30 Participants NeededMy employer runs this trial

Continuous Glucose Monitoring for Cystic Fibrosis

JA
Overseen ByJennifer Apsan, MD
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

As modulator therapies extend the lifespan of CF patients, the detection of complications like Cystic Fibrosis Related Diabetes (CFRD) becomes increasingly vital. The current gold standard for CFRD screening, the 2-hour OGTT, is cumbersome and suffers from low compliance. This study proposes that Continuous Glucose Monitoring (CGM) could offer a more comprehensive, easier, and potentially more compliant screening method. The research aims to correlate various CGM parameters (e.g., time in hyperglycemia) with traditional glycemic markers like OGTT glucose levels, GMI, average glucose, variability, and HbA1c. Additionally, the research seeks to understand patient and parent/guardian preferences for CFRD screening modalities. This prospective observational study will involve CF patients wearing a Dexcom CGM around the time of standard OGTT and HbA1c tests, followed by surveys, with the ultimate goal of paving the way for CGM to improve early detection and management of dysglycemia in CF children.

Are You a Good Fit for This Trial?

This trial is for children and young adults who have cystic fibrosis. Participants will need to be able to wear a continuous glucose monitor and undergo standard diabetes screening tests.

Inclusion Criteria

I am 10-25 years old and have had or will have an OGTT within 3 months of joining.
I have cystic fibrosis.

Exclusion Criteria

Does not have access to personal Bluetooth device compatible with Dexcom G7 application
I have been diagnosed with type 1 or type 2 diabetes.
I currently have heart disease, another cancer, kidney failure, or have had a lung transplant.
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What Are the Treatments Tested in This Trial?

Trial Overview

The study is testing whether using a continuous glucose monitor (CGM) can better detect early signs of diabetes in people with cystic fibrosis compared to the usual oral glucose tolerance test (OGTT). Participants will use a Dexcom CGM during routine screenings.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Pediatric Cystic Fibrosis Patients Undergoing Concurrent CGM Monitoring and OGTT TestingExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+