Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
Part of paid clinical trials in New Haven, Connecticut.
- Sponsor
- Yale University
- Study ID
- NCT07155252
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 8 Years - 45 Years
- Healthy Volunteers
- Not accepted
Interventions
- GTT@Home — DIAGNOSTIC_TESTself-administered fingerstick based glucose tolerance test
Study Details
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.
Key Dates
- Start date
- Aug 26, 2025
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2027
- Completion
- Sep 30, 2027
Study Design
- Enrollment
- 60 participants (estimated)
Arms
- Arm: Single islet autoantibodyParticipants with single islet autoantibody
- Arm: 2 or more positive islet antibodiesParticipants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia
- Arm: Recently diagnosed with diabetesParticipants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis
Primary Outcome Measure
Accuracy of GTT@Home [ Time Frame: up to 4 weeks from enrollment ]
Central Contacts
- Marcia DeSousa, BA203-737-4805
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Yale University Pediatric and Adult Diabetes Clinic | New Haven | Connecticut | 06520 | - |
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