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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07442682
- Acronym / sponsor ID
- HUB2025082
- 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
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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)
- -
Key exclusion criteria (1 listed)
- Refusal to participate Inability to complete questionnaires
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
- Background: PubMed 35433304Gupta 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.
- Background: PubMed 34185606Marks 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.
- Background: PubMed 19091936Tierney 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.
- Background: PubMed 26547591Tsabari 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent Crenier study director
Erasme University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Lifte and Cystic Fibrosis (CF), run by Erasme University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07442682, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.