RECRUITING

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

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Conditions

Type 1 Diabetes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-26
Study Completion:2027-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07155252

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 45 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Body weight ≥43 kg
  2. * Presence of at least one islet autoantibody and/or≥ diagnosis of clinical T1D within 100 days.
  3. * Documentation of the presence at least 1 islet autoantibody
  4. * 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.
  5. * 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,
  6. * Ability to give consent/assent
  7. * Able to understand written and spoken English
  1. * Currently pregnant or becomes pregnant during the study
  2. * Participants on sodium glucose cotransporter inhibitors (SGLTi).
  3. * Donated blood in the past 8 weeks.

Contacts and Locations

Study Contact

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

Principal Investigator

Alfonso Galderisi, MD
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Yale University

  • Alfonso Galderisi, MD, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-26
Study Completion Date2027-09

Study Record Updates

Study Start Date2025-08-26
Study Completion Date2027-09

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes