OGTT at Home Using CGM vs at the Clinic (NCT06862128) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
OGTT at Home Using CGM vs at the Clinic
Sweden70 participantsStarted 2025-06-11
Plain-language summary
This randomized, crossover study evaluates the feasibility and accuracy of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT. Participants with prediabetes will undergo both home-based and clinic-based OGTTs, with glucose levels measured via CGM and venous plasma glucose. The primary outcome is the correlation between CGM-based glucose values and standard OGTT results. Secondary outcomes include diagnostic agreement, metabolic hormone associations, and feasibility of home-based testing as a diagnostic tool for dysglycemia.
Who can participate
Age range
18 Years – 70 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:
* Prediabetes indicated by any of the following values:
* \- Fasting venous plasma glucose ≥5.6 but \<7.0 mmol/L
* \- HbA1c ≥39 but \<48 mmol/mol
* Access to a smart phone which is compatible with the CGM application and has working Bluetooth connectivity
* Ability to read and respond to online instructions and questionnaires in Swedish.
Exclusion Criteria:
* T2D indicated by ≥2 of the following values, measured at different occasions or through different analyses:
* \- Fasting venous plasma glucose ≥7.0 mmol/L
* \- Non-fasting venous plasma glucose value ≥11.1 mmol/L
* \- HbA1c ≥48 mmol/mol
* Previous bariatric surgery e.g., gastric by-pass or gastric sleeve surgery
* Body mass index \<20 kg/m2
* Body weight \<43 kg
* Current pregnancy
* Need of regular use of GLP-1 receptor agonists, SGLT-2 inhibitors, acetaminophen or ascorbic acid supplements during the study period
* Fear of needle sticks
* Shift work during the study period
* Involvement in the study design, data collection, analysis, or participant recruitment.
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
Diagnostic accuracy of the 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT