Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment
- Disease/Condition
- Cystic Fibrosis
- Drug/Device/Intervention
- elexacaftor-tezacaftor-ivacaftor treatment
- Study type
- Observational
- Intervention type
- drug
- Primary sponsor
- University Hospital, Strasbourg, France
- Phase
- N/A
- Start date
- Mar 01, 2024
- End date
- Mar 01, 2025
- Enrollment
- 100 participants
Evaluate time in range of blood glucose variation 140 mg/dl during 2 weeks in a cohort of adult patients treated for one year with elexacaftor-tezacaftor-ivacaftor
The development of CFTR (cystic fibrosis conductance transmembrane regulator) modulators for
 people with cystic fibrosis (pwCF) and eligible for these treatments is a true therapeutic
 revolution. The major beneficial effect of CFTR modulators (CFTRm) on pulmonary function and
 the reduction of pulmonary exacerbations should have a considerable impact on the quality of
 life and patient's life expectancy. Data on the impact of CFTRm on glucose tolerance
 abnormalities are still very fragmentary. The investigators can think that their use, earlier
 and earlier in the history of the disease, will transform the evolutionary trajectories of
 patients on the respiratory, nutritional and metabolic levels.
 
 Diabetes represents a major challenge in the management of pwCF because it is a factor in
 morbidity and mortality at all stages of the disease, from children to patients with terminal
 respiratory failure requiring lung transplantation. Early abnormalities in glucose tolerance
 observed in childhood, before the stage of diabetes, are also associated with poor pulmonary
 and nutritional outcomes. Experimental data suggest a positive effect of CFTRm on insulin
 secretion. However, investigators do not currently know the impact of CFTRm in patients with
 very early glucose disorders or at the stage of diabetes treated with insulin. Recently
 continuous glucose measurement (CGM) devices represent very effective tools for assessing
 abnormalities in glucose tolerance before the stage of diabetes and for monitoring patients
 treated with insulin.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06331000
- Type
- Non-Device Trial
Access comprehensive clinical trial information for NCT06331000 through Pure Global AI's free database. This phase not specified trial is sponsored by University Hospital, Strasbourg, France and is currently Not yet recruiting. The study focuses on Cystic Fibrosis. Target enrollment is 100 participants.
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