Recruiting

T1CARE

Sponsor:

Yale University

Code:

NCT07059806

Conditions

Type 1 Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Interventions

T1CARE

Study Details

Brief 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.

Conditions

Type 1 Diabetes

Study ID

NCT07059806

Start date

Sep 5, 2025

Status verified date

Jan, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: T1CARE

Patients who are randomized to the intervention arm will be contacted by the Community Health Navigator (CHN) from Project Access-New Haven (PA-NH) (PA-NH). The CHN will conduct an in-depth in-person intake interview to understand the patient's social and clinical need. Additional assessment will include access to insulin, diabetes technologies, and other supplies. The intake will be the basis for a personalized intervention that will respond to patient's unique needs. The initial interview will be audio-recorded to allow for qualitative data analysis. Outcomes will be measured at 6 months. Participants in the T1CARE group will have an option to join a social media platform in addition to receiving individualized support from the CHN.

no intervention: Standard Care

Participants in the control group will be receive standard screening for SDOH and standard diabetes care at their respective clinics.

Interventions

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.

Primary outcome measure

  • Number of participants with resolution of health-related social needs [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kasia J Lipska, MD

203-500-3053Kasia.lipska@yale.edu

Locations

Yale Adult Diabetes Center

Recruiting

New Haven, Connecticut, United States, 06520

Yale Children's Diabetes Center

Recruiting

New Haven, Connecticut, United States, 06520

More Information

Sponsor

Yale University

Last update posted

Jan 12, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Yale University on 2026-01-12. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.