Glycemic Monitoring in Cystic Fibrosis (NCT02211235) | Clinical Trial Compass
CompletedNot Applicable
Glycemic Monitoring in Cystic Fibrosis
United States146 participantsStarted 2014-08
Plain-language summary
Current guidelines on the diagnoses and management of cystic fibrosis (CF) related diabetes recommend treatment for diabetes based on diagnostic criteria derived from adults with type 2 diabetes. Increasing evidence supports treating early glucose abnormalities in cystic fibrosis patients to target CF specific outcomes, including lung function and nutrition (BMI-Body Mass Index). However, the criteria and timing of when to start insulin therapy in the 'prediabetic' state are unclear. A more accurate characterization of blood sugar variability in youth with and without CF will help the investigators better interpret continuous glucose monitor (CGM) findings in patients with CF prediabetes and diabetes and more accurately identify those individuals at greatest risk for disease progression.
Who can participate
Age range
6 Years – 25 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 10-25 years
. BMI \<85th percentile
. Baseline health at enrollment
. Age 10-25 years
. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
Exclusion criteria
. Age 10-25 years
. Diagnosis of cystic fibrosis (by newborn screen, sweat chloride testing, or genetic testing)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. History of abnormal oral glucose tolerance testing (2h-glucose \>140, fasting plasma glucose \>100,1hr glucose \>200)
. If taking medication that affects glucose metabolism (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics), should be on a stable dose over the past 3 months
. Known diagnosis of diabetes or prediabetes (including type 1, type 2, MODY), abnormal oral glucose tolerance test (OGTT) (ie. fasting plasma glucose ≥100 or 2hr ≥140 mg/dl) or HbA1c ≥ 5.7%
. BMI ≥85th percentile
. Chronic disease that may affect glucose metabolism or use of medications affecting glucose metabolism in the past 3 months (ex. Insulin, insulin sensitizers, glucocorticoids, atypical antipsychotics)
. Presence of type 1 diabetes auto-antibodies in any individuals with a first degree relative with type 1 diabetes (will only include first degree relatives if they have had previous negative auto-antibody screening performed as part of participation in other studies such as the Trial Net studies at the Barbara Davis Center)