Continuous Glucose Monitoring for Cystic Fibrosis

(ProspeC-F Trial)

Recruiting at 3 trial locations

Overseen By Katherine Desjardins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Institut de Recherches Cliniques de Montreal

Must not be taking: Diabetes medications

Disqualifiers: Lung/liver transplant, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

121 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for screening diabetes in people with cystic fibrosis (CF). It uses continuous glucose monitoring (CGM), which is easier and less unpleasant than the standard test. The goal is to determine if CGM can better predict the development of CF-related diabetes and other health issues. Individuals with CF who are 18 or older and not currently on diabetes medication may qualify. As an unphased trial, this study allows participants to contribute to innovative research that could enhance diabetes screening for the CF community.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are receiving pharmaceutical treatment for diabetes.

What prior data suggests that continuous glucose monitoring is safe for cystic fibrosis patients?

Research has shown that continuous glucose monitoring (CGM) devices, like those used in this trial, are generally easy to use and safe. The FDA has approved these devices for managing diabetes, confirming their safety for people. Some individuals might experience minor skin irritation where the device is attached, but serious problems are rare. Many studies have demonstrated that CGM devices effectively track blood sugar levels without major issues. Although any medical device can have rare side effects, CGMs maintain a strong safety record for monitoring glucose levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Continuous Glucose Monitoring (CGM) for cystic fibrosis patients because it offers a real-time, dynamic way to track blood sugar levels, which isn't possible with traditional finger-prick tests. Unlike standard methods that provide only snapshots of glucose levels, CGM continuously records data throughout the day and night. This continuous data stream allows for early detection of dysglycemia, potentially leading to more timely interventions and better management of the patient's health over time.

What evidence suggests that continuous glucose monitoring is effective for cystic fibrosis-related diabetes?

Research has shown that continuous glucose monitoring (CGM) can help manage blood sugar levels. Studies have found that CGM devices improve blood sugar control in individuals with both Type 1 and Type 2 diabetes. These devices provide real-time updates on blood sugar levels, enabling users to make quick decisions about their diet and insulin use. In diabetes related to cystic fibrosis, CGM might help identify early signs of abnormal blood sugar levels, potentially predicting risks such as lung function decline and future diabetes. However, more research is needed to establish specific CGM guidelines for individuals with cystic fibrosis. ^{1 6 7 8 9}

Who Is on the Research Team?

Laurence Kessler

Principal Investigator

CHU de Strasbourg

Rémi Rabasa-Lhoret

Principal Investigator

Institut de recherches cliniques de Montréal

Isabelle Durieu

Principal Investigator

Hospices Civils de Lyon

Are You a Good Fit for This Trial?

Inclusion Criteria

Have cystic fibrosis

Have given clear and informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Retrospective Data Collection

Retrospective file-based data collection covering 2 years before inclusion

2 years

Prospective Data Collection

Prospective data collection with CGM installation at inclusion, 1 year, and 2 years

2 years

3 visits (in-person)

Additional Prospective Data Collection

An additional one-year prospective data collection on file only

1 year

Follow-up

Participants are monitored for changes in lung function, BMI, and CFRD diagnosis

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Continuous Glucose Monitoring

Who Is Running the Clinical Trial?

Institut de Recherches Cliniques de Montreal

Lead Sponsor

Trials

72

Recruited

10,300+

Centre Hospitalier Lyon Sud

Collaborator

Trials

8

Recruited

15,800+

Fondation Francophone pour la Recherche sur le Diabete

Collaborator

Trials

4

Recruited

16,200+

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborator

Trials

389

Recruited

143,000+

University Hospital, Strasbourg, France

Collaborator

Trials

854

Recruited

1,080,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37987208/

Effectiveness of Continuous Glucose Monitoring on Metrics ... Both rt-CGM and flash CGM led to modest but statistically significant declines in HbA1c among individuals with T2DM, with little heterogeneity in the results.

2. diabetes.org diabetes.org/advocacy/cgm-continuous-glucose-monitors

Continuous Glucose Monitoring (CGM) CGMs continually monitor your blood glucose (blood sugar), giving you real-time updates through a device that is attached to your body.

3. e-enm.org e-enm.org/journal/view.php?number=2600

Advances in Continuous Glucose Monitoring: Clinical ... Continuous glucose monitoring systems have revolutionized diabetes management, significantly improving glycemic control in both Type 1 and Type 2 diabetes.

4. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.30.10-b.s30

Using continuous glucose monitoring to measure and ... The Glucose Management Indicator can be used as a measure of glucose control. This article discusses the benefits of value-based care, the importance of ...

5. diabetesjournals.org diabetesjournals.org/clinical/article/43/1/139/157329/Continuous-Glucose-Monitoring-in-Individuals-With

Continuous Glucose Monitoring in Individuals With Type 2 ... A quality improvement (QI) program to evaluate the feasibility and impact of CGM use in its patients with type 2 diabetes.

6. my.clevelandclinic.org my.clevelandclinic.org/health/articles/continuous-glucose-monitoring-cgm

Continuous Glucose Monitoring (CGM): What It Is A continuous glucose monitor (CGM) is a wearable device that tracks your glucose (sugar) levels in real time. It's a tool people with diabetes use.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf12/P120005S018b.pdf

FDA - Summary of Safety and Effectiveness Data (SSED) The Dexcom G4 PLATINUM Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons (age ...

8. freestyle.abbott freestyle.abbott/us-en/safety-information.html

Safety Information | The FreeStyle Libre System Read safety information regarding your FreeStyle Libre 14 day system, including MRI contraindications, insulin contraindications, and sensor removal ...

9. niddk.nih.gov niddk.nih.gov/health-information/diabetes/overview/managing-diabetes/continuous-glucose-monitoring

Continuous Glucose Monitoring - NIDDK Continuous glucose monitoring means using a device to automatically estimate your blood glucose level, also called blood sugar, throughout the day and night.