An interventional study of OGTT at home using CGM and OGTT at the clinic in Pre-diabetes and Diabetes, sponsored by Linkoeping University. Active, not recruiting at 3 sites in Sweden. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by Linkoeping University · Not applicable, Interventional, and Diagnostic
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.
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: 70 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 evaluate the diagnostic accuracy and agreement of the 2-hour CGM glucose value from a home OGTT compared with the 2-hour venous plasma glucose value from a clinic OGTT.
Secondary Objectives To evaluate the lag-adjusted CGM timing and reproducibility across 2 home OGTTs.
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.
778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.
This study's enrollment of 70 is above the median of 60 across 645 interventional studies indexed under Glucose Intolerance.
Browse Glucose Intolerance studies →Linkoeping University is the lead sponsor of 189 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
OGTT at the clinic then at home
Diagnostic Test: OGTT at home using CGM · Diagnostic Test: OGTT at the clinic
OGTT at home then at the clinic
Diagnostic Test: OGTT at home using CGM · Diagnostic Test: OGTT at the clinic
OGTT at home using CGM
Also known as: OGTT-home
OGTT at the clinic
Also known as: OGTT-clinic
Diagnostic accuracy of the 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
The diagnostic accuracy of the 2-hour interstitial glucose measured by CGM during a home-based oral glucose tolerance test (OGTT) will be evaluated against the 2-hour venous plasma glucose obtained during a clinic-based OGTT (reference standard) for the classification of normoglycemia, prediabetes, and diabetes. The 2-hour CGM value will be defined as the first CGM recording at or within 5 minutes after the 2-hour timepoint (i.e., between 120 and 125 minutes). Diagnostic accuracy will be assessed using sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen's kappa coefficient for overall classification agreement, each reported with 95% CIs. Systematic bias and limits of agreement between the two continuous glucose measurements will further be assessed using Bland-Altman analysis.
Time frame: 2 hours after the start of the OGTT
Diagnostic accuracy of the lag-adjusted 2-hour CGM glucose value during home-based OGTT compared with 2-hour venous plasma glucose during clinic-based OGTT
The diagnostic accuracy of a lag-adjusted CGM glucose value during a home-based oral glucose tolerance test (OGTT) will be evaluated against the 2-hour venous plasma glucose during a clinic-based OGTT (reference standard) for the classification of normoglycemia, prediabetes, and diabetes. The lag-adjusted timepoint will be identified from the clinic-based OGTT as the CGM recording between 120 and 140 minutes showing the highest concordance with the 2-hour venous plasma glucose, assessed using Lin's concordance correlation coefficient (CCC), and applied accordingly during the home-based OGTT. Diagnostic accuracy will be assessed using sensitivity, specificity, PPV, NPV, and Cohen's kappa, each with 95% CIs, and Bland-Altman analysis will be used to assess systematic bias and limits of agreement.
Time frame: 0-20 minutes after the 2-hour timepoint of the OGTT (lag-adjusted)
Reproducibility of home-based OGTT using CGM
Reproducibility of the 2-hour CGM glucose value across the two home-based OGTTs will be assessed using intraclass correlation coefficients (ICC), and agreement in glycemic classification (normoglycemia, prediabetes, and diabetes) will be assessed using weighted Cohen's kappa. Both the unadjusted and lag-adjusted 2-hour CGM values will be evaluated.
Time frame: 2 hours and 2 hours plus 0-20 minutes lag-adjustment after the start of the OGTT
Plan to share: Undecided — If suitable according to ethical guidelines.
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This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Linkoeping University