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

Study acronym: ProspeC-F
StatusRecruiting
PhaseNot specified
Started
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Record status
This record was last updated November 6, 2024 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Minor 2 versions Re-verified since Apr 24, 2023, no change to tracked fieldsv4-v5
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 2021 to Nov 25, 2021
    • Site details revised at 4 of 4 sites
    v3
  3. Minor Study description revisedv2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05099939
Lead Sponsor Institut de Recherches Cliniques de Montreal
Collaborators: Centre hospitalier de l'Université de Montréal (CHUM), University Hospital, Strasbourg, France, Centre Hospitalier Lyon Sud, Fondation Francophone pour la Recherche sur le Diabete
Conditions
(from sponsor)
Cystic Fibrosis
Related terms Cystic Fibrosis, Diabetes Mellitus
Enrollment 121 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov