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NCT Number: NCT07155252

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

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.

Recruiting

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Key information

Age range

8 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University Pediatric and Adult Diabetes Clinic

New Haven, Connecticut, 06520, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GTT@Home

Diagnostic Test

self-administered fingerstick based glucose tolerance test

Primary outcomes

  1. Accuracy of GTT@Home

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Marcia DeSousa, BA

CONTACT

[email protected]

203-737-4805

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • Breakthrough T1D

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 4, 2025
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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