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

NCT05097534 | Completed

• 1 other identifier: 21-0194
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change from baseline HbA1c

  measurement of hemoglobin A1c (HbA1c %)

  at 6 months

• Change from baseline HbA1c

  measurement of hemoglobin A1c (HbA1c %)

  at 12 months

Secondary Outcomes (32)

• Change from baseline weight

  at 6 months

• Change from baseline weight

  at 12 months

• Change from baseline blood pressure

  at 6 months

• Change from baseline blood pressure

  at 12 months

• Change from baseline lipid profile

  at 6 months

Study Arms (2)

iDSMES

ACTIVE COMPARATOR

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.

Other: iDSMES

Standard of Care

PLACEBO COMPARATOR

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

Other: Standard of Care

Interventions

iDSMES OTHER

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

iDSMES

Standard of Care OTHER

Standard of Care for patients with type 2 diabetes

Standard of Care

Eligibility Criteria

• Age: 13 Years - 84 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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
• Prisoners

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

St. Vincent House Clinic

Galveston, Texas, 77550, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 28, 2021
• Study Start: December 7, 2021
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)