What this study is
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.
What's being tested
- GTT@Home
Intervention · DIAGNOSTIC TEST
self-administered fingerstick based glucose tolerance test
Study details
- Sponsor
- Yale University
- Conditions
- Type 1 Diabetes
- Enrolling
- 60 people
- Starts
- 2025-08-26
- Est. completion
- 2027-09
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 8 Years – 45 YearsSex ALLHealthy volunteers Not acceptedYou 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 can't join if
- Currently pregnant or becomes pregnant during the study
- Participants on sodium glucose cotransporter inhibitors (SGLTi).
- Donated blood in the past 8 weeks.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openYale University Pediatric and Adult Diabetes Clinic
New Haven, Connecticut, United States
Recruiting
Study team
Sponsor
Yale University
Study ID 2000040441
Principal investigator
Alfonso Galderisi, MD
Yale University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.