Recruiting

GTT@Home

Sponsor:

Yale University

Code:

NCT07155252

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 8 - 45

Healthy Volunteers: Not accepted

Interventions

GTT@Home

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Study ID

NCT07155252

Start date

Aug 26, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 45

Healthy Volunteers: Not accepted

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:

  • Currently pregnant or becomes pregnant during the study
  • Participants on sodium glucose cotransporter inhibitors (SGLTi).
  • Donated blood in the past 8 weeks.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Single islet autoantibody

Participants with single islet autoantibody

2 or more positive islet antibodies

Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia

Recently diagnosed with diabetes

Participants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis

Interventions

GTT@Home

self-administered fingerstick based glucose tolerance test

Primary outcome measure

  • Accuracy of GTT@Home [ Time Frame: up to 4 weeks from enrollment ]

Central Contacts and Locations

Central contacts

Marcia DeSousa, BA

203-737-4805marcia.desousa@yale.edu

Locations

Yale University Pediatric and Adult Diabetes Clinic

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Yale University on 2026-03-06.