OGTT at Home Using CGM vs at the Clinic

Launched by LINKOEPING UNIVERSITY · Mar 1, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether people with prediabetes can accurately perform an oral glucose tolerance test (OGTT) at home using a continuous glucose monitor (CGM), compared to doing the test in a clinic. The OGTT helps to measure how your body processes sugar. In this study, participants will have their glucose levels checked in both settings to see how closely the home test results match those from the clinic. The researchers also want to learn if testing at home is practical and reliable for diagnosing blood sugar issues.

To be eligible for this study, participants need to have prediabetes, which means they have specific blood sugar levels that are higher than normal but not high enough to be classified as diabetes. They must also have access to a smartphone that can work with the CGM and be able to read instructions in Swedish. Throughout the study, participants will be guided on how to use the CGM and will need to complete some online questionnaires. It's important to note that this study is not yet recruiting participants, so if you're interested, keep an eye out for when it begins!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * Prediabetes indicated by both of the following in the past 2 years:
• • - ≥1 fasting venous plasma glucose ≥6.1 but ≤6.9 mmol/L OR ≥1 non-fasting venous plasma glucose ≥7.8 but ≤11.0 mmol/L
• • - ≥1 HbA1c ≥39 but ≤47 mmol/mol
• • Use of GLP-1 receptor agonists or SGLT-2 inhibitors
• • 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:
• • Previous oral glucose tolerance test (OGTT)
• * T2D indicated by any of the following at any time:
• • - 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 \<25 kg/m2, indicating an increased risk of type 1-diabetes, maturity-onset diabetes of the young or latent autoimmune diabetes in adults
• • Body weight \<43 kg, which is a contraindication to administer the full OGTT glucose solution according to Swedish guidelines
• • Current pregnancy, because gestational diabetes is a unique entity
• • Need of regular use of acetaminophen or ascorbic acid supplements during the study period, which may interfere with CGM accuracy33
• • Fear of needle sticks
• • Involvement in the study design, data collection, analysis, or participant recruitment.