Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
This study aims at quantifying the accuracy of a self-administered fingerstick based glucose tolerance test (GTT@Home) respect to the gold-standard in-clinic venous plasma measures during the oral glucose tolerance test (OGTT) across a wide range of glycemic values in people at risk for clinical type 1 diabetes (T1D) (
| Condition(s) | Type 1 Diabetes |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | This study aims at quantifying the accuracy of a self-administered fingerstick based glucose tolerance test (GTT@Home) respect to the gold-standard in-clinic venous plasma measures during the oral glucose tolerance test (OGTT) across a wide range of glycemic values in people at risk for clinical type 1 diabetes (T1D) (carriers of at least one islet autoantibody) or with new onset Stage 3 T1D within 100 days from the diagnosis. |
| Who can participate | Inclusion Criteria: * Body weight ≥43 kg * Presence of at least one islet autoantibody and/or≥ diagnosis of clinical T1D within 100 days. * Documentation of the presence at least 1 islet autoantibody * If participants meet ADA diagnostic criteria for Stage 3 type 1 diabetes, they will be eligible if the enrollment occurs within 100 days from the diagnosis and are at least 12 years old. * Participants must be in good general health without other acute (e.g. infectious disease) febrile or chronic illnesses (e.g. uncontrolled asthma requiring high steroid doses, chronic arthritis) that in the judgment of the investigator could jeopardize participant safety or interfere with the study, * Ability to give consent/assent * Able to understand written and spoken English Exclusion Criteria: * Curren |
| Ages | 8 Years to 45 Years |
| Sex | All |
| Lead sponsor | Yale University |
| Locations | New Haven, Connecticut, United States |
| Start date | 2025-08-26 |
| NCT ID | NCT07155252 |
| Official listing | https://clinicaltrials.gov/study/NCT07155252 |