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_TEST
    self-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 autoantibody
    Participants with single islet autoantibody
  • Arm: 2 or more positive islet antibodies
    Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia
  • Arm: Recently diagnosed with diabetes
    Participants 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

Locations (1)

FacilityCityStateZIPSite coordinators
Yale University Pediatric and Adult Diabetes ClinicNew HavenConnecticut06520-

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