Clinical trial NCT02671656: Study of the Reliability of a Device (HumanSens Plus) Allowing Immediate Measurement Uric Acid in the Blood Obtained by Finger Tip Puncture.
Official title: Reliability Assessment of the HumaSens Plus Measurement of Uricemia in Capillary Blood
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Diabetes
Keywords: Uricemia
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: ART-Viggo, Rheumatology department, Lariboisière Hospital, Paris, France
First posted: 2016-02-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Diabetes

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.

Detailed description: The aim of this study is

* to assess the validity of the capillary measure of uric acid level by the HumaSens plus system by comparing the measurement of total blood uric acid level by the HumaSens plus system with the routine measurement of serum uric acid by a standard and validated automated colorimetric method (primary objective).
* to look for a systematic bias and confounding factors (secondary objectives)

Methods

Design : This is a mono-centric prospective study. Patients will be recruited from the diabetology day hospital of hospital Lariboisière, Paris

Data collection : For each patient included at the Lariboisière Diabetology day hospital and included in this study, serum uric acid levels will be measured once from venous blood samples in the biochemistry laboratory using standard automated colorimetric methods, as presently routinely done and by liquid chromatography coupled with mass spectroscopy. In, addition, uric acid levels will also be simultaneously measured from capillary blood with the HumaSensplus system.

Hematocrit, glucose, cholesterol and triglycerides will be measured as well from venous blood samples and taken medications will be listed.

Planned analysis :

Planned sample size:

To obtain an estimated intraclass correlation of 0,800, with a two-sided 95% confidence interval with a width of 0,100, if the uric acid level is measured twice for each subject, we calculated that we needed a random sample of 204 subjects.

Statistical analyses:

Primary aim This study aims at studying the reliability of measurements of acid uric level by HumanSensplus against laboratory and measurements by liquid chromatography coupled with mass spectroscopy on serum from venous blood. There is no structure to the replicate measurements in the sense that nothing ties the first or second measurement on one patient to the first or second on another. The study thus conforms to a one-way random effect model. The data will be analyzed using a one-way random-effects ANOVA model.

The estimator of the intraclass correlation coefficient will be

With BMS=between-subject mean square, WMS=within-subject mean square and k0 = number of replicates. In this study k0=2.

The intraclass correlation coefficient will be calculated and the two-sided 95%CI will be provided for each comparison.

In addition differences between measurements will be plotted against mean of measurements in accordance with Bland and Altman.

Secondary aims The search for systematic bias and effect of confounding factors (hematocrit, glycemia, lipid concentrations and concomitant medications) will use different models of multiple regression

Logistic aspects

Ethical aspects:

Agreement will be sought from the local Ethics committee. All patients will be fully informed and will be provided with an information form. The data will be entered into an excel database and will be analysed anonymously. Fingertip glycaemia is presently systematically obtained in all these day hospital patients, and the addition of fingertip uricaemia in view of substituting this measurement to the systematic serum uric acid measurement presently done from a venous system in the biochemistry laboratory can be considered as a mere attempt to improve routine patient care.

Inclusion procedure:

The study will target 200 patients seen in diabetology day hospitalisation and fulfilling the inclusion criteria. As 15 patients are seen in the diabetology day hospitalisation ward every day, we estimate that the necessary patients sample size could be obtained within 6 weeks.

Eligibility criteria: 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)

Primary outcomes:
measure: Uricemia
timeFrame: Day0
Secondary outcomes:
measure: Uricemia on capillary blood vs on serum
timeFrame: Day0
measure: Haematocrit, glucose and lipid levels, medications
timeFrame: Day0
Other outcomes:
Locations:
city: Paris
country: France
facility: Service de Rhumatologie, Hôpital Lariboisière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Thomas BARDIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: