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Diabetes devices put to the test: can home monitors match lab accuracy?

NCT ID NCT06170515

Diagnosis 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are evaluating four blood glucose meters and four HbA1c point-of-care devices to see how accurately they measure blood sugar and long-term glucose control compared with standard lab methods. The study includes people with diabetes, both adults and teenagers, some of whom have never used a home glucose monitor. Participants will use the devices under supervision, and researchers will also assess how easy the devices are to understand and operate, especially for first-time users.

What this could mean

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

Active substance
blood glucose meters and HbA1c point-of-care testing devices
What this could lead to
If these devices prove accurate and easy to use, people with diabetes could get more reliable blood sugar and HbA1c readings from portable meters, including at home or in clinics without a lab.
What could go wrong
This is a device performance study, not a treatment trial. Results may not apply to all meters or all users, and accuracy in a controlled study may differ from everyday use.

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

910 people

The number who actually took part.

Started

Jun 2023

Finished

Jul 2024

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

13 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: Arm 1: * 13-17 years, diagnosed with diabetes and able to manage condition independently (ideally at least 10% of total Arm 1 population) •≥18 years, diagnosed with diabetes * Able and willing to provide informed consent/assent * Naïve to the SMBG use of the investigational devices * 10% naïve to any SMBG (defined as not having performed any SMBG in the last 24 months) * Haematocrit within 20-60% * Pre-screen BGM result qualifies for inclusion in any of the five glucose concentration ranges based on % of subjects required to meet the target number per concentration range Arm 2: •≥18 years * Able and willing to provide informed consent * Diagnosed or not diagnosed with diabetes * Haemoglobin values ≥ 8g/dL * Pre-screen HbA1c result qualifies for inclusion in the target HbA1c range and % of subjects required for the mid-range values Exclusion Criteria: Arm 1: * \<13 years * 13-17 years and not diagnosed with diabetes or unable to manage condition independently * Previous use of investigational BGM for SMBG * Haematocrit outside normal range * Pre-screen BGM result falling in a glucose concentration range that already has sufficient participants. Arm 2: * \<18 years * Haemoglobin value \< 8g/dL * Pre-screen HbA1c result falling in a concentration range that already has sufficient participants.

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Conditions

The condition(s) this trial relates to.

diabetes mellitus

As listed by the trial registrant

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

Diabetes

Contacts and locations

Locations

  • Asociación Colombiana de Diabetes

    Bogotá, Bogota D.C., 111311, Colombia

  • Lagos University Teaching Hospital

    Lagos, Lagos, Nigeria

  • Sihanouk Hospital Centre of Hope

    Phnom Penh, Phnom Penh, 12253, Cambodia

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