Improving Diabetes Care with THRIVE-DM and Community Partnerships

This study is looking at ways to improve care for people with uncontrolled type 2 diabetes (T2DM). It tests two approaches: "THRIVE-DM" and "Standard of care." THRIVE-DM involves connecting you with community organizations through a directory, and for some, additional support from a patient navigator. Standard of care includes support from your primary care team and referrals to community organizations if clinic staff decide it's needed. The study wants to see how well these approaches help people connect with community resources and if they lead to better blood sugar control (measured by HbA1c). You might be able to join if you are 18 or older, have type 2 diabetes, and your HbA1c is 9% or higher.

Study design
This is an interventional study planning to enroll 900 participants. It compares two different approaches to diabetes care.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 3, 6, and 12 months to see how often they connect with community organizations and for changes in their HbA1c levels.

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NCT07043426

Improving Diabetes Care With Strategies For Addressing Health-Related Social Needs and Community Partnerships

Recruiting
NAAges 18+InterventionalHealth services
Boston Medical Center
~900 participants
Updated 2025-12-30 on ClinicalTrials.gov
What's tested:THRIVE-DMStandard of care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants that connect to Community-Based Organizations
Measured over 3 months, 6 months, 3 months post intervention
+2 more outcomes measured
Diabetes Mellitus, Type 2
1 sites across 1 states
Massachusetts1
  • Michael Fischer, MD · PRINCIPAL_INVESTIGATOR · Boston Medical Center, Internal Medicine

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Eligibility criteria

Inclusion

Diagnosis: Must have a diagnosis of Type 2 Diabetes Mellitus (T2DM), confirmed by a current diagnosis in the medical record or at least two billing codes in the last two years, or an HbA1c level ≥6.5% in the last two years.
Uncontrolled T2DM: Must have an HbA1c ≥9% at the time of screening.
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.

Exclusion

Patients enrolled in Complex Care Management (CCM).
Patients receiving hospice care.
Patients who are deceased
Patients with Type 1 Diabetes Mellitus (T1DM).
  • Number of participants that connect to Community-Based Organizations3 months, 6 months, 3 months post intervention

    Connection to Community-Based Organizations will be assessed through several sources and documented in REDCap

  • Number of participants that are helped by Community-Based Organizations3 months, 6 months, 12 months post intervention

    Data will be collected from participant interviews

  • Changes in HbA1c3 months, 6 months, 12 months post intervention

    HbA1c data will be extracted from the EPIC electronic health record (EHR).