An interventional study of Lit-control®pH Meter and Reactive strips in Cystinuria, sponsored by Devicare S.L.. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-21.
Sponsored by Devicare S.L. · Not applicable, Interventional, and Other
This study evaluates the superiority of daily self-pH monitorization of Lit-control®pH meter compared to the monitorization of reactive strips (standard of care).
Cystinuria is a disease of autosomal recessive inheritance. This disease belongs to the so-called orphan diseases although its prevalence may change depending on the country.
It is known that urinary pH is a risk factor for the formation of cystine crystals because their solubility is pH-dependent. In different studies it has been shown that the solubility of cystine in urine increases when alkalinizing urinary pH, thus reducing the likelihood of crystal formation. Therefore, the control of urinary pH along with hygienic-dietetic measures that alkalize the urine or decrease the urinary concentration of cystine (abundant intake of water, food, etc.) are highly recommended as a preventive method to prevent the formation of cystine crystals whose retention and growth results in the formation of stones.
The Lit-control®pH Meter is a pH meter that allows a patient to self-monitor its urinary pH in a comfortable and simple way. With this tool the patient is able to know if his urinary pH is within the recommended limits. In other medical fields it has been observed that home monitoring of clinically relevant physiological parameters is a way of empowering the patient that can positively affect their attitudes and behaviors (adherence to received treatment, quality of life) and potentially improve their medical condition. Specifically, in patients with chronic diseases, the self-monitoring has been associated with a significant reduction in hospitalizations and hospital readmissions.
21 studies on the registry are indexed under Cystinuria; 5 are open to participants now.
Browse Cystinuria studies →Devicare S.L. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the Lit-control®pH Meter device.
Device: Lit-control®pH Meter
The control of the urinary pH will be carried out twice a day: with the first urine in the morning and in the evening-night (approximately every 12h and at the same time). Measurements will be performed using the reactive strips.
Diagnostic Test: Reactive strips
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.
Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
Urinary pH measurement
Time frame: 183 measurements (morning) in 6 months.
Percentage of days with pH levels within range 7 and 8, during 6 months of home self-monitoring.
Urinary pH measurement
Time frame: 183 measurements (afternoon) in 6 months.
Measurement of the volume of crystalluria.
volume of crystalluria
Time frame: 1 measurement at the moment of enrollment
Measurement of the volume of crystalluria.
volume of crystalluria
Time frame: 1 measurement at 6 months
Blood: DNA extraction.
Extraction of DNA for genetic study of mutations for cystinuria.
Time frame: 1 measurement at the moment of enrollment
Sediment analysis for the determination of urinary infection.
Sediment analysis for the determination of Ulcer Index (UI)
Time frame: 1 measurement at the moment of enrollment
Sediment analysis for the determination of urinary infection.
Sediment analysis for the determination of UI
Time frame: 1 measurement at 6 months
Total time within the margins established as safe in the pH control (months).
Amount of time within the pH margins established as safe
Time frame: 1 measurement through study completion [up to 6 months]
Adherence level in pH measurements
% compliance of the pH measurements
Time frame: Through study completion, fraction of pH measurements on the total possible. [up to 6 months]
Adherence level to treatment
% of the intakes of the medication.
Time frame: Through study completion, fraction of intakes on the total possible. [up to 6 months]
Total number of adverse events reported.
Amount of adverse events reported
Time frame: Through study completion, number of events. [up to 6 months]
Blood Analysis. Glucose
Glucose in mmol/L
Time frame: Change from Baseline measurement at 6 months
Blood Analysis. Calcium phosphate
calcium phosphate in µmol/L
Time frame: Change from Baseline measurement at 6 months
Blood Analysis. Estimated Glomolecular Filtration Chronic Kidney Disease Epidemiology Collaboration (FG CKD-EPI)
estimated FG CKD-EPI
Time frame: Change from Baseline measurement at 6 months
Blood Analysis. Cystatin
cystatin in mg/L (to be measured only if estimated FG\> 45 or \<ml /min / 1.73 m2 and albumin / creatinine in the urine \<3 mg / mmol)
Time frame: Change from Baseline measurement at 6 months
Blood Analysis. Creatinine
creatinine in µmol/L
Time frame: Change from Baseline measurement at 6 months
Blood Analysis. Urate
urate in μmol/L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Weight
Weight in kg
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Size
Size in m
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Urinary volume
Urinary volume in L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Calcium phosphate
calcium phosphate in µmol/L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Citrate
citrate in μmol/L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Urate
urate in μmol/L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Magnesium
magnesium in μmol/L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Sodium
sodium in μmol/L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. BMI
weight and height will be combined to report BMI in kg/m\^2
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Potassium
potassium in μmol/L
Time frame: Change from Baseline measurement at 6 months
24h Urine Analysis. Urea
urea in µmol/L
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Schedule
First urine of the morning (totality) for the study of crystalluria. Patient will provide the last hour of urination and hour of urine obtention in the morning.
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Crystalline volume
overall crystalline volume (μm3 / mL)
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Crystals
type and number of crystals (crystals / μL)
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Urine volume
urine volume in L
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. pH
pH
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Size
size in μm
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Density
Density in mg / mL.
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Aggregation
aggregation
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Twinning
twinning
Time frame: Change from Baseline measurement at 6 months
Urine for the study of crystalluria. Quotient
Quotient albumin / creatinine
Time frame: Change from Baseline measurement at 6 months
Sociodemographic and anthropometric questionnaire.
Family and personal background and general data (sex, age, etc.).
Time frame: 1 day of enrollment
Patient satisfaction questionnaire with the pH measurement method
Visual Analogue Scale ranging from 1 (very dissatisfied) to 10 (very satisfied)
Time frame: 3 times in 6 months
Physician satisfaction questionnaire with the pH measurement method
Likert Scale with 4 categories: very dissatisfied, dissatisfied, satisfied, very satisfied
Time frame: 3 times in 6 months
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Devicare S.L.