indicating hypoglycemia awareness. Score \> ou = 4: impaired - \< 4: normal. 2/ Gold score: visual scale ranging from 1 (hypoglycemia always perceived) to 7 (hypoglycemia never perceived). 3/ Hypoglycemia Fear Survey II : a 33 items questionnaire with 15 items behaviour subscale, et 18 items worry subscale. Each item is rated from 0 (never) to 4 (almost always) . Total score 132. Higher score = greater fear of hypoglycemia 4/ PAID-SF = Problem Areas in Diabetes Scale = questionnaire to assess diabetes-related emotional distress. 5 items: each rated from 0 (not a problem) to 4 (serious problem). Total score 20. Higher scores indicates greater distress. 5/ Diabetes Treatment Satisfaction Questionnaire (DTSQs) - 8 items, each scored from 0 to 6. Total 36. Higher score = greater treatment satisfaction
Time frame: 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 control will be assessed by comparing Time in Range (TIR) (%) and HbA1c levels (%) in patients with CFRD before and after the initiation of CFTR modulator therapy.
Time frame: 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
Plan to share: No — Individual participant-level data from this study will not be shared with other researchers. The study includes a small, monocentric cohort of adults with cystic fibrosis, which may increase the risk of re-identification of participants even after de-identification. Additionally, the data contain sensitive clinical and health-related information, including quality-of-life assessments and diabetes status. To protect participant privacy and comply with ethical and institutional regulations, data sharing is not planned.
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Erasme University Hospital