Home oral glucose tolerance test with continuous glucose monitoring compared to a clinic OGTT
Oral Glucose Tolerance Test at Home With Continuous Glucose Monitoring vs Standard Clinic-based Testing
This tests whether a self‑administered home oral glucose tolerance test using a continuous glucose monitor gives similar results to the standard clinic OGTT in adults with prediabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Linkoeping University Government |
| Locations | 3 sites (Huskvarna, Jönköping County and 2 other locations) |
| Trial ID | NCT06862128 on ClinicalTrials.gov |
What this trial studies
This randomized crossover study enrolls 75 adults with prediabetes who will each complete a home-based OGTT monitored by continuous glucose monitoring (CGM) and a standard clinic OGTT with venous plasma glucose, in randomized order. Glucose responses from the CGM during the home test will be compared to venous plasma glucose from the clinic OGTT to determine correlation and diagnostic agreement. Secondary analyses examine variability between methods, associations with metabolic and sex hormones, and participant adherence and feasibility of home testing. The study tests whether a validated home OGTT approach could serve as a practical diagnostic tool for dysglycemia.
Who should consider this trial
Good fit: Adults with prediabetes who meet the trial’s glucose/HbA1c criteria, have a compatible smartphone with Bluetooth, can read Swedish instructions, and meet the study’s weight and BMI thresholds are ideal candidates.
Not a fit: People with established type 2 diabetes, current pregnancy, prior bariatric surgery, low body weight/BMI below study limits, those taking excluded medications, or those without a compatible smartphone or ability to follow Swedish instructions are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this approach could allow accurate glucose tolerance testing at home, improving access and convenience while reducing clinic visits.
How similar studies have performed: Previous work using CGM to track glucose responses has shown reasonable correlation with plasma glucose, but using a self‑administered home OGTT as a validated diagnostic alternative is relatively novel and not yet widely established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Huskvarna, Jönköping County and 2 other locations
- Primary Health Care Center Bra Liv Rosenhälsan — Huskvarna, Jönköping County, Sweden (Recruiting)
- Primary Health Care Center Cityhälsan Centrum — Norrköping, Norrköping, Sweden (Recruiting)
- Primary Care Center Vårdcentralen Kärna — Linköping, Östergötland County, Sweden (Recruiting)
Study contacts
- Principal investigator: Peder af Geijerstam, MD, PhD — Linkoeping University
- Study coordinator: Peder af Geijerstam, MD, PhD
- Email: peder.af.geijerstam@liu.se
- Phone: +46739597426
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.