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Village health workers take on diabetes with app support

NCT ID NCT05743387

Disease control Sponsor: University Hospital, Basel, Switzerland 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This trial tests whether trained village health workers, using a smartphone app, can provide effective type 2 diabetes care in rural Lesotho. 252 adults with diabetes will either receive community-based care (lifestyle advice, metformin, statins) or be referred to a clinic. The goal is to see if community care can control blood sugar as well as or better than standard clinic visits.

What this could mean

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

Active substance
Type 2 diabetes care package (lifestyle advice, metformin, statins) delivered by lay village health workers with eHealth app support
What this could lead to
If successful, this could show that trained village health workers can safely manage uncomplicated type 2 diabetes in remote areas, improving access to care.
What could go wrong
This is a relatively small trial in one rural setting, so results may not apply elsewhere. The intervention relies on app guidance and lay workers, which may not work as well as clinic-based care.

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

252 people

The number who actually took part.

Started

May 2023

Expected to finish

Dec 2027

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

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: * Participant of the ComBaCaL cohort study (signed informed consent available) * Living with DM, defined as reporting intake of antidiabetic medication or being newly diagnosed during screening via standard diagnostic algorithm Exclusion Criteria: * Known type 1 diabetes mellitus * Reported pregnancy

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Noncommunicable Diseases type 2 diabetes mellitus

As listed by the trial registrant

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

Type 2 diabetes mellitus (DM) Type 2 diabetes mellitus (T2D)

Contacts and locations

Locations

  • SolidarMed Lesotho

    Maseru, Lesotho

  • University of Basel, Division of Clinical Epidemiology

    Basel, 4051, Switzerland

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