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New fingerstick test could simplify PKU monitoring at home

NCT ID NCT05998109

Diagnosis Sponsor: Lumos Diagnostics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested a new device called PheCheck that measures phenylalanine levels from a fingerstick blood sample, intended for home use by people with PKU. Researchers compared its accuracy to the standard lab test in 30 participants aged 10 and older. The goal was to see if the device is easy to use and gives reliable results.

What this could mean

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

Active substance
PheCheck™ rapid test device
What this could lead to
If successful, this could give people with PKU a convenient way to monitor their phenylalanine levels at home, reducing the need for frequent clinic visits.
What could go wrong
This is a small feasibility study with only 30 participants, so results may not apply to everyone. The test may not be as accurate as the lab method, and home use could introduce errors.

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.

Participants

30 people

The number who actually took part.

Started

Dec 2023

Finished

Jul 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients ≥ 10 years who are undergoing monitoring for Phenylketonuria (PKU)

Ages

10 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: * 10 years of age or older * Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent Exclusion Criteria: * Younger than 10 years of age * Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy * Lack of signed informed consent * Previous enrollment in the study and has completed study visit 1 and 2

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Conditions

The condition(s) this trial relates to.

hyperphenylalaninemia due to tetrahydrobiopterin deficiency phenylketonuria

As listed by the trial registrant

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

Phenylketonurias

Contacts and locations

Locations

  • UPMC Children's Hospital of Pittsburgh

    Pittsburgh, Pennsylvania, 15224, United States

More trials for these conditions

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