DiabetesPERF-LUCIENCT06640270
Performance Evaluation of Lucie™ for Hydration of Dialysis Patients
A study testing Diabetes Treatment in people with Diabetes, run by Home Habilis.
Trial summary
The main objective of the observatory study is to evaluate the performance of the Lucie™ medical device for measuring water balance before and after dialysis (water overload, dry weight) in patients with chronic renal failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Diabetes Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients age : 18 years min
- Weight minor than 125 kg
- must be able to read
- able to get on and off a bathroom scale, with or without assistance;
- Patient able to stand in balance for 45 seconds with support, alone and barefoot.
Who cannot join
- persons with vulnerabilities : pregnant women, nursing mothers, persons deprived of their liberty, adults under legal protection, persons in emergency situations (art. L. 1121-5 to 8 and L.1122-1-2 of the Public Health Code)
- patient with an open wound on the extremities (palms and soles of the feet in contact with the device);
- Patient with an electronic cardiac implant;
- An amputee, with or without a prosthesis;
- Patients with paralysis, even partial paralysis;
- Patients with a 3-month mean natraemia of less than 130 mmol/L;
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- Patients fitted with a metal prosthesis;
- Patients with behavioural problems that prevent them from taking part in the study;
- Patient already included in another interventional research study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the PERFormances of a Bioelectrical Impedancemetry Device (Lucie™), for the Measurement of Hydration Parameters in Patients with Renal Failure: a Multicentre Comparative Study
The main objective of the observatory study is to evaluate the performance of the Lucie™ medical device for measuring water balance before and after dialysis (water overload, dry weight) in patients with chronic renal failure. We will compare the results and performance of the device with the reference device in nephrology: the BCM®. This comparison is based on bioimpedance. Bioimpedance is an effective technology for monitoring hydration if used regularly, and will give you greater autonomy in your home monitoring. It competes with other technologies that we have found to be less effective. This is what clinical research is seeking to demonstrate: only a clinical study can verify the reliability of this hypothesis. The aim is to help Lucie technology mature so that it can detect early signs of fluid overload, and ultimately prevent complications or hospitalisation.
The process is as follow:
Read more
- After removing their shoes and socks, the patient will be invited to step onto the scale;
- Patient will insert a personal card into the card reader and place his right hand loosely on the LucieTM handle, keeping a natural posture;
- The device will take measurements for 45 seconds under the nurse\'s supervision;
- Patient will go down Lucie and will answer a short form;
- The device is cleaned after each use For optimum results, we recommand patients to keep their feet dry and their hands clean (without cream), and we recommend them to remove their jewellery, to keep their smartphones away from the device (to avoid interference), and to wear a minimum of nylon-free clothing, with empty pockets.
In practical terms, patients are familiar with monitoring their fluid overload using the Fresinus BCM® bathroom scale. They already use it as part of their clinical routine when entering and leaving the dialysis room. This BCM® is used at the start of the dialysis session, before the session begins, by a nurse trained by the manufacturer in its use: he or she knows how to place the electrodes and read the results for status and fluid overload. The nurse also takes patients\' usual vital signs (blood pressure, temperature) and notes any incidents during the dialysis session (low blood pressure, cramps, headaches, nausea, etc.) in line with standard practice.
With Lucie™
Read the detailed description
The goal of this observational study is to evaluate the performance of the Lucie™ medical device for the measurement of pre-dialytic hyperhydration by bioimpedance (water volume in L) in groups of patients with renal failure, compared with the reference device, the BCM. The main question its aimed to answer is
The primary hypothesis will be to determine the degree of agreement between the BMC measure of pre-dialytic hyperhydration and Lucie\'s water balance (volume (L)).
Participants will do the following tasks :
- Patients weigh themselves on entering the dialysis room to find out their total weight and have it checked by the nurse (routine care) with a scale that complies with weighing standard NF EN 45501:2015 and Directive 2014/31/EU;
- Patients weigh themselves with Lucie™ and complete a bio-impedance measurement cycle in 45 seconds (interventional research);
- A nurse measures the blood pressure on the cuff (CE medical mark), standing and lying down, and determines the ultrafiltration for the dialysis session to be entered on the machine (routine care). She records the pre-dialysis information;
- The nurse performs a bio-impedance measurement with the BCM™ reference device from Fresenius Medical Care and records measurements of hyperhydration - or overhydration (OH) -, extracellular water (ECW), total body water (TBW), the ECW/TBW ratio, the E/I ratio (deep breathing test), the OH/ECW ratio (interventional research);
- Patients begin their dialysis session (routine care);
- The nurse records blood pressure, standing and lying down, after the dialysis session and records post-dialysis information and lists any undesirable events during the dialysis session (e.g. cramps, low blood pressure, headaches, etc.);
- Patients are weighed on leaving the dialysis room to check that they are achieving the prescribed target weight (routine care);
- Patients weigh themselves with Lucie™ and complete a cycle of bioimpedance measurements in 45 seconds under the control of a nurse (interventional research).
- Patients weigh themselves a second time with the Lucie™ device and again complete one cycle of bio-impedance measurement in 45 seconds without nurse supervision (interventional research, the aim of which here is to measure inter-operator reliability).
- No bio-impedance measurement by the BCM™ device after the dialysis session given the difficulty of devoting an extra 30 minutes to patients to carry out a second measurement;
- Lucie™ device surfaces are cleaned according to the procedure provided.
- Conditions
- Diabetes
- Being tested
- Diabetes Treatment
- Keywords
- bioimpedance, concordance, hydration match, overhydration, Total Body Water, Extra Cellular Water, Intra Cellular Water, hydration, Over Hydration, predictive value
- Medical subject headings
- Diabetes Mellitus, Water Intoxication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes TreatmentDevice
Lucie™ is an innovative medical device for measurement by bio-impedancemetry. It has been developed specifically to meet medical needs in nephrology. The aim of the study is to compare its performance with a reference device validated in nephrology nephrology, the Body Composition Monitor® (BCM) from Fresenius.
| Study group | Role | What they receive |
|---|---|---|
| Main Arm for PREF-Lucie | Experimental | Interventional, quasi-experimental, multicentre, comparative clinical research study Receives: Device: Diabetes Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydratation parameters
Extra Cellular Water (ECW), Total Body Water (TBW), Intra Cellular Water (ICW) ; the agreement of the variation before and after dialysis with Lucie™ of the hydration parameters (ECW, ICW, ECW/ICW, OH/ECW, TBW) and the actual ultrafiltration of the session displayed on the generator (UF). This measure will help to calculate Bioimpedance measure.
Measured: Through study completion (2 months)
Concordance of Hydration parameters (%)
Concordance of hydration parameters (OH/ECW (%) (Over Hydration) to Extra Cellular Water), ECW/ICW (%) (Extra Cellular Water to Intra Cellular Water) between the 2 medical devices (Lucie™ and BCM® reference device), as well as sensitivity, specificity, positive predictive value, negative predictive value by Lucie™ medical device.
Measured: Through study completion (2 months)
Secondary outcomes (5)
Weight Measures
The agreement between the total weight (kg) measured by the reference device and that measured by Lucie
Measured: Through study completion (2 months)
Skin/eat Temperature Agreement
The agreement between the skin temperature (°C) measured by Lucie and the ear temperature measured at the patient's bed ;
Measured: Through study completion (2 months)
Satisfactiory Questionnaire
Patient satisfaction questionnaire to be completed during the dialysis session and at the end of the study by the healthcare professionals who took part.
Measured: Through study publication (4 months)
Medico-economic Impact
Questionnaire on the medico-economic impact of the use of the Lucie™ device to be completed at the end of the study by the healthcare professionals who took part.
Measured: From the end of inclusion to one year after CER publication, assessed to 16 months
Organisational Impact
Questionnaire on the organisational impact of the deployment of the Lucie™ system to be completed at the end of the study by the healthcare professionals who took part.
Measured: From the end of inclusion to one year after CER publication, assessed to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start15 Oct 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Home Habilis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640270
- Sponsor's protocol ID
- PERF-LUCIE
- Acronym
- PERF-LUCIE
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PERFormances of a Bioelectrical Impedancemetry Device (Lucie™), for the Measurement of Hydration Parameters in Patients with Renal Failure: a Multicentre Comparative Study
- ClinicalTrials.gov ID
- NCT06640270
- Acronym / sponsor ID
- PERF-LUCIE / PERF-LUCIE
- Conditions
- Diabetes
- Keywords
- bioimpedance, concordance, hydration match, overhydration, Total Body Water, Extra Cellular Water, Intra Cellular Water, hydration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Home HabilisIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the observatory study is to evaluate the performance of the Lucie™ medical device for measuring water balance before and after dialysis (water overload, dry weight) in patients with chronic renal failure. We will compare the results and performance of the device with the reference device in nephrology: the BCM®. This comparison is based on bioimpedance. Bioimpedance is an effective technology for monitoring hydration if used regularly, and will give you greater autonomy in your home monitoring. It competes with other technologies that we have found to be less effective. This is what clinical research is seeking to demonstrate: only a clinical study can verify the reliability of this hypothesis. The aim is to help Lucie technology mature so that it can detect early signs of fluid overload, and ultimately prevent complications or hospitalisation.
The process is as follow:
- After removing their shoes and socks, the patient will be invited to step onto the scale;
- Patient will insert a personal card into the card reader and place his right hand loosely on the LucieTM handle, keeping a natural posture;
- The device will take measurements for 45 seconds under the nurse\'s supervision;
- Patient will go down Lucie and will answer a short form;
- The device is cleaned after each use For optimum results, we recommand patients to keep their feet dry and their hands clean (without cream), and we recommend them to remove their jewellery, to keep their smartphones away from the device (to avoid interference), and to wear a minimum of nylon-free clothing, with empty pockets.
In practical terms, patients are familiar with monitoring their fluid overload using the Fresinus BCM® bathroom scale. They already use it as part of their clinical routine when entering and leaving the dialysis room. This BCM® is used at the start of the dialysis session, before the session begins, by a nurse trained by the manufacturer in its use: he or she knows how to place the electrodes and read the results for status and fluid overload. The nurse also takes patients\' usual vital signs (blood pressure, temperature) and notes any incidents during the dialysis session (low blood pressure, cramps, headaches, nausea, etc.) in line with standard practice.
With Lucie™
Detailed description
The goal of this observational study is to evaluate the performance of the Lucie™ medical device for the measurement of pre-dialytic hyperhydration by bioimpedance (water volume in L) in groups of patients with renal failure, compared with the reference device, the BCM. The main question its aimed to answer is
The primary hypothesis will be to determine the degree of agreement between the BMC measure of pre-dialytic hyperhydration and Lucie\'s water balance (volume (L)).
Participants will do the following tasks :
- Patients weigh themselves on entering the dialysis room to find out their total weight and have it checked by the nurse (routine care) with a scale that complies with weighing standard NF EN 45501:2015 and Directive 2014/31/EU;
- Patients weigh themselves with Lucie™ and complete a bio-impedance measurement cycle in 45 seconds (interventional research);
- A nurse measures the blood pressure on the cuff (CE medical mark), standing and lying down, and determines the ultrafiltration for the dialysis session to be entered on the machine (routine care). She records the pre-dialysis information;
- The nurse performs a bio-impedance measurement with the BCM™ reference device from Fresenius Medical Care and records measurements of hyperhydration - or overhydration (OH) -, extracellular water (ECW), total body water (TBW), the ECW/TBW ratio, the E/I ratio (deep breathing test), the OH/ECW ratio (interventional research);
- Patients begin their dialysis session (routine care);
- The nurse records blood pressure, standing and lying down, after the dialysis session and records post-dialysis information and lists any undesirable events during the dialysis session (e.g. cramps, low blood pressure, headaches, etc.);
- Patients are weighed on leaving the dialysis room to check that they are achieving the prescribed target weight (routine care);
- Patients weigh themselves with Lucie™ and complete a cycle of bioimpedance measurements in 45 seconds under the control of a nurse (interventional research).
- Patients weigh themselves a second time with the Lucie™ device and again complete one cycle of bio-impedance measurement in 45 seconds without nurse supervision (interventional research, the aim of which here is to measure inter-operator reliability).
- No bio-impedance measurement by the BCM™ device after the dialysis session given the difficulty of devoting an extra 30 minutes to patients to carry out a second measurement;
- Lucie™ device surfaces are cleaned according to the procedure provided.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main Arm for PREF-Lucie | Experimental | Device: Diabetes TreatmentInterventional, quasi-experimental, multicentre, comparative clinical research study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients age : 18 years min
- Weight minor than 125 kg
- must be able to read
- able to get on and off a bathroom scale, with or without assistance;
- Patient able to stand in balance for 45 seconds with support, alone and barefoot.
Key exclusion criteria (9 listed)
- persons with vulnerabilities : pregnant women, nursing mothers, persons deprived of their liberty, adults under legal protection, persons in emergency situations (art. L. 1121-5 to 8 and L.1122-1-2 of the Public Health Code)
- patient with an open wound on the extremities (palms and soles of the feet in contact with the device);
- Patient with an electronic cardiac implant;
- An amputee, with or without a prosthesis;
- Patients with paralysis, even partial paralysis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetes TreatmentLucie™ is an innovative medical device for measurement by bio-impedancemetry. It has been developed specifically to meet medical needs in nephrology. The aim of the study is to compare its performance with a reference device validated in nephrology nephrology, the Body Composition Monitor® (BCM) from Fresenius. | Device | Main Arm for PREF-Lucie |
Primary outcome
Hydratation parameters
Time frame: Through study completion (2 months)
Extra Cellular Water (ECW), Total Body Water (TBW), Intra Cellular Water (ICW) ; the agreement of the variation before and after dialysis with Lucie™ of the hydration parameters (ECW, ICW, ECW/ICW, OH/ECW, TBW) and the actual ultrafiltration of the session displayed on the generator (UF). This measure will help to calculate Bioimpedance measure.
Concordance of Hydration parameters (%)
Time frame: Through study completion (2 months)
Concordance of hydration parameters (OH/ECW (%) (Over Hydration) to Extra Cellular Water), ECW/ICW (%) (Extra Cellular Water to Intra Cellular Water) between the 2 medical devices (Lucie™ and BCM® reference device), as well as sensitivity, specificity, positive predictive value, negative predictive value by Lucie™ medical device.
5 secondary outcomes
Weight Measures
Time frame: Through study completion (2 months)
Skin/eat Temperature Agreement
Time frame: Through study completion (2 months)
Satisfactiory Questionnaire
Time frame: Through study publication (4 months)
Medico-economic Impact
Time frame: From the end of inclusion to one year after CER publication, assessed to 16 months
Organisational Impact
Time frame: From the end of inclusion to one year after CER publication, assessed to 16 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- General website of the SponsorLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes Treatment in people with Diabetes, run by Home Habilis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julien Gautier, CEO and Founder (+336 51 53 61 01, julien.gautier@home-habilis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydratation parameters (time frame: Through study completion (2 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.