Continuous Glucose Monitoring for Cystic Fibrosis
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
Exclusion Criteria
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
Pediatric Cystic Fibrosis patients (ages 10-25 years) will wear a continuous glucose monitor (Dexcom G7) for up to 10 days within 3 months of an annual Oral Glucose Tolerance Test (OGTT) and complete a survey to evaluate correlations between CGM parameters and OGTT values and assess patient/guardian preferences for CFRD screening methods.
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Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
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