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NCT Number: NCT07059806

T1CARE: A Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Adult Diabetes Center, New Haven, Connecticut, United States

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About this study

Primary Objective To determine whether the T1CARE intervention improves resolution of health-related social needs compared to usual care.

Secondary Objectives

  • To assess the feasibility and acceptability of the T1CARE intervention.
  • To evaluate the impact of T1CARE on patient-reported outcomes, including diabetes distress, illness intrusiveness, and quality of life.
  • To examine preliminary effects on clinical outcomes, particularly changes in HbA1c.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

T1CARE

Behavioral

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 outcomes

  1. Number of participants with resolution of health-related social needs

    Time frame: 6 months

    Resolution of health-related social needs, assessed via adapted Accountable Health Communities (AHC) Model screening questions. Yes/No for resolution.

Secondary outcomes

  1. Mean score Diabetes Distress Scale (T1-DDS)

    Time frame: 6 months

    The T1-DDS is a 28-item self-report instrument. Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." Total score range 1-6 with higher scores indicating more distress. Investigators will analyze between-group change of the within-group change.

  2. Mean score Illness intrusiveness rating scale (IIRS)

    Time frame: 6 months

    IIRS comprised of 13 items that ask patients to rate the degree to which their "illness and/or its treatment" interfere with life domains central to quality of life. Total score range 13 to 91, with higher scores indicating greater illness intrusiveness. Investigators will analyze between-group change of the within-group change.

  3. Mean score DAWN Impact of Diabetes Profile (DIDP) scale

    Time frame: 6 months

    Quality of life measured by the brief (7 item) DIDP scale (DAWN Impact of Diabetes Profile). Total score range 1-7 with higher scores indicating more negative impact. Investigators will analyze between-group change of the within-group change.

  4. Mean score Patient satisfaction survey

    Time frame: 6 Months

    Patient satisfaction with the intervention will be assessed with 2 questions on a 5-point Likert scale that address whether they were satisfied and would recommend the approach used for their care (which could have been T1CARE or usual care alone) to other patients. Total score range 1-5, higher scores indicate more satisfaction.

  5. Change in HbA1c

    Time frame: 6 months

    Change in HbA1c at baseline and 6 months. Investigators will analyze between-group change of the within-group change.

Study contacts

Contact information is provided by the study sponsor or research team.

Kasia J Lipska, MD

CONTACT

[email protected]

203-500-3053

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

T1CARE: A Randomized Trial of a Novel Intervention to Address Social Determinants of Health in Young Adults With Type 1 Diabetes

Acronym: T1CARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 11, 2025
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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