Actively Recruiting
CGM Dynamic Index (CDI) for Predicting Prediabetes in People With Cystic Fibrosis
Led by Indiana University · Updated on 2025-07-29
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people with cystic fibrosis to develop a model using continuous glucose monitoring (CGM) that can predict the progression from prediabetes to diabetes. This pilot study focuses on individuals aged 12 to 55 years who have cystic fibrosis and either no diabetes or prediabetes. The goal is to better understand how glucose levels change in these groups to improve early detection of diabetes related to cystic fibrosis. Participants will take part in a one-time oral glucose tolerance test (OGTT) and wear a CGM device for up to 10 days to collect glucose data. The study includes two groups: people with cystic fibrosis without diabetes and those with cystic fibrosis-related prediabetes. People with cystic fibrosis-related diabetes already using CGM will have their personal CGM data collected without additional tests. During the study, participants will use a CGM device linked to a compatible smartphone to monitor glucose levels continuously. Researchers will analyze the data to create a CGM Dynamic Index (CDI) that predicts prediabetes progression. The main outcome is the CDI measured over 10 days. The study does not involve randomization or masking, and participant safety and glucose data accuracy will be monitored throughout the process.
CONDITIONS
Brief Title
CGM Dynamic Index for Predicting Prediabetes in Cystic Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with cystic fibrosis aged 12 to 55 years
- Cystic fibrosis without diabetes or with prediabetes as defined by OGTT and HbA1c
- Willingness to use a continuous glucose monitoring system with a compatible smartphone for glucose data collection
You will not qualify if you...
- Pregnancy
- History of transplant
- Use of immunosuppressant drugs
- Use of oral steroids or medications known to interfere with glucose
- Allergy to adhesives
- Severe concurrent medical conditions that could affect glucose monitoring data (e.g., terminal illness, major organ failure)
- Conditions making study participation unsafe or confounding, as determined by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 days
Participants will undergo a one-time oral glucose tolerance test (OGTT) and wear a continuous glucose monitoring (CGM) device for up to 10 days to collect glucose data.
1 baseline visit for device placement and 1 visit for device removal
Trial Site Locations
Total: 1 location
1
Indiana University Health, University Hospital
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
E
Eslam Montaser, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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