T1CARE for Type 1 Diabetes

(T1CARE Trial)

Not yet recruiting at 1 trial location
KJ
Overseen ByKasia J Lipska, MD
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Yale University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve care for people with Type 1 Diabetes by testing a new approach called T1CARE. Participants receiving T1CARE will work with a Community Health Navigator to tailor support based on individual needs, including access to insulin and other diabetes supplies. The trial seeks to determine if this personalized support better meets patients' needs compared to standard diabetes care. People with Type 1 Diabetes who have at least one social need affecting their health and live in the greater New Haven area might be a good fit for this trial. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative diabetes care solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to ask the trial coordinators for more details.

Is there any evidence suggesting that T1CARE is likely to be safe?

Research is examining the effectiveness and safety of T1CARE for people with Type 1 Diabetes. While detailed safety information is not yet available, T1CARE includes a Community Health Navigator who assists patients in managing their diabetes. This approach emphasizes support over medication, typically resulting in fewer side effects.

The study aims to enhance diabetes management, potentially improving health without introducing new medical risks. No negative effects have been reported from this type of support, suggesting it is safe. However, participants should communicate any concerns to their study team.12345

Why are researchers excited about this trial?

Researchers are excited about T1CARE for type 1 diabetes because it offers a personalized approach, unlike the standard treatments that primarily focus on insulin management. T1CARE involves a comprehensive intake interview to identify each patient's unique social and clinical needs, which is then used to tailor a specific intervention plan. This method could potentially address broader challenges, such as access to diabetes technologies and supplies, which are not typically covered by standard care. By addressing these personalized needs, T1CARE aims to improve overall diabetes management and quality of life for patients.

What evidence suggests that T1CARE might be an effective treatment for Type 1 Diabetes?

Research shows that T1CARE, which participants in this trial may receive, might assist people with type 1 diabetes by offering personalized support tailored to their needs. Similar studies have shown that programs addressing both social and medical needs can improve health, such as lowering HbA1c levels, a measure of blood sugar control. By providing a customized plan and support from a health guide, patients may manage their diabetes more effectively and enhance their overall health. Early results suggest that T1CARE could be effective in managing diabetes, but more data is needed to confirm these benefits.12345

Who Is on the Research Team?

KL

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: T1CAREExperimental Treatment1 Intervention
Group II: Standard CareActive Control1 Intervention

Find a Clinic Near You

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+

Citations

T1CARE: A Trial of a Novel Intervention to Address Social ...To examine preliminary effects on clinical outcomes, particularly changes in HbA1c. Official Title. T1CARE: A Randomized Trial of a Novel ...
lipska, kasia joannaAim 2: Estimate preliminary signals of the efficacy of T1CARE vs. usual care for the following outcomes at 6 months post intervention: (2.1) resolution of ...
T1CARE for Type 1 Diabetes · Info for ParticipantsThe T1CARE medical study, being run by Yale University, needs participants to evaluate whether T1CARE will have tolerable side effects & efficacy for ...
T1CARE: A Trial of a Novel Intervention to Address Social ...Outcomes will be measured at 6 months. Description: Participants in the control group will receive standard diabetes care at their respective ...
Positive Psychology to Promote Adherence in Adolescents ...The proposed study has the potential to improve adherence to the diabetes regimen in adolescents with type 1 diabetes without compromising their quality of life ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security