Diabetes Mellitus, Type 2NCT05097534
A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
A study testing iDSMES in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 84 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- iDSMES
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Dec 2021to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 84 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- iDSMES, Standard of Care
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iDSMESOther
Intensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health
Standard of CareOther
Standard of Care for patients with type 2 diabetes
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline HbA1c
measurement of hemoglobin A1c (HbA1c %)
Measured: at 6 months
Change from baseline HbA1c
measurement of hemoglobin A1c (HbA1c %)
Measured: at 12 months
Secondary outcomes (32)
Change from baseline weight
measurement of body weight in Kg
Measured: at 6 months
Change from baseline weight
measurement of body weight in Kg
Measured: at 12 months
Change from baseline blood pressure
measurement of systolic and diastolic blood pressure in mm Hg
Measured: at 6 months
Change from baseline blood pressure
measurement of systolic and diastolic blood pressure in mm Hg
Measured: 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
Measured: 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
Measured: at 12 months
Change from baseline frequency of provider encounter
Frequency of provider encounter
Measured: at 6 months
Change from baseline frequency of provider encounter
Frequency of provider encounter
Measured: at 12 months
Change from baseline frequency of feet examination for neuropathy
Frequency of feet examination for neuropathy
Measured: at 6 months
Change from baseline frequency of feet examination for neuropathy
Frequency of feet examination for neuropathy
Measured: at 12 months
Change from baseline frequency of urine exam for microalbuminuria
Frequency of urine exam for microalbuminuria
Measured: at 6 months
Change from baseline frequency of urine exam for microalbuminuria
Frequency of urine exam for microalbuminuria
Measured: at 12 months
Change from baseline frequency of oral health checkup
Frequency of oral health checkup
Measured: at 6 months
Change from baseline frequency of oral health checkup
Frequency of oral health checkup
Measured: at 12 months
Change from baseline frequency of eye fundus examination
Frequency of eye fundus examination
Measured: at 6 months
Change from baseline frequency of eye fundus examination
Frequency of eye fundus examination
Measured: 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
Measured: 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
Measured: at 12 months
Change from baseline frequency of hospitalizations and re-admissions
Frequency of hospitalizations and re-admissions
Measured: at 6 months
Change from baseline frequency of hospitalizations and re-admissions
Frequency of hospitalizations and re-admissions
Measured: at 12 months
Participation in iDSMES classes (for those in the intervention arm only)
Participation in iDSMES classes (total number of sessions attended)
Measured: at 12 months
Lifestyle change outcomes (for those in the intervention arm only)
Physical activity minutes in the last week prior to session
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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.
Measured: at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2021
- Study start7 Dec 2021
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097534
- Sponsor's protocol ID
- 21-0194
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2021
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Community Approach for Diabetes Prevention and Care for a Vulnerable Population in Galveston
- ClinicalTrials.gov ID
- NCT05097534
- Acronym / sponsor ID
- 21-0194
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 7 Dec 2021 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 28 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iDSMES | Active comparator | Other: iDSMESEligible 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. |
| Standard of Care | Placebo comparator | Other: Standard of CareEligible study subjects randomized to the intervention arm will receive standard of care offered to patients with diabetes. |
Who may qualify
- Ages
- 13 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iDSMESIntensive Diabetes Self-Management Education and Support combined with Addressing Social Determinants of Health | Other | iDSMES |
| Standard of CareStandard of Care for patients with type 2 diabetes | Other | Standard of Care |
Primary outcome
Change from baseline HbA1c
Time frame: at 6 months
measurement of hemoglobin A1c (HbA1c %)
Change from baseline HbA1c
Time frame: at 12 months
measurement of hemoglobin A1c (HbA1c %)
32 secondary outcomes
Change from baseline weight
Time frame: at 6 months
Change from baseline weight
Time frame: at 12 months
Change from baseline blood pressure
Time frame: at 6 months
Change from baseline blood pressure
Time frame: at 12 months
Change from baseline lipid profile
Time frame: at 6 months
Change from baseline lipid profile
Time frame: at 12 months
Change from baseline frequency of provider encounter
Time frame: at 6 months
Change from baseline frequency of provider encounter
Time frame: at 12 months
Change from baseline frequency of feet examination for neuropathy
Time frame: at 6 months
Change from baseline frequency of feet examination for neuropathy
Time frame: at 12 months
Change from baseline frequency of urine exam for microalbuminuria
Time frame: at 6 months
Change from baseline frequency of urine exam for microalbuminuria
Time frame: at 12 months
Change from baseline frequency of oral health checkup
Time frame: at 6 months
Change from baseline frequency of oral health checkup
Time frame: at 12 months
Change from baseline frequency of eye fundus examination
Time frame: at 6 months
Change from baseline frequency of eye fundus examination
Time frame: at 12 months
Change from baseline frequency of emergency care visits for treatment of T2-related issues
Time frame: at 6 months
Change from baseline frequency of emergency care visits for treatment of T2-related issues
Time frame: at 12 months
Change from baseline frequency of hospitalizations and re-admissions
Time frame: at 6 months
Change from baseline frequency of hospitalizations and re-admissions
Time frame: at 12 months
Participation in iDSMES classes (for those in the intervention arm only)
Time frame: at 12 months
Lifestyle change outcomes (for those in the intervention arm only)
Time frame: every session through study completion, an average of 1 year
Change from baseline patient-centeredness
Time frame: at 6 months
Change from baseline patient-centeredness
Time frame: at 12 months
Change from baseline secondary diabetes self-management behaviors
Time frame: at 6 months
Change from baseline secondary diabetes self-management behaviors
Time frame: at 12 months
Change from baseline self-efficacy in managing diabetes
Time frame: at 6 months
Change from baseline self-efficacy in managing diabetes
Time frame: at 12 months
Change from baseline diabetes distress
Time frame: at 6 months
Change from baseline diabetes distress
Time frame: at 12 months
Change from baseline medication Adherence
Time frame: at 6 months
Change from baseline medication Adherence
Time frame: at 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iDSMES in people with Diabetes Mellitus, Type 2, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline HbA1c (time frame: at 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.