Study to evaluate the reliability and practicability of the PKU Sensor and PKU App in home settings of patients with phenylketonuria

Study to evaluate the reliability and practicability of the PKU Sensor and PKU App in home settings of patients with phenylketonuria - PKU Sensor

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00031972

Enrollment

Registered

2023-06-05

Start date

2024-04-03

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E70.0 E70.1

Interventions

Group 1: The planned study will investigate whether the PKU Sensor and the associated PKU App provide reliable phenylalanine values. Furthermore, the duration until obtaining the results, the safety a

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Genetically confirmed phenylalanine hydroxylase deficiency • Patients or their parents are capable to give informed consent (written informed consent, signed and dated) • Willing and able to comply with the protocol and study procedures • Male/ female/diverse patients • Newborns (after birth until the end of the 4th week of life or • Toddlers (5th week of life to the end of the 1st year of life) or • Infants (1st to the end of the 5th year of life) or • Children (6th to the end of the 11th year) or • Adolescents (from the age of 12 to the end of 17) or • Adults (18-99 years) or • Pregnant women

Exclusion criteria

Exclusion criteria: • The individual, in the opinion of the investigator, is unwilling or unable to adhere to the requirements of the study • Any other know genetic disorder in amino acid metabolism • Participation in interventional clinical studies • Mentally disabled persons that are needing a legal representative

Design outcomes

Primary

Measure	Time frame
Evaluation of the reliability of phenylalanine (PHE) measurements as point-of-care analyses in patients with phenylketonuria (PKU) at home compared to the standard flow injection analysis using tandem mass spectrometry (FIA-MS-MS)	—

Secondary

Measure	Time frame
• To evaluate the differences in duration between blood sampling and result, measured by PoC analyses and FIA-MS-MS. • To assess the safety of PKU Sensor use in subjects with PKU. • To evaluate the practicability of the PKU Sensor and the app via survey for the total collective and subgroups (age groups)	—

Countries

Germany

Contacts

Public ContactThomas Opladen

University Hospital Heidelberg, Centre for Child and Adolescent Medicine

thomas.opladen@med.uni-heidelberg.de++49-(0)6221-56-4002

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026