Identification of Dysglycemia With Continuous Glucose Monitoring to Assess Clinical Evolution in Cystic Fibrosis (ProspeC-F)

Identification of Dysglycemia With Continuous Glucose Monitoring: A Prospective Study to Assess the Relationship With Clinical Evolution in Cystic Fibrosis

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.

Study Overview

• Status: Recruiting
• Conditions: Cystic Fibrosis

Detailed Description

The investigators propose an international multicenter observational study to evaluate the predictive value of CGM variables on the evolution of the clinical state in adult patients with CF.

To do this, the following will be evaluated:

• The clinical condition of the patients over a period of 5 years (2 years before, up to 3 years after inclusion);
• The detailed glycemic profile using a CGM system during 3 visits (on inclusion, 1 year, then 2 years after inclusion).

The primary objective is to identify which CGM variable, at inclusion in the study, is the most strongly linked to the risk of a decrease in pulmonary function of more than 2% / year measured by the FEV1% over the 5 years of follow-up of the study. The investigators will also i) investigate which CGM variables are most strongly linked to other clinical markers (ex. nutritional status, CFRD diagnosis and pulmonary exacerbations; ii) assess the association between changes in CGM variables (ex. increased number of glycemic excursions >11.0 mmol/L over 2 years) and changes in clinical status over time; and iii) evaluate the correlation between plasma glucose values during the standard routine OGTT and CGM values.

This study includes 3 visits with participants: inclusion (V1), the visit at 1 year (V2), then 2 years after inclusion (V3).

This study consists of 3 phases:

• Phase 1: A retrospective file-based data collection, which covers 2 years before inclusion;
• Phase 2: Prospective data collection, including the installation of a CMG 3 times over a period of 2 years, then;
• Phase 3: An additional one-year prospective data collection on file only.

Only phase 2 includes visits for the participant. A CMG system will be installed for 14 days at inclusion (visit 1), at 1 year (visit 2) and 2 years (visit 3) during a regular routine visit and / or an annual OGTT visit. The participants' only involvement will be to wear the CMG system and return it to the research center at the end of the 14-day period. All data obtained during a routine visit will be collected directly from medical records over a period of 5 years (two years before inclusion until the final visit): pulmonary function (FEV1), nutritional status (weight and height), bronchial colonization by Pseudomonas aeruginosa, number of exacerbations, number of intravenous antibiotic courses, number of hospitalizations, and annual OGTT results.

• Study Type: Observational
• Enrollment (Estimated): 121

Contacts and Locations

• Study Contact: Name: Katherine Desjardins; Phone Number: 5149875666; Email: katherine.desjardins@ircm.qc.ca

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Recruiting
      • Institut de recherches cliniques de Montreal
      • Contact: Katherine Desjardins; Phone Number: 5149875666; Email: katherine.desjardins@ircm.qc.ca
      • Principal Investigator: Rémi Rabasa-Lhoret
    • Montreal, Quebec, Canada, H2X 3E4
      • Not yet recruiting
      • Centre Hospitalier de l'Université de Montréal
      • Principal Investigator: Rémi Rabasa-Lhoret
      • Contact: Remi Rabasa-Lhoret; Phone Number: 3227 5149875500
• France
  • Lyon, France
    • Not yet recruiting
    • Hospices Civils de Lyon
    • Contact: Isabelle Durieu; Email: isabelle.durieu@chu-lyon.fr
    • Principal Investigator: Isabelle Durieu
    • Sub-Investigator: Quitterie Reynaud
  • Strasbourg, France
    • Not yet recruiting
    • CHU de Strasbourg
    • Contact: Laurence Kessler; Phone Number: 03 88 11 65 98; Email: Laurence.Kessler@chru-strasbourg.fr
    • Principal Investigator: Laurence Kessler

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body mass index	Change in body mass index weight category from inclusion to 2 years (underweight, adequate weight, overweight).	2 years
Number of pulmonary exacerbations	Average annual number of pulmonary exacerbations per year (validated Fuchs questionnaire), including exacerbations that are treated at home or at the hospital.	1 year
CFRD diagnosis	Development of new cases of CFRD diagnosed with standard OGTT and initiation of all anti-diabetic treatment.	3 years

Collaborators and Investigators

• Sponsor: Institut de Recherches Cliniques de Montreal
• Collaborators: University Hospital, Strasbourg, France; Centre hospitalier de l'Université de Montréal (CHUM); Centre Hospitalier Lyon Sud; Fondation Francophone pour la Recherche sur le Diabete
• Investigators: Principal Investigator: Laurence Kessler, CHU de Strasbourg; Principal Investigator: Isabelle Durieu, Hospices Civils de Lyon; Principal Investigator: Rémi Rabasa-Lhoret, Institut de recherches cliniques de Montreal

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: October 19, 2021
• First Submitted That Met QC Criteria: October 19, 2021
• First Posted (Actual): October 29, 2021

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 5, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Screening Test; Continuous glucose monitoring; Oral glucose tolerance test
• Additional Relevant MeSH Terms: Pathologic Processes; Genetic Diseases, Inborn; Respiratory Tract Diseases; Digestive System Diseases; Lung Diseases; Infant, Newborn, Diseases; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: ProspeC-F

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No