T1CARE: A program to address social needs for 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
NA · Yale University · NCT07059806
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Yale University (other) |
| Locations | 2 sites (New Haven, Connecticut and 1 other locations) |
| Trial ID | NCT07059806 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New Haven, Connecticut and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 1 Diabetes