T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes
NCT ID: NCT07059806
Last Updated: 2026-01-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-09-05
2027-11-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Standard Care
Participants in the control group will be receive standard screening for SDOH and standard diabetes care at their respective clinics.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* fluent in Spanish or English who reside in the greater New Haven area
Exclusion Criteria
18 Years
40 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Kasia Lipska, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Adult Diabetes Center
New Haven, Connecticut, United States
Yale Children's Diabetes Center
New Haven, Connecticut, United States
Countries
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Central Contacts
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Other Identifiers
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2000040438
Identifier Type: -
Identifier Source: org_study_id
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