Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-01 @ 3:43 AM
Study NCT ID:
NCT06862128
Status:
RECRUITING
Last Update Posted:
2025-09-24
First Post:
2025-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
OGTT at Home Using CGM vs at the Clinic
Sponsor:
Linkoeping University
Organization:
Study Overview
Official Title:
Oral Glucose Tolerance Test at Home With Continuous Glucose Monitoring vs Standard Clinic-based Testing
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OGTT-CGM
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 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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: