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

NCT ID: NCT07155252

Last Updated: 2025-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-26

Study Completion Date

2027-09-30

Brief Summary

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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

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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

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Type 1 Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single islet autoantibody

Participants with single islet autoantibody

GTT@Home

Intervention Type DIAGNOSTIC_TEST

self-administered fingerstick based glucose tolerance test

2 or more positive islet antibodies

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

GTT@Home

Intervention Type DIAGNOSTIC_TEST

self-administered fingerstick based glucose tolerance test

Recently diagnosed with diabetes

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

GTT@Home

Intervention Type DIAGNOSTIC_TEST

self-administered fingerstick based glucose tolerance test

Interventions

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GTT@Home

self-administered fingerstick based glucose tolerance test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Breakthrough T1D

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alfonso Galderisi, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University Pediatric and Adult Diabetes Clinic

New Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Marcia DeSousa, BA

Role: CONTACT

203-737-4805

Other Identifiers

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2000040441

Identifier Type: -

Identifier Source: org_study_id

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