NCT06640270: PERF-LUCIE

Performance Evaluation of Lucie™ for Hydration of Dialysis Patients

Not yet recruiting NA Last updated 15 October 2024

What this trial tests

NA trial testing Diabetes Treatment in Diabetes in 150 participants. Not yet recruiting.

Timeline

15 October 2024

Primary endpoint
30 December 2024

31 March 2025

Quick facts

Lead sponsor	Home Habilis
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	150
Start date	15 October 2024
Primary completion	30 December 2024
Estimated completion	31 March 2025

Drugs / interventions tested

• Diabetes Treatment — full drug profile →

Conditions studied

• Diabetes — all drugs for Diabetes →

Sponsor

Home Habilis

Who can join

18 and older, any sex, with Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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™

Publications & conference data

No peer-reviewed publications indexed yet for this trial.