Dietary Balance Assessment in Stage 4–5 Chronic Kidney Disease Patients Using URIKI, a Connected Urine Strip and In-Vitro Diagnostic Medical Device

 

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Dietary Balance Assessment in Stage 4–5 Chronic Kidney Disease Patients Using URIKI, a Connected Urine Strip and In-Vitro Diagnostic Medical Device

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Corinne
ISNARD BAGNIS
Corinne ISNARD BAGNIS corinne.bagnis@aphp.fr AP-HP et UNIREIN Tiers Lieux UNIREIN and Nephrology PARIS France *
Charly Gutierrez charly.unirein@gmail.com AP-HP et UNIREIN Tiers Lieux UNIREIN Paris France -
Johanna Tadjine johanna.tadjine@aphp.fr AP-HP Tiers Lieux UNIREIN Paris France -
Nicolas Chauveau nc.entreautre.fr Entreautre Tiers Lieux UNIREIN Montpellier France -
Olivier Marcellin olivier@innovusages.com Innovusages Company Paris France -
Craig Coutanceau craig.coutanceau@skezi.eu AP-HP SKEZI et UNIREIN Paris France -
Jean philippe Bertocchio jean-philippe.bertocchio@skezi.eu AP-HP SKEZI et UNIREIN Paris France -
Isabelle Durand Zaleski isabelle.durand-zaleski@aphp.fr AP-HP URC-Eco et UNIREIN Paris France -
Laure Guilbaud laure.guilbaud@aphp.fr AP-HP DRCI Paris France -
Thomas Levy thomas.levy@aphp.fr AP-HP DRCI Paris France -
Beatrice MBark beatrice@mobydi.org Mobydi UNIREIN Pont Audemer France -
Jan Marc Charrel francerein74@orange.fr RENIF UNIREIN Paris France -
Anne-Laure Camarroque anne.laure-camarroque@calydial.org Calydial UNIREIN Vienne France -
Jean Christophe Cau jc.cau@iki-diag.com IKI UNIREIN Bordeaux France -
 

Nutritional management is a cornerstone of nephroprotection in chronic kidney disease (CKD), yet the traditional 24-hour urine collection remains cumbersome, error-prone, and infrequently performed. As a result, dietary assessment and individualized nutritional counseling are often delayed or incomplete. URIKI is a connected urine strip designed for home use that measures ten urinary biomarkers in four minutes and automatically transmits results to both patients and healthcare professionals. This study aims to evaluate the organizational, clinical, and patient-related impacts of implementing URIKI in the nutritional management of patients with stage 4–5 CKD

A quasi-experimental, interrupted time-series (ITS) design will be used to assess changes before and after URIKI deployment within the Nephrology Department of AP-HP Sorbonne Université. Two open cohorts (100 patients each) will be compared over a 24-month period (6 months pre-intervention, 6 months post-intervention, plus analysis). Eligible participants are adults with CKD 4–5 (eGFR < 30 mL/min/1.73 m²) performing a nutritional assessment either through standard care or with URIKI. Data are collected via interoperable interfaces linking the hospital information system (Orbis), the URIKI dashboard, and the Skezia data-collection platform.
The primary endpoint is the proportion of CKD 4–5 patients achieving a complete nutritional assessment. Secondary endpoints include (1) number of complete CKD bundled payments; (2) changes in eGFR slope and proteinuria; (3) patient satisfaction and therapeutic education scores; (4) quality of work life (QWL) among dietitians; and (5) carbon footprint analysis of the care pathway.

Preliminary data from the ongoing proof-of-concept study (n ≈ 50) indicate high patient acceptability, reliable data transmission, and reduced workload for dietitians. The full study is expected to demonstrate a ≥ 15% reallocation of dietitians’ time to new patients, a higher proportion of complete CKD nutritional assessments, and improved patient engagement through real-time feedback on dietary behavior. Clinical impacts will be explored through longitudinal monitoring of kidney function decline and proteinuria.

URIKI offers a patient-centered, digital alternative to traditional 24-hour urine collection, potentially improving early detection of dietary imbalances, supporting self-management, and optimizing clinical resources. Its integration into the CKD bundled-payment program could enhance both care efficiency and quality of life for patients and professionals while reducing the environmental footprint of care pathways. Ethical compliance: The study adheres to the Declaration of Istanbul and all ethical principles governing human research, with approval from the AP-HP institutional review board.


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