Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT06862128
Brief 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.
Detailed Description:
This study aims to evaluate the feasibility, accuracy, and diagnostic utility of a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT.
Study Design Type: Randomized, crossover study Participants: 75 adults with prediabetes Intervention: Each participant will complete both a home-based OGTT with CGM and a clinic-based OGTT with venous plasma glucose measurement.
Primary Objective To assess the correlation between glucose values obtained from a CGM-based home OGTT and a standard venous OGTT performed in the clinic.
Secondary Objectives Evaluate diagnostic agreement between CGM-derived and venous glucose measurements.
Assess variability in glucose responses between the two methods. Investigate associations between OGTT results and metabolic/sex hormones. Determine feasibility and patient adherence to home-based testing.
Methods Participants will be randomized into two groups: one starting with a clinic-based OGTT, the other with a home-based OGTT, followed by a crossover period. CGM will continuously monitor glucose responses, and standard venous plasma glucose measurements will serve as the reference method.
Clinical Relevance A validated home-based OGTT using CGM could improve access to glucose tolerance testing, reduce patient burden, and enhance early detection of dysglycemia.
Study:
NCT06862128
Study Brief:
Protocol Section:
NCT06862128