NCT07059806

T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes

T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	T1CARE	The intervention includes navigation by a Community Health Navigator (CHN), who will assess and help address patients' SDOH-related needs, coordinate care, and provide social support.

Timeline

• Start date: 2025-09-05
• Primary completion: 2027-06-01
• Completion: 2027-11-01
• First posted: 2025-07-11
• Last updated: 2026-01-12

Locations

2 sites across 1 country: United States