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

Diabetes Mellitus Clinical Trial

— TELXCODIA  

Official title:

Evaluation of the Feasability of a Care Pathway Integrating Collaborative Tele-expertise for the Prevention of Recurrent Hospitalisations for Patients With Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04769765
• Other study ID #: ARS/2018/AMG-01
• Status: Recruiting
• Phase: N/A
• Start date: May 4, 2022
• Est. completion date: May 4, 2024

Study information

• Verified date: January 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Anne-Marie GUEDJ, Dr
• Phone: +33 4.66.68 33.21
• Email: anne.marie.guedj[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 4, 2024
• Est. primary completion date: May 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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).

Locations

Country	Name	City	State
France	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 cedex
France	Centre Hospitalier Saint Jean	Perpignan
France	Hopital St Clair Hbt Sete	Sète

Sponsors (8)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Centre Hospitalier Saint Jean Perpignan, CH Bagnols sur Cèze, CH Béziers, CH Narbonne HÔTEL DIEU, HOPITAL ST CLAIR HBT SETE, Hospital Center, Alès, University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sex of patients	The sex of all patients' will be recorded (M/F/other).	At the inclusion visit (Month 0)
Other	Age of patients	All patients' ages will be recorded in years.	At the inclusion visit (Month 0)
Other	Weight of patients	All patients' weights will be recorded in kilograms.	At the inclusion visit (Month 0)
Other	Weight of patients	All patients' weights will be recorded in kilograms.	At the second visit (Month 3)
Other	Weight of patients	All patients' weights will be recorded in kilograms.	At the third visit (Month 6)
Other	Weight of patients	All patients' weights will be recorded in kilograms.	At the fourth visit (Month 9)
Other	Weight of patients	All patients' weights will be recorded in kilograms.	At the final visit (Month 12)
Other	Height of patients	All patients' heights will be recorded in centimeters.	At the inclusion visit (Month 0)
Other	Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the inclusion visit (Month 0)
Other	Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the second visit (Month 3)
Other	Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the third visit (Month 6)
Other	Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the fourth visit (Month 9)
Other	Systolic blood pressure	Systolic blood pressure will be recorded for all patients in mmHg	At the final visit (Month 12)
Other	Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the inclusion visit (Month 0)
Other	Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the second visit (Month 3)
Other	Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the third visit (Month 6)
Other	Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the fourth visit (Month 9)
Other	Diastolic blood pressure	Diastolic blood pressure will be recorded for all patients in mmHg	At the final visit (Month 12)
Other	Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the inclusion visit (Month 0)
Other	Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the second visit (Month 3)
Other	Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the third visit (Month 6)
Other	Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the fourth visit (Month 9)
Other	Blood sugar levels	Blood sugar levels (HbA1c) will be recorded for all patients as a percentage	At the final visit (Month 12)
Other	Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the inclusion visit (Month 0)
Other	Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the second visit (Month 3)
Other	Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the third visit (Month 6)
Other	Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the fourth visit (Month 9)
Other	Glomerular Filtration Rate	Glomerular Filtration Rate will be recorded for all patients in ml/mn	At the final visit (Month 12)
Other	Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the inclusion visit (Month 0)
Other	Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 3)
Other	Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the third visit (Month 6)
Other	Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
Other	Total cholesterol	Total cholesterol will be recorded for all patients in mmol/L	At the final visit (Month 12)
Other	Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the inclusion visit (Month 0)
Other	Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 3)
Other	Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the third visit (Month 6)
Other	Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
Other	Low-density lipoprotein cholesterol	Low-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the final visit (Month 12)
Other	High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 0)
Other	High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the second visit (Month 3)
Other	High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the third visit (Month 6)
Other	High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
Other	High-density lipoprotein cholesterol	High-density lipoprotein cholesterol will be recorded for all patients in mmol/L	At the final visit (Month 12)
Other	Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the inclusion visit (Month 0)
Other	Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the second visit (Month 3)
Other	Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the third visit (Month 6)
Other	Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the fourth visit (Month 9)
Other	Triglycerides	Triglycérides will be recorded for all patients in mmol/L	At the final visit (Month 12)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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)
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)