Quality of LifteNCT07442682
Characterisation of a Population of Adults Suffering From Cystic Fibrosis in a Belgian Reference Center
An observational study of Quality of Lifte and Cystic Fibrosis (CF), run by Erasme University Hospital at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Lifte, Cystic Fibrosis (CF), Diabetes
- How many people
- 162 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2025to Jul 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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)
- -
Who cannot join
- Refusal to participate Inability to complete questionnaires
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Hôpital Erasme - HUB 808 route de Lennik 1070 Brussels Belgium
Brussels, 1070
About this study
Official 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
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.
Read the 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.
- Conditions
- Quality of Lifte, Cystic Fibrosis (CF), Diabetes
- Keywords
- Impact of CFRD on BMI, Impact of CFRD on quality-of-life, Impact of CFRD on ppFEV1, Impact of CFTR modulators on glycemic control
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: FEV₁ data will be collected retrospectively from medical records, using the value closest to the time of study inclusion
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start11 Dec 2025
- Primary completionMay 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Quality of LifteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agnes Burniat, Erasme University Hospital
- Investigators
- Laurent Crenier, Study director, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07442682
- Sponsor's protocol ID
- HUB2025082
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Gupta N, Gupta A, Narayanan M R V. Current status of nitrous oxide use in pediatric patients. World J Clin Pediatr. 2022 Mar 9;11(2):93-104. doi: 10.5409/wjcp.v11.i2.93. eCollection 2022 Mar 9.
PubMed 35433304Marks BE, Kilberg MJ, Aliaj E, Fredkin K, Hudson J, Riva D, Roman C, Kelly A, Putman MS. Perceptions of Diabetes Technology Use in Cystic Fibrosis-Related Diabetes Management. Diabetes Technol Ther. 2021 Nov;23(11):753-759. doi: 10.1089/dia.2021.0201. Epub 2021 Jul 20.
PubMed 34185606Tierney S, Webb K, Jones A, Dodd M, McKenna D, Rowe R, Whitehouse J, Deaton C. Living with cystic fibrosis-related diabetes or type 1 diabetes mellitus: a comparative study exploring health-related quality of life and patients' reported experiences of hypoglycaemia. Chronic Illn. 2008 Dec;4(4):278-88. doi: 10.1177/1742395308094240.
PubMed 19091936Tsabari R, Elyashar HI, Cymberknowh MC, Breuer O, Armoni S, Livnat G, Kerem E, Zangen DH. CFTR potentiator therapy ameliorates impaired insulin secretion in CF patients with a gating mutation. J Cyst Fibros. 2016 May;15(3):e25-7. doi: 10.1016/j.jcf.2015.10.012. Epub 2015 Nov 4.
PubMed 26547591