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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 8 Years and 45 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Single islet autoantibody Participants with single islet autoantibody
  • Diagnostic Test: GTT@Home
    self-administered fingerstick based glucose tolerance test
2 or more positive islet antibodies Participants with 2 or more positive islet antibodies who are in (Stage 1) or (Stage 2) without dysglycemia
  • Diagnostic Test: GTT@Home
    self-administered fingerstick based glucose tolerance test
Recently diagnosed with diabetes Participants meeting the diagnostic criteria for diabetes (stage 3 T1D) within 100 days from the diagnosis
  • Diagnostic Test: GTT@Home
    self-administered fingerstick based glucose tolerance test

Recruiting Locations

Yale University Pediatric and Adult Diabetes Clinic
New Haven, Connecticut 06520

More Details

Status
Recruiting
Sponsor
Yale University

Study Contact

Marcia DeSousa, BA
203-737-4805
marcia.desousa@yale.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.