Cystic FibrosisProspeC-FNCT05099939
Identification of Dysglycemia With Continuous Glucose Monitoring to Assess Clinical Evolution in Cystic Fibrosis
An observational study of Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 121 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 25 Nov 2021to Jul 2026
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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).
Who may be able to join
- Have cystic fibrosis
- Be 18 years of age or older
- Have given clear and informed consent
Who cannot join
- 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)
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Canada2 sites, 2 recruiting
- Recruiting
Institut de recherches cliniques de Montréal
Montreal, Quebec, H2W 1R7
Katherine Desjardins, 5149875666, katherine.desjardins@ircm.qc.ca
Rémi Rabasa-Lhoret
- Not yet recruiting
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
Remi Rabasa-Lhoret, 5149875500 ext. 3227
Rémi Rabasa-Lhoret
France2 sites, 2 recruiting
- Not yet recruiting
Hospices Civils de Lyon
Lyon
Isabelle Durieu, isabelle.durieu@chu-lyon.fr
Isabelle Durieu
- Not yet recruiting
CHU de Strasbourg
Strasbourg
Laurence Kessler, 03 88 11 65 98, Laurence.Kessler@chru-strasbourg.fr
Laurence Kessler
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Cystic Fibrosis
- Keywords
- Diabetes, Screening Test, Continuous glucose monitoring, Oral glucose tolerance test
- Medical subject headings
- Cystic Fibrosis, Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years
Secondary outcomes (3)
Change in body mass index
Change in body mass index weight category from inclusion to 2 years (underweight, adequate weight, overweight).
Measured: 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.
Measured: 1 year
CFRD diagnosis
Development of new cases of CFRD diagnosed with standard OGTT and initiation of all anti-diabetic treatment.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start25 Nov 2021
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
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.
- 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
- Other
- Enrolment
- 121 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Rémi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de MontrealLaurence Kessler, Principal investigator, CHU de StrasbourgIsabelle Durieu, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099939
- Sponsor's protocol ID
- ProspeC-F
- Acronym
- ProspeC-F
- Status last verified
- Nov 2024
- First submitted
- 19 Oct 2021
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Dysglycemia With Continuous Glucose Monitoring: A Prospective Study to Assess the Relationship With Clinical Evolution in Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT05099939
- Acronym / sponsor ID
- ProspeC-F / ProspeC-F
- Conditions
- Cystic Fibrosis
- Keywords
- Diabetes, Screening Test, Continuous glucose monitoring, Oral glucose tolerance test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 121 participants (estimated)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- 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
- Study start
- 25 Nov 2021 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 29 Oct 2021 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- Have cystic fibrosis
- Be 18 years of age or older
- Have given clear and informed consent
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in lung function
Time frame: 5 years
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.
3 secondary outcomes
Change in body mass index
Time frame: 2 years
Number of pulmonary exacerbations
Time frame: 1 year
CFRD diagnosis
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- 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.
Rémi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
Laurence Kessler principal investigator
CHU de Strasbourg
Isabelle Durieu principal investigator
Hospices Civils de Lyon
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Institut de Recherches Cliniques de Montreal at 4 sites in 2 countries.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Canada, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katherine Desjardins (5149875666, katherine.desjardins@ircm.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in lung function (time frame: 5 years). 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 6 Nov 2024.