RecruitingOBSERVATIONAL

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

This study investigates if a continuous glucose monitor (CGM) can help identify sugar level changes in adults with cystic fibrosis (CF). Many people with CF develop a type of diabetes called CFRD, which can affect their health. The current test for this, called an OGTT, can be inconvenient. We believe CGM might be an easier and more useful way to find early sugar problems. Researchers will follow CF patients for three years, using CGM devices for short periods. They will compare these readings with changes in lung function and other health markers over five years. The goal is to find better ways to spot and manage health risks for people with CF in the future.

At a glance

Status

Recruiting

Sponsor

Institut de Recherches Cliniques de Montreal

Enrolment target

121

Start

25 Nov 2021

Estimated completion

01 Jul 2026

Cystic Fibrosis

What is this study about?

Cystic fibrosis (CF) is a condition that affects many parts of the body, including how the body handles sugar. Many people with CF can develop a specific type of diabetes called CF-related diabetes (CFRD). This is an important health concern, as it can be linked to other health issues like problems with your lungs. It’s quite common, affecting about 1 in 10 children with CF by age 10, and nearly half of adults with CF. There's also a milder form of sugar imbalance, often called pre-diabetes.

Currently, to check for CFRD, people with CF usually need to take a test called an oral glucose tolerance test (OGTT) every year. This test involves drinking a sugary drink and having blood samples taken over a couple of hours. Many patients and healthcare teams find this test a bit unpleasant and time-consuming, meaning not everyone gets screened as often as recommended. Researchers are looking for a simpler, less invasive test that can still give important information about sugar levels and potential health risks.

This study explores whether a continuous glucose monitor (CGM) could be a better option. A CGM is a small sensor you wear, often on your arm or tummy, that automatically checks your sugar levels throughout the day and night. It’s generally easy to use. The study aims to see if using a CGM can spot early changes in sugar levels that might predict how your lung function or weight might change, or if you might develop CFRD in the future. By finding CF-specific patterns in CGM readings, this research could help identify people who might benefit from early support and treatment.

Key takeaways

This study is for adults with Cystic Fibrosis aged 18 and over.
It aims to find better ways to monitor blood sugar using a small device called a CGM.
Participation involves wearing a CGM for 14 days during three clinic visits over two years.
The study hopes to identify early signs of health changes in CF, including lung function and diabetes risk.
It's an observational study, meaning you won't be given any new treatments.
You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To join this study, you must be an adult with cystic fibrosis, aged 18 or older. It's very important that you understand what the study involves and agree to take part freely. This is called 'giving informed consent'.

There are some reasons why you wouldn't be able to join. For example, if you are already taking medication for diabetes, or if you have had a lung or liver transplant. Also, if you are currently pregnant or taking part in another major clinical trial at the same time (for more than three months), you wouldn't be eligible.

If you have any questions about whether you can join, it's always best to speak to your CF care team or the study doctors.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have Cystic Fibrosis?
Am I 18 years old or older?
Am I currently taking medication for diabetes?
Have I had a lung or liver transplant?
Am I pregnant?
Am I comfortable wearing a small device on my skin for two weeks at a time?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will look at your health over a total of five years, combining past and future information. For the first two years of the study, we will look back at your existing medical records. Then, for the next two years, you will have three study visits. These visits will align with your regular CF clinic appointments, which makes it easier for you.

During each of these three visits (at the start, after one year, and after two years), you will wear a continuous glucose monitor (CGM) for 14 days. These are small devices that stick to your skin and painlessly measure your sugar levels. Your only job will be to wear the device for two weeks and then return it to the clinic. After these three visits, the study will continue for one more year, using information from your medical records only. The entire time you are actively involved with visits will be about two years.

Potential risks and benefits

Taking part in research always has potential benefits and risks. A potential benefit of this study is that it might help us find better ways to monitor sugar levels and predict health changes in people with CF, leading to earlier support in the future. For you personally, wearing the CGM might give you some interesting insights into your own blood sugar patterns, but this study won't provide direct medical advice based on those readings. Minimal risks are expected, mainly related to wearing the CGM, which is generally well-tolerated. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Institut de recherches cliniques de Montréal
Verified postcode
Montreal, Canada· Recruiting
Centre Hospitalier de l'Université de Montréal
Verified postcode
Montreal, Canada· Not yet recruiting
Hospices Civils de Lyon
Verified postcode
Lyon, France· Not yet recruiting
CHU de Strasbourg
Verified postcode
Strasbourg, France· Not yet recruiting

Common questions

What is a continuous glucose monitor (CGM)?

It's a small sensor worn on your skin that automatically checks your blood sugar levels throughout the day and night.

Why is this study important for people with CF?

It aims to find an easier and more effective way to spot early sugar problems in CF, which could help prevent future health complications.

Will I have to take any new medication if I join?

No, this is an observational study; you will not be given new medications as part of it.

How long will I be actively involved in the study?

You will have three visits over two years where you wear a CGM. The full study follow-up period is five years, using your existing medical records for some of that time.

Can I stop being part of the study once I've started?

Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.

How to find out more

Katherine Desjardins

katherine.desjardins@ircm.qc.ca 5149875666 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.