OGTT at Home Using CGM vs at the Clinic

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.

Eligibility

Inclusion Criteria:

* Prediabetes indicated by ≥2 of the following values, measured at separate occasions or through different analyses during the past 2 years:
* \- 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
* Ability to read and respond to online instructions and questionnaires in Swedish.

Exclusion Criteria:

* T2D indicated by ≥2 of the following values, measured at different occasions or through different analyses:
* \- 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
* Body mass index \<20 kg/m2
* Body weight \<43 kg
* Current pregnancy
* Need of regular use of GLP-1 receptor agonists, SGLT-2 inhibitors, acetaminophen or ascorbic acid supplements during the study period
* Fear of needle sticks
* Shift work during the study period
* Involvement in the study design, data collection, analysis, or participant recruitment.

Conditions2

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