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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07155252

Enrollment

Registered

2025-09-04

Start date

2025-08-26

Completion date

2027-09-01

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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.

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.

Interventions

DIAGNOSTIC_TESTGTT@Home

self-administered fingerstick based glucose tolerance test

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 45 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of GTT@Home	up 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.

Countries

United States

Contacts

CONTACTMarcia DeSousa, BA

marcia.desousa@yale.edu203-737-4805

PRINCIPAL_INVESTIGATORJennifer Sherr, MD

Yale University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026