Taking people in United StatesNo phase

Home Fingerstick Glucose Test Checked Against Clinic Blood Tests

Compares a home fingerstick sugar test with clinic blood tests in people at risk.

Key facts

Who runs it: Yale University
Where: New Haven, United StatesSee the site
Trial code: NCT07155252
Registry title: Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
Status: Recruiting
People taking part: 60 people, planned
Started: 26 Aug 2025
Expected to end: Sept 2027
Type of study: Observational, 3 groups
Treatments tested: GTT@Home
Record updated: 6 March 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people at risk of type 1 diabetes (with at least one islet autoantibody) or with newly diagnosed stage 3 type 1 diabetes. It tests a fingerstick glucose tolerance test done at home.

Age: 8 to 45 years. People with stage 3 type 1 diabetes must be at least 12 years old.
Sex: All sexes can join.
Disease stage: Either at least one islet autoantibody, or clinical type 1 diabetes diagnosed within the last 100 days (stage 3).
Earlier treatment: Cannot be taking sodium glucose cotransporter inhibitors (SGLTi). Cannot have donated blood in the past 8 weeks.
Biomarker or test result: At least one islet autoantibody must be documented.

Main reasons for not taking part

Currently pregnant or becoming pregnant during the study
Taking sodium glucose cotransporter inhibitors (SGLTi)
Donated blood in the past 8 weeks
Body weight under 43 kg (95 lb)
Other acute or chronic illness that could affect safety or the study

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

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

Who cannot take part

Participants on sodium glucose cotransporter inhibitors (SGLTi)
Currently pregnant or becomes pregnant during the study
Donated blood in the past 8 weeks

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 8 and 45 years old?

Where in United States

Yale University Pediatric and Adult Diabetes ClinicNew Haven, United StatesContact: Marcia DeSousa, BATaking people

About the trial

What the trial wants to find out

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.

The 3 groups in the trial

Single islet autoantibody
Participants with single islet autoantibody
Treatment: GTT@Home
2 or more positive islet antibodies
Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia
Treatment: GTT@Home
Recently diagnosed with diabetes
Participants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis
Treatment: GTT@Home