Phenylketonuria (PKU)NCT06940193
A Self-test Home-use Blood Phenylalanine Monitoring System Under the Brand Name Egoo Phe System Has Been Developed for Measurement of Phenylalanine (Phe) in Individuals Diagnosed With Phenylketonuria (PKU): The Study Purpose is to Evaluate Accuracy and Usability
An observational study of Phenylketonuria (PKU), run by Egoo Health Aps at 1 site in United Kingdom.
Trial summary
A home-use self-test blood phenylalanine monitoring system under the brand name Egoo Phe System from manufacturer Egoo Health Aps has been developed for measurement of phenylalanine (Phe) in individuals diagnosed with phenylketonuria (PKU). Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Phenylketonuria (PKU)
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2025to 31 Oct 2025
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with PKU (3-17 years of age)
Who may be able to join
- All individuals with PKU aged 3 years and over
- Subjects with a confirmed diagnosis of PKU detected from newborn screening
- Healthy adult volunteers (>18 years of age) without PKU
- Male and female subjects will be included in this study.
Who cannot join
- Children under the age of 3 years
- Individuals with needle phobia
- Patients with comorbidities that may affect tolerance of blood sampling e.g. autism or other neurodiversity disorders
- Patients with acute illness e.g. chicken pox, tonsillitis requiring antibiotics
- Patients with chronic illness and taking long term medications e.g. diabetes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, B4 6NH
About this study
Official title: Egoo Phe System - A Blood Phenylalanine Self-Test Measuring System
A home-use self-test blood phenylalanine monitoring system under the brand name Egoo Phe System from manufacturer Egoo Health Aps has been developed for measurement of phenylalanine (Phe) in individuals diagnosed with phenylketonuria (PKU). This home monitor is intended to be an adjunct to current clinical practice in the management of individuals with PKU. The objective of this investigation is to perform multi blood comparison studies between the Egoo Phe System and the standard analytical methods (finger prick blood spots) to demonstrate the Egoo Phe System's accuracy.
Read the detailed description
The Egoo Phe System is intended to be used by Healthcare Professionals in the hospital, for near-patient testing in the home of the PKU patients, and for self-testing guided by the manufacturer's instructions-for-use and after being trained by healthcare professionals.
Currently, no home-based method exists for convenient and timely monitoring of blood phenylalanine (Phe) levels. The standard practice is for patients to collect their own blood samples on a sample collection filter paper. These dried blood spot samples are posted to the hospital. The laboratories then give the results to the dietitians within 2 working days. The dietitians report the results to the patients' caregivers the same day the results become available. However, the process may take anything from 3 to 7 days, dependent on the reliability of the postal system. This delay in feedback prevents timely adjustment of dietary treatment.
Research studies, clinical guidelines, and the PKU patient organizations have highlighted a need for more frequent blood Phe testing and more timely/real-time results for the better management and treatment of PKU. Many of these studies and reports have outlined the critical need for a simple, rapid, and accurate method for monitoring Phe blood levels, especially during the first years of life. A number of these studies have also indicated that a home monitor could make management of the condition easier and more effective. In particular, the immediate, and possibly daily, feedback supplied by such a monitor would allow for better dietary adjustments so that Phe blood levels could be more consistently maintained. A survey of PKU patients and their primary caregivers have highlighted the potential utility of a home monitor in managing PKU. A large majority of the respondents believed a home monitor would facilitate better management of PKU through more regular and timely feedback. Therefore, a more accessible and convenient method of testing and monitoring blood Phe levels on a regular schedule with immediate results at home would greatly improve the management of PKU.
- Conditions
- Phenylketonuria (PKU)
- Keywords
- phenylketonuria, phenylalanine, Phe, Self-test
- Medical subject headings
- Phenylketonurias
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure is blood phenylalanine.
A drop of blood (40ul) is collected by the patient using a patient led home testing device (study device). The result is compared with a parallel collected blood sample on a dried blood spot (DBS) card which is analyzed in a lab using tandem mass spectrometry (standard practice).
Measured: Monitoring of patient phenylalanine levels for 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start15 Apr 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phenylketonuria (PKU)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Egoo Health Aps
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anita MacDonald, Principal investigator, Birmingham Women's and Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06940193
- Sponsor's protocol ID
- IRAS ID 350589
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Comparison data
Publications
Gondrand C, Reischl-Hajiabadi AT, Bonedeau E, Weiss N, Schneider G, Fahn M, Myers F, Stadle PM, Jeltsch K, Hoffmann GF, Okun JG, Haas D, Garbade SF, Johnsson K, Opladen T. Real-Life Application of a Point-of-Care Biosensor for Phenylalanine in Patients With Phenylketonuria. J Inherit Metab Dis. 2026 May;49(3):e70187. doi: 10.1002/jimd.70187.
PubMed 41989430
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Egoo Phe System - A Blood Phenylalanine Self-Test Measuring System
- ClinicalTrials.gov ID
- NCT06940193
- Acronym / sponsor ID
- IRAS ID 350589
- Conditions
- Phenylketonuria (PKU)
- Keywords
- phenylketonuria, phenylalanine, Phe, Self-test
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Egoo Health ApsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A home-use self-test blood phenylalanine monitoring system under the brand name Egoo Phe System from manufacturer Egoo Health Aps has been developed for measurement of phenylalanine (Phe) in individuals diagnosed with phenylketonuria (PKU). This home monitor is intended to be an adjunct to current clinical practice in the management of individuals with PKU. The objective of this investigation is to perform multi blood comparison studies between the Egoo Phe System and the standard analytical methods (finger prick blood spots) to demonstrate the Egoo Phe System's accuracy.
Detailed description
The Egoo Phe System is intended to be used by Healthcare Professionals in the hospital, for near-patient testing in the home of the PKU patients, and for self-testing guided by the manufacturer's instructions-for-use and after being trained by healthcare professionals.
Currently, no home-based method exists for convenient and timely monitoring of blood phenylalanine (Phe) levels. The standard practice is for patients to collect their own blood samples on a sample collection filter paper. These dried blood spot samples are posted to the hospital. The laboratories then give the results to the dietitians within 2 working days. The dietitians report the results to the patients' caregivers the same day the results become available. However, the process may take anything from 3 to 7 days, dependent on the reliability of the postal system. This delay in feedback prevents timely adjustment of dietary treatment.
Research studies, clinical guidelines, and the PKU patient organizations have highlighted a need for more frequent blood Phe testing and more timely/real-time results for the better management and treatment of PKU. Many of these studies and reports have outlined the critical need for a simple, rapid, and accurate method for monitoring Phe blood levels, especially during the first years of life. A number of these studies have also indicated that a home monitor could make management of the condition easier and more effective. In particular, the immediate, and possibly daily, feedback supplied by such a monitor would allow for better dietary adjustments so that Phe blood levels could be more consistently maintained. A survey of PKU patients and their primary caregivers have highlighted the potential utility of a home monitor in managing PKU. A large majority of the respondents believed a home monitor would facilitate better management of PKU through more regular and timely feedback. Therefore, a more accessible and convenient method of testing and monitoring blood Phe levels on a regular schedule with immediate results at home would greatly improve the management of PKU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with PKU (3-17 years of age)
Key inclusion criteria (4 listed)
- All individuals with PKU aged 3 years and over
- Subjects with a confirmed diagnosis of PKU detected from newborn screening
- Healthy adult volunteers (>18 years of age) without PKU
- Male and female subjects will be included in this study.
Key exclusion criteria (5 listed)
- Children under the age of 3 years
- Individuals with needle phobia
- Patients with comorbidities that may affect tolerance of blood sampling e.g. autism or other neurodiversity disorders
- Patients with acute illness e.g. chicken pox, tonsillitis requiring antibiotics
- Patients with chronic illness and taking long term medications e.g. diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary outcome measure is blood phenylalanine.
Time frame: Monitoring of patient phenylalanine levels for 6 months.
A drop of blood (40ul) is collected by the patient using a patient led home testing device (study device). The result is compared with a parallel collected blood sample on a dried blood spot (DBS) card which is analyzed in a lab using tandem mass spectrometry (standard practice).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Derived from this study: PubMed 41989430Gondrand C, Reischl-Hajiabadi AT, Bonedeau E, Weiss N, Schneider G, Fahn M, Myers F, Stadle PM, Jeltsch K, Hoffmann GF, Okun JG, Haas D, Garbade SF, Johnsson K, Opladen T. Real-Life Application of a Point-of-Care Biosensor for Phenylalanine in Patients With Phenylketonuria. J Inherit Metab Dis. 2026 May;49(3):e70187. doi: 10.1002/jimd.70187.
- Individual participant dataSharing planned: Yes. Comparison data
Related trials for Phenylketonuria (PKU)
RecruitingPhase 2
A Study of MZE782 in Adults With PKU
Phenylketonuria (PKU)
Not yet recruiting
Market Research of a Slow Release Protein Substitute for the Dietary Management of PKU
Phenylketonuria (PKU) and Hyperphenylalaninemia, Brain Diseases, Metabolic, Inborn
Not yet recruiting
PKU Microtablets Case Studies
Phenylketonuria (PKU)
Recruiting
The Impact of Frequency of Home Phenylalanine Measurements on Metabolic Control in a Population of Patients With Classic Phenylketonuria
Phenylketonuria (PKU)
Not yet recruitingEarly Phase 1
To Evaluate the Safety and Efficacy of GS1168 Injection in Adult Phenylketonuria
Phenylketonuria (PKU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anita MacDonald principal investigator
Birmingham Women's and Children's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Phenylketonuria (PKU), run by Egoo Health Aps at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure is blood phenylalanine. (time frame: Monitoring of patient phenylalanine levels for 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06940193, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025; AzTrials last refreshed its copy on 26 Oct 2026.