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
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.
Eligibility
Sex
ALL
Min age
—
Max age
3 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
The primary outcome measure is blood phenylalanine. — 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).
Trial sites (1)
Facility
City
Region
Status
Birmingham Women's and Children's NHS Foundation Trust
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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