Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
ID06862128

Oral Glucose Tolerance Test at Home with Continuous Glucose Monitoring Compared to Standard Clinic Testing

Led by Linkoeping University · Updated on 2026-05-19

75

Participants Needed

3

Research Sites

761 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

Researchers are evaluating a self-administered oral glucose tolerance test (OGTT) at home using continuous glucose monitoring (CGM) compared to a standard clinic-based OGTT in adults with prediabetes. This randomized, crossover study aims to assess the accuracy, feasibility, and diagnostic utility of the home-based test by comparing glucose levels measured by CGM with those from venous plasma glucose in a clinical setting. The study also explores metabolic hormone associations and patient adherence to home testing. Participants will be randomly assigned to complete either the clinic-based OGTT first followed by the home-based OGTT, or vice versa. The home OGTT uses CGM to continuously monitor glucose levels, while the clinic OGTT measures venous plasma glucose. Both tests are performed within a crossover design to allow comparison within each participant. The study includes 75 adults with prediabetes, and the interventions focus on diagnostic testing methods. During the study, participants will undergo both OGTT procedures with glucose monitoring and blood tests to measure plasma glucose. Researchers will evaluate the primary outcome of diagnostic accuracy by comparing the 2-hour CGM glucose reading at home with the 2-hour venous plasma glucose obtained in the clinic. Secondary outcomes include reproducibility of home testing, diagnostic agreement, and hormone relationships. Study participation involves following instructions, using CGM devices, and completing questionnaires, with monitoring of adherence and feasibility throughout the study.

CONDITIONS

Brief 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
  • Diagnosis of prediabetes indicated by at least two of the following within the past 2 years: fasting venous plasma glucose 6.1 to 6.9 mmol/L, non-fasting venous plasma glucose 7.8 to 11.0 mmol/L, or HbA1c 39 to 47 mmol/mol
  • Access to a smartphone compatible with the CGM app with working Bluetooth
  • Ability to read and respond to online instructions and questionnaires in Swedish
Not Eligible

You will not qualify if you...

  • Diagnosis of type 2 diabetes indicated by at least two of the following: fasting venous plasma glucose 6.9 mmol/L, non-fasting venous plasma glucose 11.1 mmol/L, or HbA1c 48 mmol/mol
  • Previous bariatric surgery such as gastric bypass or gastric sleeve
  • Body mass index less than 20 kg/m2
  • Body weight less than 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
  • Shift work during the study period
  • Involvement in the study design, data collection, analysis, or recruitment

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or remote)

Diagnostic Evaluation

Duration - Up to 2 weeks

Participants complete two oral glucose tolerance tests (OGTT): one at home using continuous glucose monitoring (CGM) and one at the clinic with venous plasma glucose measurement, in a randomized order.

2 visits (one home-based and one clinic-based OGTT)

Long-term Monitoring

Duration - Up to 4 weeks

Participants' glucose responses are monitored and compared between home-based CGM and clinic-based testing to assess diagnostic accuracy and feasibility.

Follow-up assessments may occur via remote monitoring and questionnaires

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

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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