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

This study is looking at a new way to screen for Type 1 Diabetes (T1D) called GTT@Home. This is a self-administered fingerstick test that you can do at home. Researchers want to see how accurate GTT@Home is compared to the standard in-clinic test. You might be able to join if you are between 8 and 45 years old, weigh at least 43 kg, and have at least one islet autoantibody (a marker in your blood that shows you're at risk for T1D). If you've been diagnosed with Stage 3 T1D within the last 100 days and are at least 12 years old, you may also be eligible. The main goal is to understand how well GTT@Home works. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 60 participants. It will involve comparing a home-based test with a standard clinic test.
What's involved
You will complete one unsupervised GTT@Home test, a standard OGTT (oral glucose tolerance test) at a research facility, and a supervised GTT@Home. You will also have up to 10 days of blinded-CGM (continuous glucose monitoring) data collected.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, accuracy of GTT@Home, will be measured up to 4 weeks from enrollment.

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NCT07155252

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

Recruiting
Not specifiedAges 8–45Observational
Yale University
~60 participants
Updated 2026-03-06 on ClinicalTrials.gov
What's tested:GTT@Home

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of GTT@Home
Measured over up to 4 weeks from enrollment
Type 1 Diabetes
1 sites across 1 states
Connecticut1
  • Jennifer Sherr, MD · PRINCIPAL_INVESTIGATOR · Yale University

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Eligibility criteria

Inclusion

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

Currently pregnant or becomes pregnant during the study
Participants on sodium glucose cotransporter inhibitors (SGLTi).
Donated blood in the past 8 weeks.
  • Accuracy of GTT@Homeup to 4 weeks from enrollment

    The accuracy will be quantified by correlation between GTT@Home and OGTT glucose measures as well as by the mean absolute relative difference between the two measures.