THRIVE-DM for Type 2 Diabetes

(THRIVE-DM Trial)

Overseen By Uma Khemraj, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Disqualifiers: Complex care management, Hospice, T1DM, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new care model for people with uncontrolled type 2 diabetes and unmet social needs. The goal is to determine if a special tool within a digital health record, combined with support from community health workers, can better connect patients with community services and improve their health. Participants will either receive this enhanced care (THRIVE-DM) or continue with their usual treatment to compare outcomes. It suits individuals with type 2 diabetes who have high blood sugar levels (HbA1c ≥9%) and identified social needs, such as access to food or housing. As an unphased trial, this study offers a unique opportunity to potentially improve health and access to community resources.

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 discuss this with the trial coordinators or your doctor.

What prior data suggests that this triage and referral model is safe for patients with type 2 diabetes?

Research has shown that THRIVE-DM is a safe and easy-to-use method for managing type 2 diabetes. The study does not involve a new drug or any invasive treatment. Instead, it aims to improve healthcare access and support through community health workers and data tools. This approach typically carries low risks because it builds on existing healthcare practices.

The available information does not mention serious side effects. The focus is on helping patients connect with community resources to better manage their diabetes. This suggests that any potential risks are likely minimal and relate more to program implementation. In terms of safety, THRIVE-DM appears well-tolerated since it enhances care rather than introducing new medical procedures or medications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for type 2 diabetes, which typically involves medications like metformin and insulin to control blood sugar levels, THRIVE-DM introduces a personalized care approach. This treatment is unique because it employs a Community Health Worker who uses an EPIC-based triage tool to classify patients based on their health-related social needs and self-efficacy. Researchers are excited about THRIVE-DM because it targets the individual’s social and behavioral factors, potentially leading to better management of diabetes by addressing the root causes that affect a patient’s ability to manage their condition effectively.

What evidence suggests that the THRIVE-DM model is effective for improving outcomes in type 2 diabetes?

Research has shown that the THRIVE-DM model, which participants in this trial may receive, helps people with uncontrolled type 2 diabetes by connecting them to essential social services. This approach uses a tool within the electronic health record system to provide personalized care. Early findings suggest that combining medical and social support can improve health outcomes, such as lowering hemoglobin A1C levels, which measure blood sugar control. The model also simplifies access to community resources, potentially leading to better overall health. Early studies have demonstrated that similar programs can increase access to social services and improve health outcomes.

Who Is on the Research Team?

Michael Fischer, MD

Principal Investigator

Boston Medical Center, Internal Medicine

Are You a Good Fit for This Trial?

This trial is for individuals with uncontrolled type 2 diabetes who also have unmet health-related social needs. Participants should be patients at Boston Medical Center where the THRIVE infrastructure exists. The study excludes details on specific inclusion and exclusion criteria.

Inclusion Criteria

Health-Related Social Needs: Must have been screened for health related social needs (HRSNs) during a General Internal Medicine (GIM) visit in the last 3 months and screened positive for at least one HRSN

I have been diagnosed with Type 2 Diabetes Mellitus.

My HbA1c level is 9% or higher, indicating uncontrolled diabetes.

Exclusion Criteria

Patients enrolled in Complex Care Management (CCM)

I am currently receiving hospice care.

This criterion is not applicable to living individuals.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive care through the enhanced THRIVE-DM model, including the use of a triage tool and engagement with community health workers

12 months

Follow-up

Participants are monitored for safety and effectiveness after intervention, with data collected at 3, 6, and 12 months post intervention

12 months

What Are the Treatments Tested in This Trial?

Interventions

• THRIVE-DM

Trial Overview The study tests a new model called THRIVE-DM, which combines medical care with social support by using community health workers and referrals to community organizations, against the standard diabetes care. It aims to see if this approach helps manage diabetes better.

How Is the Trial Designed?

Group I: Intervention- THRIVE-DM Experimental Treatment 1 Intervention

Participants randomized to the intervention group will receive care through the enhanced THRIVE-DM model. A Community Health Worker (CHW) will utilize the triage tool - an EPIC based tool- an EPIC based tool that categorizes patients into Low-SS or High-SS classifications based on their HRSN complexity and self-efficacy proxies.

Group II: Control- Standard of care Active Control 1 Intervention

Participants randomized to the control group will be evaluated under an intention-to-treat framework. These participants will continue to receive routine clinical care.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. reporter.nih.gov reporter.nih.gov/search/55gLqWYLakq1awbEP_C4vQ/project-details/11167858

RePORT RePORTER - National Institutes of Health (NIH) | We will conduct a hybrid type 3 implementation-effectiveness trial to assess the feasibility and preliminary effectiveness of the THRIVE-DM intervention.

2. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-2-8-2025-996a3

THRIVE-DM for Type 2 Diabetes · Info for Participants The THRIVE-DM medical study, being run by Boston Medical Center, needs participants to evaluate whether THRIVE-DM will have tolerable side effects ...

3. reporter.nih.gov reporter.nih.gov/project-details/10972880

THRIVE-DM: Improving Diabetes Care with Strategies ... We will assess the feasibility of data collection on key person-centered clinical outcome measures to evaluate the effectiveness of this enhanced protocol ...

4. ichgcp.net ichgcp.net/clinical-trials-registry/542714-improving-diabetes-care-with-strategies-for-addressing-health-related-social-needs-and-community-partnerships

THRIVE-DM: A Better Way to Manage Type 2 Diabetes Through ... THRIVE-DM study tests a new approach combining medical care with community support to help people better manage Type 2 Diabetes, especially those facing ...

5. diabetes.org diabetes.org/newsroom/press-releases/breakthrough-studies-automated-insulin-delivery-and-cgm-type-2-diabetes

Breakthrough Studies on Automated Insulin Delivery and ... Three studies showing advancements for type 2 diabetes were presented at the American Diabetes Association's (ADA) 84th Scientific Sessions in Orlando, FL.