Cystic FibrosisDIATRIMNCT06331000
Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment
An observational study of Cystic Fibrosis, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- elexacaftor-tezacaftor-ivacaftor treatment
- How many people
- 184 participants
- Where
- 1 siteFrance
- Study dates
- 8 Apr 2024to 24 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cystic fibrosis aged over 18, followed in cystic fibrosis ambulatory care services of 18 french centers
Who may be able to join
- Patients with cystic fibrosis aged over 18
- Patients treated for 1 year by elexacaftortezacaftor-ivacaftor
- Normal tolerant or intolerant to glucose or presenting with cystic fibrosis related diabetes treated or not with insulin
- Patient who had a continuous glucose monitoring in the 6 months before and 6 months after one year of treatment with elexacaftor-tezacaftor-ivacaftor
Who cannot join
- Patient not eligible for triple CFTR modulator
- Patient intolerant to triple corrector
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIATRIM : Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment on Glucose Tolerance Abnormalities in Adult Patients With Cystic Fibrosis.
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.
- Conditions
- Cystic Fibrosis
- Being tested
- elexacaftor-tezacaftor-ivacaftor treatment
- Keywords
- Cystic fibrosis, Elexacaftor-Tezacaftor-Ivacaftor, Glucose tolerance abnormalities
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elexacaftor-tezacaftor-ivacaftor treatmentDrug
Effect of one year elexacaftor-tezacaftor-ivacaftor treatment on glucose tolerance abnormalities in adult patients with cystic fibrosis
| Study group | Role | What they receive |
|---|---|---|
| Adult patients with cystic fibrosis | Not described Receives: Drug: elexacaftor-tezacaftor-ivacaftor treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: time in range of blood glucose variation >140 mg/dl one year before and one year after the begining of elexacaftor-tezacaftor-ivacaftor treatment
Secondary outcomes (10)
Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: HbA1c (mmol/l)
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: HbA1c (%)
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: C-Peptid (µg/L)
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: C-Peptid (nmol/L)
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Markers of nutritional status: Evaluation of weight monitoring (kg)
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Markers of nutritional status: Body Mass Index (BMI)
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl)
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Assessment of respiratory function parameters : number of IV antibiotics
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Number patients with severe hypoglycaemia and serious adverse events
Measured: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start8 Apr 2024
- Primary completion20 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331000
- Sponsor's protocol ID
- 9248
- Acronym
- DIATRIM
- Status last verified
- May 2025
- First submitted
- 23 Feb 2024
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIATRIM : Effect of One Year Elexacaftor-tezacaftor-ivacaftor Treatment on Glucose Tolerance Abnormalities in Adult Patients With Cystic Fibrosis.
- ClinicalTrials.gov ID
- NCT06331000
- Acronym / sponsor ID
- DIATRIM / 9248
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic fibrosis, Elexacaftor-Tezacaftor-Ivacaftor, Glucose tolerance abnormalities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 26 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients with cystic fibrosis | – | Drug: elexacaftor-tezacaftor-ivacaftor treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cystic fibrosis aged over 18, followed in cystic fibrosis ambulatory care services of 18 french centers
Key inclusion criteria (4 listed)
- Patients with cystic fibrosis aged over 18
- Patients treated for 1 year by elexacaftortezacaftor-ivacaftor
- Normal tolerant or intolerant to glucose or presenting with cystic fibrosis related diabetes treated or not with insulin
- Patient who had a continuous glucose monitoring in the 6 months before and 6 months after one year of treatment with elexacaftor-tezacaftor-ivacaftor
Key exclusion criteria (3 listed)
- Patient not eligible for triple CFTR modulator
- Patient intolerant to triple corrector
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| elexacaftor-tezacaftor-ivacaftor treatmentEffect of one year elexacaftor-tezacaftor-ivacaftor treatment on glucose tolerance abnormalities in adult patients with cystic fibrosis | Drug | Adult patients with cystic fibrosis |
Primary outcome
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
Time frame: time in range of blood glucose variation >140 mg/dl one year before and one year after the begining of elexacaftor-tezacaftor-ivacaftor treatment
10 secondary outcomes
Evaluate other CGM parameters : time in range of blood glucose >180mg/dl ; >140mg/dl ; <70mg/dl ; 70-180 mg/dl ; 70-140mg/dl
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: HbA1c (mmol/l)
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: HbA1c (%)
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: C-Peptid (µg/L)
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Marker of metabolic status: C-Peptid (nmol/L)
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Markers of nutritional status: Evaluation of weight monitoring (kg)
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Markers of nutritional status: Body Mass Index (BMI)
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Diabetes treatment (assess insulin needs) : mean glucose value per day (mg/dl)
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Assessment of respiratory function parameters : number of IV antibiotics
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Number patients with severe hypoglycaemia and serious adverse events
Time frame: One year before and one year after the start of elexacaftor-tezacaftor-ivacaftor treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: time in range of blood glucose variation >140 mg/dl one year before and one year after the begining of elexacaftor-tezacaftor-ivacaftor treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.