Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05099939 |
| Other study ID # |
ProspeC-F |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 25, 2021 |
| Est. completion date |
July 2026 |
Study information
| Verified date |
April 2023 |
| Source |
Institut de Recherches Cliniques de Montreal |
| Contact |
Katherine Desjardins |
| Phone |
5149875666 |
| Email |
katherine.desjardins[@]ircm.qc.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
