Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06862128

OGTT at Home Using CGM vs at the Clinic

Led by Linkoeping University · Updated on 2026-03-24

75

Participants Needed

3

Research Sites

811 weeks

Total Duration

On this page

Sponsors

L

Linkoeping University

Lead Sponsor

R

Region Jönköping County

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

OGTT at Home Using CGM vs at the Clinic

Who Can Participate

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to 70 years
  • Prediabetes indicated by at least two of the following measured on separate occasions or by different analyses within the past 2 years:
  • Fasting venous plasma glucose between 6.1 and 6.9 mmol/L
  • Non-fasting venous plasma glucose between 7.8 and 11.0 mmol/L
  • HbA1c between 39 and 47 mmol/mol
  • Access to a smartphone compatible with the CGM app and Bluetooth connectivity
  • Ability to read and respond to online instructions and questionnaires in Swedish
Not Eligible

You will not qualify if you...

  • Type 2 diabetes indicated by at least two of the following measured on separate occasions or by different analyses:
  • Fasting venous plasma glucose 7.0 mmol/L or higher
  • Non-fasting venous plasma glucose 11.1 mmol/L or higher
  • HbA1c 48 mmol/mol or higher
  • Previous bariatric surgery such as gastric bypass or sleeve surgery
  • Body mass index under 20 kg/m2
  • Body weight under 43 kg
  • Current pregnancy
  • Regular use of GLP-1 receptor agonists, SGLT-2 inhibitors, acetaminophen, or ascorbic acid supplements during the study
  • Fear of needle sticks
  • Working shift hours during the study period
  • Involvement in study design, data collection, analysis, or recruitment

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 3 locations

1

Primary Health Care Center Bra Liv Rosenhälsan

Huskvarna, Jönköping County, Sweden, 55185

Actively Recruiting

2

Primary Health Care Center Cityhälsan Centrum

Norrköping, Norrköping, Sweden, 60239

Actively Recruiting

3

Primary Care Center Vårdcentralen Kärna

Linköping, Östergötland County, Sweden, 58662

Actively Recruiting

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Research Team

P

Peder af Geijerstam, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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OGTT at Home Using CGM vs at the Clinic | DecenTrialz