T1CARE for Type 1 Diabetes

(T1CARE Trial)

Recruiting at 1 trial location

Overseen By Kasia J Lipska, MD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Parallel-arm 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.

Who Is on the Research Team?

Kasia Lipska, MD, MHS

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for young adults with Type 1 Diabetes who speak Spanish or English and live in the greater New Haven area. They must have at least one health-related social need. People with cognitive impairments or those unable to consent to participate are not eligible.

Inclusion Criteria

I speak Spanish or English and live in the greater New Haven area.

I have been diagnosed with Type 1 Diabetes.

Report at least 1 health-related social need on a screening questionnaire

Exclusion Criteria

I am able to understand and consent to participate in this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the T1CARE intervention or standard care for 6 months

6 months

Initial in-person intake interview, followed by ongoing support

Follow-up

Participants are monitored for resolution of health-related social needs and changes in clinical outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• T1CARE

Trial Overview The T1CARE program is being tested, where participants receive support from a Community Health Navigator. It's a randomized controlled trial comparing T1CARE against usual care on a wait list, assigning participants equally to both groups.

How Is the Trial Designed?

Group I: T1CARE Experimental Treatment 1 Intervention

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.

Group II: Standard Care Active Control 1 Intervention

Participants in the control group will receive standard diabetes care at their respective clinics.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+