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T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
Randomized controlled trial with a wait list control arm. Participants will be randomized 1:1 to T1CARE or wait list usual care arm. Participants will be recruited from the Yale Adult and Pediatric Diabetes Centers. Patients assigned to T1CARE will receive support from a Community Health Navigator at Project Access-New Haven.
Primary Objective To determine whether the T1CARE intervention improves resolution of health-related social needs compared to usual care. Secondary Objectives 1. To assess the feasibility and acceptability of the T1CARE intervention. 2. To evaluate the impact of T1CARE on patient-reported outcomes, including diabetes distress, illness intrusiveness, and quality of life. 3. To examine preliminary effects on clinical outcomes, particularly changes in HbA1c.
Age
18 - 40 years
Sex
ALL
Healthy Volunteers
No
Yale Adult Diabetes Center
New Haven, Connecticut, United States
Yale Children's Diabetes Center
New Haven, Connecticut, United States
Start Date
September 5, 2025
Primary Completion Date
June 1, 2027
Completion Date
November 1, 2027
Last Updated
January 12, 2026
100
ESTIMATED participants
T1CARE
BEHAVIORAL
Lead Sponsor
Yale University
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07455994