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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: iDSMES; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77550
      • St. Vincent House Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 84 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: iDSMES; Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health
Placebo Comparator: Standard of Care; Eligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes.	Other: Standard of Care; Standard of Care for patients with type 2 diabetes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline weight	measurement of body weight in Kg	at 6 months
Change from baseline weight	measurement of body weight in Kg	at 12 months
Change from baseline blood pressure	measurement of systolic and diastolic blood pressure in mm Hg	at 6 months
Change from baseline blood pressure	measurement of systolic and diastolic blood pressure in mm Hg	at 12 months
Change from baseline lipid profile	measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL	at 6 months
Change from baseline lipid profile	measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL	at 12 months
Change from baseline frequency of provider encounter	Frequency of provider encounter	at 6 months
Change from baseline frequency of provider encounter	Frequency of provider encounter	at 12 months
Change from baseline frequency of feet examination for neuropathy	Frequency of feet examination for neuropathy	at 6 months
Change from baseline frequency of feet examination for neuropathy	Frequency of feet examination for neuropathy	at 12 months
Change from baseline frequency of urine exam for microalbuminuria	Frequency of urine exam for microalbuminuria	at 6 months
Change from baseline frequency of urine exam for microalbuminuria	Frequency of urine exam for microalbuminuria	at 12 months
Change from baseline frequency of oral health checkup	Frequency of oral health checkup	at 6 months
Change from baseline frequency of oral health checkup	Frequency of oral health checkup	at 12 months
Change from baseline frequency of eye fundus examination	Frequency of eye fundus examination	at 6 months
Change from baseline frequency of eye fundus examination	Frequency of eye fundus examination	at 12 months
Change from baseline frequency of emergency care visits for treatment of T2-related issues	Frequency of emergency care visits for treatment of T2-related issues	at 6 months
Change from baseline frequency of emergency care visits for treatment of T2-related issues	Frequency of emergency care visits for treatment of T2-related issues	at 12 months
Change from baseline frequency of hospitalizations and re-admissions	Frequency of hospitalizations and re-admissions	at 6 months
Change from baseline frequency of hospitalizations and re-admissions	Frequency of hospitalizations and re-admissions	at 12 months
Participation in iDSMES classes (for those in the intervention arm only)	Participation in iDSMES classes (total number of sessions attended)	at 12 months
Lifestyle change outcomes (for those in the intervention arm only)	Physical activity minutes in the last week prior to session	every session through study completion, an average of 1 year
Change from baseline patient-centeredness	General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".	at 6 months
Change from baseline patient-centeredness	General self-rated Health (GSRH): a single item survey- self-administered single question such as "in general, would you say that your health is? excellent, very good, good, fair, or poor?", where excellent is scored as "5" and poor is scored as "0".	at 12 months
Change from baseline secondary diabetes self-management behaviors	fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.	at 6 months
Change from baseline secondary diabetes self-management behaviors	fifty-six-item survey. This includes a series of secondary diabetes self-management behaviors to explore mediating factors that might influence changes in glycemic control. We will assess the proportion of individuals with severe hypoglycemic episodes and use the brief modified Block seven-item diet screener with a four-week time horizon to determine the number of servings per day of fruit and vegetables.	at 12 months
Change from baseline self-efficacy in managing diabetes	This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).	at 6 months
Change from baseline self-efficacy in managing diabetes	This self-management resource center validated eight-item survey on patient confidence in performing certain activities. The survey is scored from 0 to 10 on a visual analog scale (VAS).	at 12 months
Change from baseline diabetes distress	a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".	at 6 months
Change from baseline diabetes distress	a two-item screening tool on 17 potential problems in the life of patients with diabetes. Patients are asked to score the distress ensuing from each problem during the last month from 1 to 6, where 1 is "Not a problem" and 6 is "a very serious problem".	at 12 months
Change from baseline medication Adherence	"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.	at 6 months
Change from baseline medication Adherence	"Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.	at 12 months

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2021
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): October 31, 2025

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 21-0194

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No