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

NCT02671656 | Withdrawn

• 1 other identifier: UC1501
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Uricemia

Outcome Measures

Primary Outcomes (1)

• Uricemia

  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.

  Day0

Secondary Outcomes (2)

• Uricemia on capillary blood vs on serum

  Day0

• Haematocrit, glucose and lipid levels, medications

  Day0

Interventions

Uricemia DEVICE

serum uric acid levels is measured once from venous blood samples in the biochemistry laboratory using standard automated colorimetric methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Diabetes

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ART-Viggo, Rheumatology department, Lariboisière Hospital, Paris, France: collaborator

Study Sites (1)

Service de Rhumatologie, Hôpital Lariboisière

Paris, 75010, France

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hyperuricemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas BARDIN, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: February 2, 2016
• Study Start: March 1, 2016
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)