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

NCT07155252 | Recruiting FDA Device

• 1 other identifier: 2000040441
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Accuracy of GTT@Home

  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.

  up to 4 weeks from enrollment

Study Arms (3)

Single islet autoantibody

Participants with single islet autoantibody

Diagnostic Test: GTT@Home

2 or more positive islet antibodies

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

Diagnostic Test: GTT@Home

Recently diagnosed with diabetes

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

Diagnostic Test: GTT@Home

Interventions

GTT@Home DIAGNOSTIC_TEST

self-administered fingerstick based glucose tolerance test

2 or more positive islet antibodies; Recently diagnosed with diabetes; Single islet autoantibody

Eligibility Criteria

• Age: 8 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

A total of 60 participants will be enrolled at the Yale University Pediatric and Adult Diabetes Clinic (New Haven, CT). To ensure there is wide variation in glucose ranges with glucose tolerance testing a total of 3 cohorts will be recruited.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• Breakthrough T1D: collaborator

Study Sites (1)

Yale University Pediatric and Adult Diabetes Clinic

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jennifer Sherr, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcia DeSousa, BA

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 4, 2025
• Study Start: August 26, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)