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| Name | Class |
|---|---|
| University Hospital, Montpellier | OTHER |
| Alès Hospital | UNKNOWN |
| Bagnols sur Cèze Hospital | UNKNOWN |
| Sète Hospital |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Alès | Alès | 30100 | France | |||
| CH de Bagnols sur Cèze |
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| UNKNOWN |
| Narbonne Hospital | OTHER |
| Béziers Hospital | UNKNOWN |
| Perpignan Hospital Center | OTHER |
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.
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|
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) |
| 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) |
| Bagnols-sur-Cèze |
| France |
| CH de Beziers | Béziers | 34525 | France |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | France |
| CH de Narbonne HÔTEL DIEU | Narbonne | 11108 | France |
| Centre Hospitalier Saint Jean | Perpignan | 66000 | France |
| Hopital St Clair Hbt Sete | Sète | 34207 | France |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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