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Lakota diabetes study aims to turn tide with culturally grounded approach

NCT ID NCT06770673

Disease control Sponsor: Johns Hopkins Bloomberg School of Public Health Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a diabetes program called Together Overcoming Diabetes (TOD), designed specifically for Lakota and other American Indian/Alaska Native communities. About 140 adults with type 2 diabetes who care for a young person aged 10-25 will take part. The program focuses on social and cultural factors to help manage blood sugar and improve health.

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

About 140 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Oct 2028

An estimate. End dates often move.

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

10 years and older

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 - Adult Index Participants: * 18 years and older * Self-identifies as American Indian or Alaska Native * Rapid City-based participants who reside within 1 hour transportation range of the Oyate Health Center * Verification from a health provider to confirm Type 2 Diabetes diagnosis by laboratory test. * Caregiver to a 10- to 25-year-old in their home at the time of screening. * Willing to complete all implementation and follow-up assessments. * Willing to be randomized for the intervention. Exclusion Criteria - Adult Index Participants: * Inability to participate in full intervention or evaluation (e.g., planned move, residential treatment, etc.) * Willing to serve as 'support person' for the adult participant. * Has a circumstance that might impact successful participation based on provider judgment considering instances where diabetes control can become more difficult with advanced disease or special conditions including: pregnant, nursing, or planning to become pregnant, end-stage renal disease on dialysis, diabetes due to secondary causes such as Cushing's or Cystic Fibrosis, or any condition that may inhibit participation Inclusion Criteria - Youth Support Participants: * Between 10 years and 25 years old * Self-identifies as American Indian or Alaska Native. * Willing to serve as 'support person' for the adult participant. * Willing to complete all implementation and follow-up assessments. * Willing to be randomized for the intervention. Exclusion Criteria - Youth Support Participants: * Cognitively or visually impaired * Youth in foster care (due to potential mobility of foster youth).

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Indigenous Health - Great Plains Hub

    RECRUITING

    Rapid City, South Dakota, 57701, United States

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