Identification of Dysglycemia With Continuous Glucose Monitoring to Assess Clinical Evolution in Cystic Fibrosis

NCT05099939 | Recruiting

• 1 other identifier: ProspeC-F
• Study Type: observational
• Target: 121
• Locations: 2 countries
• Sites: 4

Brief Summary

Cystic fibrosis (CF)-related diabetes (CFRD) is the most important emerging complication after pulmonary complications. This specific form of diabetes is associated with an increased morbidity and mortality. CFRD prevalence at the age of 10 is 10% and reaches 40 to 50% in adulthood, while a similar percentage is afflicted with milder dysglycemia also called pre-diabetes abnormalities. In order to identify patients at risk and to implement early therapeutic measures, an annual CFRD screening test is recommended for CF patients after 10 years of age. The standard 2-hour oral glucose tolerance test (OGTT) is the recommended screening test. However, this test is perceived by both patients and CF care teams as unpleasant while adding a significant burden and workload, resulting in screening rates lower than 50% in most centers. An ideal alternative test should be simpler, less invasive, more sensitive than an OGTT to establish risks for lung function and/or nutritional deterioration, and predict future CFRD risk. To date, compared to the OGTT, no alternative screening method has demonstrated its effectiveness. However, continuous glucose monitoring (CGM) is emerging as a possible alternative method. In patients living with CF, CGM is easy to use and can identify early dysglycemia, which in turn, can predict increased risk of accelerated decline of pulmonary function and/or weight, higher risk of pseudomonas colonization, and future risk of CFRD. However, these observations are based on studies of small sample size with very limited prospective data. Furthermore, many of the multiple CGM metrics that have been standardized are based on the risk of complications associated with Type 1 and Type 2 Diabetes. Thus, there is a need for prospective studies to identify the CGM metrics and the cut-off level that is relevant as a predictor of clinical deterioration and/or CFRD risk in CF. The identification of such CF-specific criteria would provide important information to target at-risk patients.

Conditions

Cystic Fibrosis

Keywords

Diabetes; Screening Test; Continuous glucose monitoring; Oral glucose tolerance test

Outcome Measures

Primary Outcomes (1)

• Change in lung function

  The primary outcome is the mean annual rate of change in lung function (FEV1%) from 2 years before inclusion to 3 years later, for a total of 5 years of follow-up.

  5 years

Secondary Outcomes (3)

• Change in body mass index

  2 years

• Number of pulmonary exacerbations

  1 year

• CFRD diagnosis

  3 years

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 individuals living with cystic fibrosis who are being followed at the following centers: Centre Hospitalier de l'Université de Montréal (CHUM), Université de Lyon (Hospices Civils de Lyon) and Université de Strasbourg (CHU de Strasbourg).

You may qualify if:

• Have cystic fibrosis
• Be 18 years of age or older
• Have given clear and informed consent

You may not qualify if:

• Receive pharmaceutical treatment for diabetes
• Have had a lung or liver transplant
• Participate in a randomized controlled trial for more than 3 months in parallel with this study
• Currently pregnant
• Patients under legal protection (for centers in France)

Sponsors & Collaborators

• Institut de Recherches Cliniques de Montreal: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator
• University Hospital, Strasbourg, France: collaborator
• Centre Hospitalier Lyon Sud: collaborator
• Fondation Francophone pour la Recherche sur le Diabete: collaborator

Study Sites (4)

Institut de recherches cliniques de Montréal

Montreal, Quebec, H2W 1R7, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

NOT YET RECRUITING

Hospices Civils de Lyon

Lyon, France

NOT YET RECRUITING

CHU de Strasbourg

Strasbourg, France

NOT YET RECRUITING

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

• Rémi Rabasa-Lhoret

  Institut de recherches cliniques de Montréal

  PRINCIPAL INVESTIGATOR

• Laurence Kessler

  CHU de Strasbourg

  PRINCIPAL INVESTIGATOR

• Isabelle Durieu

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katherine Desjardins

CONTACT

5149875666; katherine.desjardins@ircm.qc.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: November 25, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); CA (2)