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Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home (EDUC@DOM)

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
telemonitoring
Usual care
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes focused on measuring Telemedicine, Telemonitoring, Education, Nutrition, Food behaviour, Weight, Physical activity, Glycaemia, Self-monitoring blood glucose

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with type 2 diabetes
  • Older than 18 years
  • With an insulin treatment or not
  • Having a glycemic impairment characterized by 6.5% <HbA1c ≤10
  • Having an active internet connection at home.
  • Accepting the terms of training, loan and use of the device
  • Benefiting from social protection system
  • Having given his/her free and informed consent and signed the consent

Exclusion Criteria:

  • Serious illness recently (<3 months) or decompensated may influence glycemic control of the patient permanently according to the judgment of the physician in charge of monitoring
  • Retinal state that does not allow optimization in equilibrium of glycaemia
  • Known severe renal impairment defined by creatinine clearance <30ml/min
  • Known hemoglobinopathy
  • Visual or intellectual resulting inability to use the remote monitoring tool according to the judgment of the physician in charge of monitoring
  • Inability to understand all or part of the software information according to the judgment of the physician in charge of monitoring
  • Subject to disabled
  • Person with severe behavioral disorders (anorexia, bulimia, ...) according to the judgment of the physician in charge of monitoring
  • Person who had, or in preparation for bariatric surgery (software nutrition education are not suitable for this type of care.)
  • Person with a medical device implanted electronic pacemakers and defibrillators with cardiac (possibility of interference with the impedance)
  • Another person involved in research including a period of ongoing exclusion to inclusion,
  • A person under legal protection
  • Subject living in institutions
  • Desire for pregnancy, pregnancy or breastfeeding

Sites / Locations

  • University Hospitals of Toulouse (Rangueil and Salies-Du-Salat)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Telemonitoring

Usual care

Arm Description

Patient with type 2 diabetes randomized in telemonitoring group have a telemonitoring device with educational Tools at their home

patient randomized in this group have a usual care

Outcomes

Primary Outcome Measures

To assess effectiveness of our telemonitoring program in Diabetes care, HbA1C assays will be compared between the two groups.The change of HbA1c between day 0, month 1,month 3, month 6, month 9 and month 12

Secondary Outcome Measures

Assessment efficacy of our program by the measure of HbA1C will
Questionnaires will be given to patients to assess the improvement of nutritional knowledge
Food inquiries will be given to patients to assess the improvement of eating habits
Questionnaires will be given to patients to assess the physical activity practice
Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),
The self-monitoring blood glucose books will be copied to assess mean of blood glycaemia
A blood sample will be collected to assess lipid status
Two questionnaires will be given to patients to assess quality of life of patients
A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects
For the telemonitoring arm, assessment of food behavior through meals registered with the Nutri-Educ software
For the telemonitoring arm, assessment of nutritional knowledge through rate of good choices playing games of Nutri-Kiosk software
For the telemonitoring arm, assessment of physical activity declared through Acti-Kiosk software and measures collected with the pedometer (number of steps, number of stairs climbed up)
For the telemonitoring arm, measure of weight, fat rate and lean rate collected with the balance
For the telemonitoring arm, means of glycaemia collected with the self-monitoring blood glucose device
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the patients with the number and time of connections and a questionnaire
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections leading to a medical decision (phone call or medical appointment) and a questionnaire

Full Information

First Posted
August 22, 2013
Last Updated
August 25, 2021
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT01955031
Brief Title
Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home
Acronym
EDUC@DOM
Official Title
Effectiveness and Cost-effectiveness Analysis of a Telemonitoring Program on Lifestyle for People With Type 2 Diabetes at Home. Study Based on a Health Network in Diabetology.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Severity of diabetes is related to the development of disabling and costly complications (12.9 billion euros in 2007). The French High Health Authority recommends a therapeutic education on lifestyle and dietary rules in first-line treatment of Type 2 Diabetes Mellitus. Despite these recommendations, patients often have difficulties to implement dietary recommendations every day. The objective of EDUC@DOM is to help people with diabetes to improve lifestyle and equilibrium of glycaemia in order to avoid or delay chronic complications of diabetes. Our main goal is to assess effectiveness of our telemonitoring program in type 2 patients' care compared to a usual care of diabetes, on the glycaemia of the patients. It is expected that our program leads to a better monitoring of health status, a greater adherence to medical and non-medical prescriptions, an empowerment of the patient, and as a consequence, a more efficient health care consumption.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Telemedicine, Telemonitoring, Education, Nutrition, Food behaviour, Weight, Physical activity, Glycaemia, Self-monitoring blood glucose

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
282 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Telemonitoring
Arm Type
Experimental
Arm Description
Patient with type 2 diabetes randomized in telemonitoring group have a telemonitoring device with educational Tools at their home
Arm Title
Usual care
Arm Type
Sham Comparator
Arm Description
patient randomized in this group have a usual care
Intervention Type
Other
Intervention Name(s)
telemonitoring
Intervention Description
A telemonitoring program with educational tools is given to people with type 2 diabetes at their home. It is composed of three softwares to improve eating habits available on touchpad, a self-monitoring blood glucose device, a balance to measure weight and fat mass, and a pedometer to evaluate physical activity. Data are securely sent and stored into a web service which delivers a synthesis to patients and health professionals.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Patients are recruited during therapeutic educational sessions or appointments by general practitioners or diabetologists who take part into the Regional Health Network in Diabetes DIAMIP. If patients accept to participate to the study and sign up the protocol consent, they are given questionnaires about nutrition, physical activity and quality of life. A dietician analyses with each patient the results of a food inquiry. Patients are randomised into two groups: one arm is trained to the telemonitoring program before receiving it at home, and the other arm follows usual care. During 12 months, the telemonitoring group uses the device. The investigators (GP or diabetologists) can use the specific secured website to follow the measured parameters and to make appropriate decisions about health care of their patient. No consultation are scheduled in advance.
Primary Outcome Measure Information:
Title
To assess effectiveness of our telemonitoring program in Diabetes care, HbA1C assays will be compared between the two groups.The change of HbA1c between day 0, month 1,month 3, month 6, month 9 and month 12
Time Frame
HbA1c will be measured at Day 0, month 1, month 3, month 6, month 9 and month 12
Secondary Outcome Measure Information:
Title
Assessment efficacy of our program by the measure of HbA1C will
Time Frame
At month 15, month 18, month 21 and month 24
Title
Questionnaires will be given to patients to assess the improvement of nutritional knowledge
Time Frame
At day 0 and month 24
Title
Food inquiries will be given to patients to assess the improvement of eating habits
Time Frame
At day 0 and month 24
Title
Questionnaires will be given to patients to assess the physical activity practice
Time Frame
At day 0 and month 24
Title
Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),
Time Frame
At day 0 and month 24
Title
The self-monitoring blood glucose books will be copied to assess mean of blood glycaemia
Time Frame
At day 0, month 12 and month 24
Title
A blood sample will be collected to assess lipid status
Time Frame
At day 0 and month 24
Title
Two questionnaires will be given to patients to assess quality of life of patients
Time Frame
At day 0 and month 24
Title
A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects
Time Frame
At month 24
Title
For the telemonitoring arm, assessment of food behavior through meals registered with the Nutri-Educ software
Time Frame
Everytime patients use the software from Day 0 to month 24
Title
For the telemonitoring arm, assessment of nutritional knowledge through rate of good choices playing games of Nutri-Kiosk software
Time Frame
Everytime patients use the software from Day0 to month 24
Title
For the telemonitoring arm, assessment of physical activity declared through Acti-Kiosk software and measures collected with the pedometer (number of steps, number of stairs climbed up)
Time Frame
Every time patients use the software and the pedometer from day 0 to month 24
Title
For the telemonitoring arm, measure of weight, fat rate and lean rate collected with the balance
Time Frame
Everytime patients use the balance from day 0 to month 24
Title
For the telemonitoring arm, means of glycaemia collected with the self-monitoring blood glucose device
Time Frame
Everytime patients use the blood glucose device from day 0 to month 24
Title
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the patients with the number and time of connections and a questionnaire
Time Frame
At month 24
Title
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections
Time Frame
At month 24
Title
For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections leading to a medical decision (phone call or medical appointment) and a questionnaire
Time Frame
At month 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with type 2 diabetes Older than 18 years With an insulin treatment or not Having a glycemic impairment characterized by 6.5% <HbA1c ≤10 Having an active internet connection at home. Accepting the terms of training, loan and use of the device Benefiting from social protection system Having given his/her free and informed consent and signed the consent Exclusion Criteria: Serious illness recently (<3 months) or decompensated may influence glycemic control of the patient permanently according to the judgment of the physician in charge of monitoring Retinal state that does not allow optimization in equilibrium of glycaemia Known severe renal impairment defined by creatinine clearance <30ml/min Known hemoglobinopathy Visual or intellectual resulting inability to use the remote monitoring tool according to the judgment of the physician in charge of monitoring Inability to understand all or part of the software information according to the judgment of the physician in charge of monitoring Subject to disabled Person with severe behavioral disorders (anorexia, bulimia, ...) according to the judgment of the physician in charge of monitoring Person who had, or in preparation for bariatric surgery (software nutrition education are not suitable for this type of care.) Person with a medical device implanted electronic pacemakers and defibrillators with cardiac (possibility of interference with the impedance) Another person involved in research including a period of ongoing exclusion to inclusion, A person under legal protection Subject living in institutions Desire for pregnancy, pregnancy or breastfeeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Christine TURNIN, MD
Organizational Affiliation
University Hospital of Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals of Toulouse (Rangueil and Salies-Du-Salat)
City
Toulouse
State/Province
Midi-Pyrénées
ZIP/Postal Code
31059
Country
France

12. IPD Sharing Statement

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http://www.sante.gouv.fr/IMG/pdf/Rapport_final_Telemedecine.pdf
Description
Simon P, Acker D. La place de la telemedicine dans l'organisation des soins. Rapport :2008

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Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home

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