OGTT at Home Using CGM vs at the Clinic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLinkoeping University
About this trial
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.
Eligibility criteria
Qualifiers
- Fasting venous plasma glucose ≥6.1 but ≤6.9 mmol/L
- Non-fasting venous plasma glucose ≥7.8 but ≤11.0 mmol/L
- HbA1c ≥39 but ≤47 mmol/mol
Access to a smart phone which is compatible with the CGM application and has working Bluetooth connectivity
Disqualifiers
- 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
Trial design
Treatments tested in this trial
- OGTT at home using CGM
- OGTT at the clinic
Treatment groups
75 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov