T1CARE: A program to address social needs for young adults with Type 1 diabetes
Official title: T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
Run by Yale University · NCT07059806 · Data updated 2026-11-12
This program will see if giving young adults with Type 1 diabetes support from a Community Health Navigator helps resolve social needs and improve diabetes-related well-being and care.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | All |
| Enrollment | 114 (estimated) |
| Sponsor | Yale University Academic / other |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Status | Recruiting |
| Started | September 5, 2025 |
| Main results expected | September 30, 2027 |
| Study ends | November 2027 |
| Registry record updated | October 26, 2026 |
| Trial ID | NCT07059806 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People with Type 1 diabetes who live in the greater New Haven area and speak English or Spanish are ideal candidates for this program.
✕Probably not a fit
People who live outside the New Haven area, cannot communicate in English or Spanish, or who have cognitive impairment that prevents informed consent are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized controlled trial with a 1:1 allocation to the T1CARE intervention or a wait-list usual care arm, recruiting from Yale Adult and Pediatric Diabetes Centers. Participants assigned to T1CARE receive individualized support from a Community Health Navigator through Project Access-New Haven to address health-related social needs. The primary outcome is resolution of those social needs, with secondary measures of feasibility, acceptability, patient-reported outcomes (including diabetes distress, illness intrusiveness, and quality of life), and preliminary effects on HbA1c. The design includes a wait-list control so usual-care participants can later access the intervention.
Why it matters
Potential benefit: If successful, T1CARE could reduce unmet social needs and improve diabetes-related distress and clinical outcomes for young adults with Type 1 diabetes.
How similar studies have gone: Similar programs using community health workers or navigators have improved access to services and patient-reported outcomes in other populations, though effects on glycemic control have been variable.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Type 1 Diabetes * fluent in Spanish or English who reside in the greater New Haven area Exclusion Criteria: * cognitive impairment and otherwise unable to give written informed consent about participating in this study
Where it's running
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Yale Adult Diabetes Center
New Haven, Connecticut, United States Recruiting -
Yale Children's Diabetes Center
New Haven, Connecticut, United States Recruiting
Study contacts
- Principal investigator: Kasia Lipska, MD, MHS — Yale University
- Study coordinator: Kasia J Lipska, MD
- Email: Kasia.lipska@yale.edu
- Phone: 203-500-3053
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.