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New community program aims to improve diabetes care for vulnerable populations

NCT ID NCT05097534

Disease control Sponsor: The University of Texas Medical Branch, Galveston Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study tested a community-based program for people with type 2 diabetes. Participants received diabetes education, dietary counseling, physical and occupational therapy, and help with social needs like finances and mental health. The goal was to see if this approach could improve blood sugar control, weight, and blood pressure compared to standard care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
community-based program including diabetes education, dietary counseling, physical and occupational therapy, and social needs support
What this could lead to
If successful, this approach could offer a practical model for improving diabetes control in vulnerable communities.
What could go wrong
This is a small, completed study with 98 participants, so results may not apply broadly. The program is complex and may be hard to replicate elsewhere.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

98 people

The number who actually took part.

Started

Dec 2021

Finished

Oct 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

13 to 84 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2

Contacts and locations

Locations

  • St. Vincent House Clinic

    Galveston, Texas, 77550, United States

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Other studies related to the condition(s) this trial covers.