Clinical Trial: Testing of Four Home Phenylalanine Monitoring Prototype Devices

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Testing of Four Home Phenylalanine Monitoring Prototype Devices Using Whole Blood From Normal and PKU Subjects

Brief Summary: The objective of this study is to test four home phenylalanine monitoring prototype devices, selected out of a pool of candidates by the National PKU Alliance Scientific Committee.

Detailed Summary:

A real time, point-of-care and home phenylalanine monitoring system would provide patients with quick results and feedback. Home monitoring devices' phenylalanine measurements will be compared to the current gold-standard measurement of phenylalanine (plasma concentration) in four subjects with PKU and one control subject. The study will enroll subjects with different baseline phenylalanine concentrations (i.e., patients with poor to good metabolic control, assessed by comparing current phenylalanine concentrations to established treatment ranges).

For each prototype device, three separate measurements of phenylalanine per subject will be performed. Three prototype devices require whole blood, thus 1 teaspoon (approximately 4mL) of whole blood will be collected through venipuncture and blood spots will be used to conduct tests. One prototype requires capillary blood to be collected through a fingerstick, and will require three blood spots from the stick. A single plasma amino acid analysis for each participant will also be performed using leftover whole blood from the 4mL blood draw through quantitative ion exchange chromatography, reported as micromoles/L.


Sponsor: Emory University

Current Primary Outcome: Intra-variability of the four devices, assessed by phenylalanine values [ Time Frame: Day 1 ]

Phenylalanine values for each of the three runs on each device for the same individual will be compared. Each PKU subject will be assessed separately to assess the reliability of each device since the subjects will have a range of phenylalanine concentrations.


Original Primary Outcome: Same as current

Current Secondary Outcome: Inter-variability of the four devices, assessed by average phenylalanine concentrations [ Time Frame: Day 1 ]

Average phenylalanine values measured by the four tests of each device in each subject will be calculated. Mean concentrations for each device will be compared to the control (gold standard measure of plasma phenylalanine).


Original Secondary Outcome: Same as current

Information By: Emory University

Dates:
Date Received: May 13, 2015
Date Started: May 2015
Date Completion:
Last Updated: December 9, 2015
Last Verified: December 2015