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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInstitut de Recherches Cliniques de Montreal

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have cystic fibrosis

Be 18 years of age or older

Have given clear and informed consent

Disqualifiers

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

Trial 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).

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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.

Time frame
5 years

Secondary outcomes

1

Change in body mass index

Change in body mass index weight category from inclusion to 2 years (underweight, adequate weight, overweight).

Time frame
2 years
2

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.

Time frame
1 year
3

CFRD diagnosis

Development of new cases of CFRD diagnosed with standard OGTT and initiation of all anti-diabetic treatment.

Time frame
3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut de Recherches Cliniques de Montreal

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

University Hospital, Strasbourg, France

Collaborator

Centre Hospitalier Lyon Sud

Collaborator

Fondation Francophone pour la Recherche sur le Diabete

Collaborator