DiabetesITINERANCENCT07634718
Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events
A study testing Health-related messages in people with Diabetes and Renal Failure , Chronic, run by Nantes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes, Renal Failure , Chronic
- What is being tested?
- Health-related messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125,000 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2026to Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Biogroup laboratories
Nantes, 44000
Claire Vignault, MD, 0645644018, claire.vignault@biogroup.fr
About this study
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.
- Conditions
- Diabetes, Renal Failure , Chronic
- Being tested
- Health-related messages
- Keywords
- implementation, heatlh-related message, Renal and cardiovascular event
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health-related messagesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| health-related arm | Experimental | 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. Receives: Other: Health-related messages |
| Control group | No intervention | Participants will get as in the routine care, no message will be disseminated for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years after randomization and dissemination of health-related messages
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 2 years after randomization and dissemination of health-related messages
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2029 (estimated)
- Study completionJun 2032 (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.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ITINERANCE is a controlled, multicentric, randomized cluster trial in two parallel arms. Randomization units will be Medical Laboratories (ML) sites. All ML sites will be randomized concomitantly.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 125,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hospices Civils de Lyon, University Hospital, Toulouse, University Hospital, Tours, Biogroup Laboratoire de biologie médicale, Santé publique France-InVS (Institut National de Veille sanitaire)
- Responsible party
- Sponsor
- Investigators
- Samy Hadjadj, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07634718
- Sponsor's protocol ID
- RC25_0253
- Other IDs
- 2025-A01341-48
- Acronym
- ITINERANCE
- Status last verified
- Jun 2026
- First submitted
- 18 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Trial In patieNts With rEnal failuRe and diAbetes for Major Adverse reNal and Cardiovascular Events
- ClinicalTrials.gov ID
- NCT07634718
- Acronym / sponsor ID
- ITINERANCE / RC25_0253
- Conditions
- Diabetes, Renal Failure , Chronic
- Keywords
- implementation, heatlh-related message, Renal and cardiovascular event
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 125,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- Hospices Civils de Lyon, University Hospital, Toulouse, University Hospital, Tours, Biogroup Laboratoire de biologie médicale, Santé publique France-InVS (Institut National de Veille sanitaire)
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 9 Jun 2026 (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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- ITINERANCE is a controlled, multicentric, randomized cluster trial in two parallel arms. Randomization units will be Medical Laboratories (ML) sites. All ML sites will be randomized concomitantly.
| Arm | Type | Receives |
|---|---|---|
| health-related arm | Experimental | Other: Health-related messagesParticipants 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. |
| Control group | No intervention | –Participants will get as in the routine care, no message will be disseminated for this group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Health-related messagesPatient 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. | Other | health-related arm |
Primary outcome
Major Adverse Renal and Cardiovascular Events (MARCE) occurrence
Time frame: 2 years after randomization and dissemination of health-related messages
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)
4 secondary outcomes
Specific health outcomes
Time frame: 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
Time frame: 6 months and 2 years after randomization and dissemination of health-related messages
Biological characteristics
Time frame: 2 years before and after randomization and dissemination of health-related messages
Impact on medical costs
Time frame: 2 years after randomization and dissemination of health-related messages
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Samy Hadjadj, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health-related messages in people with Diabetes and Renal Failure , Chronic, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samy Hadjadj, PU-PH (+33244768545 ext. +33244768545, samy.hadjadj@univ-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Renal and Cardiovascular Events (MARCE) occurrence (time frame: 2 years after randomization and dissemination of health-related messages). 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 9 Jun 2026.