Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events (ITINERANCE)

The goal of this clinical study is to establish if the use of public health-related messages, designed and disseminated to a targeted population, will result in tangible improvements in patient outcomes and healthcare practices.

Specific health-related messages oriented towards patients, through their biological results and HealthCare Professionals (HCPs), will be sent to participants included in the intervention group. The control group will not receive any health-related message (routine care).

The aim is to evaluate if this intervention leads to differences in Major Adverse Renal and Cardiovascular Events (MARCE), compared to routine care (no dissemination of health messages) in patients suffering in diabetes and renal failure.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes; Renal Failure , Chronic
• Intervention / Treatment: Other: Health-related messages

• Study Type: Interventional
• Enrollment (Estimated): 125000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Samy Hadjadj, PU-PH; Phone Number: +33244768545 +33244768545; Email: samy.hadjadj@univ-nantes.fr
• Study Contact Backup: Name: Sonia Brinet; Phone Number: +33253526126; Email: sonia.brinet@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44000
    • Biogroup laboratories
    • Contact: Claire Vignault, MD; Phone Number: 0645644018; Email: claire.vignault@biogroup.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Main inclusion criteria:

• Subject attending a ML participating to the study
• Subject presenting a HbA1c ≥ 6.5% and an estimated GFR (CKD-EPI formula) in the range 60 to 15 ml/min (included) and/or albumin to creatinine ratio ≥ 300 mg albumin/g creatinine (or 30 mg/mmol creatinine), on the same biological determination.

Main exclusion criteria:

• Subject previously identified as opposed to the use of their medical data and/or access of their SNDS data,
• Subject not registered to the French social security system,
• Subject with estimated GFR < 15 ml/min on the day of inclusion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: health-related arm; Participants will receive an health-related message included in the biological results form. A short graphical illustration will indicate the patient-risk level according the biological results and video detailing national recommendations. HCPs will receive a SIGNAL BIO message which was elaborated on evidence-based treatments and/or strategy for patients with diabetes.	Other: Health-related messages; Patient will be included in the intervention according to the laboratory's randomization arm.The intervention consists in delivering patient information messages in laboratory reports, providing access to an educational video for patients and a specific message for the prescribing physician in the intervention arm, without modifying patient care.
No Intervention: Control group; Participants will get as in the routine care, no message will be disseminated for this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major Adverse Renal and Cardiovascular Events (MARCE) occurrence	Change in Major Adverse Renal and Cardiovascular Events (MARCE) occurrence defined as a composite outcome including the following items (first occurring): All-cause death; Myocardial infarction (universal definition); Stroke (universal definition); Sustained (over 45 days) use of renal replacement therapy; Heart failure leading to hospitalization (definition by the European Society of Cardiology)	2 years after randomization and dissemination of health-related messages

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specific health outcomes	Change in specific health outcomes (separately analysed): All-cause death; Myocardial infarction; Stroke; Sustained (over 1 month) use of renal replacement therapy; Heart failure leading to hospitalization; Lower limb amputation, with special information on the site of amputation (toe, transmetatarsal, transtibial, transfemoral); Arterial revascularization in the coronary, cerebrovascular and/or lower aorta/lower limb territories; Severe diabetic retinopathy (laser procedure, eye surgery for diabetes complication and intravitreal injection associated with specific drug delivery and/or their combinations	2 years after the randomization and dissemination of health-related messages
Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology	Change in Reimbursement claims of medications of special interest and visits to general practitioners and to specialists in cardiology, nephrology and diabetology	6 months and 2 years after randomization and dissemination of health-related messages
Biological characteristics	Changes in biological results of: lipids, liver and renal functions, blood cell count, HbA1c, CRP , Blood chemistry and Blood and urine urea	2 years before and after randomization and dissemination of health-related messages
Impact on medical costs	Changes between groups: in euros of patients healthcare costs,; in type of costs (consultation, hospitalisation, etc),; in euros of the intervention impact,; in QALY of cost-effectiveness	2 years after randomization and dissemination of health-related messages

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Collaborators: Hospices Civils de Lyon; University Hospital, Toulouse; University Hospital, Tours; Santé publique France-InVS (Institut National de Veille sanitaire); Biogroup Laboratoire de biologie médicale
• Investigators: Principal Investigator: Samy Hadjadj, MD, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2032

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: June 2, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: implementation; heatlh-related message; Renal and cardiovascular event
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Metabolic Diseases; Glucose Metabolism Disorders; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Diabetes Mellitus; Renal Insufficiency, Chronic
• Other Study ID Numbers: RC25_0253; 2025-A01341-48 (Registry Identifier: IDRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No