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Study of the Reliability of a Device (HumanSens Plus) Allowing Immediate Measurement Uric Acid in the Blood Obtained by Finger Tip Puncture. (URICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02671656
Recruitment Status : Unknown
Verified January 2016 by Assistance Publique - Hôpitaux de Paris.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2016
Last Update Posted : February 2, 2016
ART-Viggo, Rheumatology department, Lariboisière Hospital, Paris, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:
Lowering the level of uric acid in the serum under 6mg/dL on the long term is a key factor of gout management success. Monitoring of uricemia in gout patients is therefore important and is presently done in the laboratory on serum samples obtained after venous puncture. This study aims at assessing the reliability of immediate uricemia measurement in a blood sample obtained by a mere fingertip puncture, by the HumaSensplus system, which is commercially available in the EU. Results obtained by the Humasens device will be compared to those of the standard measurement technique in serum and with a reference technique (liquid chromatography and mass spectroscopy). If the device appears reliable, it will allow self-measurement of uric acid by the gouty patient, in a similar way as diabetic patients measure their glycaemia following a fingertip puncture. This should improve patient monitoring and management effects.

Condition or disease Intervention/treatment
Diabetes Device: Uricemia

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Study Type : Observational
Estimated Enrollment : 200 participants
Time Perspective: Prospective
Official Title: Reliability Assessment of the HumaSens Plus Measurement of Uricemia in Capillary Blood
Study Start Date : March 2016
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : April 2016

Intervention Details:
  • Device: Uricemia
    serum uric acid levels is measured once from venous blood samples in the biochemistry laboratory using standard automated colorimetric methods

Primary Outcome Measures :
  1. Uricemia [ Time Frame: Day0 ]

    Comparison the measurement of uric acid level by the HumaSensplus system with the routine measurement of uric acid by the automated colorimetric uricase method (Abbot), and with a reference method: liquid chromatography coupled with mass spectroscopy.

    This will be done once for every patient.

Secondary Outcome Measures :
  1. Uricemia on capillary blood vs on serum [ Time Frame: Day0 ]
    Search for a systematic bias (the HumaSens measurement is on capillary blood whereas the other techniques are done on serum)

  2. Haematocrit, glucose and lipid levels, medications [ Time Frame: Day0 ]
    Search for confounding factors (haematocrit, glucose and lipid levels, medications) which may affect the results of the HumaSens measurement

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Diabetes

Inclusion Criteria:

  • Patients seen in the diabetology day hospital
  • Patients aged at least 18 years-old
  • French-speaking patients
  • Patients able to understand the study and the information form

Exclusion Criteria:

  • Patients unable to understand the aim of study aind the information sheet
  • Patients not affiliated to a social security scheme (beneficiary or assignee)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02671656

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Contact: Thomas BARDIN, MD, PhD 33 1 49 95 62 90

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Service de Rhumatologie, Hôpital Lariboisière
Paris, France, 75010
Contact: Thomas BARDIN, MD, PhD    33 1 49 95 62 90   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
ART-Viggo, Rheumatology department, Lariboisière Hospital, Paris, France
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Principal Investigator: Thomas BARDIN, MD, PhD Assistance Publique - Hôpitaux de Paris
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT02671656    
Other Study ID Numbers: UC1501
First Posted: February 2, 2016    Key Record Dates
Last Update Posted: February 2, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Assistance Publique - Hôpitaux de Paris: