Clinical trial Recruiting at 2 sites Interventional Ages 18 to 40

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.

More Type 1 Diabetes trials

Quick facts

Study typeInterventional
Ages18 Years to 40 Years
SexAll
Enrollment114 (estimated)
SponsorYale University
Academic / other
Locations2 sites (New Haven, Connecticut and 1 other locations)
StatusRecruiting
StartedSeptember 5, 2025
Main results expectedSeptember 30, 2027
Study endsNovember 2027
Registry record updatedOctober 26, 2026
Trial IDNCT07059806 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

  • Yale Adult Diabetes Center
    New Haven, Connecticut, United States
    Recruiting
  • Yale Children's Diabetes Center
    New Haven, Connecticut, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.