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

Yale University

Status: Enrolling

Conditions: Type 1 Diabetes

Treatments: Diagnostic Test: GTT@Home

Study type: Observational

Funder types: Other

Identifiers

NCT07155252

2000040441

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

Single islet autoantibody

Description:

Participants with single islet autoantibody

Treatment:

Diagnostic Test: GTT@Home

2 or more positive islet antibodies

Description:

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

Treatment:

Diagnostic Test: GTT@Home

Recently diagnosed with diabetes

Description:

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

Treatment:

Diagnostic Test: GTT@Home