Feasability of a Care Pathway Integrating Collaborative Tele-expertise to Prevent Recurring Hospitalisations for Diabetic Patients

NCT ID: NCT04769765

Last Updated: 2025-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-04
• Study Completion Date: 2023-05-09

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

All patients on the basic diabetic program, eligible for an individualized care pathway.

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.

Group Type: EXPERIMENTAL

Definition of the Individualized Care Pathway

Intervention Type: OTHER

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).

Interventions

Definition of the Individualized Care Pathway

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: collaborator

Alès Hospital

UNKNOWN

Sponsor Role: collaborator

Bagnols sur Cèze Hospital

UNKNOWN

Sponsor Role: collaborator

Sète Hospital

UNKNOWN

Sponsor Role: collaborator

Narbonne Hospital

OTHER

Sponsor Role: collaborator

Béziers Hospital

UNKNOWN

Sponsor Role: collaborator

Centre hospitalier de Perpignan

OTHER

Sponsor Role: collaborator

Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centre Hospitalier d'Alès

Alès, , France

CH de Bagnols sur Cèze

Bagnols-sur-Cèze, , France

CH de Beziers

Béziers, , France

Centre Hospitalier Universitaire de Montpellier

Montpellier, , France

CH de Narbonne HÔTEL DIEU

Narbonne, , France

Centre Hospitalier Saint Jean

Perpignan, , France

Hopital St Clair Hbt Sete

Sète, , France

Countries

France

Other Identifiers

ARS/2018/AMG-01

Identifier Type: -

Identifier Source: org_study_id