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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Other: telemonitoring
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring<br>Patient with type 2 diabetes randomized in telemonitoring group have a telemonitoring device with educational Tools at their home | Other: telemonitoring<br>* 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.<br>|
| Sham Comparator: Usual care<br>patient randomized in this group have a usual care | Other: Usual care<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | HbA1c will be measured at Day 0, month 1, month 3, month 6, month 9 and month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment efficacy of our program by the measure of HbA1C will |  | At month 15, month 18, month 21 and month 24 | 
| Questionnaires will be given to patients to assess the improvement of nutritional knowledge |  | At day 0 and month 24 | 
| Food inquiries will be given to patients to assess the improvement of eating habits |  | At day 0 and month 24 | 
| Questionnaires will be given to patients to assess the physical activity practice |  | At day 0 and month 24 | 
| Waist circumference will be measured to assess the body composition, BMI (Body Mass Index), |  | At day 0 and month 24 | 
| The self-monitoring blood glucose books will be copied to assess mean of blood glycaemia |  | At day 0, month 12 and month 24 | 
| A blood sample will be collected to assess lipid status |  | At day 0 and month 24 | 
| Two questionnaires will be given to patients to assess quality of life of patients |  | At day 0 and month 24 | 
| A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects |  | At month 24 | 
| For the telemonitoring arm, assessment of food behavior through meals registered with the Nutri-Educ software |  | Everytime patients use the software from Day 0 to month 24 | 
| For the telemonitoring arm, assessment of nutritional knowledge through rate of good choices playing games of Nutri-Kiosk software |  | Everytime patients use the software from Day0 to month 24 | 
| 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) |  | Every time patients use the software and the pedometer from day 0 to month 24 | 
| For the telemonitoring arm, measure of weight, fat rate and lean rate collected with the balance |  | Everytime patients use the balance from day 0 to month 24 | 
| For the telemonitoring arm, means of glycaemia collected with the self-monitoring blood glucose device |  | Everytime patients use the blood glucose device from day 0 to month 24 | 
| For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the patients with the number and time of connections and a questionnaire |  | At month 24 | 
| For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections |  | At month 24 | 
| 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 |  | At month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemonitoring, Education, Nutrition, Food behaviour, Weight, Physical activity, Glycaemia, Self-monitoring blood glucose, Telemedicine