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NCT Number: NCT01955031

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

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.

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Key information

Conditions

Type 2 Diabetes Behavior Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Toulouse, Midi-Pyrénées, 31059, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemonitoring

Other

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.

Usual Care

Other

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 outcomes

  1. 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 outcomes

  1. Assessment efficacy of our program by the measure of HbA1C will

    Time frame: At month 15, month 18, month 21 and month 24

  2. Questionnaires will be given to patients to assess the improvement of nutritional knowledge

    Time frame: At day 0 and month 24

  3. Food inquiries will be given to patients to assess the improvement of eating habits

    Time frame: At day 0 and month 24

  4. Questionnaires will be given to patients to assess the physical activity practice

    Time frame: At day 0 and month 24

  5. Waist circumference will be measured to assess the body composition, BMI (Body Mass Index),

    Time frame: At day 0 and month 24

  6. 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

  7. A blood sample will be collected to assess lipid status

    Time frame: At day 0 and month 24

  8. Two questionnaires will be given to patients to assess quality of life of patients

    Time frame: At day 0 and month 24

  9. A cost-effectiveness ratio and a markov modelisation will be realized to assess the economic aspects

    Time frame: At month 24

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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.

Acronym: EDUC@DOM

Important dates

Study start
2013
Primary completion
2016
Study completion
2019
First posted
Oct 7, 2013
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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