Clinical trial NCT04769765: Feasability of a Care Pathway Integrating Collaborative Tele-expertise to Prevent Recurring Hospitalisations for Diabetic Patients
Official title: Evaluation of the Feasability of a Care Pathway Integrating Collaborative Tele-expertise for the Prevention of Recurrent Hospitalisations for Patients With Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
Collaborators: name: University Hospital, Montpellier
name: Alès Hospital
name: Bagnols sur Cèze Hospital
name: Sète Hospital
name: Narbonne Hospital
name: Béziers Hospital
name: Centre hospitalier de Perpignan
First posted: 2021-02-24
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of patients eligible for the Individualized Care Pathway as well as the basic diabetic program.
timeFrame: At the end of the study period: Month 12 + 5 days
measure: 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.
timeFrame: At the end of the study period: Month 12 + 5 days
Secondary outcomes:
measure: Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
timeFrame: Month 0
measure: Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
timeFrame: Month 3
measure: Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
timeFrame: Month 6
measure: Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
timeFrame: Month 9
measure: Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.
timeFrame: Month 12
measure: Re-hospitalization rate
timeFrame: 2 years (concernining the period M0 to M12)
measure: Number of incidents of ketoacidosis
timeFrame: 2 years (Month -12 to Month 12)
measure: Number of incidents of hypoglycemia
timeFrame: 2 years (Month -12 to Month 12)
measure: Number of incidents of serious wounds
timeFrame: 2 years (Month -12 to Month 12)
measure: Number of cardiovascular accidents
timeFrame: 2 years (Month -12 to Month 12)
measure: Number of incidents of diabetic microangiopathy
timeFrame: 2 years (Month -12 to Month 12)
measure: Cost of care of diabetic patients
timeFrame: 2 years (Month -12 to Month 12)
measure: Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Number of centers involved.
timeFrame: 1 year (Month 12)
measure: Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Number of centers connected.
timeFrame: 1 year (Month 12)
measure: Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Number of participants connected.
timeFrame: 1 year (Month 12)
measure: Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise. Duration of meetings.
timeFrame: 1 year (Month 12)
measure: Logistic feasability of managing these patients (who have had at least one unscheduled hospitalization during the year) by tele-expertise.Technical difficulties.
timeFrame: 1 year (Month 12)
measure: 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.
timeFrame: 1 year (Month 12)
measure: 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.
timeFrame: 1 year (Month 12)
measure: 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.
timeFrame: 1 year (Month 12)
measure: 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.
timeFrame: 1 year (Month 12)
measure: 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.
timeFrame: 1 year (Month 12)
Other outcomes:
measure: Sex of patients
timeFrame: At the inclusion visit (Month 0)
measure: Age of patients
timeFrame: At the inclusion visit (Month 0)
measure: Weight of patients
timeFrame: At the inclusion visit (Month 0)
measure: Weight of patients
timeFrame: At the second visit (Month 3)
measure: Weight of patients
timeFrame: At the third visit (Month 6)
measure: Weight of patients
timeFrame: At the fourth visit (Month 9)
measure: Weight of patients
timeFrame: At the final visit (Month 12)
measure: Height of patients
timeFrame: At the inclusion visit (Month 0)
measure: Systolic blood pressure
timeFrame: At the inclusion visit (Month 0)
measure: Systolic blood pressure
timeFrame: At the second visit (Month 3)
measure: Systolic blood pressure
timeFrame: At the third visit (Month 6)
measure: Systolic blood pressure
timeFrame: At the fourth visit (Month 9)
measure: Systolic blood pressure
timeFrame: At the final visit (Month 12)
measure: Diastolic blood pressure
timeFrame: At the inclusion visit (Month 0)
measure: Diastolic blood pressure
timeFrame: At the second visit (Month 3)
measure: Diastolic blood pressure
timeFrame: At the third visit (Month 6)
measure: Diastolic blood pressure
timeFrame: At the fourth visit (Month 9)
measure: Diastolic blood pressure
timeFrame: At the final visit (Month 12)
measure: Blood sugar levels
timeFrame: At the inclusion visit (Month 0)
measure: Blood sugar levels
timeFrame: At the second visit (Month 3)
measure: Blood sugar levels
timeFrame: At the third visit (Month 6)
measure: Blood sugar levels
timeFrame: At the fourth visit (Month 9)
measure: Blood sugar levels
timeFrame: At the final visit (Month 12)
measure: Glomerular Filtration Rate
timeFrame: At the inclusion visit (Month 0)
measure: Glomerular Filtration Rate
timeFrame: At the second visit (Month 3)
measure: Glomerular Filtration Rate
timeFrame: At the third visit (Month 6)
measure: Glomerular Filtration Rate
timeFrame: At the fourth visit (Month 9)
measure: Glomerular Filtration Rate
timeFrame: At the final visit (Month 12)
measure: Total cholesterol
timeFrame: At the inclusion visit (Month 0)
measure: Total cholesterol
timeFrame: At the second visit (Month 3)
measure: Total cholesterol
timeFrame: At the third visit (Month 6)
measure: Total cholesterol
timeFrame: At the fourth visit (Month 9)
measure: Total cholesterol
timeFrame: At the final visit (Month 12)
measure: Low-density lipoprotein cholesterol
timeFrame: At the inclusion visit (Month 0)
measure: Low-density lipoprotein cholesterol
timeFrame: At the second visit (Month 3)
measure: Low-density lipoprotein cholesterol
timeFrame: At the third visit (Month 6)
measure: Low-density lipoprotein cholesterol
timeFrame: At the fourth visit (Month 9)
measure: Low-density lipoprotein cholesterol
timeFrame: At the final visit (Month 12)
measure: High-density lipoprotein cholesterol
timeFrame: At the second visit (Month 0)
measure: High-density lipoprotein cholesterol
timeFrame: At the second visit (Month 3)
measure: High-density lipoprotein cholesterol
timeFrame: At the third visit (Month 6)
measure: High-density lipoprotein cholesterol
timeFrame: At the fourth visit (Month 9)
measure: High-density lipoprotein cholesterol
timeFrame: At the final visit (Month 12)
measure: Triglycerides
timeFrame: At the inclusion visit (Month 0)
measure: Triglycerides
timeFrame: At the second visit (Month 3)
measure: Triglycerides
timeFrame: At the third visit (Month 6)
measure: Triglycerides
timeFrame: At the fourth visit (Month 9)
measure: Triglycerides
timeFrame: At the final visit (Month 12)
measure: Treatment method
timeFrame: At the inclusion visit (Month 0)
measure: Treatment method
timeFrame: At the second visit (Month 3)
measure: Treatment method
timeFrame: At the third visit (Month 6)
measure: Treatment method
timeFrame: At the fourth visit (Month 9)
measure: Treatment method
timeFrame: At the final visit (Month 12)
measure: Date of diagnosis of diabetes
timeFrame: At the inclusion visit (Month 0)
measure: Complications
timeFrame: At the inclusion visit (Month 0)
measure: Complications
timeFrame: At the second visit (Month 3)
measure: Complications
timeFrame: At the third visit (Month 6)
measure: Complications
timeFrame: At the fourth visit (Month 9)
measure: Complications
timeFrame: At the final visit (Month 12)
Locations:
city: Alès
country: France
facility: Centre Hospitalier d'Alès
city: Bagnols-sur-Cèze
country: France
facility: CH de Bagnols sur Cèze
city: Béziers
country: France
facility: CH de Beziers
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Narbonne cedex
country: France
facility: CH de Narbonne HÔTEL DIEU
city: Perpignan
country: France
facility: Centre Hospitalier Saint Jean
city: Sète
country: France
facility: Hopital St Clair Hbt Sete
Study officials:
References: