Alternate Measures of Glucose During OGTT Testing for CFRD (NCT05568134) | Clinical Trial Compass
CompletedNot Applicable
Alternate Measures of Glucose During OGTT Testing for CFRD
United States14 participantsStarted 2023-07-17
Plain-language summary
Although early detection and treatment of cystic fibrosis-related diabetes (CFRD) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (OGTT). The investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (CGM) and a home OGTT kit (GTT@home). If this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based OGTT screening.
Who can participate
Age range
10 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:
* Diagnosis of cystic fibrosis
* ≥ 10 years of age
* Fluency in written and spoken English as the GTT@Home is currently only available in English
Exclusion Criteria:
* Hospitalization or treatment with IV antibiotics or supraphysiologic glucocorticoids within 4 weeks
* Major medical or psychiatric disorders other than CF
* Use of medications known to impact the accuracy of the Dexcom G7 (hydroxyurea, \>2g acetaminophen per day)
* History of severe adhesive reactions that may lead to an inability to tolerate CGM wear
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.
What they're measuring
1
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Timeframe: Fasting glucose before OGTT
2
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose
Timeframe: 1 hour mark in OGTT
3
Agreement between plasma glucose, CGM measured glucose using the Dexcom G7, and GTT@home glucose