Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) (MitrAlanine)

December 18, 2023 updated by: University Hospital, Grenoble

Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria

The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.

Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Grenoble, France, 38043
        • Recruiting
        • Chu Grenoble Alpes
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Pediatric population

Description

Inclusion Criteria:

  • Children aged 3 months to 18 years
  • suffering from phenylketonuria or hyperphenylalaninemia
  • who have had a capillary and blood test including a phenylalanine assay at CHUGA
  • Whose parents or legal guardians are affiliated to the social security system.
  • For whom parents or legal guardians have not objected to the MitrAlanine study.

Exclusion Criteria:

  • Parents or legal guardians opposed to the MitrAlanine study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of phenylalanine concentrations
Time Frame: Day 1
Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ease of use of research device
Time Frame: Day 1
ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers
Day 1
sample conformity
Time Frame: Day 1
Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer
Day 1
comparison of concentrations of tyrosin
Time Frame: Day 1
comparison of concentrations of other amino acids (tyrosin) dosed at the same time as phenylalanine
Day 1
comparison of concentrations of total leucin
Time Frame: Day 1
comparison of concentrations of other amino acids (total leucin) dosed at the same time as phenylalanine
Day 1
comparison of concentrations of methionin
Time Frame: Day 1
comparison of concentrations of other amino acids (methionin) dosed at the same time as phenylalanine
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Grenoble

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2023

Primary Completion (Estimated)

December 12, 2025

Study Completion (Estimated)

December 12, 2025

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

December 22, 2023

Last Update Submitted That Met QC Criteria

December 18, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC22.0319
  • 2023-A01180-45 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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