NCT07059806

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
17mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress33%
Sep 2025Nov 2027

First Submitted

Initial submission to the registry

July 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.7 years

First QC Date

July 1, 2025

Last Update Submit

January 8, 2026

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Number of participants with resolution of health-related social needs

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

    6 months

Secondary Outcomes (5)

  • Mean score Diabetes Distress Scale (T1-DDS)

    6 months

  • Mean score Illness intrusiveness rating scale (IIRS)

    6 months

  • Mean score DAWN Impact of Diabetes Profile (DIDP) scale

    6 months

  • Mean score Patient satisfaction survey

    6 Months

  • Change in HbA1c

    6 months

Study Arms (2)

T1CARE

EXPERIMENTAL

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.

Behavioral: T1CARE

Standard Care

NO INTERVENTION

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

Interventions

T1CAREBEHAVIORAL

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.

T1CARE

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Type 1 Diabetes
  • fluent in Spanish or English who reside in the greater New Haven area

You may not qualify if:

  • cognitive impairment and otherwise unable to give written informed consent about participating in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yale Adult Diabetes Center

New Haven, Connecticut, 06520, United States

RECRUITING

Yale Children's Diabetes Center

New Haven, Connecticut, 06520, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kasia Lipska, MD, MHS

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kasia J Lipska, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will complete a standardized Social Determinants of Health (SDOH) screening.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2025

First Posted

July 11, 2025

Study Start

September 5, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share

Metadata associated with the datasets will be submitted to the NIDDK repository or Vivli.

Time Frame
Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at time of publication. All other data generated will be shared no later than the end of the award. Study data will be stored for 10 years (this is Vivli's policy).
Access Criteria
* Health/Medical/Biomedical - The dataset can only be used for studying health, medical, or biomedical conditions and does not include the study of population origins or ancestry. * IRB Approval Required (IRB) - The requesting institution's IRB or equivalent body must approve the requested use.

Locations

US(2)