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

NCT04769765 | Terminated

• 1 other identifier: ARS/2018/AMG-01
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 7

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 .

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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.

  Month 0

• Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.

  Month 3

• Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.

  Month 6

• Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.

  Month 9

• Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.

  Month 12

Other Outcomes (59)

• Sex of patients

  At the inclusion visit (Month 0)

• Age of patients

  At the inclusion visit (Month 0)

• Weight of patients

  At the inclusion visit (Month 0)

Study Arms (1)

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.

Other: Definition of the Individualized Care Pathway

Interventions

Definition of the Individualized Care Pathway 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).

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetic patients hospitalized on an unscheduled basis in the diabetology department of one of the 8 study centers.
• Patients affiliated to or beneficiary of a health insurance plan.

You may not qualify if:

• Patients with significant language barrier
• Homeless patients.
• Minor patients.
• Patients under legal protection, guardianship or curatorship.
• Patient for whom it is impossible to give informed information.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead
• University Hospital, Montpellier: collaborator
• Alès Hospital: collaborator
• Bagnols sur Cèze Hospital: collaborator
• Sète Hospital: collaborator
• Narbonne Hospital: collaborator
• Béziers Hospital: collaborator
• Centre hospitalier de Perpignan: collaborator

Study Sites (7)

Centre Hospitalier d'Alès

Alès, 30100, France

Location

CH de Bagnols sur Cèze

Bagnols-sur-Cèze, France

Location

CH de Beziers

Béziers, 34525, France

Location

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Location

CH de Narbonne HÔTEL DIEU

Narbonne, 11108, France

Location

Centre Hospitalier Saint Jean

Perpignan, 66000, France

Location

Hopital St Clair Hbt Sete

Sète, 34207, France

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 24, 2021
• Study Start: May 4, 2022
• Primary Completion: October 10, 2022
• Study Completion: May 9, 2023
• Last Updated: March 10, 2025

Record last verified: 2025-03

Locations

FR (7)