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A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston

NCT05097534 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2026-01-15

No results posted yet for this study

Summary

To improve diabetes self-management outcomes, patients with type 2 diabetes (n=150 - aged 13-84) recruited from St. Vincent Clinic (SVC) and Teen Health Center Inc., Clinics will be randomized using block randomization to receive standard of care or the integrated model. Patients in the intervention arm will be assessed for social and physical needs before being enrolled in a year-long education program (iDSMES). Enrollees will receive dietary counseling, physical and occupational therapy, in addition to other mental, financial and social benefits counseling. The investigators will compare the intervention outcomes.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

OTHER

iDSMES

Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health

OTHER

Standard of Care

Standard of Care for patients with type 2 diabetes

Sponsors & Collaborators

  • The University of Texas Medical Branch, Galveston

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
84 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-07
Primary Completion
2025-10-31
Completion
2025-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05097534 on ClinicalTrials.gov