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Completed

NCT Number: NCT05097534

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

13 year–84 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Vincent House Clinic

Galveston, Texas, 77550, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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

Treatment and study plan

iDSMES

Other

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

Standard of care

Other

Standard of Care for patients with type 2 diabetes

Primary outcomes

  1. Change from baseline HbA1c

    Time frame: at 6 months

    measurement of hemoglobin A1c (HbA1c %)

  2. Change from baseline HbA1c

    Time frame: at 12 months

    measurement of hemoglobin A1c (HbA1c %)

Secondary outcomes

  1. Change from baseline weight

    Time frame: at 6 months

    measurement of body weight in Kg

  2. Change from baseline weight

    Time frame: at 12 months

    measurement of body weight in Kg

  3. Change from baseline blood pressure

    Time frame: at 6 months

    measurement of systolic and diastolic blood pressure in mm Hg

  4. Change from baseline blood pressure

    Time frame: at 12 months

    measurement of systolic and diastolic blood pressure in mm Hg

  5. Change from baseline lipid profile

    Time frame: at 6 months

    measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL

  6. Change from baseline lipid profile

    Time frame: at 12 months

    measurement of lipid profile: Total Cholesterol, Triglycerides, High-Density Lipoprotein, and Low-Density Lipoprotein in mg/dL

  7. Change from baseline frequency of provider encounter

    Time frame: at 6 months

    Frequency of provider encounter

  8. Change from baseline frequency of provider encounter

    Time frame: at 12 months

    Frequency of provider encounter

  9. Change from baseline frequency of feet examination for neuropathy

    Time frame: at 6 months

    Frequency of feet examination for neuropathy

  10. Change from baseline frequency of feet examination for neuropathy

    Time frame: at 12 months

    Frequency of feet examination for neuropathy

  11. Change from baseline frequency of urine exam for microalbuminuria

    Time frame: at 6 months

    Frequency of urine exam for microalbuminuria

  12. Change from baseline frequency of urine exam for microalbuminuria

    Time frame: at 12 months

    Frequency of urine exam for microalbuminuria

  13. Change from baseline frequency of oral health checkup

    Time frame: at 6 months

    Frequency of oral health checkup

  14. Change from baseline frequency of oral health checkup

    Time frame: at 12 months

    Frequency of oral health checkup

  15. Change from baseline frequency of eye fundus examination

    Time frame: at 6 months

    Frequency of eye fundus examination

  16. Change from baseline frequency of eye fundus examination

    Time frame: at 12 months

    Frequency of eye fundus examination

  17. Change from baseline frequency of emergency care visits for treatment of T2-related issues

    Time frame: at 6 months

    Frequency of emergency care visits for treatment of T2-related issues

  18. Change from baseline frequency of emergency care visits for treatment of T2-related issues

    Time frame: at 12 months

    Frequency of emergency care visits for treatment of T2-related issues

  19. Change from baseline frequency of hospitalizations and re-admissions

    Time frame: at 6 months

    Frequency of hospitalizations and re-admissions

  20. Change from baseline frequency of hospitalizations and re-admissions

    Time frame: at 12 months

    Frequency of hospitalizations and re-admissions

  21. Participation in iDSMES classes (for those in the intervention arm only)

    Time frame: at 12 months

    Participation in iDSMES classes (total number of sessions attended)

  22. Lifestyle change outcomes (for those in the intervention arm only)

    Time frame: every session through study completion, an average of 1 year

    Physical activity minutes in the last week prior to session

  23. Change from baseline patient-centeredness

    Time frame: at 6 months

    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".

  24. Change from baseline patient-centeredness

    Time frame: at 12 months

    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".

  25. Change from baseline secondary diabetes self-management behaviors

    Time frame: at 6 months

    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.

  26. Change from baseline secondary diabetes self-management behaviors

    Time frame: at 12 months

    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.

  27. Change from baseline self-efficacy in managing diabetes

    Time frame: at 6 months

    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).

  28. Change from baseline self-efficacy in managing diabetes

    Time frame: at 12 months

    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).

  29. Change from baseline diabetes distress

    Time frame: at 6 months

    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".

  30. Change from baseline diabetes distress

    Time frame: at 12 months

    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".

  31. Change from baseline medication Adherence

    Time frame: at 6 months

    "Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.

  32. Change from baseline medication Adherence

    Time frame: at 12 months

    "Morisky Green Levine" Medication Adherence Scale: a four-item tool queries about forgetfulness, carelessness, and feelings around taking medications, scored from 0 to 4.

Sponsors and collaborators

Lead sponsor

The University of Texas Medical Branch, Galveston

Other

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 28, 2021
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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