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

February 24, 2026 updated by: Agnes Burniat, Erasme University Hospital

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

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 Type

Observational

Enrollment (Estimated)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Hôpital Erasme - HUB 808 route de Lennik 1070 Brussels Belgium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
cross-sectional assessment at study inclusion
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
FEV₁ data will be collected retrospectively from medical records, using the value closest to the time of study inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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
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.
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.
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erasme University Hospital

Investigators

  • Study Director: Laurent Crenier, Erasme University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 11, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

March 2, 2026

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUB2025082

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe