Home fingerstick oral glucose tolerance test for people at risk for or newly diagnosed with Type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational longitudinal study compares a self‑administered fingerstick GTT@Home to the gold‑standard in‑clinic venous plasma OGTT across a wide range of blood glucose values. Each participant will complete one unsupervised home GTT, one standard supervised OGTT at the Yale research clinic, and one supervised GTT@Home, with up to 10 days of blinded continuous glucose monitoring (CGM) collected. The study enrolls people who carry at least one islet autoantibody or who have Stage 3 Type 1 diabetes diagnosed within the prior 100 days, and includes safety and eligibility screening. Data will quantify the accuracy and concordance between home fingerstick values and clinic venous plasma measurements.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale University Pediatric and Adult Diabetes Clinic
  New Haven, Connecticut, United States Recruiting

Study contacts

• Principal investigator: Jennifer Sherr, MD — Yale University
• Study coordinator: Marcia DeSousa, BA
• Email: marcia.desousa@yale.edu
• Phone: 203-737-4805

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.