Clinical trial NCT01955031: Effectiveness and Cost-effectiveness of a Telemonitoring Program for Diabetic People at Home
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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Telemedicine
Telemonitoring
Education
Nutrition
Food behaviour
Weight
Physical activity
Glycaemia
Self-monitoring blood glucose
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 282
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: 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
timeFrame: HbA1c will be measured at Day 0, month 1, month 3, month 6, month 9 and month 12
Secondary outcomes:
measure: Assessment efficacy of our program by the measure of HbA1C will
timeFrame: At month 15, month 18, month 21 and month 24
measure: Questionnaires will be given to patients to assess the improvement of nutritional knowledge
timeFrame: At day 0 and month 24
measure: Food inquiries will be given to patients to assess the improvement of eating habits
timeFrame: At day 0 and month 24
measure: Questionnaires will be given to patients to assess the physical activity practice
timeFrame: At day 0 and month 24
measure: Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),
timeFrame: At day 0 and month 24
measure: The self-monitoring blood glucose books will be copied to assess mean of blood glycaemia
timeFrame: At day 0, month 12 and month 24
measure: A blood sample will be collected to assess lipid status
timeFrame: At day 0 and month 24
measure: Two questionnaires will be given to patients to assess quality of life of patients
timeFrame: At day 0 and month 24
measure: A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects
timeFrame: At month 24
measure: For the telemonitoring arm, assessment of food behavior through meals registered with the Nutri-Educ software
timeFrame: Everytime patients use the software from Day 0 to month 24
measure: For the telemonitoring arm, assessment of nutritional knowledge through rate of good choices playing games of Nutri-Kiosk software
timeFrame: Everytime patients use the software from Day0 to month 24
measure: 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)
timeFrame: Every time patients use the software and the pedometer from day 0 to month 24
measure: For the telemonitoring arm, measure of weight, fat rate and lean rate collected with the balance
timeFrame: Everytime patients use the balance from day 0 to month 24
measure: For the telemonitoring arm, means of glycaemia collected with the self-monitoring blood glucose device
timeFrame: Everytime patients use the blood glucose device from day 0 to month 24
measure: For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the patients with the number and time of connections and a questionnaire
timeFrame: At month 24
measure: For the telemonitoring arm, acceptability and satisfaction of the telemonitoring system by the health professionals with the number and time of connections
timeFrame: At month 24
measure: 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
timeFrame: At month 24
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospitals of Toulouse (Rangueil and Salies-Du-Salat)
state: Midi-Pyrénées
Study officials:
affiliation: University Hospital of Toulouse
name: Marie-Christine TURNIN, MD
role: PRINCIPAL_INVESTIGATOR
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