Status:
RECRUITING
Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
Lead Sponsor:
Yale University
Collaborating Sponsors:
Breakthrough T1D
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
8-45 years
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 glu...
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. Additional...
Eligibility Criteria
Inclusion
- 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
- Currently pregnant or becomes pregnant during the study
- Participants on sodium glucose cotransporter inhibitors (SGLTi).
- Donated blood in the past 8 weeks.
Key Trial Info
Start Date :
August 26 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07155252
Start Date
August 26 2025
End Date
September 1 2027
Last Update
September 4 2025
Active Locations (1)
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1
Yale University Pediatric and Adult Diabetes Clinic
New Haven, Connecticut, United States, 06520