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New approach aims to close diabetes care gap for ethnic minorities

NCT ID NCT06131411

Disease control Sponsor: Azienda Ospedaliero-Universitaria Careggi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study tested whether a health behavior program designed with input from immigrant communities can improve diabetes management in first-generation immigrants with type 2 diabetes. Researchers compared the culture-sensitive program to standard care in 202 participants, measuring changes in blood sugar (HbA1c) and other heart-related factors over 12 months. The goal was to find better ways to support diabetes care in ethnic minorities.

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

202 people

The number who actually took part.

Started

Nov 2023

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

18 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: * Immigrant status: Self-identification of being born in High migration pressure countries from parents born in high migration pressure countries * Age ≥ 18 years * Type 2 diabetes newly diagnosed or with HbA1c \> 8% in the last assessment within 24 months before the visit Exclusion Criteria: * Patients who will not provide the informed consent * Patients with HbA1c ≤ 8% in the last assessment within 24 months before the visit * Severe psychiatric disorders * Pregnant women * Critical illness * Impaired cognitive or physical ability that could make the intervention not feasible, as judged by clinical staff members

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Conditions

The condition(s) this trial relates to.

Ambulatory Care Sensitive Conditions cardiovascular disorder hypertensive disorder Obesity 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

  • AUSL - IRCCS in Tecnologie Avanzate e Modelli Assistenziali in Oncologia di Reggio Emilia

    Reggio Emilia, Reggio Emilia, 42122, Italy

  • Azienda Ospedaliera Universitaria Renato Dulbecco

    Catanzaro, Catanzaro, 88100, Italy

  • Azienda Ospedaliera-Universitaria Careggi

    Florence, Florence, 50134, Italy

  • Istituto Nazionale per la promozione della salute delle popolazioni Migranti e il contrasto delle malattie della Povertà (INMP)

    Rome, Rome, 00153, Italy

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