Diabetes MellitusTELXCODIANCT04769765
Feasability of a Care Pathway Integrating Collaborative Tele-expertise to Prevent Recurring Hospitalisations for Diabetic Patients
A study testing Definition of the Individualized Care Pathway in people with Diabetes Mellitus, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.
Trial summary
Telemedicine for diabetic patients is currently based simply on remotely monitoring capillary blood glucose levels. This experimental approach remains limited to insulin-treated diabetic patients with sufficient motivation and ability to use connected devices and only considers one aspect of the care required by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Definition of the Individualized Care Pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- 4 May 2022to 9 May 2023
- 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
- Diabetic patients hospitalized on an unscheduled basis in the diabetology department of one of the 8 study centers.
- Patients with at least two unscheduled hospitalizations in less than one year (i.e. at least one other hospitalization in the last 365 days in addition to the hospitalization on the day of the pre-inclusion visit).
- Patient with diabetes for more than one year at the time of inclusion
- Patients affiliated to or beneficiary of a health insurance plan.
Who cannot join
- Patients with significant language barrier
- Homeless patients.
- Patients in a period of exclusion determined by another study.
- Minor patients.
- Patients under legal protection, guardianship or curatorship.
- Patient for whom it is impossible to give informed information.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
Centre Hospitalier d'Alès
Alès, 30100
CH de Bagnols sur Cèze
Bagnols-sur-Cèze
CH de Beziers
Béziers, 34525
Centre Hospitalier Universitaire de Montpellier
Montpellier
CH de Narbonne HÔTEL DIEU
Narbonne, 11108
Centre Hospitalier Saint Jean
Perpignan, 66000
Hopital St Clair Hbt Sete
Sète, 34207
About this study
Official title: Evaluation of the Feasability of a Care Pathway Integrating Collaborative Tele-expertise for the Prevention of Recurrent Hospitalisations for Patients With Diabetes
Telemedicine for diabetic patients is currently based simply on remotely monitoring capillary blood glucose levels. This experimental approach remains limited to insulin-treated diabetic patients with sufficient motivation and ability to use connected devices and only considers one aspect of the care required by diabetic patients. So far, telemedicine has not offered a more global approach to the therapeutic support of patients. This failing leads to recurrent hospitalizations for acute metabolic events.
This project aims to demonstrate the feasibility of an individualized care pathway based on a multidisciplinary tele-medical network on a territorial scale. This pathway will include a base program with follow-up that can be adapted and revised thanks to the regular use of collaborative tele-expertise.
The possibility of monthly multidiciplinary meetings via Tele-expertise between the different diabetes centers of the hospital groups would help to define and implement an individualized care pathway for diabetic patients hospitalized on a recurring basis (≥2 hospitalizations/year), which would be defined collegially during the multidiciplinary meetings .
Read the detailed description
Diabetes control, assessed on the level of glycated hemoglobin (HbA1c), improves complications such as microangiopathy. To reduce cardiovascular disease, better global management including an individualized care pathway is required. Inadequate care results in a high rate of re-hospitalizations during the year (approximately 15 to 20% of all diabetic patients).
So far, the only contribution of telemedicine in the context of diabetes has been the teletransmission of data from electronic monitoring logs, including insulin doses and capillary blood glucose measurements, to platforms accessible to healthcare teams (physicians and non-medical staff). Remote monitoring according to these methods can lead to asynchronous therapeutic proposals whose effectiveness on HbA1c levels has already been demonstrated and the contribution of telemonitoring has also already been validated on the improvement of certain cardiovascular risk factors.
However, this experimental approach remains limited to insulin-treated diabetic patients with sufficient capacity and motivation to use connected devices. It only considers one component of the care required by patients with diabetes.
Until now, telemedicine has not proposed a global approach to the therapeutic accompaniment of diabetic patients. Thus, recurrent hospitalizations for acute metabolic events (ketoacidosis, severe hypoglycemia) or complications related to diabetes (severe foot wounds, cardiovascular accidents, visual or renal alterations) are frequently observed.
The ambition of our project is therefore to demonstrate the feasibility of setting up an individualized care pathway that can be supported by a multidisciplinary tele-medical network on a regional level. This pathway will include a basic program and a follow-up which can be adapted and revised through regular use of collaborative tele-expertise.
- Conditions
- Diabetes Mellitus
- Being tested
- Definition of the Individualized Care Pathway
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Definition of the Individualized Care PathwayOther
Implementation of an individualized care pathway defined in concertation with a multidisciplinary tele-expertise meeting held every 3 months for one year. These multidisciplinary tele-expertise meetings will be held between each of the normal routine consultations which are part of the normal, basic diabetic program which includes a consultation with a dietitian, monitoring by a state-registered nurse and treatment prescribed by the patient's general practitioner (with or without a consultation with the clinical pharmacist).
| Study group | Role | What they receive |
|---|---|---|
| All patients on the basic diabetic program, eligible for an individualized care pathway. | Experimental | This research aims to demonstrate the feasibility of telemedicine through collaborative tele-expertise for the collegial definition of an individualized care pathway, in the context of diabetic patients with unscheduled hospitalizations repeated throughout the year (≥ 2/year). The feasibility will be assessed by the number of patients who have had at least 3 of the 4 planned follow-up visits, that is to say, who are eligible for the individualized care pathway. Receives: Other: Definition of the Individualized Care Pathway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients eligible for the Individualized Care Pathway as well as the basic diabetic program.
After the intial pre-inclusion visit, 30 days before inclusion, a multidiciplinary tele-expertise meeting will be held to decide which patients are eligible for inclusion in the individualized care pathway. The aim is to demonstrate the feasibility of telemedicine through collaborative tele-expertise for the collegial definition of an individualized care pathway, in the context of diabetic patients with unscheduled hospitalization, iteratively over the year (≥ 2/year). The feasibility will be assessed by the number of inclusions and the number of patients included who have had at least 3 of the 4 planned follow-up visits.
Measured: At the end of the study period: Month 12 + 5 days
Number of patients on the basic diabetic program, included in the study, who have completed at least three of the four scheduled follow-up visits.
This research aims to demonstrate the feasibility of telemedicine through collaborative tele-expertise for the collegial definition of an individualized care pathway, in the context of diabetic patients with unscheduled hospitalization, iteratively over the year (≥ 2/year). The feasibility will be assessed by :
The number of inclusions and the number of patients included who have completed at least 3 of the 4 planned follow-up visits.
Measured: At the end of the study period: Month 12 + 5 days
Secondary outcomes (22)
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
The rate of HbA1c will be measured as a percentage.
Measured: Month 0
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
The rate of HbA1c will be measured as a percentage.
Measured: Month 3
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
The rate of HbA1c will be measured as a percentage.
Measured: Month 6
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
The rate of HbA1c will be measured as a percentage.
Measured: Month 9
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
The rate of HbA1c will be measured as a percentage.
Measured: Month 12
Re-hospitalization rate
The SNIIRAM (Système National d'Information Inter Régimes de l'Assurance Maladie) which is the French Health Insurance database, will be used to observe the number of re-hospitalizations throughout the year. For each patient, in the database, YES or NO will be recorded to answer the question: Re-hospitalization? and, if the patient has been re-hospitalized, the number of re-hospitalizations will be noted.
Measured: 2 years (concernining the period M0 to M12)
Number of incidents of ketoacidosis
The number of serious incidents of ketoacidosis will be noted from data in the patient file.
Measured: 2 years (Month -12 to Month 12)
Number of incidents of hypoglycemia
The number of serious incidents of hypoglygemia will be noted from data in the patient file.
Measured: 2 years (Month -12 to Month 12)
Number of incidents of serious wounds
The number of serious wounds will be noted from data in the patient file.
Measured: 2 years (Month -12 to Month 12)
Number of cardiovascular accidents
The number of cardiovascular accidents will be noted from data in the patient file.
Measured: 2 years (Month -12 to Month 12)
Number of incidents of diabetic microangiopathy
The number of incidents of diabetic microangiopathy will be noted from data in the patient file.
Measured: 2 years (Month -12 to Month 12)
Cost of care of diabetic patients
The total cost of caring for these diabetic patients who have had unscheduled hospitalization(s) during the year will be measured in Euros. Expenses will include consultations, hospitalizations, drug treatments, etc.). This information will be extracted from the French Health Insurance database (SNIIRAM).
Measured: 2 years (Month -12 to Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Number of centers involved.
Number of centers involved in each multidisciplinary tele-expertise meeting.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Number of centers connected.
Number of centers connected at each multidisciplinary tele-expertise meeting.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Number of participants connected.
Number of participants per center connected at each multidisciplinary tele-expertise meeting.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Duration of meetings.
Duration of each multidisciplinary tele-expertise meeting in terms of minutes.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Technical difficulties.
Number of technical difficulties encountered at each multidisciplinary tele-expertise meeting (connection etc.)
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. New patient files per center.
Number of new patient files presented per center.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Patient follow-up files per center.
Number of patient follow-up files presented per center.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. New patient files at each meeting.
Number of new patient files presented at each multidisciplinary tele-expertise meeting.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Patient follow-up files at each meeting.
Number of patient follow-up files presented at each multidisciplinary tele-expertise meeting.
Measured: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Number of follow-up visits per patient per center.
Number of 3-monthly follow-up visits per patient per centre.
Measured: 1 year (Month 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start4 May 2022
- Primary completion10 Oct 2022
- Study completion9 May 2023
Why it stopped: * Low involvement of required centers despite positive responses to feasibility surveys * Lack of people available for each visio (2 to 3 centers present at most out of the 8 planned)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Establishment of a care pathway (basic and specific) discussed and validated via a tele-expertise pluridisciplinary meeting by the 8 centers, quarterly monitoring of the course and for one year.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Montpellier, Alès Hospital, Bagnols sur Cèze Hospital, Sète Hospital, Narbonne Hospital, Béziers Hospital, Perpignan Hospital Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769765
- Sponsor's protocol ID
- ARS/2018/AMG-01
- Acronym
- TELXCODIA
- Status last verified
- Mar 2025
- First submitted
- 23 Feb 2021
- Last updated
- 10 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasability of a Care Pathway Integrating Collaborative Tele-expertise for the Prevention of Recurrent Hospitalisations for Patients With Diabetes
- ClinicalTrials.gov ID
- NCT04769765
- Acronym / sponsor ID
- TELXCODIA / ARS/2018/AMG-01
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: * Low involvement of required centers despite positive responses to feasibility surveys * Lack of people available for each visio (2 to 3 centers present at most out of the 8 planned)
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Collaborators
- University Hospital, Montpellier, Alès Hospital, Bagnols sur Cèze Hospital, Sète Hospital, Narbonne Hospital, Béziers Hospital, Perpignan Hospital Center
- Study start
- 4 May 2022 (actual)
- Primary completion
- 10 Oct 2022 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 24 Feb 2021 (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.
Telemedicine for diabetic patients is currently based simply on remotely monitoring capillary blood glucose levels. This experimental approach remains limited to insulin-treated diabetic patients with sufficient motivation and ability to use connected devices and only considers one aspect of the care required by diabetic patients. So far, telemedicine has not offered a more global approach to the therapeutic support of patients. This failing leads to recurrent hospitalizations for acute metabolic events.
This project aims to demonstrate the feasibility of an individualized care pathway based on a multidisciplinary tele-medical network on a territorial scale. This pathway will include a base program with follow-up that can be adapted and revised thanks to the regular use of collaborative tele-expertise.
The possibility of monthly multidiciplinary meetings via Tele-expertise between the different diabetes centers of the hospital groups would help to define and implement an individualized care pathway for diabetic patients hospitalized on a recurring basis (≥2 hospitalizations/year), which would be defined collegially during the multidiciplinary meetings .
Detailed description
Diabetes control, assessed on the level of glycated hemoglobin (HbA1c), improves complications such as microangiopathy. To reduce cardiovascular disease, better global management including an individualized care pathway is required. Inadequate care results in a high rate of re-hospitalizations during the year (approximately 15 to 20% of all diabetic patients).
So far, the only contribution of telemedicine in the context of diabetes has been the teletransmission of data from electronic monitoring logs, including insulin doses and capillary blood glucose measurements, to platforms accessible to healthcare teams (physicians and non-medical staff). Remote monitoring according to these methods can lead to asynchronous therapeutic proposals whose effectiveness on HbA1c levels has already been demonstrated and the contribution of telemonitoring has also already been validated on the improvement of certain cardiovascular risk factors.
However, this experimental approach remains limited to insulin-treated diabetic patients with sufficient capacity and motivation to use connected devices. It only considers one component of the care required by patients with diabetes.
Until now, telemedicine has not proposed a global approach to the therapeutic accompaniment of diabetic patients. Thus, recurrent hospitalizations for acute metabolic events (ketoacidosis, severe hypoglycemia) or complications related to diabetes (severe foot wounds, cardiovascular accidents, visual or renal alterations) are frequently observed.
The ambition of our project is therefore to demonstrate the feasibility of setting up an individualized care pathway that can be supported by a multidisciplinary tele-medical network on a regional level. This pathway will include a basic program and a follow-up which can be adapted and revised through regular use of collaborative tele-expertise.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Establishment of a care pathway (basic and specific) discussed and validated via a tele-expertise pluridisciplinary meeting by the 8 centers, quarterly monitoring of the course and for one year.
| Arm | Type | Receives |
|---|---|---|
| All patients on the basic diabetic program, eligible for an individualized care pathway. | Experimental | Other: Definition of the Individualized Care PathwayThis research aims to demonstrate the feasibility of telemedicine through collaborative tele-expertise for the collegial definition of an individualized care pathway, in the context of diabetic patients with unscheduled hospitalizations repeated throughout the year (≥ 2/year). The feasibility will be assessed by the number of patients who have had at least 3 of the 4 planned follow-up visits, that is to say, who are eligible for the individualized care pathway. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diabetic patients hospitalized on an unscheduled basis in the diabetology department of one of the 8 study centers.
- Patients with at least two unscheduled hospitalizations in less than one year (i.e. at least one other hospitalization in the last 365 days in addition to the hospitalization on the day of the pre-inclusion visit).
- Patient with diabetes for more than one year at the time of inclusion
- Patients affiliated to or beneficiary of a health insurance plan.
Key exclusion criteria (6 listed)
- Patients with significant language barrier
- Homeless patients.
- Patients in a period of exclusion determined by another study.
- Minor patients.
- Patients under legal protection, guardianship or curatorship.
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 |
|---|---|---|
| Definition of the Individualized Care PathwayImplementation of an individualized care pathway defined in concertation with a multidisciplinary tele-expertise meeting held every 3 months for one year. These multidisciplinary tele-expertise meetings will be held between each of the normal routine consultations which are part of the normal, basic diabetic program which includes a consultation with a dietitian, monitoring by a state-registered nurse and treatment prescribed by the patient's general practitioner (with or without a consultation with the clinical pharmacist). | Other | All patients on the basic diabetic program, eligible for an individualized care pathway. |
Primary outcome
Number of patients eligible for the Individualized Care Pathway as well as the basic diabetic program.
Time frame: At the end of the study period: Month 12 + 5 days
After the intial pre-inclusion visit, 30 days before inclusion, a multidiciplinary tele-expertise meeting will be held to decide which patients are eligible for inclusion in the individualized care pathway. The aim is to demonstrate the feasibility of telemedicine through collaborative tele-expertise for the collegial definition of an individualized care pathway, in the context of diabetic patients with unscheduled hospitalization, iteratively over the year (≥ 2/year). The feasibility will be assessed by the number of inclusions and the number of patients included who have had at least 3 of the 4 planned follow-up visits.
Number of patients on the basic diabetic program, included in the study, who have completed at least three of the four scheduled follow-up visits.
Time frame: At the end of the study period: Month 12 + 5 days
This research aims to demonstrate the feasibility of telemedicine through collaborative tele-expertise for the collegial definition of an individualized care pathway, in the context of diabetic patients with unscheduled hospitalization, iteratively over the year (≥ 2/year). The feasibility will be assessed by : The number of inclusions and the number of patients included who have completed at least 3 of the 4 planned follow-up visits.
22 secondary outcomes
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
Time frame: Month 0
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
Time frame: Month 3
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
Time frame: Month 6
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
Time frame: Month 9
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
Time frame: Month 12
Re-hospitalization rate
Time frame: 2 years (concernining the period M0 to M12)
Number of incidents of ketoacidosis
Time frame: 2 years (Month -12 to Month 12)
Number of incidents of hypoglycemia
Time frame: 2 years (Month -12 to Month 12)
Number of incidents of serious wounds
Time frame: 2 years (Month -12 to Month 12)
Number of cardiovascular accidents
Time frame: 2 years (Month -12 to Month 12)
Number of incidents of diabetic microangiopathy
Time frame: 2 years (Month -12 to Month 12)
Cost of care of diabetic patients
Time frame: 2 years (Month -12 to Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Number of centers involved.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Number of centers connected.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Number of participants connected.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Duration of meetings.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Technical difficulties.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. New patient files per center.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Patient follow-up files per center.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. New patient files at each meeting.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Patient follow-up files at each meeting.
Time frame: 1 year (Month 12)
Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Number of follow-up visits per patient per center.
Time frame: 1 year (Month 12)
Results and safety
The study was stopped early (reason given: * Low involvement of required centers despite positive responses to feasibility surveys * Lack of people available for each visio (2 to 3 centers present at most out of the 8 planned)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Definition of the Individualized Care Pathway in people with Diabetes Mellitus, run by Centre Hospitalier Universitaire de Nīmes at 7 sites in France.
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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
The study was stopped early (reason given: * Low involvement of required centers despite positive responses to feasibility surveys * Lack of people available for each visio (2 to 3 centers present at most out of the 8 planned)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients eligible for the Individualized Care Pathway as well as the basic diabetic program. (time frame: At the end of the study period: Month 12 + 5 days). 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 10 Mar 2025.