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

NCT07442682 | Enrolling By Invitation

• 1 other identifier: HUB2025082
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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 have diabetes.

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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

  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.

  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 parameters will be recorded retrospectively at the visit closest to the initiation of CFTR modulator treatment and at the visit closest to study inclusion

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• Refusal to participate Inability to complete questionnaires

Sponsors & Collaborators

• Erasme University Hospital: lead

Study Sites (1)

Hôpital Erasme - HUB 808 route de Lennik 1070 Brussels Belgium

Brussels, 1070, Belgium

Location

Related Publications (4)

• 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.

  PMID: 35433304 BACKGROUND

• Marks 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.

  PMID: 34185606 BACKGROUND

• Tierney 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.

  PMID: 19091936 BACKGROUND

• Tsabari 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.

  PMID: 26547591 BACKGROUND

MeSH Terms

Conditions

Cystic Fibrosis; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Laurent Crenier

  Erasme University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University hospital professor

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: March 2, 2026
• Study Start: December 11, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)