Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT07442682

Characterisation of a Population of Adults Suffering From Cystic Fibrosis in a Belgian Reference Center

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Quality of Lifte Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Cystic Fibrosis (CF) Diabetes Diabetes Mellitus Digestive System Diseases Endocrine System Diseases Genetic Diseases, Inborn Glucose Metabolism Disorders Infant, Newborn, Diseases Lung Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Erasme - HUB 808 route de Lennik 1070 Brussels Belgium

Brussels, 1070, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  1. Comparison of BMI between patients with cystic fibrosis according to the presence or absence of diabetes

    Time frame: Data will be collected retrospectively from medical records, using the value closest to the time of study inclusion

    Body mass index (kg/m2) will be compared between patients with cystic fibrosis with and without diabetes.

  2. 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.

    Time frame: Cross-sectional assessment at study inclusion

    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

  3. Comparison of glycemic control parameters in patients with Cystic Fibrosis Related Diabetes before and after 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

    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.

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 2, 2026
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.