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Can skin sensors replace finger pricks for diabetes care in kenya?

NCT ID NCT05944731

NEW Disease control Sponsor: Foundation for Innovative New Diagnostics, 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers in Kenya are studying whether continuous glucose monitors help people with type 1 diabetes control their blood sugar better than standard finger-prick testing. The trial enrolls about 246 people with type 1 diabetes, including children and adolescents, at three clinics. Participants are assigned to use the monitors continuously, use them intermittently, or continue standard care. The study measures changes in long-term blood sugar levels and how stable glucose stays, and it also looks at whether the approach is practical, acceptable, and affordable.

What this could mean

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

Active substance
continuous glucose monitoring device
What this could lead to
If it works, this could give clinics in low- and middle-income countries a practical way to offer glucose monitoring without daily finger pricks. It could also show whether using the devices part-time helps people who cannot afford them full-time.
What could go wrong
The trial measures blood sugar changes over a limited period, so it may not show lasting benefits. Devices can be costly, may not suit everyone, and results in Kenya may not apply to other 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

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 246 people

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

Started

Sep 2023

Expected to finish

Oct 2026

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 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: Recipient of care participants are eligible to be included in the Study only if all the following inclusion criteria apply: 1\. People living with T1 diabetes with HbA1c levels ≥10% (with at least 1 measurement over 18 months prior to study enrolment) who are attending for diabetes care at the 3 study clinics. Care givers to children/adolescents living with T1 diabetes are eligible to be included in the study only if all the following inclusion criteria apply: 1\. The child/adolescent that the person is a care giver to is enrolled in the study. Healthcare providers are eligible to be included in the study only if all the following inclusion criteria apply: 1\. Healthcare provider at the study sties engaged in diabetes care provision related to the study. Exclusion Criteria: Participants are excluded from the Study if any of the following exclusion criteria apply: 1. People living with type 1 diabetes under 4 years of age 2. People diagnosed with Type 1 diabetes within the last 2 years. 3. People who have used a CGM in the last 18 months prior to enrollment 4. People living with type 2 diabetes. 5. Known pregnancy at the time of study enrolment.

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

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

Type 1 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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Diabetes Management & Information Centre (DMI)

    Nairobi, Nairobi County, 00100, Kenya

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