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

NCT ID: NCT05097534

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-07

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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iDSMES

Eligible study subjects randomized to the intervention arm will receive:

A. Intensive Diabetes Self-Management, Education, and Support (iDSMES). Participants will be enrolled in groups in a virtual or in-person setting with their lifestyle coach, in this one-year educational program B. Services addressing Social Determinants of Health All study subjects will have their data collected at time points around baseline, 6 months and 12 months from consenting including glycemic control, hypertension management, dyslipidemia management, prevention or management of complications, healthcare outcomes, lifestyle change outcomes, patient-centeredness outcomes, Secondary diabetes self-management behaviors, self-efficacy in managing diabetes, diabetes distress, and Morisky Green Levine Medication Adherence Scale.

Group Type ACTIVE_COMPARATOR

iDSMES

Intervention Type OTHER

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

Standard of Care

Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.

Group Type PLACEBO_COMPARATOR

Standard of Care

Intervention Type OTHER

Standard of Care for patients with type 2 diabetes

Interventions

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iDSMES

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

Intervention Type OTHER

Standard of Care

Standard of Care for patients with type 2 diabetes

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Ages \<13 or \>84
2. Pregnancy. If a subject becomes pregnant, they will advised to discontinue the study.
3. Previous diagnosis of type 1 diabetes
4. 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
5. Other medical condition or medication administration deemed exclusionary by the study investigators
6. Prisoners
Minimum Eligible Age

13 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St. Vincent House Clinic

Galveston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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21-0194

Identifier Type: -

Identifier Source: org_study_id