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Could a simple sensor transform diabetes care for african youth?

NCT ID NCT05454176

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a flash continuous glucose monitor (CGM) can help children and young adults in Uganda with type 1 diabetes keep their blood sugar in a healthy range more often than standard finger-prick testing. Half of the 180 participants will use the CGM for the first six months, while the other half will use standard testing. After six months, the groups switch. The study also looks at whether the CGM is cost-effective in a low-resource country.

What this could mean

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

Active substance
FreeStyle Libre 2 continuous glucose monitor (CGM)
What this could lead to
If successful, this could show that flash CGM is a practical and cost-effective tool to help young people in low-resource settings manage their diabetes better.
What could go wrong
This is a Phase 4 trial with 180 participants, so results may not apply to all populations. The device requires consistent use and access to supplies, which could be challenging in some settings.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 180 people

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

Started

Aug 2022

Expected to finish

Aug 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

4 to 26 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: * Children and youth in Uganda, age 4-26 years at the beginning of the baseline assessment * T1D (determined by clinical criteria, as autoantibody testing is not regionally available) of at least 12 months duration at the beginning of the baseline assessment * Receiving insulin therapy * Access to a cell phone (nearly ubiquitous in Uganda, even in remote areas) * At least one parent or guardian (or as per local regulations) is present in clinic and able to give consent for children under 18 years of age (those age 18-26 may give consent for themselves) Exclusion Criteria: * Unwilling or unable to be seen monthly at the pediatric diabetes clinic * Pregnant or breast-feeding; women likely to become pregnant in the next year * Major medical conditions which the investigator feels would interfere with study participation * Patient already has CGM * Inability during the baseline assessment period to wear the sensor for at least 7 days or return it * Participant deemed unlikely or unable to comply with the protocol

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55455, United States

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