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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Yale University Pediatric and Adult Diabetes Clinic
RECRUITING
New Haven
Contact Information
Primary
Marcia DeSousa, BA
marcia.desousa@yale.edu
203-737-4805
Time Frame
Start Date: 2025-08-26
Estimated Completion Date: 2027-09
Participants
Target number of participants: 60
Treatments
Single islet autoantibody
Participants with single islet autoantibody
2 or more positive islet antibodies
Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia
Recently diagnosed with diabetes
Participants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis
Related Therapeutic Areas
Sponsors
Leads: Yale University
Collaborators: Breakthrough T1D

This content was sourced from clinicaltrials.gov