Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GTT@Home.
- Who it may be relevant to
- Registry conditions: Type 1 Diabetes. Basic parameters: 8 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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. Additionally, participants will have up to10-day blinded-CGM data collected.
Interventions
- Diagnostic test GTT@Home
self-administered fingerstick based glucose tolerance test
Primary outcome measures
- Accuracy of GTT@Home [Time frame: up to 4 weeks from enrollment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Yale University Pediatric and Adult Diabetes Clinic — New Haven
Identifiers
NCT: NCT07155252 · 2000040441