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

The University of Texas System (UT)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Standard of Care; Other: iDSMES

Study type: Interventional

Funder types: Other

Identifiers

NCT05097534

21-0194

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 13 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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98 participants in 2 patient groups, including a placebo group

iDSMES

Active Comparator group

Description:

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.

Treatment:

Other: iDSMES

Standard of Care

Placebo Comparator group

Description:

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

Treatment:

Other: Standard of Care