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

Completed · Not applicable

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID: NCT05097534
Run by: The University of Texas Medical Branch, Galveston
People needed: 98
Starts: 2021-12-07
Expected to finish: 2025-10-31
Last updated by the study team: 2026-01-15

Who can join

Age: 13 and older, up to 84. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients aged 13-84, and
Patients diagnosed with type 2 diabetes, and
Patients have a BMI equal to or >25 (23, if Asians), and
Hemoglobin A1c value equal to or >7%

You may not qualify if…

Ages <13 or >84
Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.
Previous diagnosis of type 1 diabetes
Inability to participate for 12-month duration (e.g., Disorders that might compromise survival, planning to relocate outside the geographical coverage of University of Texas Medical Branch (UTMB) clinics
Other medical condition or medication administration deemed exclusionary by the study investigators
Prisoners

Where it is running

St. Vincent House Clinic — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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