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 groupsLocations
3Primary Health Care Center Bra Liv Rosenhälsan55185, HuskvarnaJönköping County, Sweden
Primary Health Care Center Cityhälsan Centrum60239, NorrköpingNorrköping, Sweden
Primary Care Center Vårdcentralen Kärna58662, LinköpingÖstergötland County, Sweden
Sponsors and collaborators
Linkoeping University
Lead sponsor
Region Jönköping County
Collaborator
Region Östergötland
Collaborator
Source ClinicalTrials.gov