OGTT at Home Using CGM vs at the Clinic

About this trial

Last updated 2 months ago

Study ID

ogtt_cgm

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

18 to 70 Years

All Sexes

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

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.