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

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 .

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Definition of the Individualized Care Pathway

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anne-Marie GUEDJ, Dr; Phone Number: +33 4.66.68 33.21; Email: anne.marie.guedj@chu-nimes.fr
• Study Contact Backup: Name: Annissa MEZGARI; Phone Number: +33 4 66 68 30 52; Email: anissa.megzari@chu-nimes.fr

Study Locations

• France
  • Alès, France, 30100
    • Recruiting
    • Centre Hospitalier d'Alès
    • Contact: Ingrid JULIER, Dr.
    • Sub-Investigator: Ingrid JULIER, Dr.
  • Bagnols-sur-Cèze, France
    • Recruiting
    • CH de Bagnols sur Céze
    • Contact: Thierry SAUVEAYRE, Dr.; Email: tsauveayre@ch-bagnolssurceze.fr
    • Principal Investigator: Thierry SAUVEAYRE, Dr.
  • Béziers, France, 34525
    • Recruiting
    • CH de Béziers
    • Contact: Jean-Michel ANDRIEU, Dr.; Phone Number: +33 4.67.35.79.28; Email: Jean-michel.andrieu@ch-beziers.fr
    • Principal Investigator: Jean-Michel ANDRIEU, Dr.
    • Sub-Investigator: Frédérique CARRIE, Dr.
  • Montpellier, France
    • Recruiting
    • Centre Hospitalier Universitaire de Montpellier
    • Contact: Eric RENARD, Prof.; Email: e-renard@chu-montpellier.fr
    • Principal Investigator: Eric RENARD, Prof.
  • Narbonne cedex, France, 11108
    • Recruiting
    • CH de Narbonne HÔTEL DIEU
    • Contact: Hélène BONNAURE; Phone Number: +33 4.68.42.61.20; Email: Helene.bonnaure@ch-narbonne.fr
    • Principal Investigator: Hélène BONNAURE, Dr.
  • Perpignan, France, 66000
    • Recruiting
    • Centre Hospitalier Saint Jean
    • Contact: Muriel BENICHOU, Dr.; Email: Muriel.benichou@ch-perpignan.fr
    • Principal Investigator: Muriel BENICHOU, MD
    • Principal Investigator: Nelly-Carole MORTINIERA, MD
  • Sète, France, 34207
    • Recruiting
    • Hopital St Clair Hbt Sete
    • Contact: Alexandre FILLE, Dr.; Phone Number: 04 67 46 58 81; Email: afille@ch-bassindethau.fr
    • Principal Investigator: Alexandre FILLE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evolution of blood glucose (sugar) levels in patients benefitting from the individualized care pathway.	The rate of HbA1c will be measured as a percentage.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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).	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.	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.	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.	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.	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.)	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.	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.	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.	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.	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.	1 year (Month 12)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sex of patients	The sex of all patients' will be recorded (M/F/other).	At the inclusion visit (Month 0)
Age of patients	All patients' ages will be recorded in years.	At the inclusion visit (Month 0)
Weight of patients	All patients' weights will be recorded in kilograms.	At the inclusion visit (Month 0)
Weight of patients	All patients' weights will be recorded in kilograms.	At the second visit (Month 3)
Weight of patients	All patients' weights will be recorded in kilograms.	At the third visit (Month 6)
Weight of patients	All patients' weights will be recorded in kilograms.	At the fourth visit (Month 9)
Weight of patients	All patients' weights will be recorded in kilograms.	At the final visit (Month 12)
Height of patients	All patients' heights will be recorded in centimeters.	At the inclusion visit (Month 0)
Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the inclusion visit (Month 0)
Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the second visit (Month 3)
Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the third visit (Month 6)
Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the fourth visit (Month 9)
Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the final visit (Month 12)
Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the inclusion visit (Month 0)
Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the second visit (Month 3)
Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the third visit (Month 6)
Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the fourth visit (Month 9)
Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the final visit (Month 12)
Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the inclusion visit (Month 0)
Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the second visit (Month 3)
Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the third visit (Month 6)
Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the fourth visit (Month 9)
Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the final visit (Month 12)
Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the inclusion visit (Month 0)
Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the second visit (Month 3)
Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the third visit (Month 6)
Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the fourth visit (Month 9)
Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the final visit (Month 12)
Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the inclusion visit (Month 0)
Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 3)
Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the third visit (Month 6)
Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the final visit (Month 12)
Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the inclusion visit (Month 0)
Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 3)
Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the third visit (Month 6)
Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the final visit (Month 12)
High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 0)
High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 3)
High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the third visit (Month 6)
High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the final visit (Month 12)
Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the inclusion visit (Month 0)
Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the second visit (Month 3)
Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the third visit (Month 6)
Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the final visit (Month 12)
Treatment method	The treatment method will be recorded for all patients : injection or pump, non-insulin antidiabetics, basal or multi-injection insulin, oral anti-diabetic drugs; Dipeptidyl peptidase-4 inhibitor; glucagon-like peptide-1 analog, Statins, Beta-blockers, anti aggregation, Antibiotics: (YES/NO).	At the inclusion visit (Month 0)
Treatment method	The treatment method will be recorded for all patients : injection or pump, non-insulin antidiabetics, basal or multi-injection insulin, oral anti-diabetic drugs; Dipeptidyl peptidase-4 inhibitor; glucagon-like peptide-1 analog, Statins, Beta-blockers, anti aggregation, Antibiotics: (YES/NO).	At the second visit (Month 3)
Treatment method	The treatment method will be recorded for all patients : injection or pump, non-insulin antidiabetics, basal or multi-injection insulin, oral anti-diabetic drugs; Dipeptidyl peptidase-4 inhibitor; glucagon-like peptide-1 analog, Statins, Beta-blockers, anti aggregation, Antibiotics: (YES/NO).	At the third visit (Month 6)
Treatment method	The treatment method will be recorded for all patients : injection or pump, non-insulin antidiabetics, basal or multi-injection insulin, oral anti-diabetic drugs; Dipeptidyl peptidase-4 inhibitor; glucagon-like peptide-1 analog, Statins, Beta-blockers, anti aggregation, Antibiotics: (YES/NO).	At the fourth visit (Month 9)
Treatment method	The treatment method will be recorded for all patients : injection or pump, non-insulin antidiabetics, basal or multi-injection insulin, oral anti-diabetic drugs; Dipeptidyl peptidase-4 inhibitor; glucagon-like peptide-1 analog, Statins, Beta-blockers, anti aggregation, Antibiotics: (YES/NO).	At the final visit (Month 12)
Date of diagnosis of diabetes	For each patient, the date and the year when diabètes was first diagnosed will be recorded.	At the inclusion visit (Month 0)
Complications	The presence of any eventual complications will be noted for each patient : nephropathy, retinopathy, coronaropathy, trophic disorders, coma (YES/NO)	At the inclusion visit (Month 0)
Complications	The presence of any eventual complications will be noted for each patient : nephropathy, retinopathy, coronaropathy, trophic disorders, coma (YES/NO)	At the second visit (Month 3)
Complications	The presence of any eventual complications will be noted for each patient : nephropathy, retinopathy, coronaropathy, trophic disorders, coma (YES/NO)	At the third visit (Month 6)
Complications	The presence of any eventual complications will be noted for each patient : nephropathy, retinopathy, coronaropathy, trophic disorders, coma (YES/NO)	At the fourth visit (Month 9)
Complications	The presence of any eventual complications will be noted for each patient : nephropathy, retinopathy, coronaropathy, trophic disorders, coma (YES/NO)	At the final visit (Month 12)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Collaborators: University Hospital, Montpellier; Hospital Center, Alès; CH Bagnols sur Cèze; CH Béziers; HOPITAL ST CLAIR HBT SETE; Centre Hospitalier Saint Jean Perpignan; CH Narbonne HÔTEL DIEU

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2022
• Primary Completion (Anticipated): May 4, 2024
• Study Completion (Anticipated): May 4, 2024

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 24, 2021

Study Record Updates

• Last Update Posted (Estimate): January 26, 2023
• Last Update Submitted That Met QC Criteria: January 25, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: ARS/2018/AMG-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No