Home fingerstick oral glucose tolerance test for people at risk for or newly diagnosed with Type 1 diabetes
Home-based Oral Glucose Tolerance Test for Type 1 Diabetes Screening
This project tries a self‑administered fingerstick oral glucose tolerance test at home to see if it gives similar results to the standard in‑clinic venous test for people at risk for or newly diagnosed with Type 1 diabetes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 8 Years to 45 Years |
| Sex | All |
| Sponsor | Yale University Academic / other |
| Locations | 1 site (New Haven, Connecticut) |
| Trial ID | NCT07155252 on ClinicalTrials.gov |
What this trial studies
This observational longitudinal study compares a self‑administered fingerstick GTT@Home to the gold‑standard in‑clinic venous plasma OGTT across a wide range of blood glucose values. Each participant will complete one unsupervised home GTT, one standard supervised OGTT at the Yale research clinic, and one supervised GTT@Home, with up to 10 days of blinded continuous glucose monitoring (CGM) collected. The study enrolls people who carry at least one islet autoantibody or who have Stage 3 Type 1 diabetes diagnosed within the prior 100 days, and includes safety and eligibility screening. Data will quantify the accuracy and concordance between home fingerstick values and clinic venous plasma measurements.
Who should consider this trial
Good fit: Ideal candidates are people aged at least 12 years who weigh at least 43 kg and either carry at least one islet autoantibody or were diagnosed with Stage 3 Type 1 diabetes within the prior 100 days, are in generally good health, and can give consent and understand English.
Not a fit: People who are pregnant, taking SGLT inhibitors, who recently donated blood, who have uncontrolled chronic illnesses, or who are under the age/weight limits are unlikely to benefit from participating.
Why it matters
Potential benefit: If accurate, a validated home fingerstick GTT could allow easier, more convenient screening and monitoring outside the clinic, reducing travel and burden for patients.
How similar studies have performed: While home glucose monitoring and CGM are well established for remote glucose tracking, using a fingerstick‑based home OGTT compared directly to venous plasma OGTT is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New Haven, Connecticut
- Yale University Pediatric and Adult Diabetes Clinic — New Haven, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer Sherr, MD — Yale University
- Study coordinator: Marcia DeSousa, BA
- Email: marcia.desousa@yale.edu
- Phone: 203-737-4805
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.