NCT07155252

Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 60 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 8 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Investigators will conduct an observational longitudinal study that will include one home-based unsupervised GTT@Home test, a standard OGTT at a research facility and a supervised GTT@Home. Additionally, participants will have up to10-day blinded-CGM data collected.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	GTT@Home	self-administered fingerstick based glucose tolerance test

Timeline

• Start date: 2025-08-26
• Primary completion: 2027-09-01
• Completion: 2027-09-01
• First posted: 2025-09-04
• Last updated: 2026-03-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study